Safety
-
Enforcement Report for April 13, 2011
April 13, 2011 11-15
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
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PRODUCT
1) Peppermint Tea leaves blended and packaged as Organic Moroccan Mint Tea packaged in 2, 5 & 10 lbs. plastic (zip lock) bags; and 30-45 lbs polyurethane bags placed in boxes. Big bulk label reads: "***sungarden tea. ***Organic Moroccan Mint***”; Item # 90215-B. Recall # F-0705-2011;
2) Peppermint Tea leaves packaged in 2, 5 & 10 lbs. plastic (zip lock) bags; and 30-45 lbs polyurethane bags placed in boxes. Big bulk label reads: "***sungarden tea. ***Organic Peppermint***”; Item#HPO-11503. Recall # F-0706-2011;
3) Peppermint Tea leaves blended and packaged as Organic Orange Ginger Mint Tea, packaged in 2, 5 & 10 lbs. plastic (zip lock) bags; and 30-45 lbs polyurethane bags placed in boxes. Big bulk label reads: "***sungarden tea. ***Organic Orange Ginger Mint***; Item # 90219-B. Recall # F-0707-2011;
4) Peppermint Tea leaves blended and packaged as Organic Sex Booster packaged in 2, 5 & 10 lbs. plastic (zip lock) bags; and 30-45 lbs polyurethane bags placed in boxes. Big bulk label reads: "***sungarden tea. ***Organic Sex Booster***; Item # JD51710. Recall # F-0708-2011;
5) Peppermint Tea leaves blended and packaged as Organic Zoe Tea packaged in 2, 5 & 10 lbs. plastic (zip lock) bags; and 30-45 lbs polyurethane bags placed in boxes. Big bulk label reads: "***sungarden tea. ***Organic Zoe***”; Item # SB1000. Recall # F-0709-2011;
6) Peppermint Tea leaves blended and packaged as Organic Rainforest Mint Green Tea packaged in 2, 5 & 10 lbs. plastic (zip lock) bags; and 30-45 lbs polyurethane bags placed in boxes. Big bulk label reads: "***sungarden tea. ***Organic Rainforest Mint Green***”; Item # IT17002. F-0710-2011;
7) Peppermint Tea leaves blended and packaged as Organic Moroccan Mint SA Blend Tea, packaged in 2, 5 & 10 lbs. plastic (zip lock) bags; and 30-45 lbs polyurethane bags placed in boxes. Big bulk label reads: "***sungarden tea. ***Organic Moroccan Mint SA Blend***”; Item # SA90215-B. Recall # F-0711-2011;
8) Peppermint Tea leaves blended and packaged as Organic Mate Citrus Buzz Tea, packaged in 2, 5 & 10 lbs. plastic (zip lock) bags; and 30-45 lbs polyurethane bags placed in boxes. Big bulk label reads: "***sungarden tea. ***Organic Mate Citrus Buzz***”, Item # TG60005. Recall # F-0712-2011;
9) Peppermint Tea leaves blended and packaged as Paromi Sweet Tea, packaged in 2, 5 & 10 lbs. plastic (zip lock) bags; and 30-45 lbs polyurethane bags placed in boxes. Big bulk label reads: "***sungarden tea. ***Paromi Sweet Tea***”. Item # PT1000. Recall # F-0713-2011;
10) Peppermint Tea leaves blended and packaged as Orange Mint Herbal Blend Tea, packaged in 2, 5 & 10 lbs. plastic (zip lock) bags; and 30-45 lbs polyurethane bags placed in boxes. Big bulk label reads: "***sungarden tea***Orange Mint Herbal Blend”. Item # 90219-B.
Recall # F-0714-2011
CODE
1) Lot # (Batch #) OMM-121510, OMM-122810, OMM-011211, 21436-OMM-021011, n/a;
2) Lot # (Batch#) AB-10-831-OPL C/S;
3) Lot # (Batch#) 6566-OGMHB-122310;
4) Lot # (Batch#) OSXBST-010611;
5) Lot # (Batch#) E1228-OZOE-010711;
6) Lot # (Batch#) E1228-ORMG-011011;
7) Lot # (Batch#) 2940-OMNT-011111, 2987-OMNT-021511;
8) Lot # (Batch#) E0124-OMCB-012811;
9) Lot # (Batch#) 88-OGSM-021011;
10) Lot # 2940-OGMHB-011111
RECALLING FIRM/MANUFACTURER
Sun Garden Specialty Tea, Inc., Alhambra, CA, by letter on March 4, 2011. Firm initiated recall is ongoing.
REASON
Organic peppermint tea leaves from Aromatics were tested positive for salmonella.
VOLUME OF PRODUCT IN COMMERCE
309.05 lbs.
DISTRIBUTION
CA, NY, WA, FL, CO, MD, AZ, and Canada
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PRODUCT
1) Granum blends the Organic Moroccan Mint tea for under a private label White Lion. There are two different package sizes: 40 Counts and 200 Counts: 1) The Organic Moroccan Mint Fine Green Tea packaged in 2 gram tea bags, 40 counts per box, and 2 boxes to a case. The box has a UPC 658535 73440 4. There is no lot code or ingredient statement for this package. The product is labeled in part: "Organic Moroccan Mint***SIR AUBREY's WHITE LION***Steep 4 to 5 minutes in boiling water.” 2) Organic Moroccan Mint teas are packaged as 400 gram bags, 200 counts per foil pouch, and 5 pouches to a case. This foil pouch does not have any UPC. The foil pouch is labeled in part: "Organic Moroccan Mint***Ingredients: OG Green tea and OG Peppermint***Net weight 14.12 oz/ 400g***Quantity: 200 ct. Recall # F-0735-2011;
2) Granum blends the Organic Ginger Snap tea for Sir Aubrey's Tea Company, Ltd. under a private label White Lion. The product is packaged in a 400 gram package. The product is labeled in part: Organic Ginger Snap***Ingredients: OG Orange Peel, OG Ginger Root, OG Peppermint***Net weight 14.12 oz/ 400g***Quantity: 200 ct. Recall # F-0736-2011
CODE
1) 1) Lot # 130112; 2) Lot # 121227
2) Lot # 130104
RECALLING FIRM/MANUFACTURER
Recalling Firm: Granum Inc., Seattle, WA, by telephone and e-mail on March 2, 2011.
Manufacturer: Sun Garden Specialty Tea, Inc., Alhambra, CA. Firm initiated recall is complete.
REASON
Products were manufactured using peppermint tea leaves recalled by Aromatics Inc. because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
187 cases (2 Boxes/40 counts/ 2 gram per case) and 20 cases (5 pouches/200 count/400 gram per case) of Organic Moroccan Mint;
20 Cases (5 pouches/200 count/400 gram per case) of Ginger Snap Tea
DISTRIBUTION
AZ
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PRODUCT
1) WheyFit Protein Natural Chocolate, Item #94-822, 5lb. & Item 94-89, 2lb. Recall # F-0737-2011;
2) WheyFit Isolate Dutch Chocolate, Item #94-944, 5lb. & Item# 94-93, 2lb. Recall # F-0738-2011;
3) NutraFit Dark Chocolate, Item #94-52, 3lb. Recall # F-0739-2011;
4) MuscleFit Chocolate Ice Cream, Item #94-323, 5lb. Recall # F-0740-2011;
5) WheyFit Isolate Strawberry Swirl, Item #94-966, 5lb. Recall # F-0741-2011;
6) WheyFit Protein Dutch Chocolate, Item #94-812, 5lb. Recall # F-0742-2011;
7) WheyFit Isolate Creamy Vanilla, Item #94-90, 2lb. Recall # F-0743-2011;
8) Protein Blend Natural Vanilla, Item #99-380, 5lb. & Item#99-3853, 5oz. Recall # F-0744-2011;
9) WheyFit Protein Strawberry Swirl, Item #94-814, 5lb. Recall # F-0745-2011;
10) MuscleFit Vanilla Ice Cream, Item #94-322 5lb. Recall # F-0746-2011;
11) MuscleFit Strawberry Ice Cream, Item #94-324 5lb. Recall # F-0747-2011;
12) WheyFit Protein Natural Vanilla, Item #94-816, 5lb. Recall # F-0748-2011;
13) NutraFit Strawberry Swirl, Item #94-54, 3lb. Recall # F-0749-2011;
14) WheyFit Protein Creamy Vanilla, Item #94-810, 5lb. Recall # F-0750-2011
CODE
1) Lot #55393;
2) Lot #54991; Lot# 55302;
3) Lot #55348;
4) Lot #55423, 55424;
5) Lot #55350;
6) Lot #55407 & 55408;
7) Lot #55349;
8) Lot #55335, 55336, 55337, 55890;
9) Lot #55397 & 55398;
10) Lot #55419;
11) Lot #55427;
12) Lot #55399;
13) Lot #55346;
14) Lot #55609
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nutrition Express Corp., Torrance, CA, by fax and e-mail on February 17, 2011.
Manufacturer: AOE International, Carson, CA. Firm initiated recall is ongoing.
REASON
The whey protein isolates used in the products has the potential to be contaminated with salmonella.
VOLUME OF PRODUCT IN COMMERCE
2,530 units total
DISTRIBUTION
Nationwide
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PRODUCT
Serrano Peppers 10 LB. (Master Carton label as: "melissa's Chile Peppers Serrano PRODUCT OF MEXICO *** (with white label) CHILE/SERRANO 10 lb Origin: MEXICO"). Recall # F-0796-2011
CODE
Lot # 69073901
RECALLING FIRM/MANUFACTURER
Recalling Firm: World Variety Produce Inc., Vernon, CA, by telephone calls on March 17, 2011 and by press released and letter on March 18, 2011.
Manufacturer: Altiza Distribuidores, Tijuana, Mexico. Firm initiated recall is complete.
REASON
The recall was initiated because the affected serrano peppers have the potential to be contaminated with salmonella.
VOLUME OF PRODUCT IN COMMERCE
300 cases
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
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PRODUCT
1) Toxic Waste brand Nuclear Sludge Cherry Chew Bar, Net wt. 0.7 oz (20 g) package, UPC 89894 81430; and 0.3 oz (8 g) package, UPC 8989481901. Imported from Pakistan. Product is an ultra sour taffy-like candy bar. Described as "hazardously" sour candy. Recall # F-0731-2011;
2) Toxic Waste brand Nuclear Sludge Sour Apple Chew Bar, Net wt. 0.7 oz (20 g) package, UPC 0 10684 81410 7; and Net wt. 0.3 oz (8 g) package, 8989481701. Imported from Pakistan. Product is an ultra sour taffy-like candy bar. Described as "hazardously" sour candy. Recall # F-0732-2011;
3) Toxic Waste brand Nuclear Sludge Blue Raspberry PLE Chew Bar, Net wt. 0.7 oz (20 g) package, UPC 89894 81420; and Net wt. 0.3 oz (8 g) package, UPC 8989481801. Imported from Pakistan. Product is an ultra sour taffy-like candy bar. Described as “hazardously” sour candy. Recall # F-0733-2011
CODE
Lot #8288A; All lots and all flavors of the product distributed from the product's inception in 2007 through January 2011.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Circle City Marketing & Distributing, Carmel, IN, by press release on January 13, 2011and January 27, 2011 and by letters beginning January 14, 2011.
Manufacturer: Asian Food Industries Ltd., Lahore, Pakistan. Firm initiated recall is ongoing.
REASON
A recent test performed by the California Department of Public Health has indicated that a lot (#8288A) of the Toxic Waste brand Nuclear Sludge Cherry Chew Bar contains elevated levels of lead (0.24 parts per million; the U.S. FDA tolerance is 0.1 ppm) that potentially could cause health problems, particularly for infants, small children, and pregnant women.
VOLUME OF PRODUCT IN COMMERCE
Undetermined
DISTRIBUTION
Nationwide, Canada, Korea, Italy, UK, Jordan, Denmark and Belgium
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PRODUCT
Toxic Waste, Short Circuits TM Bubble Gum, Amp'd Apple, Surgin Strawberry, Blackout Blue Razz, Net wt. 3.2 oz, UPC 0 89894 31001 3. Recall # F-0734-2011
CODE
Lot # 15070SC12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Circle City Marketing & Distributing, Inc., Carmel, IN, byletter on March 25, 2011.
Manufacturer: Gujranwala Food Industries (PVT) LTD, Gujranwala, Pakistan. Firm initiated recall is ongoing.
REASON
Product contains elevated levels of lead that could potentially cause health problems, particularly in infants, small children, and pregnant women.
VOLUME OF PRODUCT IN COMMERCE
132,481 units
DISTRIBUTION
Nationwide, Canada, and Switzerland
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PRODUCT
Stahl's Famous Original Bakery Belly Button Cookies, Ingredients: Butter, Semisweet Chocolate, Walnuts, Pastry Flour, Sugar, Brown Sugar, Eggs, Water, Baking Soda, Vanilla Extract, Salt. Contains Wheat, Eggs and Walnuts. Product sold in two sizes: 10 oz (283 g) and 6 oz (170 g). Recall # F-0752-2011
CODE
Fresh-by dates being recalled include: 3/4 through 4/4.
RECALLING FIRM/MANUFACTURER
JDS Bakery LLC, New Baltimore, MI, by visit on March 5, 2011. FDA initiated recall is complete.
REASON
Finished product contains soy lecithin that is not declared on labeling, and ingredients list includes butter, but does not specify milk.
VOLUME OF PRODUCT IN COMMERCE
762 - 10 oz packages; 177 - 6 oz packages
DISTRIBUTION
MI
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PRODUCT
"PIMIENTON CHORIZERO (Product of Mexico)", Item # 09-135, 55 lb Brown Paper Bag, (Note: product may also be label "Cemix COLORANTE PARA CONCRETO ROJO INTENSO LOTE: 2340023"). Recall # F-0753-2011
CODE
Lot # 2340023
RECALLING FIRM/MANUFACTURER
El Chilerito Spice Co., South El Monte, CA, by letter on February 28, 2011. Firm initiated recall is ongoing.
REASON
Undeclared color additives.
VOLUME OF PRODUCT IN COMMERCE
25,550 lbs
DISTRIBUTION
AZ, CA, CO & WA
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PRODUCT
1) Dough, Croissant, Cinnamon Swirl, Jumbo, item #9429, 72 ct. cases. Recall # F-0754-2011;
2) Dough, Croissant, Extra Large, Bistro, item #9204, 92 ct. cases. Recall # F-0755-2011;
3) Dough Croissant, Spinach & Feta, item #79350, 54 ct. cases. Recall # F-0756-2011;
4) Croissant, Butter, Curved, Sliced, Medium, item #7836, 72 ct. packages. Recall # F-0757-2011;
5) Imperial brand Croissant, Butter, Curved, item #3141, 144 ct. cases, Item # 3180, 48 ct cases. Recall # F-0758-2011;
6) Croissant, Margarine, Large, Curved, item #7842, 48 ct. cases. Recall # F-0759-2011;
7) Imperial brand Croissant, Butter, Curved, Baked, and item #3183, 120 ct. cases. Recall # F-0760-2011;
8) Dough, French Danish, Large Swirl, Bulk, item #9538, 120 ct. cases. Recall # F-0761-2011
CODE
Codes: 1011026, 1011027, 012611 and 012711
RECALLING FIRM/MANUFACTURER
Vie De France Bakery Yamazaki In, Vienna, VA, by e-mail on
REASON
Food service breakfast goods may contain foreign objects.
VOLUME OF PRODUCT IN COMMERCE
565 cases
DISTRIBUTION
FL
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III
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PRODUCT
Member's Mark, Super B Complex with Vitamin C, 300 capsules. Recall # F-0751-2011
CODE
Lot numbers: 0GN1213, Exp. 06/2012 and 0HN1728, Exp. 06/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: L. Perrigo Co., Allegan, MI, by telephone and letter on January 4, 2010.
Manufacturer: Perrigo Co., Greenville, SC. Firm initiated recall is ongoing.
REASON
Some bottles from these packaging lots may contain tablets that do not meet label claims for Pantothenic Acid and Vitamin B12.
VOLUME OF PRODUCT IN COMMERCE
13,560 bottles
DISTRIBUTION
AR
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PRODUCT
Tom's of Maine Clean and Gentle (SLS-Free) Fluoride-Free Spearmint Toothpaste, 4.7 oz tubes; UPC: 0-77326-83110-6, Stock number: 683110. Recall # F-0797-2011
CODE
Lot number: 1031UST111
RECALLING FIRM/MANUFACTURER
Tom's of Maine, Inc., Sanford, ME, by telephone or e-mail on March 2, 2011 and by letter dated March 3, 2011. Firm initiated recall is ongoing.
REASON
Mislabeled: Fluoride-Free Spearmint Toothpaste was placed in cartons which stated both "fluoride-free" and "fluoride toothpaste."
VOLUME OF PRODUCT IN COMMERCE
21,312 tubes (888 cases, 24 tubes per case)
DISTRIBUTION
CA, CO, CT, FL, GA, IA, IN, NC, NH, NJ, NV, NY, PA, SC, TX, WA, WI
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I
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PRODUCT
Actavis Fentanyl Transdermal System 25 mcg/h strength, Rx; NDC 67767-120-18. Recall # D-426-2011
CODE
Lot number 30041, Exp. 12/2011 Lot number 30049, Exp. 12/2011 Lot number 30066, Exp. 12/2011 Lot number 30096, Exp. 01/2012 Lot number 30097, Exp. 02/2012 Lot number 30123, Exp. 01/2012 Lot number 30241, Exp. 02/2012 Lot number 30256, Exp. 02/2012 Lot number 30257, Exp. 03/2012 Lot number 30258, Exp. 03/2012 Lot number 30349, Exp. 03/2012 Lot number 30350, Exp. 03/2012 Lot number 30391, Exp. 03/2012 Lot number 30392, Exp. 04/2012 Lot number 30429, Exp. 04/2012 Lot number 30430, Exp. 04/2012 Lot number 30431, Exp. 04/2012 Lot number 30517, Exp 04/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Actavis South Atlantic LLC, Sunrise, FL, by letters on October 15, 2010 and by press releases on October 21, 2010 and November 2, 2010.
Manufacturer: Corium International, Inc., Grand Rapids, MI. Firm initiated recall is ongoing.
REASON
Exceeds Dissolution Specification; high dissolution results were obtained during stability testing
VOLUME OF PRODUCT IN COMMERCE
213,768 boxes
DISTRIBUTION
Nationwide
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PRODUCT
REVIVEXXX Herbal Supplement, Extra Strength Sexual Enhancer for Men, sublingual (under tongue) - 1 tablet, UPC 8 35470 00207 8. Recall # D-427-2011
CODE
All lots with expiration dates including and prior to August 2013.
RECALLING FIRM/MANUFACTURER
Recalling Firm: EZVILLE LTD, Ronkonkoma, NY, by press release on August 6, 2010 and August 9, 2010 and by letters dated August 9, 2010.
Manufacturers: Changsha Foreign Economic Relations and Trade Corp., Changsha, Hunan, China. Firm initiated recall is ongoing.
Velocity Pharma LLC, Farmingdale, NY
REASON
Marketed Without an Approved NDA/ANDA: Product found to contain undeclared tadalafil. Tadalafil is an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making REVIVEXXX an unapproved drug.
VOLUME OF PRODUCT IN COMMERCE
3,864 blister packs
DISTRIBUTION
Nationwide and Aruba
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PRODUCT
1) Rock Hard Extreme Capsules Dietary Supplement, All Natural herbal Aphrodisiac, 1 count blister pack and 10-count bottles, UPC 7 97882 13575 2. Recall # D-428-2011;
2) Passion Coffee, Single Packets, Net weight: 17g/sachet, UPC 7 97882 00001 2. Recall # D-429-2011
CODE
1) Lot # 1152010, Exp. date: 01/13;
2) UPC only
RECALLING FIRM/MANUFACTURER
Recalling Firm: Planet Advertising Group Inc. DBA Drive Total Energy, San Diego, CA, by press release on December 31, 2010 and by letter beginning on January 11, 2011.
Manufacturer: Colman Botanicals, Inc., Margate, FL. Firm initiated recall is ongoing.
REASON
Marketed Without an Approved NDA/ANDA: product found to contain sulfoaildenafil, an analogue of sildenafil, an FDA-approved drug used in the treatment of male Erectile Dysfunction (ED), making this product an unapproved new drug.
VOLUME OF PRODUCT IN COMMERCE
3749 (3446 blister packs, 14 x 10 ea bottles, 93 packets, 7 x 10 packs)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Reversitol Dietary Supplement Capsules, 624mg proprietary blend, 60 capsules/bottle, Anti-Aromatase, Testosterone, UPC 8 5450300113 8. Recall # D-430-2011
CODE
All lot/codes mfr through 12/09
RECALLING FIRM/MANUFACTURER
Tribravus Enterprises, LLC, Vista, CA, by telephone and letter on December 10, 2009, and press release on September 16, 2010. FDA initiated recall is ongoing.
REASON
Marketed Without an Approved NDA/ANDA; product contains 6-Etioallochol-1, 4-Diene-3, 17-Dione which is a synonym of ATD. ATD is classified as an aromatase inhibitor.
VOLUME OF PRODUCT IN COMMERCE
29,758 bottles
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
Simponi (golimumab), 50 mg/0.5 mL, one single dose SmartJect autoinjector, Rx only, NDC 57894-070-02. Recall # D-417-2011
CODE
Lot #: 09D071.AC, Exp 08/11
RECALLING FIRM/MANUFACTURER
Centocor Ortho Biotech Services LLC, Malvern, PA, by letters on February 11, 2011. Firm initiated recall is ongoing.
REASON
Miscalibrated and/or Defective Delivery System; product may not deliver the full dose.
VOLUME OF PRODUCT IN COMMERCE
839 pre-filled syringes
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Lisinopril Tablets USP, 30 mg, 100 count plastic bottles, Rx only, NDC: 68180-516-01. Recall # D-418-2011
CODE
Batch No. 3104749, Exp. date: 10/13
RECALLING FIRM/MANUFACTURER
Recalling Firm: Lupin Pharmaceuticals Inc., Baltimore, MD, by letter dated February 15, 2011.
Manufacturer: Lupin Limited, Verna, Salcette, Goa, India. Firm initiated recall is ongoing.
REASON
Adulterated Presence of Foreign Tablets: Product may contain foreign tablets.
VOLUME OF PRODUCT IN COMMERCE
14,256 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
CREON (pancrelipase) Delayed Release Capsules, 6000 USP units in 12 count professional sample bottles only, NDC 0032-1206-46, Rx Only. Recall # D-420-2011
CODE
Lot numbers: 44840, 45114 and 45398
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories, Abbott Park, IL, by letter on/about December 1, 2010.
Manufacturer: Solvay Pharmaceuticals Inc., Marietta, GA. Firm initiated recall is ongoing.
REASON
Subpotent; 12 month, 18 month and 24 month stability time-points.
VOLUME OF PRODUCT IN COMMERCE
20377 12-count bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Methylprednisolone Tablets USP, 8 mg, packaged 25 tablets/bottle, Rx only; NDC 59746-002-04. Recall # D-421-2011
CODE
Lot 9P370 exp:07/11
RECALLING FIRM/MANUFACTURER
Cadista Pharmaceuticals Inc., Salisbury, MD, by email and/or telephone followed by a letter dated March 10, 2010. Firm initiated recall is complete.
REASON
Adulterated Presence of Foreign Tablets: A foreign yellow oblong Meclizine 25 mg tablet was found in a 25-count bottle of white oblong Methylprednisolone 8 mg tablets.
VOLUME OF PRODUCT IN COMMERCE
8,724 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Topiramate Tablets, 25 mg, 1000 count bottle, Rx only; NDC 0093-0155-10. Recall # D-422-2011
CODE
Lot numbers 28T033 and 28T034
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville. PA, by letters on February 23, 2011.
Manufacturer: Teva Pharmaceutical Industries, Jerusalem, Israel. Firm initiated recall is ongoing.
REASON
CGMP Deviations; Firm's laboratory investigations were not performed in accordance with the "FDA Guidance for Industry - Investigating Out-of-Specification Test Results for Pharmaceutical Production".
VOLUME OF PRODUCT IN COMMERCE
7,770 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Tjet Demonstration Kits. The kit contains: 1 needle free injection device, 5 needle free injection heads, 2 vial adapters, 1 user manual, 1 patient welcome letter, and 1 Tev-Tropin Package Insert. Recall # D-423-2011;
2) Tev-Tropin Vial Adapters, contains 10 adapters. Recall # D-424-2011
CODE
1) Lot number 000923 exp 5/2014;
2) Lot number 000924 exp 7/2014
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ferring Pharmaceuticals Inc., Parsippany, NJ, by letter on/about November 8, 2010.
Manufacturer: Minnesota Rubber and Plastics, Minneapolis, MN. Firm initiated recall is complete.
REASON
Labeled with Incorrect Expiration Date; Tjet Demonstration Kits labeled as 05/2014 (should be 4/2013); Tev-Tropin Vial Adapters labeled as 07/2014 (should be 5/2014).
VOLUME OF PRODUCT IN COMMERCE
88 kits; 736 adapters
DISTRIBUTION
MS
___________________________________
PRODUCT
Acetadote (acetylcysteine) Injection, 200mg/mL, (6g/30mL), 30 mL Sterile, Rx Only; NDC 66220-107-30. Recall # D-425-2011
CODE
Lot #: 090304, 090331, Exp 2/11; 090401 Exp 03/11; 090511, Exp 04/11; 090602, 090616, Exp 05/11.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cumberland Pharmaceuticals Inc., Nashville, TN, by letter on December 16, 2010 and press release on December 30, 2010.
Manufacturer: Bioniche, Teo, Inverin, Ireland. Firm initiated recall is ongoing.
REASON
Presence of Particulate Matter; A small number of vials were found to contain particulate matter.
VOLUME OF PRODUCT IN COMMERCE
20,670 vials
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
DynaCirc CR (isradipine) Controlled Release Tablets, 5 mg, packaged in 30 tablet bottles, Rx only; NDC 0173-0784-01. Recall # D-419-2011
CODE
Lots: 10090217 and 10097805
RECALLING FIRM/MANUFACTURER
Recalling Firm: GlaxoSmithKline Inc., Zebulon, NC, by letter on/about March 18, 2011.
Manufacturers: Patheon Pharmaceuticals Inc., Cincinnati, OH;
Novartis Consumer Health, Lincoln, NB.
Firm initiated recall is ongoing.
REASON
Failed USP dissolution test requirements.
VOLUME OF PRODUCT IN COMMERCE
24,782 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Metformin HCl Tablets USP, 500 mg, packaged in 500 count bottles, Rx only, NDC 0378-7185-05. Recall #D-431-2011;
2) Metformin HCl Tablets USP, 1000 mg, packaged in 500 count bottles, Rx only, NDC 0378-7187-05. Recall # D-432-2011
CODE
1) Lots: 1037223 EXP MAY 2012 1037224 EXP MAY 2012 1037239 EXP MAY 2012;
2) Lots: 1029953 EXP JAN 2012 1042806 EXP JUL 2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mylan Pharmaceuticals Inc., Morgantown, WV, by letter on February 8, 2011.
Manufacturer: Matrix Laboratories Limited, (Nashik FDF), Nashik, India. Firm initiated recall is ongoing.
REASON
Superpotent (Single Ingredient Drug): Pharmaceutical available by prescription only may contain oversized tablets.
VOLUME OF PRODUCT IN COMMERCE
548,601 bottles
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0945-11;
2) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0946-11;
3) Fresh Frozen Plasma. Recall # B-0947-11
CODE
1) Units: 6097140; 6097141; 6097142; 6097143; 6097144; 6097146; 6092335; 6092339; 6092342; 6092347; 6097517; 6092190; 6092198; 6520201; 6520202; 6092251; 6092253; 6092256; 6092258; 6092260; 6092262; 6089872; 6089879; 6089883; 6097435 6097442; 6097023; 6097024; 6097030; 6097031; 6097496; 6097439; 6097500; 6097502; 6097503; 6097509; 6097512; 6089081; 6089083; 6089085; 6089103; 6092584; 6092589; 6092594; 6092596; 6089140; 6090893; 6089776; 6089777; 6089778; 6092007; 6092009; 6092010; 6098255; 6098259; 6098267; 6098269; 6089243; 6089247; 6089249; 6089253; 6089277; 6089280; 6089282; 6089291; 6092011; 6092019; 6089970;6089972; 6097151; 6097153; 6097156; 6097159; 6097183; 6097187; 6097189; 8725830; 8725837; 6520228; 6520231; 6097139; 6090965; 6090968; 6092102; 6092113; 6092118; 6092121; 6089794; 6089798; 6089799; 6089803; 6089806; 6089807; 6089814; 6097422; 6097427; 6097430; 6092123; 8725838; 8725839; 8725845; 8725847; 6090131; 6090134; 6090135; 6090137; 6080979; 8715155; 8715157; 6089077; 6089080; 6092357; 6092361; 6097148; 6089296; 6089302; 6089310; 6089314; 6089316; 6089323; 6092075; 6092077; 6092080; 6092081; 6097826; 6097829; 6097836; 6097840; 6097842; 6097845; 6097433; 6098504; 6098515; 6098516; 6098518; 6092351; 6092362; 6097185; 6092338; 6092349; 6097505; 6092370; 6092373; 6092376; 6092381; 6098453; 6098457; 6089293; 6089294; 6090142; 6090143; 6090147; 6090151; 6092365; 6092379; 6098455; 6098460; 6098465; 6098469; 6098508; 6098519; 6098522; 6098043
2) Units: 6097515; 6097438; 6097499; 6520223; 6090139; 6097833; 6090145;
3) Units: 6080979; 6089085; 6089103; 6520202; 6520228; 6520235; 6097146; 6097183; 6097189; 6089296; 6089302; 6092075; 6092077; 6092080; 6092081; 6097826; 6097829; 6090893; 6089140; 6089777; 6089778; 6089970; 6089972; 6089259; 6089247; 6089249; 6089253; 6089277; 6089280; 6089282; 6089291; 6089293; 6090145; 6090147; 6097833; 6097836; 6097840; 6097842; 6097845; 6090965; 6090968; 6092113; 6092118; 6092121
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, San Francisco, CA, by telephone beginning on February 9, 2005.
Manufacturer: Blood Centers of the Pacific, Fairfield, CA. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
VOLUME OF PRODUCT IN COMMERCE
214 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Source Plasma. Recall # B-1106-11
CODE
Units: 4140336549 4140335244 4140326360 4140319388 4140316857 4140315162 4140314324 4140312793 4140312034 4140306217 4140303281 4140301556 4140299610 4140298982 4140297061 4140296061 4140293605 4140292711 4140290662 4140288348 4140287582 4140285164 4140284288 4140282657 4140281784 4140280088 4140279316 4140277506 4140276714 4140274221 4140273390 4140271198 4140270378 4140262225 4140261220 4140259152 4140257368 4140255951 4140254157 4140252520 4140251676 4140249850 4140248063 4140247122 4140244412 4140243531 4140241153 4140238312 4140235527 4140234658 4140232315 4140228898 4140226651
RECALLING FIRM/MANUFACTURER
Recalling Firm: ZLB Bioplasma Services, Boca Raton, FL, via the internet on April 25, 2008.
Manufacturer: CSL Plasma, Inc., Minneapolis, MN. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose physical examination was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
53 units
DISTRIBUTION
IL, Germany
___________________________________
PRODUCT
Source Plasma. Recall # B-1123-11
CODE
Units: 08LWIE4439; 08LWIE3890; 08LWIE0769; 08LWIC8962; 08LWIC7319; 08LWIB9388; 08LWIB6038; 08LWIB4160; 08LWIF7856; 08LWIF6271; 08LWIF4747
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services LP, Deerfield, IL, by fax on November 24, 2008.
Manufacturer: BioLife Plasma Services, L.P., Onalaska, WI. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not respond to questions regarding increased risk for vCJD, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
CA, Austria
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1152-11;
2) Recovered Plasma. Recall # B-1153-11
CODE
1) and 2) Unit: W036510116786
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Lake Charles, LA, by letter dated January 26, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Switzerland, LA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1156-11
CODE
Unit: LH19842
RECALLING FIRM/MANUFACTURER
Stanford Medical School Blood Center, Palo Alto, CA, by facsimile on May 29, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with a history of exposure to hepatitis B, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
___________________________________
PRODUCT
Source Plasma. Recall # B-1157-11
CODE
Units: 08FNDA6005, 08FNDA4822, 08FNDA3079, 08FNDA2024
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services LP, Deerfield, IL, by facsimile on April 30, 2008.
Manufacturer: BioLife Plasma Services L.P., Fargo, ND. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have an annual physical examination, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Source Plasma. Recall # B-1158-11
CODE
Units: 0650366482, 0650365932, 0650365512, 0650364894, 0650364273, 0650362543, 0650361510, 0650360908, 0650360086, 0650359368, 0650358930, 0650358307, 0650357652, 0650357320, 0650356261, 0650355254, 0650354144, 0650353838, 0650353224, 0650352575, 0650352205, 0650351582, 0650350790, 0650350309, 0650349829, 0650349434, 0650348273, 0650347729, 0650347425, 0650346792, 0650346519, 0650345739, 0650345012, 0650344455, 0650343963, 0650343436, 0650342966, 0650342459, 0650341958, 0650341431, 0650340941, 0650340215, 0650339671, 0650339363, 0650338401, 0650337834, 0650337284, 0650336715, 0650335929, 0650334968, 0650334559, 0650333957, 0650333088, 0650332335, 0650331777, 0650331243, 0650330755, 0650330262, 0650329735, 0650329201, 0650328681, 0650328159, 0650327638, 0650327124, 0650326614, 0650325571, 0650324317, 0650324172, 0650323344, 0650323143, 0650322057, 0650321726, 0650320234, 0650319902, 0650319232, 0650318920, 0650317409, 0650316357, 0650316165, 0650314837, 0650314494
RECALLING FIRM/MANUFACTURER
Recalling Firm: ZLB Bioplasma Services, Boca Raton, FL, by facsimile and electronic notification on August 27, 2008.
Manufacturer: CSL Plasma, Inc., Racine, WI. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have an annual physical examination, were distributed.
VOLUME OF PRODUCT IN COMMERCE
81 units
DISTRIBUTION
NC, Switzerland
___________________________________
PRODUCT
Source Plasma. Recall # B-1159-11
CODE
Units: 0650403384, 0650403057, 0650402385, 0650401903, 0650401413, 8810005298, 8810004757, 8810004284, 8810003697, 8810003205, 8810002725, 8810002229, 8810001735, 8810001259, 8810000732, 8810000207, 0650400425, 0650400082, 0650399478
RECALLING FIRM/MANUFACTURER
Recalling Firm: CSL Plasma, Inc., Boca Raton, FL, by facsimile and electronic notification on July 17, 2008.
Manufacturer: CSL Plasma, Inc., Racine, WI. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have an annual physical examination, were distributed.
VOLUME OF PRODUCT IN COMMERCE
19 units
DISTRIBUTION
Switzerland, IL, NC
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1160-11
CODE
Unit: 53FN56963
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake & Potomac Region, Baltimore, MD, by facsimile and e-mail on January 27, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, MD
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1163-11
CODE
Unit: W227011000186
RECALLING FIRM/MANUFACTURER
Community Blood Center of Carolinas, Charlotte, NC, by telephone on March 1, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1169-11
CODE
Unit: W036510147138
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Beaumont, TX, by letter dated March 14, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1170-11;
2) Fresh Frozen Plasma. Recall # B-1171-11;
3) Platelets Pooled Leukocytes Reduced. Recall # B-1172-11
CODE
1) and 2) Unit: W227010036024;
3) Unit: W356510001166
RECALLING FIRM/MANUFACTURER
Community Blood Center of Carolinas, Charlotte, NC, by telephone and facsimile on March 6, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NC
___________________________________
PRODUCT
1) Red Blood Cells Apheresis. Recall # B-1173-11;
2) Platelets Pheresis Leukocytes Reduced. Recall # B-1174-11
CODE
1) and 2) Unit: W050910087611
RECALLING FIRM/MANUFACTURER
HCSC-Blood Center, Bethlehem, PA, by letter dated February 17, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had sexual contact with an individual who lived in an HIV Group O risk area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA
___________________________________
PRODUCT
Red Blood Cells Apheresis Leukocytes Reduced. Recall # B-1175-11
CODE
Units: W047011031190A, W047011031190B
RECALLING FIRM/MANUFACTURER
New York Blood Center, Inc., Westbury, NY, by telephone on February 14, 2011. Firm initiated recall is complete.
REASON
Blood products, which were labeled as leukoreduced, but were not tested to verify white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY
___________________________________
PRODUCT
Red Blood Cells. Recall # B-1176-11
CODE
Units: W065611001076; W065611001078; W065611001082; W065611002860; W065611004775; W065611007746
RECALLING FIRM/MANUFACTURER
Bergen Community Regional Blood Center, Paramus, NJ, by telephone on March 9, 2011 and by facsimile on March 14, 2011. Firm initiated recall is complete.
REASON
Blood products, incorrectly labeled “leukoreduced”, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
NY, NJ
___________________________________
PRODUCT
Plasma Frozen within 24 hours (FP24). Recall # B-1180-11
CODE
Unit: 27LC87894
RECALLING FIRM/MANUFACTURER
American Red Cross, Greater Alleghenies Region, Johnstown, PA, by telephone and letter on February 10, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WV
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1181-11
CODE
Unit: W115111013858K
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Birmingham Region, Birmingham, AL, by facsimile on January 27, 2011. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
1) Fresh Frozen Plasma. Recall # B-1145-11;
2) Fresh Frozen Plasma (Apheresis). Recall # B-1146-11;
3) Cryoprecipitated AHF. Recall # B-1147-11;
4) Plasma Frozen. Recall # B-1148-11
CODE
2) Fresh Frozen Plasma (Apheresis). Recall # B-1146-11;
3) Cryoprecipitated AHF. Recall # B-1147-11;
4) Plasma Frozen. Recall # B-1148-11
CODE
1) Units: 002FE32944, 002FE51194, 002FE51197, 002FE51207, 002FE51270, 002FE51282, 002FE51298, 002FE51325, 002FK21729, 002FK21738, 002FL31503, 002FQ19407, 002FQ19409, 002FQ19411, 002FQ19412, 002FR64965, 002FR64968, 002FR64976, 002FR64992, 002FR64994, 002FV20747, 002FV20753, 002FX26331, 002FX26490, 002FX26503, 002FX26504, 002FX26510, 002FZ30303, 002GC02818, 002GC02996, 002GC02997, 002GC03114, 002GC03127, 002GC03131, 002GC03139, 002GC03191, 002GG62343, 002GG62359, 002GG62363, 002GG62391, 002GG62395, 002GG62475, 002GG62485, 002GG62510, 002GG62520, 002GG62531, 002GG62538, 002GG62540, 002GG62551, 002GG62552, 002GG62553, 002GG62576, 002GG62596, 002GG62604, 002GG62608, 002GG62632, 002GG62674, 002GG62675, 002GG62723, 002GG62724, 002GG62738, 002GG62740, 002GG62756, 002GG62757, 002GG62779, 002GG62785, 002GG62788, 002GJ15533, 002GJ15550, 002GJ15551, 002GJ15597, 002GJ15617, 002GJ15623, 002GJ15664, 002GJ15683, 002GJ15689, 002GJ15693, 002GJ15714, 002GJ15740, 002GJ15756, 002GJ15762, 002GJ15780, 002K16596, 002K16621, 002K16628, 002K16630, 002K16632, 002K16668, 002K16695, 002K16788, 002K16799, 002K16800, 002K16802, 002K16809, 002K16836, 002K16853, 002K16856, 002K16869, 002K16879, 002KH35176, 002KH35895, 002KH35900, 002KH35929, 002KH35957, 002KH35977, 002KH35987, 002KH35990, 002KH35996, 002KH36008, 002KH363017, 002KH36022, 002KH36023, 002KH36050, 002KH36079, 002KH36170, 002KH36234, 002KH36240, 002LP19970, 002LX30393, 002W 63759, 049FE20707, 049FE20708, 049FL19146, 049FL19147, 049FL19155, 049FL19229, 049FL19236, 049FM59923, 049FM59925, 049FM59930, 049FM59931, 049FM59941, 049FM59948, 049FM59955, 049FM60042, 049FM60047, 049FM60057, 049FM60061, 049GC27529, 049GC27537, 049GC27541, 049GC27807, 049GE15790, 049GE15801, 049GE15804, 049GE15833, 049GE59869, 049GE15873, 049GE15875, 049GE15886, 049GE15890, 049GE15899, 049GE15916, 049GE15917, 049GE15924, 049GE15941, 049GH19767, 049GH19768, 049GH19770, 049GH19771, 049GJ07141, 049GJ07144, 049GK25535, 049GK25553, 049GK25567, 049GW45167, 049GW45214, 049GW45217, 049GW45221, 049K78152, 049K78166, 049K78194, 049K78196, 049K78197, 049K78198, 049K78221, 049K78460, 049K78504, 049K78507, 049KE11546, 049KE11816, 049KE11819, 049KE11828, 049KE11860, 049KM21497, 049KM21499, 049KM21503, 049KM21532, 049KM21535, 049KM21541, 049KN17642, 049KN17644, 049KQ23990, 049KT20132, 049KT20135, 049KT20137, 049LF72085, 049LF72086, 049LF72087, 049LF72090, 049LG95538, 049LG95545, 049LG95572, 049LG95748, 049LG95761, 049LG95767, 049LG95768, 049LG95770, 049LG95774, 049LG95780, 049M56451, 049M 56454, 049N63390, 049N63402, 049N63403, 049N63405;
2) Units: 049GP38548, 049GP38707, 049GP38827, 049GP38916, 049GP39417, 049GP39423;
3) Units: 011FL61130, 011FL61298, 011FS62314, 011FW46790, 011FW46795, 011FW46807, 011FW46936, 011FW46939, 011FW47487, 011FW47505, 011FX20890, 011FY44641, 011FX81967, 011FX83313, 011FX83322, 011FZ83330, 011GG65606, 011GN00008, 011GN02240, 011GQ96331, 011GQ96357, 011GQ96384, 011GR95872, 011GR96787, 011GR97514, 011GR97552, 011GR97708, 011GR97718, 011GR97838, 011GW08307, 011GW82751, 011GW83432, 011GZ70592, 011GZ71910, 011KK26284, 011KK27088, 011KK27143, 011KS28411, 011KS28418, 011KS28921, 011KS28995, 011LR15102;
4) Units: 049FF66200, 049FF66211, 049FL19256, 049FL19258, 049FM59977, 049FM60107, 049FM60214, 049FM60229, 049FM60241, 049FM60245, 049FM60279, 049GE15808, 049GE15908, 049GE15909, 049GE15910, 049GE15915, 049GE15919, 049GE15937, 049GE15940, 049GE15982, 049GE16004, 049GE16006, 049GG30556, 049GH20019, 049GH20025, 049GH20026, 049GH20061, 049GH20087, 049GH20161, 049GH20163, 049GH20165, 049GH20202, 049GH20206, 049GJ06961, 049GJ06967, 049GJ06982, 049GJ06992, 049GJ07025, 049GJ07059, 049GJ07060, 049GJ07207, 049GJ07215, 049GJ07230, 049GJ07307, 049GJ07338, 049GJ07382, 049GK25519, 049GK25571, 049GK25579, 049GK25582, 049GK25663, 049GK25683, 049GK25690, 049GK25699, 049GK25736, 049GL37524, 049GL37676, 049GL37682, 049GL37698, 049GL37722, 049GL37740, 049GL37760, 049GL37762, 049GL37766, 049GL37772, 049GL37774, 049GN63387, 049GN63594, 049GN63617, 049GN63673, 049GN63686, 049GN63687, 049GN63689, 049GN63697, 049GT14443, 049GT14467, 049GT14482, 049GT14493, 049GV46661, 049GW45258, 049GW45265, 049GW45363, 049GW45402, 049GW45423, 049GW45424, 049GW45433, 049GW45434, 049GW45441, 049GW45464, 049K78203, 049K78263, 049K78266, 049K78269, 049K78279, 049K78281, 049K78409, 049K78534, 049KC24709, 049KC24716, 049KC24857, 049KC24872, 049KC24874, 049KC24877, 049KC24885, 049KC24923, 049KC24924, 049KC24926, 049KC24929, 049KC24930, 049KC24933, 049KE11555, 049KE11881, 049KE11903, 049KE11909, 049KE11939, 049KE11962, 049KE11967, 049KE11976, 049KE11984, 049KE11989, 049KE11995, 049KK10957, 049KK10978, 049KL18118, 049KL18127, 049KL18272, 049KL18274, 049KL18279, 049KL18314, 049KL18315, 049KL18320, 049KL18325, 049KL18374, 049KL18375, 049KL18379, 049KN17676, 049KN17681, 049KN17685, 049KN17697, 049KQ23900, 049KQ23903, 049KQ24016, 049KR17177, 049KR17178, 049KR17182, 049KT20140, 049LG95550, 049LG95570, 049LG95696, 049LG95882, 049LG95887, 049LG95889, 049LG95899, 049LG95905, 049LG95913, 049LG95922, 049LG95925, 049LH78544, 049LH78604, 049LJ76867, 049LL39396, 049LL39403, 049LL39404, 049LL39409, 049LL39413, 049LL39418, 049LL39424, 049LL39518, 049M56450, 049M56529, 049M56578, 049M56582, 049FF66211, 049GE15808, 049GE15910, 049GE15915, 049GE15919, 049GE15937, 049GE15940, 049GE15982, 049GH20019, 049GH20025, 049GH20026, 049GH20161, 049GE20163, 049GE20165, 049GJ07207, 049GJ07215, 049GK25571, 049GK25582, 049GK25690, 049GK25699, 049GL37524, 049GL37676, 049GL37698, 049GL37762, 049GL37766, 049GL37772, 049GL37774, 049GN63387, 049GN63617, 049GT14467, 049GW45423, 049K 78263, 049K78266, 049K78279, 049K78281, 049KC24872, 049KC24877, 049KC24885, 049KE11962, 049KE11976, 049KE11995, 049KL18274, 049KL18279, 049KL18315, 049KR17182, 049LG95550, 049LG95913, 049M 56529;
RECALLING FIRM/MANUFACTURER
American National Red Cross SW Region – HT, Tulsa, OK, by letter dated June 13, 2008. Firm initiated recall is complete.
REASON
Blood products, stored at an unacceptable temperature, and were distributed
VOLUME OF PRODUCT IN COMMERCE
484 units
DISTRIBUTION
OK, TX, TN, MO
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1161-11
CODE
Unit: 53FN56963
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake & Potomac Region, Baltimore, MD, by facsimile and e-mail on January 27, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, MD
___________________________________
PRODUCT
Red Blood Cells. Recall # B-1162-11
CODE
Units: W041510057582H, W0415100572003
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc. dba United Blood Services, Lubbock, TX, by telephone on December 28, 2010. Firm initiated recall is complete.
REASON
Blood products, collected in expired blood collection bags, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I
___________________________________
PRODUCT
Axxent Flexishield Mini To shape the beam from a low energy radiation therapy source up to 50kVp. Recall # Z-1865-2011
CODE
Lot numbers: 800218, 800239, 800240, 800321, 800334 and 800335
RECALLING FIRM/MANUFACTURER
Xoft Inc., Sunnyvale, CA, by letter dated February 3, 2011. Firm initiated recall is ongoing.
REASON
Xoft Axxent Flexishield Mini product may shed particles identified as tungsten, and may look like suspicious calcifications on follow up scans if the product was used during Intraoperative radiation therapy.
VOLUME OF PRODUCT IN COMMERCE
165 units
DISTRIBUTION
AL, CA, CO, FL, IL, MI, MO, MS, NJ, NY, OK, PA, TN, and WI
___________________________________
PRODUCT
1) Curlin 6000 CMS Ambulatory Infusion Pump Provides a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Recall # Z-1867-2011;
2) Curlin 6000 IOD Ambulatory Infusion Pump Provides a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Recall # Z-1868-2011;
3) Curlin PainSmart Ambulatory Infusion Pump Provides a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Recall # Z-1869-2011;
4) Curlin PainSmart IOD Ambulatory Infusion Pump Provides a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Recall # Z-1870-2011
CODE
1) ERROR CODE 36: 219187, 219283, 219332, 215154, 215749, 215875, 215963, 216063, 219192, 219284, 219335, 215638, 215761, 215877, 215964, 216066, 219196, 219285, 219368, 215640, 215762, 215880, 215965, 216072, 219204, 219286, 219370, 215644, 215764, 215886, 215968, 216076, 219215, 219288, 219311, 215645, 215772, 215891, 215970, 216080, 219216, 219289, 219313, 215650, 215774, 215894, 215976, 216082, 219217, 219290, 219314, 215656, 215776, 215900, 215978, 216083, 219222, 219291, 216116, 215657, 215777, 215907, 215982, 216084, 219227, 219292, 216995, 215659, 215779, 215908, 215983, 216085, 219233, 219293, 212557, 215660, 215780, 215909, 215990, 216086, 219234, 219294, 212709, 215662, 215781, 215911, 215994, 216094, 219240, 219297, 212719, 215664, 215801, 215912, 215995, 216098, 219241, 219299, 212720, 215667, 215804, 215914, 215998, 216100, 219242, 219300, 212881, 215683, 215806, 215915, 215999, 216102, 219245, 219301, 212889, 215685, 215809, 215916, 216000, 216113, 219246, 219302, 212981, 215689, 215810, 215918, 216001, 216120, 219256, 219303, 213002, 215690, 215811, 215919, 216002, 216122, 219257, 219304, 213019, 215692, 215813, 215920, 216004, 216130, 219258, 219305, 213132, 215694, 215816, 215921, 216007, 216131, 219259, 219306, 213133, 215698, 215822, 215923, 216016, 216132, 219260, 219307, 213140, 215699, 215824, 215924, 216017, 216134, 219261, 219308, 213188, 215701, 215825, 215926, 216028, 216136, 219266, 219309, 213205, 215703, 215827, 215930, 216033, 216147, 219267, 219310, 213283, 215706, 215829, 215932, 216038, 216148, 219268, 219316, 213298, 215707, 215832, 215933, 216039, 216149, 219270, 219317, 213419, 215710, 215833, 215936, 216042, 216152, 219271, 219319, 214407, 215713, 215836, 215938, 216044, 216155, 219272, 219320, 214421, 215721, 215837, 215939, 216047, 216157, 219273, 219321, 214482, 215722, 215843, 215949, 216048, 216159, 219274, 219322, 214486, 215725, 215846, 215950, 216050, 216162, 219275, 219323, 215023, 215729, 215847, 215953, 216051, 216164, 219276, 219324, 215024, 215733, 215849, 215954, 216052, 216166, 219277, 219325, 215025, 215735, 215851, 215956, 216054, 216169, 219279, 219326, 215027, 215738, 215858, 215959, 216055, 216172, 219280, 219327, 215063, 215739, 215865, 215960, 216056, 216173, 219281, 219329, 215110, 215745, 215871, 215961, 216059, 216175, 219282, 219330, 215129, 215748, 215872, 215962, 216062, 216176, 216177, 216329, 216431, 216558, 216816, 216895, 217000, 217116, 216179, 216330, 216435, 216569, 216818, 216898, 217002, 217119, 216181, 216332, 216442, 216576, 216820, 216899, 217003, 217121, 216187, 216333, 216446, 216577, 216823, 216902, 217006, 217122, 216188, 216334, 216447, 216578, 216824, 216903, 217012, 217123, 216190, 216337, 216448, 216580, 216827, 216919, 217030, 217124, 216191, 216339, 216449, 216581, 216828, 216920, 217037, 217131, 216195, 216341, 216451, 216582, 216830, 216922, 217040, 217135, 216210, 216342, 216453, 216586, 216832, 216923, 217042, 217142, 216211, 216343, 216455, 216587, 216835, 216924, 217043, 217144, 216212, 216344, 216459, 216589, 216838, 216925, 217054, 217145, 216215, 216345, 216466, 216594, 216839, 216926, 217056, 217146, 216216, 216350, 216467, 216600, 216840, 216927, 217057, 217147, 216218, 216357, 216471, 216601, 216841, 216928, 217058, 217149, 216219, 216359, 216474, 216602, 216842, 216929, 217059, 217150, 216220, 216361, 216475, 216604, 216843, 216931, 217065, 217151, 216222, 216363, 216476, 216605, 216844, 216937, 217071, 217152, 216225, 216364, 216487, 216606, 216846, 216943, 217072, 217154, 216227, 216369, 216488, 216607, 216847, 216946, 217073, 217155, 216228, 216370, 216491, 216609, 216848, 216947, 217074, 217158, 216229, 216387, 216492, 216610, 216849, 216948, 217076, 217159, 216232, 216389, 216495, 216620, 216853, 216949, 217078, 217160, 216237, 216391, 216501, 216623, 216859, 216950, 217079, 217161, 216238, 216392, 216502, 216625, 216860, 216951, 217080, 217162, 216239, 216393, 216503, 216627, 216861, 216952, 217081, 217164, 216241, 216398, 216507, 216630, 216869, 216953, 217082, 217165, 216249, 216399, 216510, 216734, 216870, 216959, 217083, 217166, 216250, 216400, 216516, 216795, 216877, 216960, 217084, 217168, 216254, 216409, 216529, 216797, 216880, 216973, 217085, 217171, 216257, 216410, 216533, 216799, 216881, 216975, 217087, 217175, 216259, 216412, 216537, 216802, 216882, 216976, 217088, 217176, 216260, 216414, 216539, 216804, 216883, 216979, 217089, 217178, 216263, 216416, 216541, 216805, 216884, 216980, 217090, 217183, 216264, 216417, 216544, 216806, 216885, 216984, 217098, 217190, 216268, 216421, 216546, 216807, 216886, 216989, 217099, 217194, 216277, 216423, 216549, 216808, 216887, 216990, 217102, 217195, 216279, 216425, 216555, 216810, 216893, 216994, 217103, 217200, 216280, 216430, 216557, 216814, 216894, 216997, 217107, 217201, 217202, 217204, 217205, 217206, 217207, 217208, 217209, 217210, 217211, 217212, 217213, 217215, 217217, 217218, 217219, 217221, 217222, 217223, 217224, 217226, 217236, 217237, 217250, 217272, 217418, 217427, 217428, 217429, 217430, 217431, 217432, 217433, 217434, 217435, 217436, 217437, 217438, 217439, 217440. ERROR CODE 45: 200249, 200262, 200959, 201690, 201829, 202387, 202388, 202406, 202410, 202420, 202447, 202493, 202601, 202789, 206002, 206005, 206006, 206172, 206890, 206906, 207742, 208968, 209630, 210000, 210218, 211334, 211588, 212010, 212038, 212134, 212175, 212186, 212274, 212275, 212276, 212278, 212282, 212283, 212284, 212286, 212288, 212289, 212292, 212293, 212295, 212299, 212301, 212302, 212320, 212321, 212322, 212324, 212325, 212328, 212447, 212448, 212450, 212452, 212453, 212454, 212456, 212457, 212458, 213844, 213916, 213958, 206504, 207223, 200173, 200176, 201019, 202380, 202433, 202437, 202461, 202467, 202585, 202700, 203026, 203043, 203044, 203055, 203056, 203058, 203061, 203062, 203063, 203067, 203069, 203070, 203167, 203170, 203172, 203173, 203183, 203185, 203186, 203201, 203220, 204606, 204615, 204678, 204701, 204703, 204707, 204709, 204710, 204716, 204722, 204730, 204731, 204732, 204739, 204743, 204744, 204749, 204754, 204768, 204771, 204773, 204775, 204779, 204786, 204795, 204796, 204801, 204812, 204814, 204903, 205012, 205123, 205634, 205635, 205637, 205641, 205649, 205651, 205654, 205655, 205656, 205658, 205659, 205660, 205661, 205668, 205677, 205687, 205722, 205728, 205736, 205737, 205740, 205745, 205832, 205833, 205846, 205848, 205850, 205851, 205852, 205861, 205863, 205866, 205877, 205883, 205886, 205893, 205895, 205911, 205915, 205916, 205919, 205926, 205928, 205930, 205933, 205952, 205973, 205974, 206014, 206042, 206052, 206056, 206057, 206060, 206067, 206073, 206078, 206128, 206136, 206140, 206141, 206144, 206145, 206156, 206163, 206164, 206165, 206204, 206217, 206218, 206223, 206225, 206243, 206245, 206253, 206254, 206257, 206258, 206262, 206264, 206267, 206272, 206273, 206275, 206293, 206295, 206296, 206302, 206306, 206307, 206318, 206319, 206320, 206321, 206327, 206328, 206335, 206346, 206370, 206381, 206396, 206415, 206428, 206430, 206449, 206464, 206465, 206487, 206489, 206492, 206493, 206506, 206512, 206513, 206515, 206518, 206521, 206529, 206531, 206533, 206546, 206551, 206558, 206560, 206568, 206570, 206571, 206578, 206579, 206580, 206583, 206584, 206585, 206586, 206598, 206599, 206600, 206602, 206603, 206608, 206609, 206610, 206611, 206617, 206628, 206629, 206631, 206632, 206637, 206642, 206644, 206645, 206646, 206647, 206648, 206651, 206653, 206658, 206659, 206665, 206671, 206672, 206674, 206675, 206680, 206689, 206692, 206695, 206696, 206699, 206703, 206710, 206712, 206714, 206717, 206723, 206730, 206733, 206736, 206737, 206741, 206742, 206743, 206748, 206753, 206754, 206756, 206757, 206759, 206761, 206762, 206763, 206769, 206775, 206776, 206783, 206784, 206791, 206795, 206797, 206800, 206801, 206805, 206812, 206823, 206826, 206838, 206845, 206848, 206849, 206850, 206859, 206862, 206874, 206876, 206877, 206879, 206880, 206882, 206883, 206886, 206887, 206889, 206891, 206895, 206896, 206897, 206899, 206902, 206909, 206911, 206920, 206921, 206926, 206927, 206928, 206930, 206934, 206937, 206941, 206943, 206945, 206946, 206947, 206948, 206950, 206951, 206954, 206955, 206956, 206957, 206959, 206962, 206967, 206970, 206982, 206991, 206992, 206993, 206996, 207001, 207003, 207006, 207007, 207008, 207018, 207019, 207024, 207026, 207036, 207037, 207038, 207039, 207040, 207042, 207044, 207045, 207046, 207047, 207048, 207049, 207051, 207052, 207055, 207056, 207057, 207059, 207061, 207066, 207067, 207072, 207076, 207093, 207096, 207097, 207101, 207102, 207103, 207109, 207110, 207112, 207114, 207116, 207132, 207133, 207135, 207136, 207137, 207140, 207145, 207152, 207154, 207164, 207165, 207168, 207170, 207171, 207172, 207173, 207191, 207194, 207196, 207197, 207198, 207200, 207205, 207219, 207242, 207249, 207250, 207296, 207315, 207316, 207328, 207331, 207370, 207373, 207375, 207376, 207377, 207378, 207382, 207383, 207385, 207386, 207387, 207398, 207461, 207462, 207466, 207468, 207470, 207501, 207502, 207503, 207506, 207508, 207516, 207518, 207564, 207565, 207566, 207567, 207568, 207571, 207572, 207575, 207580, 207594, 207597, 207601, 207621, 207622, 207624, 207625, 207626, 207635, 207636, 207639, 207643, 207644, 207645, 207710, 207711, 207712, 207713, 207714, 207715, 207716, 207717, 207718, 207743, 207744, 207745, 207748, 207749, 207750, 207751, 207752, 207753, 207755, 207756, 207783, 207799, 207800, 207801, 207802, 207803, 207805, 207809, 207814, 207907, 207908, 207909, 207910, 207911, 207912, 207913, 207921, 207963, 207972, 207996, 207997, 208002, 208029, 208045, 208085, 208089, 208096, 208105, 208122, 208143, 208144, 208146, 208148, 208149, 208216, 208217, 208235, 208239, 208240, 208241, 208245, 208274, 208275, 208279, 208280, 208281, 208290, 208291, 208292, 208293, 208338, 208339, 208342, 208343, 208344, 208345, 208400, 208485, 208552, 208632, 208665, 208701, 208720, 208809, 208832, 208833, 208834, 208835, 208836, 208837, 208840, 208865, 208868, 208875, 208885, 208919, 208920, 208921, 208922, 208924, 208925, 208926, 208927, 208928, 208929, 208930, 208931, 208932, 208942, 208943, 208944, 208945, 208946, 208947, 208948, 208949, 208950, 208952, 208953, 208954, 208955, 208956, 208957, 208958, 208959, 208960, 208962, 208963, 208964, 208965, 208966, 208967, 208969, 208970, 208971, 208973, 208977, 208980, 208981, 208982, 208985, 208987, 208988, 208989, 208991, 208993, 208994, 208995, 208996, 208997, 208998, 208999, 209008, 209010, 209012, 209013, 209014, 209015, 209082, 209156, 209327, 209453, 209482, 209489, 209510, 209511, 209513, 209514, 209516, 209517, 209518, 209520, 209523, 209524, 209525, 209534, 209541, 209542, 209543, 209544, 209546, 209549, 209550, 209551, 209552, 209553, 209554, 209555, 209556, 209558, 209559, 209560, 209561, 209562, 209563, 209564, 209565, 209566, 209568, 209569, 209570, 209571, 209572, 209573, 209574, 209575, 209576, 209588, 209595, 209596, 209597, 209598, 209599, 209600, 209601, 209602, 209604, 209606, 209607, 209608, 209609, 209610, 209619, 209620, 209621, 209623, 209628, 209629, 209631, 209632, 209633, 209639, 209644, 209645, 209647, 209648, 209649, 209650, 209651, 209681, 209692, 209705, 209717, 209719, 209720, 209721, 209722, 209723, 209725, 209726, 209727, 209728, 209730, 209731, 209732, 209741, 209742, 209744, 209746, 209750, 209751, 209762, 209772, 209773, 209774, 209779, 209792, 209794, 209795, 209801, 209813, 209814, 209815, 209828, 209842, 209848, 209853, 209855, 209870, 209882, 209883, 209884, 209885, 209886, 209887, 209888, 209889, 209890, 209892, 209893, 209895, 209896, 209897, 209900, 209901, 209902, 209903, 209905, 209907, 209908, 209909, 209910, 209912, 209915, 209917, 209918, 209920, 209921, 209923, 209928, 209929, 209930, 209931, 209932, 209933, 209935, 209936, 209937, 209938, 209939, 209940, 209942, 209943, 209944, 209946, 209947, 209948, 209949, 209950, 209951, 209952, 209953, 209954, 209956, 209957, 209958, 209959, 209960, 209961, 209962, 209963, 209964, 209966, 209967, 209968, 209969, 209970, 209971, 209972, 209973, 209974, 209976, 209977, 209978, 209979, 209981, 209982, 209983, 209984, 209985, 209988, 209989, 209991, 209993, 209994, 209995, 209996, 209997, 209998, 210001, 210002, 210003, 210004, 210005, 210006, 210007, 210010, 210011, 210015, 210016, 210018, 210032, 210038, 210046, 210145, 210146, 210147, 210151, 210154, 210155, 210156, 210157, 210158, 210159, 210160, 210161, 210163, 210164, 210165, 210166, 210182, 210184, 210187, 210192, 210233, 210267, 210268, 210269, 210270, 210296, 210297, 210298, 210299, 210300, 210302, 210318, 210334, 210335, 210337, 210341, 210349, 210361, 210383, 210386, 210389, 210407, 210412, 210428, 210504, 210519, 210531, 210546, 210588, 210606, 210627, 210629, 210644, 210646, 210657, 210660, 210671, 210689, 210698, 210699, 210731, 210733, 210734, 210735, 210736, 210737, 210743, 210764, 210770, 210776, 210778, 210782, 210784, 210790, 210793, 210818, 210842, 210846, 210847, 210848, 210849, 210850, 210851, 210852, 210855, 210856, 210896, 210924, 210925, 210927, 210932, 210933, 210968, 210974, 210975, 210976, 210977, 210978, 210979, 210982, 210983, 210997, 211002, 211015, 211019, 211020, 211021, 211022, 211023, 211024, 211025, 211028, 211029, 211030, 211031, 211032, 211033, 211034, 211043, 211044, 211046, 211047, 211048, 211049, 211050, 211052, 211053, 211054, 211055, 211057, 211058, 211059, 211060, 211061, 211062, 211063, 211064, 211065, 211074, 211075, 211076, 211078, 211079, 211080, 211081, 211082, 211083, 211085, 211086, 211087, 211088, 211089, 211090, 211092, 211093, 211094, 211096, 211097, 211098, 211099, 211101, 211104, 211105, 211106, 211107, 211109, 211110, 211111, 211112, 211113, 211114, 211115, 211116, 211118, 211121, 211122, 211123, 211124, 211125, 211126, 211127, 211128, 211129, 211133, 211134, 211135, 211136, 211137, 211138, 211139, 211140, 211141, 211143, 211144, 211145, 211146, 211147, 211148, 211149, 211150, 211152, 211157, 211158, 211159, 211160, 211161, 211162, 211163, 211164, 211165, 211167, 211168, 211176, 211177, 211178, 211179, 211180, 211182, 211183, 211186, 211187, 211188, 211189, 211190, 211192, 211193, 211194 211197, 211200, 211201, 211202, 211204, 211206, 211207, 211210, 211223, 211224, 211226, 211227, 211230, 211231, 211232, 211240, 211241, 211242, 211244, 211248, 211249, 211250, 211252, 211253, 211254, 211255, 211267, 211268, 211270, 211271, 211272, 211273, 211274, 211275, 211276, 211278, 211279, 211281, 211282, 211284, 211472, 211473, 211474, 211499, 211561, 211565, 211567, 211568, 211569, 211570, 211571, 211572, 211573, 211574, 211575, 211577, 211578, 211579, 211580, 211581, 211582, 211591, 211592, 211594, 211597, 211602, 211607, 211608, 211610, 211612, 211613, 211614, 211615, 211618, 211619, 211620, 211621, 211622, 211623, 211624, 211625, 211626, 211799, 211800, 211801, 211802, 211803, 211804, 211805, 211806, 211808, 211821, 211823, 211830, 211834, 211837, 211842, 211843, 211844, 211845, 211847, 211848, 211849, 211850, 211851, 211852, 211853, 211854, 211855, 211858, 211859, 211861, 211862, 211863, 211864, 211866, 211867, 211872, 211879, 211880, 211881, 211882, 211885, 211889, 211892, 211893, 211894, 211896, 211897, 211898, 211899, 211901, 211922, 211923, 211928, 211933, 211935, 211937, 211938, 211939, 211940, 211943, 211944, 211946, 211957, 211961, 211962, 211963, 211965, 211966, 211972, 211978, 211980, 211981, 211983, 211984, 211985, 211987, 211989, 211990, 211991, 211992, 211993, 211995, 211996, 211997, 211998, 211999, 212000, 212001, 212004, 212005, 212007, 212008, 212009, 212012, 212014, 212015, 212018, 212019, 212020, 212030, 212034, 212059, 212060, 212061, 212062, 212063, 212064, 212066, 212075, 212076, 212077, 212078, 212079, 212080, 212081, 212082, 212083, 212094, 212121, 212123, 212128, 212129, 212130, 212131, 212132, 212133, 212136, 212137, 212138, 212139, 212141, 212144, 212146, 212147, 212148, 212150, 212151, 212153, 212154, 212163, 212164, 212165, 212166, 212167, 212169, 212171, 212176, 212177, 212178, 212179, 212180, 212181, 212182, 212184, 212185, 212187, 212188, 212189, 212190, 212191, 212192, 212194, 212203, 212204, 212205, 212208, 212209, 212210, 212211, 212212, 212213, 212215, 212216, 212217, 212218, 212219, 212220, 212221, 212222, 212223, 212225, 212226, 212227, 212228, 212229, 212230, 212231, 212232, 212233, 212235, 212236, 212237, 212238, 212240, 212241, 212242, 212245, 212246, 212248, 212249, 212250, 212251, 212252, 212253, 212254, 212255, 212256, 212258, 212259, 212260, 212262, 212263, 212264, 212265, 212266, 212267, 212269, 212270, 212271, 212272, 212273, 212277, 212280, 212281, 212285, 212290, 212291, 212294, 212297, 212298, 212303, 212304, 212306, 212307, 212309, 212310, 212311, 212312, 212313, 212315, 212316, 212317, 212318, 212323, 212326, 212327, 212329, 212330, 212332, 212339, 212340, 212341, 212343, 212344, 212345, 212346, 212347, 212348, 212349, 212350, 212351, 212353, 212354, 212355, 212356, 212357, 212358, 212359, 212360, 212362, 212364, 212365, 212366, 212367, 212368, 212369, 212370, 212371, 212372, 212374, 212375, 212376, 212377, 212378, 212379, 212380, 212382, 212383, 212385, 212386, 212387, 212388, 212389, 212390, 212391, 212392, 212393, 212395, 212396, 212397, 212399, 212400, 212401, 212403, 212405, 212406, 212416, 212417, 212418, 212419, 212420, 212421, 212422, 212423, 212424, 212426, 212427 212428, 212429, 212430, 212431, 212432, 212433, 212434, 212436, 212437, 212439, 212440, 212441, 212801, 212808, 212809, 212812, 212828, 212842, 212846, 212847, 212902, 212903, 212905, 212910, 213330, 213442, 213477, 213478, 213482, 213483, 213664, 213667, 213670, 213781, 213948, 214000, 214285, 214288, 214289, 214294, 214295, 214296, 215370, 215372, 215374, 215375, 215377, 215378, 215379, 215380, 215381, 215382, 215384, 215385, 215386, 215387, 215388, 215389, 215390, 215394, 215395, 215397, 215398, 215399, 215400, 215401, 215402, 215403, 215404, 215405, 215416, 215417, 215418, 215419, 215548, 215564, 215586, 218473, 218474, 218476, 218512, 218513, 218514, 218515, 218516, 218517, 218518, 218519, 218521, 218522, 218523, 218524, 218525, 218526, 218527, 218528, 218529, 218531, 218619, 218620, 218621, 218622, 218623, 218624 ,218625, 218626, 218628, 218629, 218630, 218631, 218632, 218634, 218635, 218636, 218637, 218639, 218640, 218641, 218642, 218643, 218644, 218645, 218646, 218647, 218649, 218650, 218652, 218653, 218654, 218655, 218656, 218657, 218658, 218660, 218661, 218662, 218663, 218664, 218665, 218666, 218667, 218668, 218670, 218676, 220312, 220313, 220314, 220316, 220317, 220318, 220319, 220321, 220322, 220323, 220324, 220325, 220326, 220327, 220328, 220329, 220331, 220332, 220333, 220334, 220335, 220336, 220337, 220339, 220340, 220342, 220343, 220344, 220345, 220346, 220347, 220348, 220349, 220351, 220353, 220354, 221433, 221434, 221435, 221436, 221437, 221439, 221440, 221442, 221443, 221444, 221445, 221446, 221447, 221448, 221449, 221450, 221452, 221453, 221454, 221455, 221456, 221457, 221458, 221459, 221460, 221462, 221463, 221464, 221465, 221466, 221468, 221469, 221470, 221471, 221473, 221474, 221475, 221476, 221477, 221478, 221479, 221480, 221481, 221540, 221541, 221542, 221543, 221544, 221545, 221546, 221547, 221548, 221550, 221551, 221552, 221553, 221554, 221555, 221556, 221557, 221558, 221560, 221561, 221562, 221563, 221564, 221565, 221566, 221567, 221568, 221570, 221571, 221572, 221573, 221574, 221575, 221576, 221577, 221578, 221580 221581, 214428, 214429, 214430, 214431, 214432, 214433, 214434, 214438, 214439, 214440, 214441, 214442, 214443, 214444, 214447, 214448, 214450, 214451, 214452, 214453, 214454, 214455, 214564, 214565, 214567, 214569, 214570, 214578, 214581, 214585, 214586, 214587, 214588, 214589, 214591, 214699, 214700, 214701, 214703, 214705, 214712, 214714, 214717, 214720, 214722, 214723, 214725, 214727, 214729, 214731, 214732, 214733, 214735, 214736, 214737, 214799, 214806, 214807, 214808, 214809, 214810, 214813, 214814, 214815, 214817, 214822, 214730, 214445, 200005, 200160, 200495, 201690, 201829, 202387, 202388, 202393, 202410, 202691, 202692, 203160, 206172, 207699, 207742, 210218, 210355, 210456, 213844, 213899, 213916 ;
2) 200083, 200091, 200111, 200174, 200181, 200235, 200238, 200256, 200260, 200293, 200300, 200304, 200963, 200972, 200976, 200979, 200992, 200999, 201021, 201050, 201060, 201069, 201093, 201095, 201125, 201130, 201136, 201174, 201176, 201182, 201187, 201188, 201208, 201210, 201211, 201220, 201232, 201233, 201249, 201262, 201270, 201271, 201273, 201285, 201286, 201692, 201692, 201699, 202044, 202386, 202394, 202405, 202405, 202413, 202509, 202565, 202803, 205273, 205355, 205380, 205678, 205702, 205706, 205762, 205800, 205840, 205924, 205935, 205959, 206000, 206001, 206004, 206055, 206076, 206117, 206117, 206120, 206159, 206197, 206221, 206236, 206240, 206241, 206283, 206334, 206345, 206403, 206405, 206407, 206432, 206446, 206447, 206473, 206475, 206477, 206479, 206480, 206497, 206509, 206867, 206900, 206958, 206965, 206965, 206971, 207005, 207029, 207031, 207185, 207195, 207201, 207212, 207230, 207246, 207247, 207265, 207686, 208053, 208054, 208108, 208203, 208236, 208273, 208319, 208320, 208321, 208558, 208567, 208567, 208589, 208662, 208778, 208778, 208975, 209047, 209047, 209069, 209089, 209090, 209091, 209092, 209093, 209094, 209095, 209113, 209114, 209116, 209117, 209118, 209120, 209140, 209145, 209146, 209215, 209215, 209262, 209267, 209269, 209278, 209279, 209280, 209281, 209284, 209286, 209291, 209292, 209292, 209293, 209294, 209295, 209297, 209299, 209299, 209300, 209302, 209303, 209304, 209305, 209306, 209309, 209314, 209318, 209321, 209322, 209323, 209331, 209331, 209333, 209333, 209335, 209338, 209339, 209340, 209340, 209343, 209343, 209346, 209347, 209359 209361 209363 209364 209365 209373 209379 209383 209390 209399 209403 209406 209411 209413 209415 209416 209418 209419 209420 209421 209423 209424 209428 209429 209430 209432 209433 209435 209436 209439 209441 209442 209444 209445 209446 209448 209449 209450 209452 209467 209469 209470 209473 209474 209475 209476 209479 209480 209483 209500 209503 209509 209512 209515 209521 209527 209528 209529 209531 209538 209594 209605 209613 209614 209615 209618 209634 209636 209637 209638 209640 209641 209642 209654 209655 209657 209661 209666 209668 209669 209670 209671 209672 209673 209674 209682 209683 209693 209701 209708 209709 209711 209712 209713 209724 209743 209745 209748 209752 209753 209754 209756 209759 209761 209763 209764 209765 209766 209767 209768 209769 209770 209785 209788 209790 209791 209805 209808 209809 209811 209859 210342 210499 210500 210501 210502 210503 210567 210570 210571 210574 210654 210788 210800 210801 210802 210803 210804 210805 210841 210843 210844 210845 210886 210961 210966 210970 211303 211309 211335 211336 211338 211339 211340 211341 211342 211344 211345 211346 211347 211348 211353 211354 211355 211356 211358 211359 211360 211361 211372 211386 211394 211398 211401 211402 211403 211407 211409 211425 211428 211434 211435 211460 211461 211462 211463 211464 211465 211466 211467 211468 211470 211471 211484 211485 211486 211487 211489 211490 211491 211506 211507 211558 211560 211562 211563 211564 211583 211584 211586 211587 211589 211590 211596 211598 211599 211600 211601 211605 211606 211611 211616 211627 211628 211629 211630 211631 211633 211634 211635 211636 211641 211645 211646 211647 211648 211650 211659 211660 211661 211662 211663 211664 211665 211666 211669 211670 211671 211672 211673 211674 211675 211676 211678 211699 211790 211817 211818 211819 211822 211828 211860 211865 211869 211870 211871 211883 211884 211886 211887 211890 211891 211914 211915 211916 211917 211918 211919 211920 211921 211926 211950 211951 211952 211953 212011 212013 212016 212017 212032 212035 212039 212045 212049 212050 212051 212052 212054 212055 212057 212058 212085 212086 212088 212090 212096 212097 212098 212100 212101 212102 212103 212104 212105 212106 212107 212108 212110 212111 212112 212114
212115 212116 212117 212118 212122 212172 212173 212174 212193 212443 212446 212451 212455 212459 212477 212478 212490 212491 212492 212493 212494 212495 212496 212501 212507 212508 212509 212510 212511 212512 212513 212514 212516 212517 212518 212520 212521 212522 212525 212526 212528 212531 212534 212535 212536 212537 212538 212539 212542 212543 212545 212546 212547 212548 212549 212554 212555 212556 212574 212583 212584 212585 212586 212587 212588 212627 212628 212629 212631 212632 212633 212634 212636 212637 212645 212647 212651 212654 212655 212656 212658 212659 212660 212661 212662 212663 212675 212680 212681 212682 212683 212684 212685 212687 212703 212705 212706 212708 212711 212713 212718 212721 212723 212724 212726 212727 212728 212729 212730 212732 212733 212734 212736 212739 212740 212741 212742 212743 212744 212745 212746 212747 212749 212758 212762 212765 212766 212767 212771 212773 212774 212776 212777 212779 212780 212783 212784 212785 212786 212787 212789 212790 212791 212792 212793 212794 212795 212796 212799 212876 212877 212879 212880 212883 212887 212888 212953 212955 212957 212960 212962 212963 212966 212967 212968 212969 212970 212973 212974 212975 212976 212977 212995 212996 213007 213009 213011 213013 213014 213016 213017 213018 213023 213036 213037 213039 213040 213041 213042 213043 213052 213055 213057 213058 213071 213072 213075 213078 213079 213081 213083 213084 213085 213088 213093 213106 213107 213108 213109 213121 213122 213123 213125 213126 213128 213137 213138 213141 213143 213147 213148 213151 213160 213161 213162 213163 213164 213165 213166 213167 213193 213194 213195 213196 213197 213198 213199 213206 213244 213246 213302 213305 213307 213309 213329 213331 213332 213333 213335 213336 213337 213338 213355 213356 213371 213372 213373 213377 213378 213379 213380 213381 213382 213383 213384 213385 213401 213402 213403 213404 213405 213407 213409 213410 213411 213421 213422 213423 213424 213425 213426 213427 213428 213438 213444 213445 213447 213448 213449 213453 213454 213455 213456 213458 213459 213460 213470 213480 213481 213495 213502 213503 213507 213517 213518 213519 213520 213522 213523 213524 213525 213527 213528 213529 213530 213532 213533 213534 213535 213536 213539 213541 213542 213543 213544 213545 213546 213547 213548 213550 213551 213552 213553 213555 213556 213557 213558 213559 213561 213562 213563 213564 213565 213569 213571 213574 213575 213577 213579 213582 213583 213584 213585 213586 213587 213588 213591 213592 213593 213596 213599 213600 213603 213614 213615 213617 213619 213620 213621 213622 213623 213624 213625 213626 213628 213629 213630 213632 213633 213634 213635 213661 213665 213688 213689 213690 213691 213692 213693 213694 213695 213698 213716 213718 213719 213720 213721 213727 213760 213786 213788 213790 213791 213792 213793 213794 213795 213813 213818 213841 213848 213849 213850 213851 213852 213854 213855 213856 213858 213860 213873 213876 213877 213878 213879 213903 213947 213951 213957 213959 213960 213961 213969 213999 214002 214136 214153 214168 214172 214173 214185 214197 214208 214213 214214 214215 214217 214218 214222 214223 214225 214226 214234 214235 214236 214263 214265 214266 214267 214269 214270 214271 214272 214273 214275 214276 214277 214278 214279 214281 214282 214284 214286 214290 214291 214292 214293 214298 214299 214300 214301 214302 214323 214327 214328 214329 214330 214331 214332 214333 214334 214336 214337 214338 214339 214340 214342 214343 214344 214345 214347 214348 214349 214350 214351 214352 214353 214355 214356 214359 214360 214361 214362 214363 214364 214365 214366 214373 214384 214391 214527 214531 214534 214538 214544 214545 214548 214738 214739 214743 214744 214745 214746 214747 214748 214749 214751 214752 214753 214754 214755 214756 214757 214758 214759 214779 214780 214781 214782 214783 214784 214847 214910 214911 215008 215009 215010 215011 215012 215013 215014 215015 215016 215018 215019 215020 215021 215022 215028 215029 215030 215031 215033 215034 215035 215036 215037 215038 215039 215040 215041 215043 215044 215045 215047 215049 215050 215051 215052 215053 215055 215056 215057 215059 215060 215062 215064 215065 215066 215068 215069 215070 215071 215072 215073 215074 215075 215076 215078 215079 215080 215081 215082 215083 215084 215085 215087 215089 215090 215091 215092 215093 215094 215095 215096 215097 215099 215100 215101 215102 215103 215104 215105 215106 215107 215109 215111 215112 215113 215114 215116 215118 215119 215120 215122 215130 215131 215153 215155 215156 215157 215158 215159 215161 215162 215163 215164 215165 215166 215167 215168 215169 215171 215172 215173 215174 215175 215176 215177 215185 215188 215373 215376 215479 215480 215558 215559 215560 215561 215562 215565 215566 215567 215568 215571 215572 215573 215574 215575 215577 215578 215637 215639 215641 215642 215643 215646 215647 215649 215651 215652 215653 215654 215655 215658 215661 215665 215669 215671 215672 215673 215674 215676 215678 215679 215680 215684 215686 215687 215688 215691 215693 215696 215702 215704 215708 215709 215711 215712 215716 215718 215720 215723 215724 215727 215728 215730 215731 215732 215734 215736 215737 215740 215743 215744 215746 215747 215750 215751 215752 215753 215755 215757 215758 215759 215760 215763 215765 215766 215767 215768 215771 215775 215778 215782 215783 215784 215785 215787 215788 215790 215791 215793 215794 215795 215796 215797 215798 215799 215803 215805 215807 215808 215812 215814 215815 215817 215818 215820 215821 215823 215826 215828 215830 215831 215834 215835 215840 215841 215844 215845 215850 215853 215854 215856 215857 215864 215866 215867 215868 215869 215870 215873 215874 215876 215879 215881 215882 215883 215884 215885 215887 215888 215889 215892 215893 215895 215896 215899 215902 215903 215904 215905 215910 215913 215917 215925 215927 215928 215929 215934 215935 215940 215941 215942 215943 215944 215945 215946 215947 215948 215952 215955 215957 215958 215966 215967 215969 215971 215972 215974 215975 215977 215979 215981 215985 215986 215987 215988 215991 215992 215993 215996 215997 216003 216005 216010 216011 216013 216014 216015 216018 216019 216020 216021 216022 216023 216027 216029 216030 216031 216032 216034 216035 216036 216037 216041 216043 216045 216049 216053 216057 216058 216060 216061 216065 216068 216069 216070 216071 216073 216074 216075 216077 216079 216087 216088 216089 216093 216095 216096 216097 216099 216103 216104 216105 216106 216107 216108 216109 216110 216111 216114 216119 216121 216123 216124 216125 216127 216128 216133 216138 216144 216151 216153 216154 216156 216158 216161 216163 216165 216168 216170 216171 216174 216178 216180 216183 216184 216185 216186 216189 216192 216193 216194 216196 216208 216209 216213 216214 216223 216224 216230 216233 216234 216236 216240 216242 216243 216245 216246 216252 216253 216255 216258 216261 216262 216265 216266 216269 216270 216271 216273 216275 216276 216278 216281 216282 216313 216331 216335 216336 216340 216346 216347 216348 216349 216351 216352 216353 216355 216358 216360 216362 216371 216372 216373 216374 216376 216377 216379 216380 216381 216382 216383 216384 216385 216386 216388 216394 216395 216396 216397 216401 216402 216403 216404 216405 216408 216411 216413 216418 216419 216420 216422 216424 216426 216428 216429 216432 216433 216434 216437 216439 216440 216441 216445 216450 216452 216454 216456 216457 216458 216460 216461 216463 216464 216465 216468 216469 216470 216472 216473 216477 216479 216480 216481 216482 216489 216490 216493 216494 216496 216498 216500 216504 216506 216508 216509 216511 216512 216513 216515 216517 216518 216519 216520 216521 216522 216523 216526 216528 216530 216531 216532 216534 216535 216536 216540 216542 216545 216547 216548 216550 216551 216552 216553 216554 216556 216567 216568 216570 216571 216572 216573 216574 216575 216579 216584 216585 216588 216590 216591 216592 216593 216595 216596 216598 216599 216603 216608 216611 216612 216613 216614 216615 216617 216618 216619 216621 216622 216626 216628 216629 216631 216633 216634 216683 216695 216705 216720 216743 216796 216798 216801 216803 216809 216811 216812 216813 216815 216819 216821 216826 216829 216831 216833 216834 216836 216837 216845 216850 216854 216855 216856 216857 216858 216862 216870 216871 216872 216876 216878 216879 216888 216889 216890 216892 216896 216897 216901 216904 216905 216906 216907 216908 216910 216911 216912 216916 216917 216918 216921 216930 216933 216934 216935 216936 216940 216941 216942 216944 216945 216954 216955 216956 216957 216961 216962 216963 216964 216965 216966 216967 216968 216969 216971 216972 216974 216977 216978 216981 216982 216983 216985 216987 216988 216991 216992 216998 216999 217001 217004 217005 217008 217009 217010 217011 217020 217021 217022 217029 217031 217033 217034 217036 217038 217039 217041 217044 217045 217049 217051 217052 217053 217055 217061 217062 217063 217064 217066 217069 217070 217077 217091 217092 217093 217094 217095 217096 217101 217102 217104 217106 217108 217109 217110 217111 217112 217115 217117 217118 217125 217127 217129 217130 217132 217133 217136 217137 217139 217140 217153 217156 217157 217167 217169 217173 217174 217177 217179 217180 217181 217182 217185 217186 217188 217191 217192 217193 217196 217197 217198 217199 217214 217228 217229 217230 217232 217235 217238 217239 217241 217242 217419 217420 217421 217422 217423 217424 217425 217426 217441 218309 218313 218430 218431 218432 218433 218434 218435 218436 218438 218439 218441 218442 218443 218444 218445 218446 218447 218450 218451 218452 218453 218454 218462 218500 218501 218603 218605 218606 218607 218609 218610 218611 218613 218614 218615 218617 218618 218651 218677 218678 218679 218680 218682 218683 218685 218686 218687 218688 218689 218690 218691 218692 218693 218695 218696 218697 218698 218699 218700 218701 218702 218703 218705 218706 218707 218708 218709 218710 218713 218715 218716 218722 218724 218725 218726 218728 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219208 219209 219210 219211 219212 219214 219218 219219 219220 219221 219223 219224 219225 219226 219229 219230 219231 219232 219235 219237 219238 219239 219243 219248 219249 219250 219251 219252 219253 219254 219255 219262 219265 219269 219278 219287 219295 219298 219328 219333 219334 219337 219339 219340 219341 219343 219344 219345 219346 219347 219349 219350 219352 219353 219354 219355 219356 219357 219358 219360 219361 219362 219378 219379 219393 219442 219443 219444 219451 219452 219453 219454 219455 219457 219458 219459 219460 219462 219463 219464 219465 219466 219467 219468 219470 219472 219474 219475 219476 219477 219478 219479 219480 219481 219482 219484 219669 219671 219672 219673 219674 219675 219676 219677 219679 219680 219681 219682 219683 219684 219686 219687 219688 219690 219691 219692 219693 219694 219695 219696 219697 219698 219700 219701 219702 219711 219716 219753 219787 219788 219789 219791 219854 219855 219856 219858 219859 219860 219861 219862 219864 219866 219870 219871 219872 219873 219874 219875 219876 219878 219879 219880 219881 219882 219885 219886 219887 219888 219890 219891 219892 219894 219895 219897 219898 219899 219901 219920 219922 219923 219925 219926 219927 219928 219929 219930 219935 219936 219937 219938 219947 219949 219952 219954 219956 219958 219959 219960 219961 219963 219965 219966 219967 219968 219970 219971 219972 219973 219974 219975 219976 219978 219979 219981 219982 219983 219984 219985 220000 220597 220598 220599 220603 220604 220605 220606 220607 220608 220610 220611 220612 220615 220616 220617 220618 220619 220620 220621 220622 220623 220625 220626 220627 220628 220629 220630 220631 220632 220633 220635 220636 220637 220638 220639 220640 220641 220642 220643 220645 220647 220648 220650 220651 220652 220653 220654 220655 220657 220658 220659 220660 220661 220662 220663 220664 220665 220667 220668 220669 220670 220671 220672 220673 220674 220675 220677 220678 220679 220680 220681 220682 220683 220684 220685 220687 220688 220689 220690 220692 220693 220694 220695 220696 220698 220699 220701 220702 220703 220704 220705 220706 220707 220709 220711 220712 220713 220714 220715 220716 220717 220718 220720 220721 220722 220723 220724 220725 220726 220727 220728 220730 220731 220732 220733 220734 220735 220736 220737 220738 220740 220743 220744 220746 220747 220748 220757 220758 220760 220763 220764 220765 220775 220776 220777 220783 220784 220788 220790 220791 220792 220793 220794 220795 220796 220798 220799 220801 220802 220803 220804 220805 220807 220808 220809 220810 220812 220813 220814 220815 220816 220817 220818 220819 220820 220823 220824 220825 220827 220828 220829 220830 220831 220832 220834 220835 220836 220837 220838 220839 220840 220841 220842 220845 220846 220847 220848 220849 220850 220851 220861 220862 220869 220870 220871 220873 220879 220880 220881 220882 220883 220885 220886 220887 220888 220889 220890 220892 220893 220894 220896 220897 220898 220899 220900 220901 220903 220904 220905 220907 220908 220909 220910 220911 220912 220913 220914 220915 220917 220918 220919 220920 220921 221159 221160 221161 221162 221164 221165 221166 221167 221168 221169 221170 221171 221173 221175 221176 221177 221178 221179 221180 221182 221183 221184 221186 221187 221188 221189 221190 221191 221192 221193 221194 221196 221197 221198 221199 221200 221201 221202 221203 221204 221206 221207 221209 221211 221212 221213 221214 221215 221216 221218 221219 221220 221221 221222 221223 221224 221225 221226 221228 221229 221230 221231 221232 221233 221234 221235 221236 221238 221239 221240 221241 221242 221243 221244 221245 221246 221248 221249 221250 221251 221253 221254 221255 221256 221257 221259 221260 221261 221262 221263 221264 221266 221267 221268 221270 221272 221273 221274 221275 221276 221277 221278 221279 221281 221482 221483 221484 221485 221486 221487 221488 221489 221491 221492 221493 221494 221495 200073 200075 200076 200085 200089 200093 200096 200100 200113 200117 200120 200121 200122 200127 200132 200134 200138 200139 200142 200158 200172 200342 200986 201020 201027 201035 201036 201071 201072 201374 201699 201711 201805 201806 202381 202424 202427 202525 202565 202596 202697 202713 202773 202784 202787 202791 202794 204407 205794 206098 206366 206516 206563 206670 206683 206794 206837 206900 206908 206963 206972 207020 207082 207162 207190 207193 207201 207207 207326 207576 207922 208055 208244 208590 209027 209108 209379 209416 209771 209778 209782 209827 209830 209992 210343 210351 210382 210485 210580 210581 210656 210760 211323 211454 213406 213469 213472 213474 213476 213491 213714 213745 213747 213749 213761 213862 213875 213959 214239 214247 214249 214258 214571 214572 214576 214577 214579 215128 216668 216669 216670 216671 219393 219876 219920 219922 219923 221270 219870 219871 219872 219937 221081 218595 218596 218597 218598 218599 218600 218601 218602 211955 211956 212022 212024 212025 212026 212155 212156 212157 212807 212823 212825 212826 212830 212858 212859 212890 213012 213757 213759 213871 219939 219940 219941 219942 219943 219944 219946 220111 220112 220113 220114 220115 220117 220118 220119 220123 220125 220127 220130 220131 220132 220134 220135 220136 220138 220139 220140 220141 220143 220144 220145 220146 220147 220149 220150 220151 220152 220153 220155 220156 220158 220159 220161 220162 220164 220165 220166 220167 220168 220169 220170 220173 220967 220968 220969 220970 220971 220972 220973 220974 220976 220977 220978 220979 220980 220981 220982 220983 220985 220987 220988 220989 220990 220991 220992 220993 220994 220995 220997 220998 220999 221000 221001 221003 221004 221005 221006 221008 221009 221010 221011 221047 221048 221049 221050 221051 221053 220749 220750 220751 220752 220753 220754 220755 220756 220779 220780 220781 220782 220787 220923 220924 220925 220926 220928 220929 220930 220931 220932 220766 220767 220768 220769 220771 220772 220773 220774 220785 220786 220934 220935 221072 221074 221075 221076 221077 221080 200310 201705 202165 202407 202669 203169 205897 206212 206313 206444 207069 207190 207696 207700 209784 209804 210443 210461 210509 211308 211324 211404 211424 211815 213889 213900 213950 213952 213996 214104 214251 214540 214991 219434 219435 219436 219439 219440 219441 219445 219446 219447 219448 219449 219456 219485 219699 219700 219852 219868 219869 219907 219950 219951 219997 219999 220037 220741 220860 220874 220876 220877 220878 221282 221307 221308 221309 222652 222727;
3) Units: 200078, 200080, 200081, 200086, 200086, 200090, 200092, 200097, 200103 200109, 200110, 200116, 200118, 200118, 200119, 200124, 200125, 200129 200135, 200136, 200137, 200137, 200143, 200143, 200144, 200144, 200147 200153, 200154, 200155, 200157, 200159, 200164, 200164, 200166, 200167, 200184, 200185, 200186, 200187, 200272, 200409, 200456, 200488, 200492, 200504, 200505, 200506, 200511, 200516, 200517, 200518, 200519, 200521, 200523, 200524, 200525, 200540, 200541, 200543, 200546, 200548, 200550, 200553, 200556, 200569, 200570, 200571,200581, 200593, 200601, 200605, 200633, 200634, 200635, 200636, 200641, 200644, 200645, 200646, 200647, 200649, 200650, 200651, 200652, 200653, 200654, 200655, 200656, 200657, 200659, 200660, 200662, 200663, 200664, 200665, 200666, 200667, 200668, 200670, 200673, 200674, 200675, 200677, 200678, 200679, 200680, 200681, 200683, 200684, 200685, 200686, 200687, 200688, 200689, 200690, 200691, 200693, 200694, 200695, 200696, 200697, 200698, 200699, 200700, 200701, 200703, 200704, 200705, 200706, 200707, 200708, 200709, 200710, 200711, 200714, 200715, 200716, 200717, 200718, 200719, 200720, 200721, 200722, 200724, 200726, 200727, 200728, 200729, 200730, 200731, 200732, 200733, 200735, 200736, 200737, 200738, 200739, 200740, 200741, 200742, 200743, 200745, 200746, 200748, 200749, 200750, 200751, 200752, 200753, 200754, 200756, 200757, 200758, 200759, 200760, 200761, 200762, 200763, 200765, 200768, 200770, 200771, 200772, 200773, 200775, 200776, 200777, 200778, 200780, 200781, 200782, 200783, 200784, 200785, 200786, 200787, 200789, 200791, 200793, 200794, 200795, 200796, 200797, 200798, 200799, 200800, 200803, 200804, 200805, 200806, 200807, 200808, 200809, 200810, 200811, 200813, 200814, 200815, 200816, 200817, 200818, 200819, 200820, 200821, 200823, 200824, 200825, 200826, 200827, 200828, 200829, 200830, 200831, 200833, 200835, 200836, 200837, 200839, 200840, 200841, 200842, 200843, 200846, 200847, 200848, 200849, 200850, 200851, 200853, 200854, 200855, 200858, 200859, 200860, 200861, 200862, 200863, 200864, 200865, 200866, 200868, 200869, 200870, 200872, 200873, 200874, 200875, 200876, 200877, 200880, 200882, 200883, 200884, 200885, 200886, 200887, 200888, 200889, 200891, 200892, 200893, 200894, 200895, 200896, 200897, 200899, 200900, 200902, 200903, 200904, 200905, 200906, 200907, 200908, 200909, 200910, 200912, 200913, 200914, 200915, 200916, 200917, 200918, 200919, 200920, 200923, 200924, 200925, 200926, 200927, 200928, 200929, 200930, 200931, 200933, 200934, 200935, 200937, 200938, 200939, 200941, 200942, 200946, 200955, 200971, 200975, 200993, 200996, 200998, 201000, 201002, 201006, 201010, 201012, 201014, 201015, 201016, 201018, 201024, 201034, 201038, 201041, 201045, 201046, 201054, 201055, 201056, 201063, 201064, 201065, 201067, 201068, 201075, 201076, 201079, 201080, 201165, 201245, 201284, 201295, 201296, 201299, 201324, 201345, 201347, 201356, 201357, 201358, 201361, 201363, 201364, 201365, 201366, 201367, 201368, 201370, 201371, 201379, 201407, 201409, 201411, 201414, 201417, 201427, 201428, 201429, 201431, 201432, 201433, 201434, 201435, 201436, 201437, 201438, 201439, 201441, 201442, 201459, 201460, 201461, 201463, 201465, 201467, 201470, 201548, 201674, 201678, 201679, 201681, 201683, 201685, 201694, 201700, 201713, 201714, 201715, 201716, 201718, 201719, 201720, 201724, 201725, 201732, 201734, 201736, 201737, 201739, 201740, 201741, 201745, 201759, 201770, 201771, 201773, 201776, 201778, 201779, 201780, 201781, 201782, 201789, 201791, 201793, 201794, 201795, 201800, 201804, 201810, 201812, 201814, 201816, 201817, 201830, 201830, 201830, 201860, 201861, 201862, 201864, 201866, 201868, 201879, 201880, 201882, 201884, 201912, 201918, 201952, 201996, 202010, 202033, 202035, 202038, 202040, 202042, 202043, 202053, 202062, 202063, 202065, 202066, 202067, 202068, 202069, 202076, 202078, 202079, 202081, 202082, 202083, 202084, 202085, 202086, 202087, 202091, 202098, 202100, 202101, 202102, 202103, 202104, 202106, 202107, 202109, 202111, 202112, 202113, 202114, 202115, 202116, 202117, 202118, 202125, 202126, 202127, 202128, 202129, 202130, 202131, 202132, 202157, 202159, 202161, 202162, 202170, 202171, 202172, 202173, 202174, 202175, 202196, 202197, 202198, 202199, 202200, 202201, 202202, 202203, 202204, 202208, 202209, 202212, 202213, 202214, 202215, 202216, 202218, 202220, 202232, 202233, 202234, 202236, 202237, 202238, 202239, 202243, 202244, 202273, 202274, 202279, 202281, 202284, 202285, 202294, 202305, 202323, 202332, 202334, 202335, 202336, 202337, 202338, 202340, 202341, 202342, 202345, 202346, 202347, 202348, 202349, 202350, 202351, 202352, 202355, 202358, 202361, 202362, 202382, 202395, 202404, 202419, 202542, 202552, 202757, 202774, 202783, 202801, 202807, 202808, 202810, 202811, 202813, 202815, 202816, 202817, 202819, 202823, 202841, 202842, 202843, 202845, 202847, 202848, 202849, 202894, 202918, 202919, 202951, 202987, 202988, 202990, 202991, 202992, 202996, 202997, 203198, 203413, 203414, 203415, 203417, 203418, 203835, 203900, 203924, 203936, 203939, 203953, 203976, 204025, 204026, 204027, 204253, 205531, 205583, 205995, 206053, 206216, 206462, 206688, 206724, 206726, 206732, 206745, 206747, 206836, 206841, 206863, 206864, 206865, 206866, 207186, 207413, 207430, 207512, 207513, 207587, 207628, 207695, 207695, 207762, 207778, 207807, 207807, 207810, 208003, 208049, 208060, 208183, 208198, 208298, 210022, 210025, 210026, 210028, 210029, 210030, 210031, 210073, 210075, 210076, 210077, 210078, 210096, 210137, 210138, 210140, 210142, 210143, 210144, 210150, 210204, 210232, 210262, 210263, 210291, 210292, 210350, 210356, 210358, 210360, 210444, 210445, 210448, 210452, 210452, 210458, 210477, 210512, 210514, 210536, 210537, 210538, 210539, 210540, 210540, 210541, 210545, 210550, 210553, 210554, 210584, 210626, 210630, 210631, 210632, 210633, 210651, 210667, 210680, 210682, 210684, 210686, 210943, 210946, 210947, 210948, 210993, 211102, 211103, 211218, 211245, 211293, 211294, 211295, 211296, 211298, 211300, 211301, 211302, 211304, 211337, 211457, 211528, 211529, 211531, 211532, 211533, 211534, 211535, 211536, 211537, 211538, 211539, 211541, 211542, 211543, 211544, 211546, 211547, 211548, 211549, 211550, 211552, 211553, 211554, 211555, 211556, 211638, 211640, 211644, 212479, 212505, 212506, 212527, 212533, 212540, 212558, 212560, 212562, 212563, 212565, 212568, 212572, 212573, 212576, 212578, 212581, 212666, 212671, 212686, 212688, 212689, 212690, 212691, 212692, 212696, 212697, 212698, 212701, 212715, 212716, 212752, 212755, 212756, 212760, 213901, 203198.;
4) Units: 200016 200017 200030 200035 200038 200041 200043 200044 200049 200050 200052 200054 200055 200057 200059 200072 200082 200084 200087 200099 200102 200104 200106 200112 200131 200140 200141 200145 200149 200150 200151 200152 200163 200165 200169 200170 200175 200177 200178 200188 200191 200192 200193 200194 200195 200196 200197 200202 200203 200204 200205 200206 200207 200208 200209 200214 200215 200217 200218 200219 200220 200221 200222 200225 200226 200227 200228 200229 200230 200231 200232 200236 200237 200239 200240 200241 200242 200243 200244 200248 200250 200253 200254 200255 200257 200258 200263 200266 200267 200269 200270 200273 200275 200276 200280 200281 200282 200287 200288 200289 200290 200292 200294 200295 200296 200297 200298 200299 200307 200309 200311 200312 200313 200314 200315 200316 200319 200320 200321 200322 200323 200324 200325 200326 200329 200330 200331 200332 200333 200334 200335 200336 200340 200341 200348 200349 200350 200351 200352 200353 200358 200359 200360 200361 200362 200363 200364 200366 200369 200370 200371 200372 200373 200374 200375 200376 200380 200381 200382 200383 200384 200385 200386 200387 200390 200391 200392 200393 200394 200395 200396 200397 200400 200401 200402 200403 200404 200405 200406 200407 200411 200412 200413 200414 200415 200416 200417 200419 200422 200423 200424 200426 200427 200428 200429 200430 200433 200434 200435 200436 200437 200438 200439 200440 200444 200445 200446 200447 200448 200449 200450 200452 200455 200457 200458 200459 200460 200461 200462 200463 200466 200467 200468 200469 200470 200471 200472 200473 200476 200477 200478 200479 200480 200481 200482 200483 200486 200487 200489 200490 200491 200536 200537 200538 200563 200564 200565 200566 200567 200568 200572 200573 200576 200577 200578 200579 200580 200582 200583 200584 200587 200588 200589 200590 200591 200592 200594 200595 200598 200599 200600 200602 200603 200604 200606 200607 200610 200611 200612 200613 200614 200615 200616 200617 200620 200621 200622 200623 200624 200625 200626 200627 200631 200632 200637 200638 200639 200640 200642 200643 200725 200769 200844 200852 200878 200898 200936 200943 200947 200948 200950 200951 200952 200953 200956 200958 200962 200964 200965 200966 200967 200968 200969 200974 200977 200978 200980 200981 200982 200983 200984 200989 200991 200995 200997 201001 201003 201004 201008 201025 201029 201030 201032 201033 201037 201043 201059 201061 201070 201073 201074 201081 201082 201084 201090 201092 201096 201099 201100 201102 201104 201105 201110 201112 201116 201117 201118 201119 201121 201122 201126 201127 201129 201131 201132 201133 201134 201137 201142 201144 201145 201147 201148 201154 201157 201158 201162 201166 201172 201173 201177 201179 201180 201181 201185 201189 201190 201191 201192 201193 201194 201195 201198 201200 201201 201202 201203 201204 201205 201206 201212 201214 201215 201216 201217 201219 201221 201222 201225 201226 201228 201230 201231 201234 201235 201236 201240 201242 201244 201246 201247 201248 201250 201251 201254 201255 201256 201257 201258 201261 201263 201264 201268 201269 201272 201274 201275 201276 201277 201280 201281 201282 201283 201287 201289 201301 201302 201305 201306 201307 201308 201309 201310 201311 201312 201315 201316 201317 201318 201319 201320 201321 201322 201326 201327 201328 201329 201331 201332 201333 201335 201338 201339 201340 201341 201342 201343 201344 201346 201351 201352 201353 201354 201355 201375 201376 201377 201381 201382 201383 201384 201385 201386 201387 201388 201391 201392 201393 201394 201395 201396 201397 201398 201401 201402 201403 201404 201405 201415 201416 201418 201421 201422 201423 201424 201425 201426 201443 201444 201449 201462 201464 201469 201471 201474 201475 201477 201481 201482 201483 201485 201486 201487 201488 201489 201494 201495 201496 201497 201498 201499 201500 201501 201506 201507 201508 201509 201510 201511 201513 201514 201519 201520 201521 201522 201523 201524 201525 201526 201529 201530 201531 201532 201533 201534 201535 201537 201540 201541 201542 201543 201544 201545 201546 201547 201551 201552 201553 201554 201555 201556 201557 201558 201562 201563 201564 201566 201568 201569 201570 201571 201574 201575 201576 201577 201578 201579 201581 201582 201585 201586 201587 201588 201589 201590 201592 201593 201597 201598 201599 201600 201601 201602 201603 201604 201607 201608 201609 201610 201611 201612 201613 201614 201617 201618 201619 201620 201621 201622 201623 201625 201628 201629 201630 201631 201634 201635 201636 201637 201641 201642 201643 201644 201645 201646 201647 201648 201651 201652 201653 201654 201655 201656 201657 201658 201661 201662 201663 201664 201665 201666 201668 201670 201673 201675 201676 201677 201680 201682 201686 201688 201697 201701 201702 201703 201704 201706 201707 201709 201768 201809 201811 201818 201820 201821 201826 201827 201828 201830 201840 201841 201844 201845 201846 201847 201848 201849 201850 201851 201854 201855 201856 201857 201858 201859 201865 201867 201871 201872 201873 201874 201875 201876 201877 201878 201895 201901 201909 201910 201911 201913 201915 201916 201922 201923 201924 201925 201928 201932 201933 201937 201940 201943 201944 201945 201946 201947 201949 201950 201957 201958 201959 201960 201961 201962 201963 201964 201967 201968 201969 201970 201971 201972 201973 201974 201977 201978 201979 201980 201981 201982 201983 201984 201987 201989 201990 201991 201992 201997 201998 201999 202002 202003 202004 202006 202007 202011 202012 202013 202016 202017 202018 202019 202020 202021 202022 202023 202026 202027 202028 202029 202030 202031 202032 202034 202039 202041 202047 202048 202049 202050 202051 202052 202057 202058 202059 202071 202072 202073 202074 202075 202093 202094 202095 202096 202121 202133 202136 202138 202145 202149 202153 202166 202187 202189 202190 202191 202194 202225 202227 202229 202230 202231 202235 202242 202247 202249 202250 202251 202252 202253 202254 202255 202258 202259 202260 202261 202262 202263 202265 202266 202270 202271 202272 202287 202288 202289 202290 202291 202295 202296 202297 202298 202299 202300 202302 202303 202307 202308 202309 202310 202311 202312 202313 202314 202317 202318 202319 202320 202321 202324 202325 202366 202378 202379 202383 202384 202385 202389 202391 202408 202409 202411 202415 202416 202417 202418 202421 202422 202426 202429 202430 202438 202439 202456 202462 202483 202494 202503 202508 202510 202512 202513 202523 202526 202527 202529 202533 202535 202536 202539 202541 202543 202544 202545 202554 202556 202557 202558 202563 202564 202571 202572 202576 202577 202580 202587 202598 202599 202600 202604 202605 202609 202619 202621 202654 202656 202660 202664 202665 202666 202673 202682 202688 202690 202696 202698 202701 202702 202704 202705 202714 202715 202716 202723 202729 202730 202731 202732 202737 202738 202739 202740 202741 202742 202743 202744 202747 202748 202749 202750 202751 202753 202755 202756 202761 202763 202764 202766 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222396 222397 222398 222399 222400 222467 222468 222469 222470 222471 222472 222646 222647 222693 222703 222710 222712 222713 222715 222716 222717 222721 222722 222723 222724 222725 222726 222730 222735 222738 222739 222740 222741 222742 222743 222744 222746 222749 222750 222751 222752 222753 222754 222755 222756 222759 222766 222767;
RECALLING FIRM/MANUFACTURER
Zevex International, Inc., Salt Lake City, UT, by letter dated February 28, 2011.
Manufacturer: Zevex International, Inc., Salt Lake City, UT. FDA initiated recall is ongoing.
REASON
Infusion pumps may exhibit false error codes which render the device inoperable until a recovery process is performed.
VOLUME OF PRODUCT IN COMMERCE
18,306 pumps
DISTRIBUTION
Nationwide, Australia, Canada, Costa Rica, Croatia, Dubai, France, Germany, Ireland, Italy, Japan, Jordan, Kuwait, Malaysia, New Zealand, Qatar, Saudi Arabia, Singapore, South Africa, Taiwan, Turkey, UAE, United Kingdom
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
1) Allura XPER FD 10 and Field Extension for XPER Cardiovascular System and Allura XPER FD 20 and Allura CV20. Angiographic X-ray systems with a solid state X-ray imaging device for cardiovascular and vascular diagnostic and interventional procedures. Recall # Z-1368-2011;
2) Allura XPER FD 20 and Allura CV20; Allura XPER FD 10 and Field Extension for XPER Cardiovascular System and Allura CV20. Angiographic X-ray systems with a solid state X-ray imaging device for cardiovascular and vascular diagnostic and interventional procedures. Recall # Z-1369-2011
CODE
1) Site Numbers: 104075, 104497, 537745, and 51333258;
2) Site Numbers: 103331, 520481, 537743, 43721190, 43796227, 51126900, and 51333259
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA, by letter dated November 4, 2010.
Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands. Firm initiated recall is ongoing.
REASON
Adjustment of the micro-switches in the footswitch used on the Philips cardiovascular X-ray systems was not implemented. If it is programmed for exposure, it is possible that after pressing the pedal on the footswitch it does not release itself. The patient may be exposed to X-ray longer than intended.
VOLUME OF PRODUCT IN COMMERCE
27 units Worldwide (6 total in US)
DISTRIBUTION
CA, IL, MA, NC, and Internationally
___________________________________
PRODUCT
Fresenius Optiflux F250NRe Hemodialyzer, Single Use, Catalog Number: 0500325E Advanced Fresenius Polysulfone. Intended for use as an artificial kidney system to the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration and hemodiafiltration. Recall # Z-1622-2011
CODE
Lot numbers: 10HU02012, Expiration Date: 06/30/2013; and 10LU02016, Expiration Date: 09/30/2013.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fresenius Medical Care Holdings, Inc., Waltham, MA, by telephone and follow-up letter on February 16, 2011.
Manufacturer: Fresenius Medical Care, North America, Ogden, UT. Firm initiated recall is ongoing.
REASON
There is an increased risk of an internal blood leak.
VOLUME OF PRODUCT IN COMMERCE
38,364 units
DISTRIBUTION
Nationwide and Canada
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PRODUCT
AFFIXUS Lag Screw Drill, REF 2112-01-303, Non-Sterile. Recall # Z-1643-2011
CODE
Lot #s: E2FGT4, E2FGS4, E28D64, E2FGR4, E2FGP4, and EL8EN4
RECALLING FIRM/MANUFACTURER
Recalling Firm: Depuy Orthopedics, Inc., Warsaw, IN, bytelephone onJanuary 12, 2011 and January 14, 2011.
Manufacturer: Symmetry Medical USA, Inc., Warsaw, IN. Firm initiated recall is ongoing.
REASON
The firm received a complaint that the cannula for the drill is not the same size at both ends. The drill is grabbing the guidewire and advancing and not allowing to finish reaming, resulting in the possibility of the guide wire progressing through and penetrating the acetabulum.
VOLUME OF PRODUCT IN COMMERCE
296 units
DISTRIBUTION
Nationwide and Switzerland
___________________________________
PRODUCT
Stryker Biotech OP-1 Putty (OP-1, BMP-7, bone morphogenetic protein) a) Catalog numbers: 300-50, b) Catalog numbers: 300-55. OP-1 Putty is authorized by Federal law for use as an alternative to autograft in compromised patients requiring revision posterolateral (intertransverse) lumbar spinal fusion, for whom autologous bone and bone marrow harvest are not feasible or are not expected to promote fusion. Examples of compromising factors include osteoporosis, smoking and diabetes. Recall # Z-1727-2011
CODE
a) Lot Number Expiry Date FC0902004 8/31/2009 FC0902005 8/31/2009 FC0903002 8/31/2009 FC0903004 8 /31/2009 FC0903005 8/31/2009 FC0905003 3/31/2010 FC0905005 3/31/2010 FC0906002 4/30/2010 FC0907002 4/30/2010 FC0907005 4/30/2010 FC0908001 4/30/2010 FC0908003 2/28/2010 FC0908004 4/30/2010 FC0908006 4/30/2010 FC0909005 4/30/2010 OP-1; b) Lot Number Expiry Date FC0909002 8/31/2010 FC0909003 8/31/2010 FC0909004 8/31/2010 FC0909008 8/31/2010 FC0909009 8/31/2010 FC0909012 8/31/2010 FC0909013 8/31/2010 FC0910003 8/31/2010 FC0910004 8/31/2010 FC0911001 8/31/2010 FC0911002 8/31/2010 FC0912002 8/31/2010 FC0912004 8/31/2010 FC1001002 8/31/2010 FC1002001 8/31/2010 FC1002004 8/31/2010 FC1002005 8/31/2010 FC1003001 10/31/2010 FC1003003 10/31/2010 FC1004001 10/31/2010 FC1005001 10/31/2010 FC1005002 10/31/2010 FC1005003 10/31/2010 FC1006001 10/31/2010 FC1007001 1/31/2012 FC1007004 1/31/2012 FC1007005 1/31/2012 FC1007006 1/31/2012 FC1007007 1/31/2012 FC1008001 1/31/2012 FC1008002 1/31/2012 FC1009002 1/31/2012 FC1009004 1/31/2012 FC1009005 1/31/2012
RECALLING FIRM/MANUFACTURER
Stryker Biotech, Hopkinton, MA, by letter on October 15, 2010. Firm initiated recall is ongoing.
REASON
A change to the Preparation for Use section was identified where 2.5cc was replaced with 2cc-3cc volume and was not approved.
VOLUME OF PRODUCT IN COMMERCE
2,861 units
DISTRIBUTION
Nationwide
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PRODUCT
Dimension(R) Creatinine Flex(R) Reagent Cartridges The CREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma, and urine on the Dimension Vista System. Catalog Number DF33A. Recall # Z-1729-2011
CODE
Lots BB1286, CA1260 and FB1251
RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc., Newark, DE, by letter dated December 2010. Firm initiated recall is ongoing.
REASON
Firm has confirmed the potential for falsely elevated creatinine results with specified CREA Flex(R) reagent cartridge lots when processing tests from a well that has been punctured. This issue may affect creatinine results for quality control (QC) and patient samples.
VOLUME OF PRODUCT IN COMMERCE
20,177 units
DISTRIBUTION
Nationwide, Austria, Belgium, Bosnia and Herzegovina, Canary Islands, Croatia, Czech Republic, Egypt, Estonia, France, Germany, Great Britain, Greece, Hungary, Italy, Latvia, Lithuania, Kuwait, Macedonia, Morocco, Norway, Poland, Portugal, Qatar, Romania, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Switzerland, Turkey and the United Arab Emirates
___________________________________
PRODUCT
Stratus(R) CS Acute Care Troponin I TestPak, Troponin I Assay. The Stratus(R) CS Acute CareTM Troponin I method (CTNI) is an in vitro diagnostic test for the measurement of cardiac Troponin I in heparinized plasma. Cardiac Troponin I measurements can be used as an aid in the diagnosis of acute myocardial infarction (AMI). Cardiac Troponin I can also be used as an aid in the risk stratification of patients with acute coronary syndromes (ACS) with respect to their relative risk of mortality. Recall # Z-1732-2011
CODE
Lot #s: 230347002, 230340002, 230333002, 230326002, 230319002, 230312002, 230305002, 230298002, 230284002, 230277002, 230270002, 230263002, 230256002, 230250002, 230242002, 230236002, 230227002, 230214002, 230207002, 230201002 and 230200002
RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc., Newark, DE, by letter dated December 2010. Firm initiated recall is ongoing.
REASON
Low frequency of non-repeatable falsely elevated CTNI results without an associated error message.
VOLUME OF PRODUCT IN COMMERCE
11,635 units
DISTRIBUTION
Nationwide, and Algeria, Armenia, Australia, Austria, Bahrain, Bangladesh,Belgium, Bosnia & Herzegovina, Canada, Canary Islands, Czech Republic, Cyprus, Croatia, Denmark, Finland, France, Germany, Great Britain, Greece, Guadeloupe, Indonesia, India, Israel, Ireland, Italy, Japan, Libya, Malaysia, Morocco, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Arab Emirates
___________________________________
PRODUCT
Abbott brand CELL-DYN Emerald Hematology Analyzer System; List Numbers: 09H39-01; The product is manufactured in France. The CELL-DYN Emerald is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories. Recall # Z-1733-2011
CODE
All serial numbers.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Santa Clara, CA, by letters dated March 23, 2010 and a follow-up letter dated July 1, 2010. Firm initiated recall is ongoing.
REASON
Abbott has determined that gain settings for the non-standard specimen types may not match the gain settings for the standard specimen type. There is the potential for impact to product performance.
VOLUME OF PRODUCT IN COMMERCE
891 units
DISTRIBUTION
Nationwide, and Australia, Brazil, Canada, Columbia, Dominican Republic, Germany, Puerto Rico, Singapore, South Korea, St. Eustalius & St. Martin, and Turks & Caicos
___________________________________
PRODUCT
115V Blanketrol III a) Model 233 Hyper/Hypothermia System, Part number: 86107; and 115V; b) CoolBlue Model 25-01 Hyper/Hypothermia System, Part number: 86000. Used to lower or to raise a patient's temperature and/or maintain a desired patient temperature through conductive heat transfer. Recall # Z-1817-2011
CODE
a) Serial Numbers: 061-3-00001 through 101-3-01389 and b) Serial Numbers: 073-CB-00001 through 094-CB-00138
RECALLING FIRM/MANUFACTURER
Cincinnati Sub-Zero Products Inc., Cincinnati, OH, by letters dated October 18, 2010. Firm initiated recall is ongoing.
REASON
The firm initiated this recall due to changes that have been made to the Blanketrol III Model 233 device's Operation and Operation/Technical Service Manuals, in order to stay in compliance with labeling regulations.
VOLUME OF PRODUCT IN COMMERCE
763 - 115V Blanketrol III Model 233; & 133 - 115V CoolBlue Model 25-01
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Access Thyroglobulin Antibody II, Part Number: A32898 The Access Thyroglobulin Antibody II (TgAb) assay intended use is for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems. Recall # Z-1818-2011
CODE
Lot Number: 012741, 014751, 016551, 016838
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter on January 26, 2011.
Manufacturer: Beckman Coulter, Inc., Chaska, MN. Firm initiated recall is ongoing.
REASON
The recall was initiated after Beckman Coulter confirmed customer reports of reagent pack to pack variability for the Access Thyroglobulin Antibody II (TgAb) reagent lot numbers identified in the recall. Erroneous results for patient and quality control samples can be generated. The Thyroglobulin Antibody II (TgAbII) reagent lots may produce: (1) Erroneously high TgAb results for both quality control and patient samples; (2) Erroneously low TgAb results when the affected pack is used to calibrate the assay, and quality control and patient samples are read from an unaffected pack. False high results could affect or delay diagnosis or treatment, including unnecessary additional diagnostic testing. False low results could affect or delay diagnosis or treatment, including delay in detection of thyroid cancer recurrence.
VOLUME OF PRODUCT IN COMMERCE
5,223 units (1,800 in US)
DISTRIBUTION
Nationwide and Argentina, Armenia, Australia, Belgium, Brazil, Bulgaria, Canada, China, Czech Republic, France, French Polynesia, Georgia, Germany, Greece, Hungary, Israel, Italy, Kazakhstan, Kuwait, Lebanon, Morocco, Netherlands, New Zealand, Oman, Poland, Puerto Rico, Romania, Russian Federation, Serbia, South Africa, Spain, Switzerland, Taiwan, Tunisia, Turkey, Ukraine, United Arab Emirates, Yemen
___________________________________
PRODUCT
Extended Brilliance Workstation (EBW) a component of the Computed Tomography X-Ray System Model Numbers EBW (CT) 728260 & EBW (Portal) 728269. The Extended Brilliance Workplace�� (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories. The EBW is also provided as a component of PET/CT and SPECT/CT systems, performing the same function as indicated above (also referred to as the NM EBW). Model Numbers EBW (CT) 728260 & EBW (Portal) 728269. EBW and NM EBW. Recall # Z-1819-2011
CODE
Software versions v2.0.5, v2.0.11. v3.0, v3.0.1, v3.0.2, v3.5, v3.5.2, v3.5.3, v3.5.4, v3.5.35, v4.0.1, v4.0.2, v4.0.3, v4.5.1 and Brilliance Workspace Portal v2.5.1.17, v2.5.1.19
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter dated September 29, 2010. FDA initiated recall is ongoing.
REASON
The firm determined that the functional analysis feature in the Comprehensive Cardiac Analysis (CCA) was displaying incorrect values on the polar fields. The calculated results for the myocardial wall thickening was incorrect in that the numbers displayed for "Wall Thickening" actually represent a reduction in wall thickness from ES to ED.
VOLUME OF PRODUCT IN COMMERCE
2,068 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
The Brilliance 64 is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes; Model #728231. Recall # Z-1820-2011
CODE
Serial #: 9089, 9551, 9548
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter dated January 31, 2011. FDA initiated recall is ongoing.
REASON
During the version 2.6 software upgrade, the system was not recalibrated with the infant phantom for the infant protocol.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
CO, IN, TN, Norway, Israel, and Germany
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PRODUCT
24k Arthroscopy Outflow/Suction Tubing Set***REF 24k100***Qty 1***MADE IN USA***Rx Only. For use in conjunction with the ConMed Linvatec 24k Pump, for pump-induced outflow and/or suction of fluid from the joint during arthroscopic procedures. Recall # Z-1821-2011
CODE
Lot: 22747-000, 22748-000, 22749-000
RECALLING FIRM/MANUFACTURER
Recalling Firm: Linvatec Corp., dba ConMed Linvatec, Largo, FL, by letter on/about September 13, 2010.
Manufacturer: Harmac Medical Products, Inc., Buffalo, NY. Firm initiated recall is ongoing.
REASON
The 24k100 Arthroscopy Outflow/Suction Tubing Set may have been incorrectly assembled and could potentially allow waste to enter the sterile field.
VOLUME OF PRODUCT IN COMMERCE
4,598 units
DISTRIBUTION
Nationwide, Saudi Arabia, Italy, France, Canada, Portugal, South Africa, Switzerland, Denmark, Germany, New Zealand, Australia, and Spain
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PRODUCT
Ossur Total Knee, Model Number: 2100 The Total Knee 2100 is an external prosthetic knee joint. It is a polycentric knee designed for multi-speed ambulators, higher impact levels and heavier loads. Recall # Z-1822-2011
CODE
Serial Numbers (new units):13241, 13243, 13245, 13246, 13247, 13248, 13251, 13252, 13253, 13254, 13255, 13256, 13259, 13260, 13261, 13262, 13263, 13264, 13265, 13266, 13267, 13268, 13269, 13270, 13271, 13272, 13282, 13284, 13285, 13286, 13287, 13289, 13290, 13293, 13296, 13297, 13298, 13300, 13301, 13302, 13304, 13306, 13307, 13308, 13309, 13310, 13311, 13312, 13313, 13314, 13315, 13317, 13318, 13319, 13320, 13321, 13322, 13323, 13324, 13325, 13326, 13327, 13329, 13330, 13331, 13332, 13333, 13334, 13335, 13336, 13337, 13338, 13339, 13340, 13341, 13342, 13344, 13345, 13346, 13347, 13348, 13349, 13350, 13351, 13352, 13353, 13354, 13358, 13360, 13363, 13364, 13365, 13368, 13369, 13370, 13371, 13372, 13373, 13374, 13375, 13376, 13377, 13378, 13379, 13380, 13381, 13384, 13385, 13386, 13387, 13393, 13394, 13395, 13397, 13399, 13400, 13401, 13407, 13409, 13410, 13411, 13412, 13413, 13414, 13415, 13416, 13417, 13418, 13420, 13431 Repairs units: 9611, 10325, 10616, 11615, 11747, 11795, 12091, 12092, 12097, 12098, 12101, 12104
RECALLING FIRM/MANUFACTURER
Ossur Engineering, Inc., Albion, MI, by letter on February 11, 2011. Firm initiated recall is ongoing.
REASON
Some units of the Total Knee 2100 produced from October 19th, 2010 until January 21st 2011, contained back links that may compromise knee function prematurely.
VOLUME OF PRODUCT IN COMMERCE
142 units
DISTRIBUTION
CA, CO, FL, LA, MD, MI, MO, NJ, NY, OH, TN, VA, WA, Australia, Canada, Czech Republic, Germany, France, United Kingdom, Ireland, Italy, Japan, The Netherlands, Russian Federation, Sweden and Turkey
___________________________________
PRODUCT
1) Phoenix x/ray analyser series. Phoenix x|ray analyser series cabinet x-ray systems are used in non-destructive testing, failure analysis, process control, and metrology. Recall # Z-1825-2011;
2) Phoenix x/ray inspector series. Phoenix x|ray inspector series cabinet x-ray systems are used in non-destructive testing, failure analysis, process control, and metrology. Recall # Z-1826-2011;
3) Phoenix x/ray v/tome/x series. Phoenix x|ray v|tome|x series cabinet x-ray systems are used in non-destructive testing, failure analysis, process control, and metrology. Recall # Z-1827-2011
4) Phoenix x/ray nanotom series. Phoenix x|ray nanotom series cabinet x-ray systems are used in non-destructive testing, failure analysis, process control, and metrology. Recall # Z-1828-2011
CODE
All affected units.
RECALLING FIRM/MANUFACTURER
GE Inspection Technologies, LP, Lewistown, PA, by letter on March 16, 2009. Firm initiated recall is ongoing.
REASON
Some of the systems do not have a safety interlock on the service access panel. Although the systems have two independent means for indicating when x-rays are being generated, some systems may have one indicator that is not discernible. Also, some systems lack proper placement of a caution label and others do not have this label affixed.
VOLUME OF PRODUCT IN COMMERCE
118 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Interventional Pain 6" 13 G (2.4 mm) Percutaneous Discectomy Probe, REF 407-265, Sterile. The DeKompressor Percutaneous Discectomy Probe is intended for use in the apiration of disc material during percutaneous discectomies in the lumbar, thoracic, and cervical regions of the spine. Recall # Z-1829-2011;
2) Interventional Pain 6" 15 G (1.85 mm) Percutaneous Discectomy Probe, REF 407-266, Sterile, Stryker Instruments, Kalamazoo, MI. The DeKompressor Percutaneous Discectomy Probe is intended for use in the apiration of disc material during percutaneous discectomies in the lumbar, thoracic, and cervical regions of the spine. Recall # Z-1830-2011
CODE
1) and 2) Lot #: 10214012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Instruments Division of Stryker Corp., Kalamazoo, MI, by letter dated February 3, 2011.
Manufacturer: Stryker Instruments, Arroyo, PR. Firm initiated recall is ongoing
REASON
The firm received five complaints that the stylet did not fit down the cannula. The investigation revealed that the incorrect probe assembly was packaged for two DeKompressor part numbers with the lot number of 10214012.
VOLUME OF PRODUCT IN COMMERCE
44 units
DISTRIBUTION
PA, NY, KS, NJ, TX, MI, OK, FL, Italy and Switzerland
___________________________________
PRODUCT
The enGenTM Laboratory Automation System consists of 3 main components including Instrument Management Subsystem (Instrument Manager), Automated Track Subsystem (TCAutomation) and Configuration File developed by Ortho-Clinical Diagnostics (OCD). The Instrument Manager is a Windows-based software product that operates on a Pentium-class (or higher) PC processor. The instrument management subsystem is capable of connectivity with clinical analyzers, a Laboratory Information Systems (LIS), barcode label printers and other third party devices. The TCAutomation is a pre-analytical and post-analytical sample management system. The configuration file enables operational support of the site specific layout and instrument selection. The VITROS 5, 1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric Immunoassay methods.) Recall # Z-1831-2011
CODE
enGenTM Laboratory Automation Systems with TCAutomation Software Versions 3.1.1 and below. Parallel Bypass for Vitros 5.1 FS AT (VITROS 5, 1 FS Chemistry System, VITROS 5600 Integrated System and CITROS 3600 Immunodiagnostics System use this bypass) Parallel Bypass for Vitros 950 Perpendicular Bypass for Vitros 250 Perpendicular Bypass for Vitros 5, 1 FS AT Parallel Bypass for Advia Centaur Parallel Bypass for Abbott Architect i2000
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ortho-Clinical Diagnostics, Rochester, NY, by letter dated January 27, 2011.
Manufacturer: Thermo Electron Oy, Vantaa, Finland. Firm initiated recall is ongoing.
REASON
A software anomaly that can occur with analyzers connected to the Bypass modules listed below on an enGen" Laboratory Automation System using TCAutomation" Software Version 3.1.1 and below. When this anomaly occurs, it is possible for a sample other than the intended sample to be aspirated, potentially leading to test results being assigned to the wrong patient without error notification.
VOLUME OF PRODUCT IN COMMERCE
63 units
DISTRIBUTION
Nationwide, Canada, Chile, England, France, Germany, Italy, Mexico, Singapore and Spain
___________________________________
PRODUCT
Acuson S2000 Ultrasound System with software and imaging. The Acuson S2000 ultrasound imaging systems are intended for these applications: fetal, abdominal, intraoperative, pediatric, small parts, transcranial, OB/GYN, cardiac, pelvic, neonatal/adult cephalic, vascular, musculoskeletal, superficial musculoskeletal, and peripheral vascular applications. Also for anatomical structures and calculation packages that provide information that provide information to the clinician...for clinical diagnosis purposes. Recall # Z-1832-2011
CODE
Material number 10041461 Serial Numbers: 200375 200906 201441 201447 201502 201504 201505 201949 200223 200189 200231 200238 200355 200596 200597 200813 200815 200790 200785 200784 200923 201255 201358 201526 201703 201777 201805 200212 200301 200304 200356 200388 200435 200660 200661 200687 200719 200917 200920 200918 200919 201045 201049 201125 201200 201394 201666 201921 201932 201990 201988 202046 202071 200651 200846 200903 200956 200988 201015 201012 201093 201332 201390 201600 201527 201725 201947 201801 200800 201936 201092 201117 200288 200252 200334 200591 200593 200599 200583 200926 200979 200995 201113 200175 200211 200216 200263 200262 200259 200261 200299 200341 200405 200561 200568 200541 200696 200708 200716 200718 200859 200862 200861 200868 200856 200895 200894 200910 200743 200939 200932 200944 201099 201192 201334 201378 201384 201374 201408 201569 201563 201590 201952 202042 200741 200742 200314 201191 201807 201808 202112 200835 200839 200834 201057 201044 200999 201018 201014 201203 201042 201105 201196 201229 201207 201230 201234 201241 201240 201245 201246 201244 201265 201247 201248 201250 201237 201269 201079 201143 201199 201223 201253 201249 201300 201317 201451 201456 201448 201426 201454 201396 200748 201449 201457 201455 201450 201421 201431 201512 201522 201462 201496 201520 201521 201528 201534 201539 201542 201545 201562 201482 201489 201509 201538 201536 201514 201561 201564 201530 201517 201500 201572 201328 201571 201567 201541 201543 201547 201566 201580 201578 201577 201573 201579 201589 201586 201721 201740 201741 201738 201796 201733 201855 201834 201860 201890 201863 201704 201835 201881 201901 201853 201729 201866 201810 201910 201903 201924 201913 201904 201826 201830 201831 201849 201908 201902 201925 201927 201923 201912 201966 201974 201941 201970 201968 201972 201977 201939 201959 201967 201911 201962 201955 201960 201965 201956 201983 202015 200728 202078 200664 200849 200928 201190 201622 201624 201642 201712 200613 200165 200183 200173 200176 200184 200206 200128 200182 200235 200229 200380 200052 200458 200412 200495 200307 200587 200210 200652 200642 200650 200654 200658 200659 200662 200283 200671 200677 200684 200688 200686 200694 200710 200720 200118 200698 200697 200810 200809 200786 200852 200749 200767 200103 200108 200829 200838 200623 200845 200863 200867 200143 200870 200892 200888 200890 200907 200877 200908 200929 200934 200104 200169 200946 200948 200953 200927 200958 200832 200975 200980 201005 200996 201010 200145 200217 201085 201098 201114 201115 200967 201148 201163 201161 201173 201186 201187 201152 201138 201094 201212 201220 201222 201225 201242 201243 201131 201295 201251 201127 201308 201201 201272 201259 201252 400144 200120 201367 201370 201388 201453 200151 201468 201476 201458 200166 201464 201623 201619 201629 201615 201630 201628 201653 201651 201525 200209 200333 200116 201635 201668 201659 201724 201770 201784 201785 201791 201820 201817 201800 201845 201877 201899 200876 201929 201945 201934 201938 201948 201996 201971 201999 202000 201997 201928 202081 202080 202051 201734 202077 202085 201950 202105 200754 201819 201909 200178 200241 201814 201842 201174 201347 200207 200246 200242 200402 200469 200378 200692 200691 200757 200789 201460 201812 201813 201847 201856 202057 202070 200554 200588 200584 200594 200751 200770 200828 200130 200319 200323 200376 200370 200371 200352 200386 200390 200439 200339 200460 200497 200493 200475 200472 200553 200644 200649 200668 200673 200676 200682 200678 200707 200693 200702 200685 200733 200734 200730 200794 200783 200782 200805 200774 200452 200904 200899 200896 200891 200898 200913 200950 200762 200971 201003 201059 201061 201060 201066 200902 200880 201083 201082 201100 201126 201128 201133 201147 201135 201145 201155 201154 201217 201198 201108 201176 200881 201205 200796 201089 201123 201304 201348 201349 201380 200110 201466 200221 200215 201621 200188 201513 201658 201671 201680 201709 201818 201873 201951 201870 201803 201991 201998 201995 201985 202041 200167 202058 202052 201811 200001 200102 200106 200213 200236 200239 200258 200256 200244 200296 200397 200392 200470 200485 200571 200463 200665 200713 200732 200721 200736 200781 200854 200930 200931 200933 200952 200965 200951 200954 200955 200957 200977 200978 200989 200993 200997 201000 200984 200985 200960 200983 200987 200990 201035 201038 201025 201080 201090 201097 200976 201016 201162 201062 201124 201132 201171 201184 201166 201172 201179 201177 201063 201204 201195 201309 201313 201303 201218 201284 201377 201437 201226 201444 201465 201544 201554 201531 201533 201535 201656 201672 201679 201695 201837 201840 201844 201862 201833 201935 201940 201872 201876 201828 202048 202059 202054 202056 202084 202082 202005 202004 200795 200850 201711 201869 200974 200746 200291 200267 200788 200778 201189 200208 200912 201307 201301 201305 201381 201368 201443 201897 202049 200395 201081 201182 201194 201323 201329 201434 201432 201540 201515 201593 201756 202018 200237 200265 200257 200264 200273 200359 200483 200491 200585 200459 200524 200441 200503 200529 200639 200723 200737 200792 200844 200822 200821 200637 200826 200869 200860 200871 200961 201056 201067 201130 201156 201004 201467 201485 201486 201493 201700 201749 201783 201792 201178 201888 201994 201993 202053 201958 201327 201315 201356 200477 200284 200364 200462 200423 200468 200476 200487 200479 200739 200740 200818 200969 200655 201101 201258 201391 201400 201401 201404 201373 201359 201405 201511 201399 201617 201627 201633 201637 201742 202006 202013 202072 202067 202124 202130 202110 202151 202135 201336 200187 200440 200218 200385 200621 200653 200663 200647 200853 200864 200900 200901 200689 201185 201383 200146 201524 201743 201829 202032 202088 200198 201110 200484 201423 201616 201705 202007 200312 200426 200421 200427 200429 200428 200494 200945 200959 201268 201331 201369 201361 201402 201613 201643 201644 201657 200234 200413 200354
200406 200220 200449 200643 200641 201746 201744 201747 202030 200548 200557 200801 200808 201054 201029 201030 201048 201037 201039 201031 201052 201053 200949 201034 201036 201046 201050 201047 201027 201028 201752 201861 200225 200595 200648 200704 200787 200797 200779 201634 201815 201839 201884 201883 200332 200292 200598 200806 200766 200884 200885 200886 200887 200941 200922 201239 201346 201398 201403 201647 201683 201694 201698 201706 201715 201693 201696 201707 200776 200248 200317 200417 200937 201206 201314 201379 201507 201745 201879 201920 200274 201321 201041 201342 201436 201495 201503 201506 201529 201618 201606 201609 201594 201636 201640 201641 201648 201865 202016 201907 200758 200744 201121 201523 201546 201854 202079 200745 202051 200164 200121 200201 200179 210001 200204 200180 200139 200202 200197 200193 200205 200272 200268 200290 200243 200408 200430 200431 200434 200447 200442 200450 200456 200478 200353 200496 200550 200549 200533 200532 200534 200679 200681 200690 200724 200760 200769 200763 200765 200843 200827 200905 200924 200840 201120 201146 201235 201311 201338 201397 201324 201821 200129 201395 201211DEL 201211 201915 201946 202045 202047 202102 201992 200107 200602 201499 200358 200657 201064 200798 201392 201498 201689 201690 201691 201702 201710 200966 200972 200177 200393 200331 200398 200383 200382 200416 200520 200521 200522 200528 200572 200556 200547 200573 200562 200510 201682 201684 201713 201788 201789 201790 201780 201802 202062 202060 202104 200909 201103 201263 201257 201353 201345 201352 201371 201393 201652 201697 201763 201825 201827 200604 200009 200271 200101 200111 200114 200109 200119 200117 200124 200126 200138 200140 210002 200113 200133 200137 200162 200163 200171 200174 200157 200149 200190 200172 200181 200195 200250 200222 200249 200232 200233 200144 200245 200251 200254 200230 200228 200240 200224 200282 200295 200305 200303 200308 200266 200306 200271 200297 200311 200310 200294 200277 200309 200318 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201084 201086 201078 201088 201095 201091 201102 201106 200837 201111 201043 201071 201074 201072 201070 201073 201139 201136 201142 200759 201134 201137 201167 201033 201158 201159 201160 200260 200986 200486 201011 201175 201169 201116 201153 201109 200755 201165 201170 201183 200982 201188 200645 201197 200831 201149 201112 200131 201150 201181 201208 201087 201216 201219 201213 201232 201122 201151 201209 201233 201231 201238 201236 201227 200576 201260 201261 201266 201270 201285 201157 201274 201277 201282 201264 201286 201278 201267 201288 200134 201298 201289 201290 201292 201293 201294 201279 201283 201281 201287 201271 201296 201297 201299 201273 201276 201119 201319 200387 201107 201202 201316 201193 201228 200409 201262 201322 201326 201312 201214 200994 200363 201118 201180 201256 201291 201330 200578 201333 201337 201340 201341 201343 201344 201221 201350 201357 201366 201372 201363 201364 201365 201355 201376 201375 201360 201386 201387 201362 201385 200349 200448 200628 201389 200123 200425 201224 201254 201354 201318 201382 201096 201215 201427 201428 201409 201306 201407 201410 201422 201433 201424 201430 201129 201275 201351 201040 201435 201438 201439 201440 201445 201446 200227 200511 201459 201442 201473 201470 201472 201461 200443 201474 201475 201477 201478 201479 201463 201339 201483 201484 201471 201518 201480 201487 201494 201516 201519 201452 201552 201553 201557 201568 201537 201510 201555 201335 201558 201570 201560 201556 201481 201548 201549 201575 201574 201592 200727 201406 201425 201488 201583 201584 201591 201595 201532 201585 201565 201599 201602 200321 201581 201610 201612 201603 201608 201429 201550 201607 201582 201587 201501 201559 201596 201588 201597 201598 201605 201601 201614 200419 200726 201632 201551 201620 201638 201626 201639 201625 201655 201646 201649 201650 200278 201611 201667 201662 201660 201664 201631 201661 201669 201670 201673 201674 201675 201678 201677 201676 201686 201685 201687 201688 201719 201699 201717 201701 201731 201708 201714 201720 201727 201728 201692 200132 201748 201750 201754 201755 201104 201751 201722 201757 201760 201758 200360 201759 201732 201762 201761 201764 201769 201779 201773 201771 201776 201772 201774 201726 201778 201767 201786 201681 201782 201781 201804 201806 201663 201765 201794 201736 201737 201787 201739 201797 201766 201809 201795 201816 201824 201753 201793 201823 201875 201880 201857 200320 201843 201885 201868 201878 200191 200858 200875 201851 201900 201838 201848 201850 201832 201858 201859 201836 201852 201905 201906 201864 201896 201841 201871 201846 201891 200329 200399 200992 201898 201914 201917 201918 201916 201922 201919 201933 201930 200105 200656 201887 201964 201969 200135 201892 201882 200168 201943 201978 201953 201942 201894 201931 201973 201984 200467 201986 202020 202021 202025 202023 202019 202024 202014 201989 202003 202009 201867 201957 202026 202027 202028 201325 202034 202035 202036 202037 202039 202031 202002 202011 202012 202038 202043 202001 202010 202076 202066 202068 202086 202093 202094 202095 202087 202089 202096 202116 202083 202097 202100 201723 202065 202101 202122 202126 202107 200411 200287 201775 202117 202137 202125 202142 202138 202132 202121 202136 202111 202133 202139 202148 200455 200897 200814 202064 200847 201645 201718 200159 200203 201077 201144 201164 201302
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Mountain View, CA, by letter on February 16, 2010. Firm initiated recall is ongoing.
REASON
Any 2D measurement performed in Exam Review or offine, on a zoomed Retrospective clip capture may be erroneous. This applies to 2D, 2D/PW, 2D/CW and 2D/M-mode.
VOLUME OF PRODUCT IN COMMERCE
1,903 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
REF 32-485050 Vanguard Knee Instrumentation Microplasty Slidex Anterior/Posterior, Qty: 1; The guide is used for femoral sizing - Neutral or 3 degree femoral rotation feet are attached to the slidex AP sizing guide. Recall # Z-1833-2011
CODE
Lot #: 32-485050; Lot #: SA10 81254
RECALLING FIRM/MANUFACTURER
Recalling firm: Biomet, Inc., Warsaw, IN, by letter dated February 11, 2011.
Manufacturers: Sandvik Medical Solutions Ltd, Sheffield, United Kingdom;
Biomet U.K., Ltd., Bridgend, South Wales, United Kingdom.
Firm initiated recall is ongoing.
REASON
Biomet has initiated this action due to the scale on the stylus of the Vanguard MP Slldex AP Sizer being incorrect for this assembly resulting in the scale being out of position.
VOLUME OF PRODUCT IN COMMERCE
17 units
DISTRIBUTION
UK, Malta, the Netherlands, Italy, Turkey, Switzerland
___________________________________
PRODUCT
Coherence Dosimetrist, version 2.2. Intended use: Medical charged-particle radiation therapy system. a) Part No. 081239953, b) SPI Patch, Part No. 08164365. Recall # Z-1834-2011
CODE
a) Version 2.2, b) Version 2.2.23
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Concord, CA, by letter beginning November 2009. Firm initiated recall is ongoing.
REASON
Software defect problem is repeatable.
VOLUME OF PRODUCT IN COMMERCE
60 units
DISTRIBUTION
CA, KY, MI, NJ, TN, Canada and Mexico
___________________________________
PRODUCT
Triathlon PKR Peg Drill, Catalog Number: 5650-4-512 (Size 1-2 Peg Drill); Catalog Number: 5650-4-536 (Size 3-6 Peg Drill); The Triathlon-PKR Knee System is indicated for primary partial knee resurfacing (PKR). This system utilizes two fixation pegs on the femoral component for fixation and alignment. To prepare for these features, a peg drill, drill guide, and drill through femoral trial are provided. The femoral Trial Drill Guide is attached to the Modular Handle and assembled into the holes on the articulation surface of the Femoral Trial. Using the appropriately sized Peg Drill (Small Drill for sizes 1-2, Large Drill for sizes 3-6), both holes are drilled. The Peg drill is advanced until the step on the drill makes contact with the front face of the Femoral Trial Drill Guide. Recall # Z-1835-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters on February 9, 2011, and February 10, 2011. Firm initiated recall is ongoing.
REASON
Stryker Orthopaedics has identified a trend of complaints involving reports of the peg drill cold welding to the drill guide, causing the Peg Drill to cease functioning. If cold welding of these components occurs, the following potential patient and/or surgeon or surgical staff harms may result.
VOLUME OF PRODUCT IN COMMERCE
5650-4-512- 754 units ; 5650-4-536 - 880 units
DISTRIBUTION
Nationwide, Sweden, Germany; France, Portugal, UK, Canada, Australia, and New Zealand
___________________________________
PRODUCT
1) ACUSON and SONOLINE Antares and Antares PE ultrasound systems at product versions 4.0 and 5.0 with cardiovascular options installed; ACUSON Antares 4.0 & 5.0: 10032747, 10037592, 10040728; ACUSON Antares PE 4.0 & 5.0: 10032746, 10037591, 10038202, 10040729; SONOLINE Antares 4.0 & 5.0: 05936518, 08653771, 10037593; Antares Cardio Options: 10036613, 10036588, 10036585, 10436250; The ACUSON Antare is a general purpose Diagnostic Ultrasound system. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in: B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, Harmonic Imaging, or 3D/4D imaging on a FPD display. The Antares ultrasound imaging system is intended for the following applications: Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Intravascular, Musculoskeletal, Superficial Musculoskeletal, Great Vessel, and Peripheral Vascular applications. The system also provides for the measurement of anatomical structures that provide information that is used for clinical diagnosis purposes. Recall # Z-1836-2011;
2) ACUSON S2000 ultrasound systems (all versions) with cardiovascular options installed; ACUSON S2000: 10041461; S2000 Cardio Option: 10041853; The ACUSON S2000 Ultrasound System is a multi-purpose mobile, software controlled diagnostic ultrasound system with and on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D/4D Imaging on a Flat Panel Display. The ACUSON S2000 ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transrectal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. Recall # Z-1837-2011;
3) ACUSON X300, X300 PE and SONOVISTA X300 (all versions) with cardiovascular options installed; ACUSON X300: 10037409, 10132987, 10038837; SONOVISTA X300: 10133170; ACUSON X300 PE: 10348531, 10348532, 10348533; X300 Cardiovascular Options: 10133037, 10348777, 10349032, 10427797, 10427822 10427816, 10563788; The Siemens Acuson X300 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes. Recall # Z-1838-2011
CODE
All units of these models.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Mountain View, CA, by letter on August 17, 2010. Firm initiated recall is ongoing.
REASON
There is an error in the estimation of mean pressure gradient in the Cardiac measurement package. The currently implemented calculation will result in an underestimation of the mean pressure gradient (PGmean) when estimated from a trace of the Doppler waveform of the stenotic flow.
VOLUME OF PRODUCT IN COMMERCE
4,336 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
The VARIANT Sickle Cell Short Program ROM Card; The VARIANT Sickle Cell Short Program is designed as a qualitative screen for the presence of hemoglobins F, A, S, D, C and E in eluates of neonatal blood collected on filter paper by high-performance liquid chromatography. For in vitro diagnostic use. a) Catalog number 270-0500, which contains ROM Card b) Catalog # 270-0507. Rom Card is included in kit Lot number 70000349 and 70000353. Recall # Z-1846-2011
CODE
a) Lot numbers 70000349, 70000353, both with expiration dates of 6/30/2011, b) Lot # LA82418
RECALLING FIRM/MANUFACTURER
Bio-Rad Laboratories Inc., Hercules, CA, by letter dated April 22, 2010. Firm initiated recall is ongoing.
REASON
The presence of parameters for Version 40400-S on the labeled VARIANT Sickle Cell Short ROM Card instead of Version 80300-S.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
MD, NJ, UT, Italy, and Singapore
___________________________________
PRODUCT
BD Phoenix" Panel NMIC/ID-123, Catalog # 448723, packaged 25 panels/carton. The BD Phoenix Automated Microbiology System is intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The Phoenix system provides results for most aerobic and facultative anaerobic Gram negative bacteria of human origin with the use of the NMIC/ID-123 panel type. Recall # Z-1847-2011
CODE
Lot # 0223498 exp 8/31/2011
RECALLING FIRM/MANUFACTURER
Becton, Dickinson and Co., Sparks, MD, by letter dated January 28, 2011. Firm initiated recall is ongoing.
REASON
In vitro diagnostic test kit is defective and may cause false positive or false negative results.
VOLUME OF PRODUCT IN COMMERCE
377 cartons
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
HGBPROKIT which contains one meter and one container of 25 test strips. HGB TEST 100; HGB PRO TEST STRIPS -100, includes four containers of 25 test strips per container; International Technidyne Corporation The Hgb Pro Professional Hemoglobin Testing System Consists of a portable battery operated meter and single-use test strips for the quantitative measurement of total hemoglobin from capillary and venous whole blood. The Hgb Pro Professional Hemoglobin Testing System is designed for near patient testing in a professional facility and is not intended for home use. Recall # Z-1854-2011
CODE
F9HGS005A Exp Date 6/30/2011 F9HGS005B Exp Date 6/30/2011 F9HGS005E Exp Date 6/30/2011 F9HGS005G Exp Date 6/30/2011 F9HGS005H Exp Date 6/30/2011 F9HGS005I Exp Date 6/30/2011 G9HGS006C Exp Date 7/31/2011 G9HGS006D Exp Date 7/31/2011 G9HGS006E Exp Date 7/31/2011 G9HGS006F Exp Date 7/31/2011 G9HGS006H Exp Date 7/31/2011
RECALLING FIRM/MANUFACTURER
ITC-Nexus Dx, Inc., Edison, NJ, by letter dated January 21, 2011. Firm initiated recall is ongoing.
REASON
ITC has determined that results obtained using certain lots of Hgb Pro Professional Hemoglobin Test Strips may differ from results obtained using a reference hemoglobin testing system.
VOLUME OF PRODUCT IN COMMERCE
2,500 containers
DISTRIBUTION
Nationwide, India, Oman, South Africa, and Singapore
___________________________________
PRODUCT
Specialty Patella Milling System Per File K2399; Catalog Number I-K2399PR00, I-K2399PR10; The Xcelerate patella milling system (as detailed in surgical protocol LSPK35) was designed to prepare a patella to accept all Scorpio or Duracon patellar implants using either a resurfacing or recessed technique. Recall # Z-1862-2011
CODE
All lots
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letter dated January 27, 2011. Firm initiated recall is ongoing.
REASON
Stryker Orthopaedics has become aware that the 10 mm on the bone remaining depth gage is incorrect thus allowing for the reamer to leave as little as 8.9mm (in a nominal condition) patella bone.
VOLUME OF PRODUCT IN COMMERCE
52 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) a) Cardiac Marker Control Level 1, List Number 136601-06F12-02; b) Cardiac Marker Control Level 2, List number 136602/06F13-02; and 3) Cardiac Marker Control Level 3, List number 136603/06F14-02. Used to verify the integrity of newly received i-STAT cTnI cartridges. Recall # Z-1863-2011;
2) Cardiac Marker Control Calibration Verification Set, List number 136604/06F15-02. Used to verify the accuracy of results over the measurement range of the i-STAT cTnI test. Recall # Z-1864-2011;
CODE
1) a) Lot number M102081; 2) Lot number M102082; and 3) Lot number M102083;
2) Lot number M10208
RECALLING FIRM/MANUFACTURER
Abbott Point Of Care Inc., Princeton, NJ, by letters on December 17, 2010. Firm initiated recall is ongoing.
REASON
Presence of CO2 in the head space of the vial can result in the generation of high results in Cardiac Marker Control Level 1, 2, and 3 which is used along with the Cardiac Marker Control Calibration Verification Set.
VOLUME OF PRODUCT IN COMMERCE
2,917 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
CVS Pharmacy Plastic Sesame Street Adhesive Bandages; a sterile, latex free, assorted sizes with multiple designs adhesive bandages; 20 bandages per box, 24 boxes per case; Made in Egypt; REF CVS 826159, UPC 0 50428 95118 7 The device is used to cover and protect wounds. Recall # Z-1875-2011
CODE
Lot number 10J10
RECALLING FIRM/MANUFACTURER
Pharmaplast S.A.E., Kafr El Zayat, Gharbia, Egypt, by telephone on February 17, 2011 and letter dated February 21, 2011. Firm initiated recall is complete.
REASON
The bandages are labeled as sterile, but failed sterility testing.
VOLUME OF PRODUCT IN COMMERCE
5,336 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) CYTO-STAT� tetraCHROME" CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number: 6607013 Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3-/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5Al. Recall # Z-1876-2011;
2) CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5, Part Number: 6607073. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3-/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5Al. Recall # Z-1877-2011
CODE
All lots since 08/2003
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter dated September 27, 2010.
Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is ongoing.
REASON
A labeling error resulted in the specimen age stability and the prepared sample stability being stated incorrectly in the instructions for use. There is no impact to the product safety or functionality.
VOLUME OF PRODUCT IN COMMERCE
105,810 units
DISTRIBUTION
Nationwide and Albania, Australia, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Bosnia and Herzegovina, Bulgaria, Burundi, Cameroon, Chile, China, Colombia, Croatia, Czech Republic, Denmark, El Salvador, Finland, France, French Guiana, French Polynesia, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Republic of Kuwait, Libyan Arab Jamahiriya, Macao, Malaysia, Mexico, Monaco, Morocco, Namibia, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan Panama, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sudan, Sweden, Switzerland, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Uruguay
___________________________________
PRODUCT
1) King System , King LTSD Kit Size 4, non-sterile, REF KLTSD414. Ventilation during anesthesia during procedures of short duration. An oropharyngeal airway is a device inserted through the mouth to provide a patent airway. Recall: Z-1878-2011;
2) King System , King LTS-D Kit Size 5, Sterile, REF KLTSD405. Ventilation during anesthesia during procedures of short duration. An oropharyngeal airway is a device inserted through the mouth to provide a patent airway. Recall # Z-1879-2011
CODE
1) Unit: IV715;
2) Unit: 201011-169
RECALLING FIRM/MANUFACTURER
Recalling Firm: King Systems, Noblesville, IN, by letter dated January 24, 2011.
Manufacturer: Bates Industries, LLC, South Glens Falls, NY. Firm initiated recall is ongoing.
REASON
The products were below the specification for hardness. This could contribute to a higher incidence of problems during the insertion and final positioning of the airway in the patient. In rare instances the softness of the tube could cause the tube to fold over.
VOLUME OF PRODUCT IN COMMERCE
2,120 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Pouch/Carton Label: REF 5023-138***9.5 x 25.5 x 0.4mm***Qty 1***Micro Sagittal Blade, Fine***Sterile***Rx Only*** Made in USA*** To cut soft tissue or bone. Recall Z-1880-2011
CODE
Lot: 180209
RECALLING FIRM/MANUFACTURER
Linvatec Corp. dba ConMed Linvatec, Largo, FL, by letter dated November 30, 2010. Firm initiated recall is ongoing.
REASON
Some units of Micro Sagittal Blade, Fine from Lot 180209 may have compromised seals in the sterile packaging.
VOLUME OF PRODUCT IN COMMERCE
415 units
DISTRIBUTION
Nationwide, Canada, and South Africa
___________________________________
PRODUCT
1) iSite PACS with Advanced Visualization Tools (AVT) R7.4V6L1, Versions: 3.6.87, 3.6.92, 4.1.87, and 4.1.92; iSite PACS: iSite PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. iSite supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM: CT, MR, NM, US, XA, PET, DX, DR, RF, RT, MG, SC, VL, as well as hospital/radiology information systems. Recall # Z-1881-2011
2) iSite PACS with iSite ViewForum Applications, R7.4V6 L1 L2, L3, Versions: 3.6.96, 3.6.101, 3.6.110, 4.1.96, 4.1.101, and 4.1.110; ViewForum Applications: iSite ViewForum Applications is an image processing workstation software package designed to run on standard PC hardware. The hardware required is made up of "off-the-shelf" standard computer components. iSite ViewForum Applications software receives image data from medical scanning devices, such as CT and MRI, or from image archives. iSite ViewForum Applications performs viewing, image manipulation, communication, printing, and quantification of images. Recall # Z-1882-2011
CODE
All units
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems, Foster City, CA, by letter dated February 23, 2011.
Manufacturer: Philips Healthcare Informatics, Inc., Foster City, CA. Firm initiated recall is ongoing.
REASON
A software anomaly that occurs when clinicians use Volume Vision to view images in 3D and uses the measurement tool to measure regions of interest. This could lead to an incorrect interpretation of the measurements which could cause an incorrect diagnosis and incorrect treatment plan.
VOLUME OF PRODUCT IN COMMERCE
144 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
MDI(R), S.A.L.T. Airway Device, Supraglottic Airway Laryngopharyngeal Tube, Intended for use with 6.5mm -9.00mm ET tubes, Including SALT(TM) airway, ET tube clamp, Latex-free securing strap, Tongue blade, Lubricating jelly, NON STERILE, REF 79-580, Manufactured in the Dominican Republic of U.S. Materials Supraglottic Airway Laryngopharyngeal Tube which can be used to facilitate blind, endotracheal intubation. Recall # Z-1885-2011
CODE
Lot Numbers: C10259 and D103334
RECALLING FIRM/MANUFACTURER
Recalling Firm: Microtek Medical Inc., Columbus, MS, by letter dated January 17, 2011.
Manufacturer: Microtek Dominican, S.A., La Romana, Dominican Republic. Firm initiated recall is ongoing.
REASON
Product contains Triad Lubricating Jelly which was recalled.
VOLUME OF PRODUCT IN COMMERCE
223 cases of 10 units
DISTRIBUTION
AZ, CA, CT, FL, IN, MS, NC, NH, PA, TX and WI
___________________________________
PRODUCT
Harmony LA/LED Monitor Arm Adapter. Model Number: LB61 The Harmony LA/LED Monitor Arm Adapter is an accessory to the Harmony LA and LED Surgical Lighting System and is attached to the end of the monitor suspension arm to allow Customers to attach other medical devices, such as non-STERIS monitors, camera or other compatible items in place of the STERIS monitor. The Harmony Surgical Lighting and Media System is a family of variable pattern, variable intensity surgical lights designed to provide visible immunization of the surgical field or the patient and to provide audio-visual procedural support for the O.R. staff. The device is intended to be used by surgeons and other medical care practitioners in a surgical setting. Recall # Z-1886-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Steris Corp., Mentor, OH, by letter dated February 18, 2011.
Manufacturer: Steris Corp., Montgomery, AL. Firm initiated recall is ongoing.
REASON
The arm adapter does not contain labeling specifying the applicable weight and moment limitations of the arm adapter.
VOLUME OF PRODUCT IN COMMERCE
15 units
DISTRIBUTION
Nationwide, Canada, China, and Australia
___________________________________
PRODUCT
1) Face Tent with 15 mm Adapter, REF MD126. An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols. Recall # Z-1887-2011;
2) Face Tent with 15 mm Adapter, REF S-MD126. An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols. Recall # Z-1888-2011;
3) Aerosol Mask with 15 mm Adapter, REF MD127. An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols. Recall # Z-1889-2011;
4) Aerosol mask with 15 mm adapter, REF S-MD127. An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols. Recall # Z-1890-2011;
5) Universal F2 Anesthesia Breathing Circuit, REF 5D440-61X-17. An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols. Recall # Z-1891-2011;
6) Universal F Anesthesia Breathing Circuit, REF 5U345-611XB. An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols. Recall # Z-1892-2011
CODE
1) IMKV8, IMNJ2, IMQX3, IMSR0, IMU97, IMXX0, IN1H1, IN3A2, IN6Z6, INAA6, INEE0, INF59, INGU4, INHT1, INJ16, INJE6, INK63, INL04, INLT4, INMV2, INPN6, INQF6, INRF2, INSP0, INRY6, INV51, INUU4, INVN4, INX39, INY27, IP0P6, IP332, IP208, IP4N1, IP5T2, IP7D7, IPAM0, IPBQ2, IPCZ7, IPE42, IPER6, IPGS5, IPIG9, IPKY4, IPLV3, IPML1, IPNS8, IPR26, IPU82, IPVM0, IPXC3, IPZ51, IQ024, IQ1E2, IQ271, IQ336, IQ3W0, IQ4Z9, IQ6Q5, IQAL8, IQCR8, IQDL1, IQIS8, IQLU4, IQMU0, IQQD4, IQSS6, IQWZ8, IR1G6, IR6J0, IR478, IRAF6, IRBP4, IRCG4, IRFT7, IRJS0, IRHK1, IRML5, IRPF5, IRU08, IRQF9, IRT66, IRSN2, IS092, IRXQ7, IS3H4, IS594, IS752, ISBS0, IS9N1, ISG89, ISHR7, ISL99, ISTV2, ISRV6, ISXQ0, IT186, IT3P1, ITAE7, IT727, ITAE8, ITBU2, ITFH4, ITI28, ITLC4, ITN42, ITPJ9, ITUQ8, ITXK1, IU4S4, IU3K4, ITZJ7, IU8B3, IUFH9, IUI17, IUKN7, IUN60, IUQL4, IUTA9, IUVY5, IUY74, IUZT5, IV1V5, IV432, IV6A3, IV887, IV7G0, IV9P8, IVCZ0, IPCF2, IQ3Y0, IQ698, IQPU1, IQUZ0, IR2I7, IRFY3, ISEX6, ISJN6 and IT3Q0;
2) IPCF2, IQ3Y0, IQ698, IQPU1, IQUZ0, IR2I7, IRFY3, ISEX6, ISJN6 and IT3Q0;
3) INPN7, INQF7, INSP1, IP5T3, IPAM1, IPCZ8, IPJB7, IQ025 and IQ594;
4) IPMM5, IQB38, IQRG9, IQUZ1 and IRMU6;
5) IMN70, IMSF9, IMUE5, IMW11, IN0M0, IN3F6, IN6N0, IN7Y1, INAH1, INCH9, INH33, INXF6, IP2D0, IP525, IP7Q1, IPAV9, IPL87, IPP26, IPRT7, IPUE1, IPWS8, IQ2B5, IQ737, IQFP8, IQJ16, IQM67, IQQK6, IQU51, IQXE9, IR0Q3, IR3C8, IR6S3, IRAY2, IRDH2, IRKC4, IRPQ9, IRWP2, IS0H1, IS4F4, ISX04, ISZJ8, IT5N6, IT8J1, ITHM8, ITJK1, ITNB5, ITTG8, ITWJ0, IU034, IU261, IU405, IU713, IUAW0, IUD40, IUGB8, IUNC2, IUQZ6, IUVE1, IV1G0, IV611 and IVB55;
6) IMPQ5, IMXP7, IN158, IN657, IN9Y0, INGD2, INNX3, INYR8, IP6S9, IPH37, IPM99, IPV16, IQ117, IQBX9, IQLF1, IQXF0, IR883, IRIZ6, IRWL2, IS4Z1, ISB52
RECALLING FIRM/MANUFACTURER
Recalling Firm: King Systems Corp., Noblesville, IN, by letter dated January 24, 2011.
Manufacturer: Unomedical A Convatec Com., Hidalgo, TX. Firm initiated recall is ongoing.
REASON
The firm is conducting a subrecall of facetent masks because the masks could have a sticky substance on the inside or outside of the mask that may manifest itself 6-8 months after the manufacture date of the product. The sticky substance could result in inconvenience or in some remote cases cause patient harm.
VOLUME OF PRODUCT IN COMMERCE
82,905 units
DISTRIBUTION
NM, GA, TX, FL, IL, VA and LA
___________________________________
PRODUCT
REF VP6528***Qty 1***Articulating Arm, Secondary Flat Panel***RX Only***See Instructions for Use*** Catalog No Product VPN6528 Articulating Arm, Secondary Flat Panel. 690-0024-00 Arm, Wall Mount, Flat Screen, GCX For mounting and positioning of flat screen monitors. Recall # Z-1893-2011
CODE
Serial Numbers: 0409 080422004 081117004 1056 1268 1314 1505 1539 1588 1661 178 1828 1896 2082 2289 2424 2543 2651 2752 2993 3343 3423 3424 3486 3507 3531 3588 3600 3611 366 3671 3701 3831 424 4269 461 6054 615 6238 652 735 787 847 887 955, and 989
RECALLING FIRM/MANUFACTURER
Recalling Firm: Linvatec Corp. dba ConMed Linvatec, Largo, FL, by letter on September 17, 2010.
Manufacturer: Gcx Corp., Petaluma, CA. Firm initiated recall is ongoing.
REASON
If the VHM Arm is left in the locked position, the gas spring can lose pressure and releasing the lock can result in a sudden downward movement.
VOLUME OF PRODUCT IN COMMERCE
373 units
DISTRIBUTION
Nationwide, Australia, Canada, Morocco, Saudi Arabia, Taiwan, Province of China
___________________________________
PRODUCT
BD Beaver XStar Safety 2.5mm Crescent Knife; REF 378234 Crescent blades are used in a variety of ophthalmic surgery. Product is a cataract surgery knife designed for optimal tunnel architecture. Recall # Z-1894-2011
CODE
Lot/serial number: 0333798
RECALLING FIRM/MANUFACTURER
Beaver-Visitec International Inc., Waltham, MA, by letter dated February 25, 2011. Firm initiated recall is ongoing.
REASON
Loose blades in the handle of knives due to uncured epoxy.
VOLUME OF PRODUCT IN COMMERCE
1680 units (1130 domestic, 550 foreign)
DISTRIBUTION
AZ, MA, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, VA and China
___________________________________
PRODUCT
Coulter PrepPlus 2 (part # 378600) is a microprocessor-controlled pipetting and diluting system. PrepPlus 2 is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples. The PrepPlus 2 is a compact, fully automated sample work station which can be programmed to perform a wide variety of liquid handling operations where volumes required range from 5 uL to 1000 uL. Recall # Z-1895-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Beckman Coulter Inc., Brea, CA, by letter dated January 18, 2011. Firm initiated recall is ongoing.
REASON
The recall was initiated after erroneous, though potentially credible; results due to intermittent reagent level sense failures could be generated. During these failures, the instrument fails to produce a warning that a reagent vial is low or out of reagent. The low or absent levels of reagent used during these failures may lead to insufficient antibody being dispensed into a daughter tube thereby generating an erroneous result. Erroneous results may lead to misdiagnosis, inappropriate testing, and/or delayed treatment of patients.
VOLUME OF PRODUCT IN COMMERCE
369 units (140 in US)
DISTRIBUTION
Nationwide, Australia, Barbados, Belarus, Belgium, Canada, Croatia, France, Germany, Ireland, Italy, Japan, Malawi, Mozambique, Namibia, Poland, Puerto Rico, Russian Federation, Slovenia, South Africa, Spain, Swaziland, Sweden, Switzerland, Ukraine, United Kingdom, Zambia
___________________________________
PRODUCT
1) Rusch Irrigation Tray w/Piston Catalogue Number 67890 For irrigation according to institutional guidelines. Recall # Z-1896-2011;
2) Rusch Irrigation Tray w/Bulb, Catalogue Number 68895. For irrigation according to institutional guidelines. Recall # Z-1897-2011
CODE
1) Lot numbers: 002508, 002514, 002519, 004514, 005508, 006509, 007510, 009511, 010502, 011502, 011510, 901526, 901543, 902507, 904510, 905501, 906512, 907509, 908502, 908524 and 911513;
2) Lot Numbers: 002516, 002520, 003512, 004513, 005510, 005528, 006510, 007513, 009512, 010507, 011506, 011511, 012514, 901524, 901545, 902506, 902519, 903508, 904511, 905502, 907516, 907528, 908518, 911512 and 912503
RECALLING FIRM/MANUFACTURER
Teleflex Medical, Durham, NC, by letters dated February 24, 2011 and March 30, 2011.
Manufacturer: Medikmark, Inc., Waukegan, IL. FDA initiated recall is ongoing.
REASON
The irrigation trays contain alcohol prep pads which are included in the scope of a recall initiated by Triad Group, due to a potential bacterial contamination.
VOLUME OF PRODUCT IN COMMERCE
95,647 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Device brochure, labeled in part : BIO -RAD***L70242709 VARIANT TM II TURBO***Hemoglobin A 1C***Cartridge Set, Cartridge Set, Analytical Cartridge, Guard Cartridge Insert. Integrated method for sample preparation, separation and the percent determination of percent hemoglobin A 1 c in EDTA human whole blood. Model Number(s): 270-2417 (Kit), with 270-2420 (Cartridge set) Code(s): LCP Listing Number(s): DO48707 for CDM 3.6T software. Recall # Z-1898-2011
CODE
Expiration date(s): Lot 70292242 EXP. Mar 31, 2010 and Lot 70292318 EXP. Jan. 31, 2010
RECALLING FIRM/MANUFACTURER
Bio-Rad Laboratories Inc., Hercules, CA, by letter dated November 29, 2009. Firm initiated recall is ongoing.
REASON
Wrong lot number was found on the Hemoglobin Cartridge Insert. The insert did not match the lot number to the device cartridge or the device cartridge label or on the Update Kit CD.
VOLUME OF PRODUCT IN COMMERCE
96 kits
DISTRIBUTION
CA, CT, GA, IL, IN, MA, ME, MS, NH, NV, OH, PA, TX, VA, WV, and France, Hong Kong, Italy, Korea and New Zealand
___________________________________
PRODUCT
ARIA versions 8.0 and 8.1. The ARIA Radiation Oncology product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Oncology also stores the treatment histories including dose delivered to defined sites and provided tools to verify performed treatments. ARIA also includes optional tools to manage the oncology department's clinical and business information. Model number: HIT-INFSYS. Recall # Z-1905-2011
CODE
Code numbers:HIT1554 HIT3338 HIT2129R1 HIT2129M HIT2129R4 HIT0968 HIT2129R2 HIT3700 HIT2129R5 HIT3692 HIT2129R3 HIT1207 HIT0565 HIT0498 HIT1084 HIT3529 HIT1359 HIT1691 HIT1050 HIT3708 HIT0737 HIT3607 HIT1778 HIT2009 HIT1581 HIT2531 HIT1771 HIT1914 HIT0040 HIT0716 HIT0606M HIT0606R1 HIT1731 HIT1861 HIT1060 HIT1729 HIT1860 HIT0942 HIT3527 HIT3010 HIT3290 HIT3209 HIT2779 HIT2777 HIT3473 HIT1010 HIT0335 HIT0594 HIT1580 HIT3365 HIT3354 HIT3564 HIT2688 HIT2016 HIT3413 HIT0631 HIT1110R1 HIT1151 HIT1679 HIT0951M HIT0419 HIT1159 HIT3270 HIT2595 HIT0426 HIT2557 HIT0651 HIT0950 HIT1548 HIT3342 HIT3018 HIT2236 HIT1121 HIT0951R1 HIT1115 HIT3732 HIT1493 HIT0402 HIT1128 HIT1592 HIT1451 HIT3706 HIT0124 HIT0843 HIT1602M HIT1602R1 HIT1380 HIT3691 HIT1129 HIT0210 HIT1668 HIT2831 HIT1926 HIT2068 HIT1719M HIT1507 HIT2223 HIT0510 HIT0195M HIT0813 HIT0139R1 HIT1719R2 HIT2098 HIT3109 HIT0140 HIT0589R1 HIT0589M HIT0851 HIT2018 HIT0868 HIT1830 HIT1987 HIT3130 HIT1029 HIT1338 HIT0516 HIT1865 HIT3198 HIT0630 HIT1956 HIT0112 HIT0809 HIT0206 HIT1765 HIT0205 HIT3454 HIT2003 HIT0143R1 HIT1135 HIT1131 HIT1719R1 HIT3722 HIT0866 HIT0532 HIT0143M HIT1506 HIT1866 HIT0088 HIT0090 HIT3615 HIT3624 HIT0887 HIT0952 HIT0401 HIT2126 HIT1889 HIT3397 HIT1968 HIT0555 HIT0542 HIT1925 HIT3315 HIT0310 HIT0886 HIT1396 HIT1625 HIT0312 HIT1697R2 HIT3587 HIT1967 HIT0127 HIT0749 HIT1389 HIT3242 HIT3705 HIT1113 HIT0849 HIT1697M HIT3314 HIT3635 HIT3360 HIT1072 HIT3525 HIT3131M HIT3131R1 HIT3592 HIT3591 HIT0268 HIT0996 HIT3726 HIT0427 HIT2319 HIT1234 HIT3677 HIT1376 HIT3713 HIT3515 HIT2222 HIT1895 HIT1799 HIT0940 HIT3469 HIT0185 HIT2027 HIT1318 HIT0833 HIT1327 HIT1446 HIT0059 HIT1408 HIT0329 HIT1369 HIT3439 HIT0066 HIT1460 HIT0236 HIT1227 HIT1306 HIT1070 HIT1642 HIT1444 HIT3499 HIT0896 HIT1332 HIT1284 HIT1760 HIT0762 HIT1348 HIT0234 HIT3435 HIT0238 HIT1454 HIT0072 HIT1462 HIT3394 HIT1267 HIT1452 HIT1563 HIT1137 HIT1301 HIT1738 HIT1392 HIT0061 HIT1203 HIT0162 HIT1440 HIT3441 HIT3537 HIT1241 HIT0297 HIT0769 HIT0286 HIT1062 HIT0331 HIT1260 HIT0721 HIT0805 HIT1325 HIT0658 HIT0167 HIT0077 HIT1394 HIT1278 HIT1361 HIT1066 HIT1567 HIT1074 HIT3483 HIT3660 HIT3661 HIT1052 HIT3585 HIT0315 HIT0487 HIT0444 HIT3541 HIT0857 HIT2350 HIT0303 HIT1331R1 HIT1331M HIT3630 HIT0892 HIT3117 HIT0225 HIT2840 HIT3702 HIT0265 HIT1397 HIT0633 HIT0782 HIT1788 HIT3179 HIT3633 HIT1820 HIT3627 HIT3302 HIT1496 HIT0823 HIT3227 HIT1522 HIT0928 HIT1347 HIT2119 HIT0485 HIT3329 HIT3100 HIT1436 HIT0754 HIT1381 HIT0627 HIT3279 HIT0563 HIT1245 HIT2475 HIT1947 HIT1404 HIT1951 HIT3052 HIT1225 HIT2968 HIT0095 HIT0150 HIT0450 HIT0448 HIT0424 HIT0864 HIT1521 HIT2999 HIT3274 HIT1882 HIT3601 HIT3054 HIT0792 HIT0519 HIT1558 HIT2577 HIT0829 HIT1189 HIT0494 HIT1617 HIT3725 HIT0649 HIT0114 HIT1188 HIT1450 HIT1489 HIT1745 HIT0613 HIT0592 HIT1134 HIT0539 HIT1922 HIT0757 HIT1594 HIT0547 HIT0084 HIT1655 HIT1674 HIT0944 HIT0537 HIT0620 HIT1651 HIT1597 HIT3304 HIT0712 HIT0566 HIT1298 HIT2939 HIT0697 HIT2980 HIT1027 HIT1492 HIT3322 HIT0305 HIT1469 HIT0776 HIT1418 HIT3631 HIT1144 HIT0954 HIT2056 HIT0406 HIT0405 HIT2171 HIT0404 HIT1736 HIT3720 HIT0199 HIT3519 HIT0988 HIT3710 HIT2547 HIT1905 HIT1945 HIT1466 HIT1628 HIT0370 HIT1904M HIT1541 HIT2076 HIT0625 HIT3598M HIT1163 HIT0467 HIT0830 HIT1704 HIT0117 HIT2546 HIT0028 HIT3505 HIT3509 HIT0105R1 HIT0665 HIT1211 HIT2574A2 HIT1426 HIT1356 HIT0366M HIT1600R3 HIT1612R1 HIT1924R1 HIT1132R1 HIT1845 HIT0326 HIT0001 HIT1498R1 HIT1079R1 HIT3521M HIT3521R1 HIT0668 HIT0932R1 HIT3112 HIT2317 HIT0055 HIT1470R2 HIT1620R5 HIT3598R1 HIT0879 HIT0413 HIT0483 HIT0219 HIT0076 HIT1620M HIT2623R2 HIT0837 HIT0932M HIT3652 HIT0292 HIT1894 HIT1714 HIT1402 HIT0429M HIT1420 HIT0963 HIT0247 HIT1212 HIT1854 HIT0178 HIT0397 HIT1980R1 HIT0808M HIT0930 HIT1600M HIT0152 HIT1470M HIT0032 HIT0474 HIT1022 HIT1903 HIT3549 HIT1693 HIT1829 HIT1932 HIT1680 HIT1385M HIT3658 HIT1498M HIT1768 HIT1969 HIT1346R1 HIT0100 HIT1518M HIT0970 HIT1415 HIT0972 HIT0013 HIT0293 HIT0244 HIT3267 HIT3614 HIT0933 HIT0520R1 HIT1170 HIT1494 HIT0342 HIT2198 HIT3573 HIT0777R1 HIT3664 HIT0820 HIT0655 HIT1606 HIT1600R2 HIT1773 HIT0795 HIT0982R1 HIT0165R1 HIT0365 HIT0838 HIT2164 HIT3659 HIT1620R6 HIT3642 HIT0998 HIT1633 HIT1386 HIT3671 HIT0789 HIT2434 HIT1811 HIT0541 HIT0570 HIT2623R1 HIT2623M HIT2856M HIT0429R1 HIT1913 HIT1353R1 HIT1353M HIT0533 HIT1824 HIT3404M HIT0475 HIT0262 HIT1546 HIT2095 HIT0726 HIT0333 HIT0503M HIT1584 HIT0157 HIT0647 HIT3516 HIT1901 HIT1043 HIT2909 HIT1410 HIT3425 HIT0876 HIT0348 HIT2409R1 HIT0948M HIT1880 HIT1688 HIT3126 HIT1329 HIT0522 HIT0701 HIT2078 HIT1039 HIT0637 HIT0948R1 HIT1904R1 HIT3116M HIT0366R1 HIT1346M HIT0585M HIT3298R1 HIT1321 HIT3513 HIT0320R1 HIT1488 HIT0814R1 HIT2574R3 HIT1600R1 HIT0982M HIT0376 HIT0513 HIT3261 HIT1350 HIT1867 HIT3524 HIT1296 HIT0082 HIT1385R1 HIT0898 HIT2900 HIT3298M HIT3298R3 HIT1470R1 HIT2510 HIT0523 HIT2693 HIT1924M HIT0729 HIT0025 HIT1294 HIT1079M HIT0615R1 HIT0699 HIT1620R3 HIT0320M HIT2615 HIT2409M HIT2029 HIT1518R1 HIT1803 HIT0703R1 HIT1612M HIT0808R1 HIT1152 HIT1428 HIT1095 HIT0703M HIT0925 HIT3555 HIT0683 HIT1723 HIT0372 HIT1577 HIT0814M HIT1963 HIT3116R1 HIT1703 HIT1551 HIT0165M HIT0593 HIT0767 HIT0132 HIT3588 HIT1231 HIT0615M HIT3370 HIT0183 HIT0604 HIT0459 HIT3298R2 HIT0174 HIT1473 HIT1852 HIT0827 HIT3521R2 HIT0615R2 HIT3404R1 HIT0549 HIT1838 HIT0130 HIT3679 HIT1166 HIT2087 HIT0747
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter dated February 18, 2011. Firm initiated recall is ongoing.
REASON
An anomaly was identified in the ARIA version 8.0 and 8.1, when an image sequence template is added to a field in RT chart and a CIAO (Completely Irradiated Aperture Opening) is calculated, the resulting CIAO display at 4DITC may be incorrect.
VOLUME OF PRODUCT IN COMMERCE
645 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Penner Manufacturing Patient Transfer/Lift System, Cascade Transfer, Models: a) 380000-1 (white) and b) 380000-2 (gray). For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff. Recall # Z-1911-2011;
2) Penner Manufacturing Transfer Electric Cascade Patient Transfer/Lift System, Models: a) 382000-1 (right entry) and b) 382000-1L (left entry). For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff. Recall # Z-1912-2011;
3) Penner Manufacturing Bariatric Patient Transfer/Lift System, Cascade Transfer, Models 382500-1 (right entry). For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff. Recall # Z-1913-2011;
4) Penner Manufacturing Transfer Electric Cascade with Scale, Patient Transfer/Lift System, Models: a) 383000-1 (right entry) and b) 383000-1L (left entry). For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff. Recall # Z-1914-2011;
5) Penner Manufacturing Transfer Electric Bariatric with Scale, Patient Transfer/Lift System, Cascade Transfer, Models 383500-1 (right entry with scale). For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff. Recall # Z-1915-2011;
6) Penner Manufacturing Transfer Electric Superior right entry, Patient Transfer/Lift System, Models 384000-1. For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff. Recall # Z-1916-2011;
7) Penner Manufacturing Transfer Electric Superior left entry, Patient Transfer/Lift System, Models 385000-1. For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff. Recall # Z-1917-2011;
8) Penner Manufacturing Transfer Electric Superior end entry, Patient Transfer/Lift System, Models 386000-1. For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff. Recall # Z-1918-2011;
9) Penner Manufacturing Transfer Electric Superior right entry with scale, Patient Transfer/Lift System, Models 387000-1. For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff. Recall # Z-1919-2011;
10) Penner Manufacturing Transfer Electric Superior left entry with scale, Patient Transfer/Lift System, Models 388000-1. For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff. Recall # Z-1920-2011;
11) Penner Manufacturing Transfer Electric Superior end entry with scale, Patient Transfer/Lift System, Models 389000-1. For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff. Recall # Z-1921-2011;
12) Penner Manufacturing Transfer Electric Pacific Chair, Patient Transfer/Lift System, Models 393000-1. For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff. Recall # Z-1922-2011;
13) Penner Manufacturing Transfer Electric Pacific Chair with scale, Patient Transfer/Lift System, Models 394000-1. For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff. Recall # Z-1923-2011
CODE
1) a) Serial numbers: 08020346201, 8020346203, 10020360901, 10020360902, 10020360903, and 08020346202; b): Serial numbers 08020346201, 08020346203, and 11020367501;
2) a) Serial numbers: 07030456102, 05030435303, 07030456101, 07030456103, 05030435301, 09030479202, 09030479201, 09030479205, 11030501601, 07030456104,
11030501602, 11030501604, 12030507602, 12030507601, 12030507603, 11030501603, 09030479203, 12030507604, 11030501605, 12030509803, 07030435302, 12030509802, 12030507605, 12030509805, 01040535102, 01040535103, 06040623302, 06040623303, 01040535101, 06040623304, 07040635502, 07040635501, 07040635503, 06040623301, 07040635504, 07040635505, 07040635506, 07040635601, 07040635602, 07040635603, 07040635604, 08040665602, 07040635605, 08040665601, 07040635606, 08040665603, 08040665604, 12030509804, 08040665605, 09040678702, 09040678701, 09040678703, 09040678704, 11040712001, 11040712002, 11040712003, 11040712004, 11040712005, 01050741002, 01050741003, 01050741004, 01050741005, 02050756702, 02050756704, 02050756701, 03050798302, 03050798305, 03050790404, 02050756703, 03050798301, 03050790402, 03050798304, 03050790401, 03050798303, 03050790403, 06050840201, 06050840202, 06050840203, 06050840204, 06050840205, 06050840206, 06050840207, 03050790405, 06050840209, 08050884101, 06050840210, 08050884401, 08050884404, 10050924102, 10050924101, 10050924103, 10050924106, 11050939502, 10050924105, 11050939503, 10050924104, 11050939601, 11050939501, 11050939504, 11050939603, 11050939604, 02060988902, 11050939602, 02060988903, 06061061801, 02060988904, 02060988901, 06061061804, 09061105901, 08050884403, 08061096702, 08061096703, 10061134503, 06071297106, 07071328104, 06050840208, and 01050741001;
b) Serial numbers: 03050798604, 03050798602, 2050756901, 03050798601, 06050845901, 03050798603, 06050867102, 08050884701, 06050845902, 06050867104, 06050867103, 08050884702, 08050884703, 08050884704, 01060954301, 01060971601, 01060954302, 01060971604, 01060971602, 01060971603, 02060989001, 02060989002, 06050867101, 02060989004, 02060989003, 02060989005, 02060989006, 06061061901, and 06061061902;
3) Serial numbers: 09050908201, 11050949102, 09050908203, 09050908204, 01060954501, 11050949103, 01060954503, 01060954502, 01060954504, and 01060954505;
4) a) Serial numbers: 06030440001, 06030447201, 06030447202, 06030447204, 06030447205, 06030440002, 09030473801, 09030473802, 09030473804, 06030447203, 09030479101, 09030473803, 09030473806, 09030479102, 09030473805, 09030479103, 09030479104, 09030479105, 09030483202, 09030483204, 09030483201, 11030504803, 11030504801, 11030504802, 11030504804, 11030504805, 01040534301, 12030507701, 12030507702, 12030507703, 12030507704, 12030507705, 01040534302, 01040534303, 09030483203, 01040535201, 01040535202, 01040535203, 01040535204, 01040535205, 03040549001, 03040549002, 03040549006, 03040549003, 03040549004, 03040549005, 03040578002, 03040578001, 03040578004, 06040607702, 06040607703, 06040607705, 06040607701, 06040607801, 06040607802, 06040607803, 06040607804, 06040607805, 05040590801, 05040590802, 05040590803, 05040590804, 05040590805, 05040590806, 06040623403, 06040623401, 06040623404, 06040623402, 06040623405, 09040678801, 09040678804, 09040678806, 09040678803, 09040678805, 03040578003, 09040678807, 11040711901, 11040711902, 11040711903, 11040711904, 01050737401, 09040678802, 01050737402, 01050737403, 01050737405, 01050737404, 01050737406, 02050756801, 02050756802, 02050762601, 02050756805, 02050762602, 02050782001, 02050762604, 02050782002, 02050782003, 02050782004, 02050762603, 03050798201, 03050798202, 03050798203, 03050798205, 03050798207, 03050798208, 03050798206, 03050798204, 06050841002, 06050841001, 03050798209, 06050841004, 03050798210, 06050841003, 07050872001, 07050872003, 02050762605, 07050872002, 07050872004, 08050884503, 08050884601, 08050884504, 08050884501, 08050884502, 10050924003, 10050924004, 10050924005, 10050924001, 08050884602, 10050924002, 11050939702, 08050884604, 11050939703, 08050884603, 11050939701, 01060954201, 10050924006, 11050939704, 01060954202, 01060954203, 01060954204, 01060954205, 02060998904, 02060998902, 02060998901, 01060954206, 02060998903, 02060998905, 02060998906, 04061024901, 04061024902, 04061024903, 04061024904, 04061024905, 06061062003, 06061062004, 06061062005, 06061062006, 04061024906, 06061062001, 06061062002, 02071210003, and 03080991702;
b) Serial numbers: 06050846002, 02050757001, 02050757002, 03050798701, 03050798703, 03050798702, 03050798704, 06050846001, 06050867202, 06050867201, 06050867203, 06050867204, 09050903601, 09050903603, 09050903602, 09050907601, 09050907603, 09050907604, 09050907602, 11050934501, 11050934502, 11050934504, 11050934503, 01060954401, 03061010201, 01060954404, 01060954402, 03061010202, 01060954403, 03061010203, 04061025002, 03061010204, 04061025001, 04061025003, 02080971502, 02080971503, and 10061134802;
5) Serial numbers: 02060996003, 02060996005, 11050949101, 02060996002, 11050949104, 02060996004, 03061002801, 03061002802, 03061002805, 03061002803, 03061002804, 05061039201, 05061039202, 05061039203, 05061039204, 05061039205, 06061062101, 06061062102, 06061062103, and 06061062104;
6) Serial numbers: 06040605701, 07040642401, 11040713201, 12040728501, 01050741401, 08050891601, 05061046301, and 11070940901;
7) Serial numbers: 12030509701, 09030477202, and 09050916001;
8) Serial numbers: 03050800801, 04050819003, 04050819002, 06050841101, 04050819004, 06050841102, 09050907401, 10050923801, 10050923802, 02060990901, 02060990902, 03061014901, 03061014902, 07061082504, 06061066602, and 12030508001;
9) Serial numbers: 01040536401, 05040593601, 08040655501, 09040675901, 09040675903, 10040692802, 09040675902, 10040692801, 03050789801, 03061006801, 03061006802, 03061006803, and 03061006804;
10) Serial numbers: 11030504601, 11040711001, 02060991001, 02060998801, and 02060998802;
11) Serial numbers: 10030487401, 11030506001, 01040534401, 03040557401, 03040557402, 03040557403, 03040557404, 09040689701, 10040695001, 01050736701, 05050835901, 05050837801, 05050837802, 05050837803, 06061066701, and 06061066702;
12) Serial numbers: 01050746601, 01050746602, 03050789301, 03050789302, 01050741301, 06050840901, 06050840902, 06050840903, 11040702801, 06050840904, 06050840906, 06050840905, 05061030401, 05061030402, 05061030403, and 05061030404;
13) Serial numbers: 09040683601, 11040702501, 03050800601, 08050878201, 12050953401, 12050953402, 05061049601, and 05061049602
RECALLING FIRM/MANUFACTURER
Penner Mfg Inc., Aurora, NE, by letter on January 19, 2009. Firm initiated recall is complete.
REASON
Incomplete weld on the pillar mounting bracket.
VOLUME OF PRODUCT IN COMMERCE
468 lifts
DISTRIBUTION
Nationwide, Canada and Mexico
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III
___________________________________
PRODUCT
10 ft. Interface Cable, 10 Pin - Shielded Tip Pins to 12 Pin - Blue, Manufacturing Part Number 01287-09, Catalog Number D128709. This cable is used to connect an Auto 10 10-pole catheter to an EP recording system. Recall # Z-1839-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Biosense Webster, Inc., Irwindale, CA, by letter dated March 16, 2011.
Manufacturer: Biosense Webster Inc., Diamond Bar, CA. Firm initiated recall is ongoing
REASON
The recall was initiated because Biosense Webster has confirmed that there is an inaccessibility of electronic version of the instruction for use (e-IFU) for the "10 ft. Interface Cable, 10 Pin-Shielded Tip Pins to 12 Pin-Blue", catalog number D128709, through the J&J Gateway (ie, e-IFU website).
VOLUME OF PRODUCT IN COMMERCE
46 units
DISTRIBUTION
GA, KY, NV, WA, PA, and UT
___________________________________
PRODUCT
Large Port Specimen Sock, used to convert the pour/accessory port of a Cardinal Suction canister into a specimen retainer. The sock is used as an accessory in a suction collection system. Its placed in a suction canister to remove solids from the liquid aspirated during surgery. The solids may consist of patient tissue that are then sent to pathology or retained for other purposes. There is no direct contact between this device and the patient. Catalog number 65652-123; Product code 65652-124. Recall # Z-1852-2011
CODE
Lot #: 1091745
RECALLING FIRM/MANUFACTURER
Cardinal Health Inc., Dublin, OH, by letter on February 18, 2011.
Manufacturer: Cardinal Health PR 218 Inc., Anasco, PR. FDA initiated recall is ongoing.
REASON
In one lot of product, the label for the small version of the sock was improperly used for the larger version of the product.
VOLUME OF PRODUCT IN COMMERCE
3,350 each
DISTRIBUTION
Nationwide, and Canada
___________________________________
PRODUCT
HydroHydrofilm is for use as a post-operative and primary dressing to protect against secondary infection and to cover non-exudating wounds and for use as a secondary dressing for fixation of cathetcannulae.film, ers or 10cm x 12.5 cm. Recall # Z-1866-2011
CODE
Lot #: 000543118
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hartmann USA, Inc., Rock Hill, SC, by letter on February 11, 2011.
Manufacturer: Paul Hartmann AG, Heidenheim An Der Brenz, Germany. Firm initiated recall is ongoing.
REASON
Misbranded; the expiry date on the primary packing incorrectly indicates 2010-10, instead of 2015-10.
VOLUME OF PRODUCT IN COMMERCE
100 boxes (10 x 12.5 cm per box)
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS III
___________________________________
PRODUCT
1) Vedco Novox Caplets (carprofen), each scored caplet contains 100 mg. of carprofen, Rx, packaged in 60 caplet tubs. NDC 50989-245-50. Recall # V-115-2011;
2) Carprofen caplets, each scored caplet contains 75 mg. of carprofen, Rx, packaged under the following brand names and labels: (1) Vedco Novox Caplets, 60 caplets per tub, NDC 50989-238-50; (2) Vedco Novox Caplets, 30 caplets per tub, NDC 50989-238-02; and (3) Putney Carprofen Caplets, 180 caplets per tub, NDC 26637-912-22. Recall # V-116-2011;
3) Vedco Novox Caplets (carprofen), each scored caplet contains 25 mg. of carprofen, Rx, packaged as 180 caplet tubs, NDC 50989-236-86. Recall # V-117-2011
CODE
1) Lot numbers: 0091-224;
2) Lot numbers: 0071-222 (30 caplet), 0071-221 (60 caplet), and 0093-220 (180 caplet);
3) Lot numbers: 0134-223
RECALLING FIRM/MANUFACTURER
Recalling Firm: Norbrook Inc., Lenexa, KA, by letters on September 13, 2010 and follow-up telephone calls and by letters dated September 21, 2010.
Manufacturer: Norbrook Laboratories Limited, N. Ireland, United Kingdom. Firm initiated recall is ongoing.
REASON
Some of the immediate containers (tubs) were unlabeled.
VOLUME OF PRODUCT IN COMMERCE
5166 tubs (total from 5 different lots)
DISTRIBUTION
MO, ME
END OF ENFORCEMENT REPORT FOR APRIL 13, 2011
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