White Sub 12" Bleached Wheat Flour, Malted Barley Flour, Potassium Bromate. Enriched Flour (Wheat Flour Malted Barley Flour, Niacin, Reduced Iron Thiamin Mononitrate, Riboflavin, Folic Acid) Datem, Dextrose, Soybean Oil. Contains 2% or less of the following: Asorbic Acid, Enzymes (contains wheat flour) L-Cysteine, Azodicarbonamide. Yeast, contains trace quantities of starch and salt. Yellow Vegetable Margarine, partially hydrogenated soybean oil, Water, Partially hydrogenated cottonseed oil, salt, Mono and Diglycerides. Artificial butter flavor. Colored with annatto. Calcium disodium EDTA Added as a preservative Vitamin A Palmitate Added. Flour, Water, Yeast, Sugar, Salt Net Wt 8oz. Recall # F-1015-2011

None

Massimos Dallas, Inc., Dallas, TX, by fax on January 26, 2011. FDA initiated recall is ongoing.

The label failed to declare eggs as an ingredient.

1,590 units

TX

1) Louie's Alfalfa Sprout Mix, Net Wt 4 oz, (114g) UPC 11324 04401 and 16 oz bag (food service only), UPC 11324 04401. Keep refrigerated, perishable. Ingredients: Alfalfa & Clover Sprout. Recall # F-1019-2011;

 

2) Louie's Clover Sprouts, Net Wt 4 oz, (114g) and 16 oz bag (food service only). Keep refrigerated, perishable. 4 oz cup and 16 oz bag UPC 11324 04406; UPC code is the same due to small amount of sales for bag. Recall # F-1020-2011;

 

3) Louie's Spicy Sprouts, Net Wt 4 oz, (114g); Keep refrigerated, perishable. Ingredients: Radish, Alfalfa & Clover Sprouts; UPC 11325 04402. Recall # F-1021-2011;

 

4) Louie's Broccoli Keep refrigerated perishable. Ingredients: Radish, Alfalfa & Clover Sprouts. UPC 11325 04407. Recall # F-1022-2011

All product with a Use By date on or before 4/14/11

Louie Foods International, Fresno, CA, by telephone on March 29, 2011 and press release on March 30, 2011. Firm initiated recall is ongoing.

USDA random sample revealed the presence of Salmonella.

Unknown

CA

Pierre pbjamwich, peanut butter + strawberry jam, 24 oz. cartons containing 12/2 oz. sandwiches, KEEP FROZEN thaw & serve; UPC 0 75999 21368 7. Recall # F-1023-2011

Best if purchased by 03-11-2011

Recalling Firm: Pierre Foods Inc., Cincinnati, OH, by press release on March 11, 2011 and by letter on March 14, 2011.

Manufacturer: Advance Pierre Foods, Easley, SC. Firm initiated recall is ongoing. 

Positive result of Listeria Monocytogenese in the product.

318 cs/12/2 oz sandwiches

PA

1) PAN DE NUEZ, UPC 95640 00172, INGREDIENTS: Flour, Water, Eggs, Vegetable Shortening, Raisins, Sugar, Salt, Baking Powder, Mexicantown, PAN NUEZ, MTB050 54 count. Recall # F-1024-2011;

 

2) MAGDELENA, Mexicantown Bakery MAGDELENA, UPC 95640 00019, INGREDIENTS: Flour, Water, Eggs, Vegetable Shortening, Raisins, Sugar, Salt, Baking Powder, Mexicantown, MAGDELENA. Recall #F-1025-2011;

 

3) MEXICANTOWN BAKERY PAN DE MAIZ, UPC 95640 0026, INGREDIENTS: Corn Meal, Flour, Water, Eggs, Vegetable oil, Baking Powder, Sugar, Salt, MEXICANTOWN PAN DE MAIZ, MTB008 75 count. Recall # F-1026-2011;

 

4) Mexicantown Bakery YOYO'S, UPC 95640 00050, INGREDIENTS: Flour, Water, Eggs, Vegetable Shortening, Margarine, Sugar, Salt, Baking Powder, YOYO'S (Mexican Sweet Bread) Imported by Mexico Lindo. Recall # F-1027-2011;

 

5) TACOS QUESO PAN DANES, UPC 9560 00186, INGREDIENTS: Flour, Eggs, Water, Vegetable Shortening, Cheese Filling, Sugar, Yeast, Salt, Cinnamon, MEXICANTOWN TACOS QUESO PAN DANES, MTB056 120 count. Recall # F-1028-2011

1) All Lots/Dates of Manufacturer; 2) – 5) Manufactured date: 6/27/2010-12/28/2010

Mexicantown Wholesale, Detroit, MI, by press release, telephone, fax, mail and e-mail on April 8, 2011. Firm initiated recall is ongoing.

The firm is recalling the products due to undeclared pecans and/or milk, wheat, and FD&C Yellow #5.

18,202 units

MI, Canada

Shredded Shrimp (Camaron Molido); packaged under the brand names of La Fiesta and Mi Pueblo. Packed in the following sizes: LaFiesta: - . 1 7/8 oz, 3 oz., 6 oz and 8 oz. MiPueblo: 1 3/4 oz, 2 1/2 oz, 6 1/4 oz and 8 oz. La Fiesta Brand UPC Codes: 32327-00150 - 1 7/8 oz; 32327-00181 - 3 oz. 32337-00259 - 6 oz 32327-00420 - 8 oz Mi Pueblo Brand UPC Codes: 00000-10507 - 1 3/4 oz 00000-10509 - 2 1/2 oz 00000-10705 - 6 1/4 oz 01660-07002 - 8 oz. Recall # F-1029-2011

None

Fiesta Food Products, Inc., San Jose, CA, by telephone and visit on April 7, 2011 and by press release on April 8, 2011. FDA initiated recall is ongoing.

FDA Samples showed sulfites at 651 ppm and 667 ppm, which are not declared on ingredient labeling.

1,755 doz

CA

Organic Coriander, Ground, 40 lb boxes: Product of Egypt; Item # 24CORGND. Recall # F-1030-2011

Lot number: CORT-5153998A-PW-543N Also put in curry blend lot # 03311-032P

High Quality Organics, Reno, NV, by e-mail on April 21, 2011. Firm initiated recall is ongoing.

FDA sample found Salmonella species Poly B in coriander.

97 lbs

CA, OR

Signature Collection, Atlantic Smoked Salmon, The Fresh Market, Net Wt. 4 oz. (113g), SGP32; UPC 737094000370. Recall # F-1031-2011

Lot number: 1459/2

Woodsmoke Provisions, LLC, Atlanta, GA, by press release on April 22, 2010. Florida initiated recall is ongoing.

Product may be contaminated with Listeria monocytogenes.

160/4 oz. units

AR, FL, IL, KY, MD, NC, OH and TN

The product is Pina Colada flavor yogurt that was mistakenly packaged in cartons for Plain yogurt. The recalled product is in 6 oz plastic tubs labeled in part: "WESTERN FAMILY 1% MILKFAT Low-Fat Yogurt Plain NET WT. 6 oz”. UPC: 15400 112666. Recall # F-1016-2011

Production Code: 41-37F-2L "BB: 04-28-11"

Sunshine Dairy Foods Management, LLC, Portland, OR, by telephone and e-mail on April 14, 2011. Firm initiated recall is ongoing.

Product is mislabeled; Pina Colada flavored yogurt is packaged in cartons labeled Plain yogurt.

Approx 140 cases each containing 12 6 oz cups.

CA, OR, MT, ID, WA

Big Train Vivaz Horchata Beverage Mix, Item number 655112 packed in 3.5 lb bags, UPC Code 642628012531. Product labeled as: "BIG TRAIN INC. !VIVAZ! Horchata BEVERAGE MIX NET WT 56 oz (3.5 lb) 1.59 kg***". Recall # F-1017-2011

Lot numbers: 1741001, 2031001, 2911071, 3171015, and 0331137

Big Train, Inc., Lake Forest, CA, by letter on March 29, 2011. Firm initiated recall is ongoing.

Product has undeclared wheat in the list of ingredients. People who have allergies to wheat run the risk of allergic reaction if they consume this product.

927 cases

Nationwide

La Carreta Fresh Flour Tortillas one dozen. Net wt. 18 oz. (blue label), 28 oz. (red label), 10" burrito, 12" burrito, and snack size. The product consists of a dozen flour tortillas in a sealed plastic bag. There are two different labels used on the packaging. On one label, the principle display panel consists of a white disc with blue lettering. The label reads in part LA *** Carreta MEXICAN STYLE PRODUCTS Fresh FLOUR *** TORTILLAS ONE DOZEN. There is a picture of a wheel barrel being pulled by 2 animals on the top of the label. The principle display panel of the second label consists of a white disc with red lettering. The information present on the white disc is the same as the first label. The words HECHAS A MANO COMO SI FUERAN are written on top over the white disc and LIKE HOMEMADE is written on the bottom of the package under the white disc. Recall # F-1018-2011

None

La Carreta Mexican Foods Co., Colton, CA, by telephone and hand delivered letter on April 4, 2011. Firm initiated recall is ongoing.

The flour tortillas made with lard lists enriched flour as an ingredient and does not declare wheat. Wheat is an allergen that must be declared on the product label.

4,044 units

CA

1) Tuna Pita w/Mixed Fruit Net wt. 6.5 oz., Keep Refrigerated, Item 958, packaged in a charcoal colored foam box and wrapped with clear plastic film. UPC 5781500958. Recall # F-1061-2011;

 

2) Low Fat Tuna Salad Sandwich Net wt. 5 oz., Keep Refrigerated, Item 963, packaged in a plastic wedge shaped container with clear plastic top seal. UPC 5781500963. Recall # F-1062-2011;

 

3) Healthy Low Fat Tuna Salad Combo Net wt. 4.25 oz., Keep Refrigerated, Item 428, packaged in a clear plastic tray type container with a side of fresh carrots and celery, UPC 5781500428. Recall # F-1063-2011

Expiration date from 4/16-4/22/2011

18th Street Deli, Inc., Hamtramck, MI, by email on April 15, 2011. Firm initiated recall is ongoing.

The finished product label does not declare yellow # 5 but the product contains relish containing yellow # 5.

198 sandwiches

MI

Very Berry Mix, in 14 oz. in line container, and 14 oz. deli containers, packaged under the following labels Rocky Peanut Company, Inc., Market Fresh Fine Foods, Zeilers Farm Market, Grand River Grocery, Colasantis Market, Market Square, Heartland Marketplace, Randazzo Fresh Market, Busch's Snacks, VC Value Center Marketplace, Jonna's Market, Kazmaier's Perryburg, VG's Fenton, Sautter's, Hollywood Markets, and 25 lb. brown cardboard box with plastic lining. The 14 oz containers are packed 12 per case. UPC for the 14 oz. containers 4338480410 and 4338481410, UPC for the bulk 25 lb container 43384 20240. Recall # F-1064-2011

No code, the firm is recalling all products.

Rocky Peanut Company, Inc., Ferndale, MI, by e-mails beginning on March 28, 2011. FDA initiated recall is ongoing.

The product contains dried papaya chunks. The papaya has FD & C yellow # 5 and yellow # 6. The finish product label does not declare yellow # 5 and yellow # 6.

374 pounds

MI, OH

Freses Spices Grajeas (Rainbow Sprinkles). Recall # F-1065-2011

No code on label

Freses Spic, Santurce, PR, by visit on April 2, 2011 and April 6, 2011. FDA initiated recall is ongoing.

FD&C Yellow #5 was not declared on the label or ingredient list, discovered on FDA inspection

72 bottles of 12 oz.

PR

 

1) Simvastatin Tablets USP, 20 mg, a) 1000-count bottle, NDC 0093-7154-10, b) 30-count bottle, NDC 0093-7154-56, Rx only. Recall # D-459-2011;

 

2) Simvastatin Tablets USP, 80 mg, 1000-count bottle, Rx only; NDC 0093-7156-10. Recall # D-460-2011

1) Lot number: a) 14S228, Exp 6/2011; and, b) 23S031, Exp 11/2012;

2) Lot number 04S406, expiration 5/2011

Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on  

Manufacturer: Teva Pharmaceutical Industries, Jerusalem, Israel. FDA initiated recall is ongoing.

CGMP Deviations. Firm's laboratory investigations were not performed in accordance with strict adherence to the "FDA Guidance for Industry - Investigating Out-of-Specification Test Results for Pharmaceutical Production".

337 bottles

Nationwide

Bacteriostatic Sodium Chloride Injection, USP, 0.9%, 30 mL, multiple dose vials, Rx only, NDC 0517-0648-25. Recall # D-461-2011

Lot # 9330, Exp 05/11; 9599, Exp 08/11; 9828, Exp 12/11

Luitpold Pharmaceuticals, Inc., Shirley, NY, by press release and letters dated March 15, 2011. FDA initiated recall is ongoing.  

Presence of Particulate Matter: some of the vials of these lots may contain visible particles.

388,725 vials

Nationwide

1) RectaGel HC, Topical Gel, Lidocaine HCl 2.8%; Hydrocortisone Acetate 0.55% Gel, Net wt 20 g, NDC 66663-357-05. Recall # D-462-2011;

 

2) Breckenridge Pharmaceutical, Inc., Bromphenex DM, 16 fl. oz bottles, Rx only, NDC 51991-147-16. Recall # D-463-2011;

 

3) Breckenridge Pharmaceutical Inc., Coldcough PD Syrup C-V, 4 fl. oz bottle, Rx only, NDC 51991-224-04. Recall # D-464-2011; 

 

4) Breckenridge Pharmaceutical Inc., Coldcough Syrup C-III, 16 fl. oz, Rx, NDC 51991-222-16. Recall #D-465-2011;

 

5) Breckenridge Pharmaceutical Inc., OtiRx Ear Drops, 10 mL, Rx, NDC 51991-671-71.  Recall # D-466-2011;

 

6) Breckenridge Pharmaceutical Inc, Dexphen w/C Liquid C-V, 16 fl oz, OTC, NDC 51991-729-16. Recall # D-467-2011;

 

7) CENTUSS DM LIQUID, 16 oz., Rx only, NDC 23359-020-16. Recall # D-468-2011;

 

8) AIRACOF LIQUID C-V, 16 fl. oz, Rx, NDC 23359-019-16. Recall # D-469-2011;

 

9) BroveX Brompheniramine Tannate/ 12 mg Suspension , 16 fl. oz (473 mL) Rx Only NDC 42919-0272-16. Recall # D-470-2011;

 

10) ED A-HIST Liquid, NDC 0485-0055-16, One Pint and NDC 0485-0055-01, 1 fl. oz, Rx. Recall # D-471-2011;

 

11) ED A-HIST Liquid, 1 pint, OTC, NDC 00485-0155-16. Recall # D-472-2011; 

 

12) ED-A-HIST DM, NDC 0485-0071-16, One Pint Rx, and NDC 0485-0071-30, 1 fl. oz Rx. Recall # D-473-0211;

 

13) MYCI-GC, NDC 0276-4510-08, 8 fl. oz, OTC; and MYCI-GC, NDC 0276-4510-04, 4 fl. oz. OTC. Recall # D-474-2011;

 

14) ED-APAP Children's, 8 fl oz, OTC, NDC 0485-0057-08. Recall # D-475-2011;

 

15) Ed ChlorPed Pediatric Drops, 2 fl oz; Rx, NDC 0485-0094-02. Recall # D-476-2011;

 

16) Ed ChlorPed Pediatric Drops, NDC 0485-0074-02, Rx, 2 fl oz; and NDC 0485-0074-10, Rx, 2 mL. Recall # D-477-2011;

 

17) ENDACOF AC syrup, 4 fl.oz, RX, NDC 68047-138-04. Recall # D-478-2011;

 

18) ENDACOF - C Liquid, 16 fl. oz, RX, NDC 68047-145-16. Recall # D-479-2011;

 

19) ENDACOF - DC Liquid, 16 fl. oz; Rx, NDC 68047-0148-16. Recall # D-480-2011;

 

20) ENDACOF - DH Liquid, 16 fl. oz, Rx, NDC 68047-139-16. Recall # D-481-2011;

 

21) ENDACOF - PD Pediatric Drops, 1 fl oz, Rx, NDC 68047-010-30. Recall # D-482-2011;

 

22) ExeClear-C Syrup, 16 fl oz, Rx, NDC 68047-222-16. Recall # D-483-2011;

 

23) ExeClear-DM Syrup, 16 fl oz, OTC, NDC 68047-120-16. Recall # D-484-2011;

 

24) LoHist D, 16 fl. oz., OTC, NDC 68047-120-16. Recall # D-485-2011;

 

25) LoHist PD Pediatric Drops, 1 fl. oz., Rx, NDC 68047-011-30. Recall # D-486-2011;

 

26) NoHist PDX Drops, 1 fl. oz., RX, NDC 68047-015-30. Recall # D-487-2011;  

 

27) NoHist-PE Syrup, 16 fl. oz., RX, NDC 68047-169-16. Recall # D-488-2011;  

 

28) Z-TUSS DM, 1 Pint, Rx, NDC 58407-810-16. Recall # D-489-2011;

 

29) Z-TUSS AC CV, NDC 58407-0755-16, Rx, 1 Pint; NDC 58407-0920-16, Rx, 1 Pint; and NDC 58407-0755-10, Rx, 10

mL. Recall # D-490-2011;

 

30) Z-Xtra Gel, 4 fl. oz., OTC, NDC 58407-303-04. Recall # D-491-2011;

 

31) Poly Tan DM Suspension, 1/2 fl oz, Rx, NDC 50991-710-15. Recall # D-492-2011;

 

32) Poly Tan D Suspension, 1/2 fl oz, Rx, NDC 50991-817-15. Recall # D-493-2011;

 

33) Brompheniramine, Maleate 1 mg Drops, 1 fl oz., RX, NDC 68032-324-21. Recall # D-494-2011;

 

34) Brompheniramine Maleate 1 mg Pseudoephedrine HCl, 7.5 mg Drops, 1 fl oz., RX, NDC 68032-325-21. Recall # D-495-

2011;

 

35) RE-DRYLEX Syrup, 16 fl. oz; RX, NDC 68032-211-16. Recall # D-496-2011;

 

36) Reme Hist DM, One Pint, RX, NDC 68032-192-16. Recall # D-497-2011;

 

37) Reme Hist DM Cough Syrup, One Pint, RX, NDC 68032-191-16. Recall # D-498-2011

1) Lot numbers: 08123, 08124, 09003, 08124, 09003;

2) Lot numbers: 08108, 09020, 09042, 09084, 10029;

3) Lot numbers: 08111UL, 08122UL, 08127UL, 09028UL, 09030UL, 09038UL, 09044UL, 09049UL, 09063UL, 09078UL, 09079UL, 09088UL, 09105UL, 09106UL, 10003UL, 10004UL;

4) Lot numbers: 08115, 08125, 09013, 09019, 09027, 09029, 09040, 09076;

5) Lot numbers: 09017, 09026, 09032, 09045, 09051, 09054, 09061, 09062, 09071, 10005, 10006, 10012;

6) Lot numbers: 10016, 10017, 10018;

7) Lot numbers: 09091, 09092, 09093;

8) Lot numbers: 09100, 09101, 09102;

9) Lot number: 08085;  

10) Lot numbers: 08102, 08106, 08120, 09018, 09031, 09037, 09041, 09052, 09053, 09074, 09075, 09077, 09083, 09096;

11) Lot numbers: 10019, 10027, 10028;  

12) Lot numbers: 08101, 08110, 08113, 08114;

13) Lot number: 08112;

14) Lot numbers: 09004, 09066, 09067, 10002;

15) Lot numbers: 10024 and 10031;

16) Lot number: 08081;

17) Lot number: 09001;

18) Lot numbers: 09046, 09047, 09048, 10007, 10008, 10009;

19) Lot numbers: 09057, 09058, 09059, 09094, 09095, 10025, 10026;

20) Lot numbers 09068, 09069, 09070, 09104;

21) Lot numbers: 08109, 08117, 08119, 09050, 09056, 09090, 09103;

22) Lot numbers: 08103, 10010;

23) Lot numbers: 08105, 09015, 09081, 09086, 09098;

24) Lot numbers: 08126, 09014, 09055, 09082, 09087, 10011, 10013;

25) Lot numbers: 09007, 09008, 09010, 09085, 09099;

26) Lot numbers: 09034, 09035, 09036;

27) Lot numbers: 09022, 09023;

28) Lot numbers: 09002, 09065, 09089, 09097, 10001;

29) Lot numbers: 09006, 09025, 10032;

30) Lot numbers: 09039, 09080;

31) Lot number: 08078;

32) Lot number: 08079;

33) Lot number: 08074;

34) Lot number: 08075;

35) Lot numbers: 09009, 09011, 09012;

36) Lot numbers: 08128, 09016, and 09043;

37) Lot numbers: 08107, 08116, 08118, 08121, 09005, 09021, and 09033

Deltex Pharmaceuticals, Inc., Rosenberg, TX, by letter on February 12, 2011. FDA initiated recall is ongoing.  

CGMP Deviations: Firm failed to comply with current good manufacturing practice requirements.

794,021 units

Nationwide

Metformin Hydrochloride Tablets, USP 500 mg, 1000-count bottle, Rx only, NDC 0093-1048-10. Recall # D-501-2011

Lot # 35201115A, Exp 10/11

Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on March 23, 2011.

Manufacturer: Novopharm Ltd., Scarborough Ontario, Canada. Firm initiated recall is ongoing.

Failed Tablet Hardness: Some tablets may not meet friability specification.

6,494 bottles

Nationwide

CYTARABINE Injection, 2 g/20 mL (100 mg/mL), 20 mL single dose vial, Rx only; Product 102020, NDC 63323-120-20, UPC 3 63323-120-20 7. Recall # D-508-2011

Lot # 6101204, Exp 03/12

Recalling Firm: App Pharmaceuticals, LLC, Schaumburg, IL, by letters dated February 11, 2011.

Manufacturer: App Pharmaceuticals, LLC, Melrose Park, IL. Firm initiated recall is ongoing.

Crystallization: APP has received customer complaints of the presence of particulate matter described as precipitation/crystallization in the vials of Cytarabine Injection.

7,629 vials

Nationwide

 

Valturna (aliskiren and valsartan) Tablets 300 mg/320 mg -- 300 mg aliskiren and 320 mg valsartan per tablet -- 7 Tablets -- Physician Sample - Not For Sale -- NDC 0078-9574-89 -- Rx only. Recall # D-499-2011

Lot F0003 (JUN 2011)

Recalling Firm: Novartis Pharmaceuticals Corp., Suffern, NY, by letter dated March 24, 2011. 
Manufacturers: Novartis Pharma Stein AG, Stein, Switzerland;

Novartis Pharmaceuticals Corp., Suffern, NY.

Firm initiated recall is ongoing.

Failed USP dissolution test requirements.

43,360 shellpacs (7 tablets per shellpacs)

Nationwide

HICON(tm), Sodium Iodide I-131 solution USP, 1000 mCi fill size, Product #502880, NDC number 65174-880-00. Recall # D-500-2011

Lot number 70663; expiration date 3/1/11

Draxis Specialty Pharmaceutical Inc., Kirkland Quebec, Canada, by telephone on February 6, 2011, and by letters on February 10, 2011 and February 11, 2011. Firm initiated recall is complete.

Incorrect expiration date.

20 vials of 1000 mCi

Nationwide

1) EMBEDA (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules, 20 mg/0.8 mg, 100 count bottle, Rx only; NDC 60793-430-01. Recall # D-502-2011;

 

2) EMBEDA (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules, 30 mg/1.2 mg, 100 count bottle, Rx only; NDC 60793-431-01. Recall # D-503-2011;

 

3) EMBEDA (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules, 50 mg/2 mg, 100 count bottle, Rx only; NDC 60793-433-01. Recall # D-504-2011;

 

4) EMBEDA (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules, 60 mg/2.4 mg, 100 count bottle, Rx only; NDC 60793-434-01. Recall # D-505-2011;

 

5) EMBEDA (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules, 80 mg/3.2 mg, 100 count bottle, Rx only; NDC 60793-435-01. Recall # D-506-2011

 

6) EMBEDA (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules, 100 mg/4 mg, 100 count bottle, Rx only; NDC 60793-437-01. Recall # D-507-2011

1) Lot number: 422K91, Exp. 07/11; Lot number: 423K91; Exp. 07/11; Lot number: 424K91, Exp. 07/11; Lot number: 425K91, Exp. 9/11; Lot number: 427K91, Exp. 9/11; Lot number: 788E01, Exp. 12/11;

 

2) Lot number: 461K91, Exp. 07/11; Lot number: 462K91, Exp. 09/11; Lot number: 463K91, Exp. 09/11; Lot number: 215C01, Exp. 12/11; Lot number: 787E01, Exp. 12/11;

 

3) Lot number: 453K91, Exp. 07/11; Lot number: 454K91, Exp. 07/11; Lot number: 456K91, Exp. 09/11; Lot number: 222C01, Exp. 12/11; Lot number: 223C01, Exp. 12/11;

 

4) Lot number: 428K91, Exp. 07/11; Lot number: 429K91, Exp. 07/11; Lot number: 431K91, Exp. 09/11; Lot number: 216C01, Exp. 12/11; Lot number: 217C01, Exp. 12/11;

 

5) Lot number: 224C01, Exp: 12/11; Lot number: 225C01, Exp: 12/11;

 

6) Lot number: 464K91, Exp: 07/11; Lot number: 465K91, Exp: 07/11; Lot number: 466K91, Exp: 09/11; Lot number: 235C01, Exp: 12/11

Recalling Firm: King Pharmaceuticals Inc., Bristol, TN, by letter beginning on March 10, 2011.

Manufacturer: Actavis Elizabeth LLC, Elizabeth, NJ. Firm initiated recall is ongoing.

Impurities/Degradation Products: Stability data do not support the acceptance criteria for related compounds through the product's labeled expiry.

106,113 bottles

Nationwide

Critic-Aid� Skin Paste 2.5 oz/71 g with lot number 2441567, NDC 11701-050-33 and 6 oz/170g with lot number 2461319, NDC, 11701-050-32; Recall # D-509-2011

Units: 2441567 and 2461319

Recalling Firm: Coloplast Manufacturing US, LLC, Minneapolis, MN, by telephone and letter on November 24, 2010.

Manufacturer: Coloplast Manufacturing US, LLC, Mankato, MN. Firm initiated recall is ongoing.

Product lacks stability: Recent observations and stability testing conducted by Coloplast showed a slight separation within the Critic-Aid Skin Paste formulation which may result in varying concentrations of the active ingredient, petrolatum.

38,004 containers ((3167 cases)

Nationwide

 

1) Red Blood Cells. Recall # B-1215-11;

2) Plasma Frozen. Recall # B-1216-11

1) and 2) Unit: W071910008550

So Ca Permamente Med Group Blood Donor Center, Los Angeles, CA, by facsimile and letter on February 01, 2011. Firm initiated recall is complete.

Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.

2 units

CA

Red Blood Cells Leukocytes Reduced. Recall # B-1217-11

Units: 012GK53420; 012GK52735

Recalling Firm: The American National Red Cross, Carolinas Region, Charlotte, NC, by electronic notification and telephone on July 13, 2007. 

Manufacturer: Whole Blood Collections-Fixed Site-Carolinas Region, Johnson City, Johnson City, TN. Firm initiated recall is complete.  

Blood products, collected from a donor for which donor suitability was not adequately determined, were distributed.

2 units

CA, NC

1) Platelets Pheresis Leukocytes Reduced. Recall # B-1235-11;

2) Red Blood Cells (Apheresis). Recall # B-1236-11;

3) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1237-11;

4) Fresh Frozen Plasma (Apheresis). Recall # B-1238-11

1) Units: FM16083, FM16085, FM23853, FM16158, FM16180, FM25344 (part 1), FM25344 (part 2), FM25353, FM16234, FM16235 (part 1), FM16235 (part 2), FM16235 (part 3);

2) Units: FM16085, FM16180;

3) Unit: FM16085;

4) Unit: FM16180

Sacramento Medical Foundation, Sacramento, CA, by telephone on August 19, 2004, October 25, 2004 and October 28, 2004. Firm initiated recall is complete. 

Blood products, collected from unsuitable donors based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.

16 units

CA, TN, MA, AZ

1) Fresh Frozen Plasma. Recall # B-1239-11;

2) Red Blood Cells Leukocytes Reduced. Recall # B-1240-11;

3) Platelets Leukocytes Reduced. Recall # B-1241-11

1), 2) and 3) Unit: 032KV53672

The American National Red Cross, Madison, WI, by letter on February 1, 2007. Firm initiated recall is complete.

Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.

3 units

IL

Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1242-11

Unit: 17FM13662

The American National Red Cross, North Central Region, Saint Paul, MN, by facsimile on November 19, 2007. Firm initiated recall is complete.  

Blood product, mislabeled as to antigen phenotype, was distributed.

1 unit

MN

1) Cryoprecipitated AHF. Recall # B-1243-11;

2) Red Blood Cells Leukocytes Reduced. Recall # B-1244-11;

3) Platelets. Recall # B-1245-11

1) Unit: W0352103357069;

2) Units: W0352103357069; W035208244377V;

3) Unit: W035208244377V

Carter BloodCare, Bedford, TX, by telephone on February 7, 2011, by letter February 25, 2011, and by e-mail on February 28, 2011. Firm initiated recall is complete.

Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.

4 units

Austria, TX

1) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1258-11; 

2) Red Blood Cells Leukocytes Reduced. Recall # B-1259-11;

3) Plasma Frozen within 24 hours (FP24). Recall # B-1260-11

1) Unit: W038110230992;

2) and 3) Unit: W038110180734

Florida's Blood Centers, Inc., Orlando, FL, by letter on January 26, 2011. Firm initiated recall is complete.

Blood products, which were collected from a donor who had a history of receiving a tattoo within twelve months of the donations, were distributed.

3 units

FL

Platelets Leukocytes Reduced. Recall # B-1272-11

Units: 032KV60392; 032KV60393; 032KV60394; 032KV60396; 032KV60403; 032KV60404; 032KV60407; 032KV60408; 032KV60411; 032KV60416

The American National Red Cross, Madison, WI, by facsimile on May 3, 2007. Firm initiated recall is complete.

Blood products, with low platelet counts, were distributed.

10 units

IL, WI, MN

Source Plasma. Recall # B-1275-11

Units: 07JWIE6717; 07JWIE6226; 07JWIE5416; 07JWIE4636; 07JWIE4074; 07JWIE2386; 07JWIE1783; 07JWID7602; 07JWID7072; 07JWID2830; 07JWID2280; 07JWID1683; 07JWID1149; 07JWID0420; 07JWIC9864; 07JWIC9102; 07JWIC8527; 07JWIC7817 06JWID8466; 06JWID8869; 06JWIE0195; 06JWIE0828 ; 06JWIE1608; 06JWIE1927; 06JWIE2619; 06JWIE2943; 06JWIE3592 ; 06JWIE4190; 06JWIE4779; 06JWIE5392; 06JWIE5762; 06JWIE6218; 06JWIE6577; 07JWIA0385; 07JWIA0858; 06JWIA1602; 07JWIA2048; 07JWIA3215; 07JWIA3495; 07JWIA4652; 07WIA5096; 07JWIB1404 ; 07JWIB1837; 07JWIB2611; 07JWIB3529; 07JWIB3976; 07JWIC4846; 07JWIC5307; 07JWIC5970; 07JWIC6517; 07JWIC7252; 07JWIB5981; 07JWIB7770 07JWIB8514; 07JWIB9064; 07JWIC0083; 07JWIC0561; 07JWIC1550; 07JWIC2286; 07JWIC2808; 07JWIC3548; 07JWIC4104

Recalling Firm: BioLife Plasma Services LP, Deerfield, IL, by facsimile on December 7, 2007.

Manufacturer: BioLife Plasma Services, L.P., Janesville, WI. Firm initiated recall is complete.

Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.

62 units

Austria, CA

1) Red Blood Cells Leukocytes Reduced. Recall # B-1276-11;

2) Plasma Frozen within 24 hours (FP24). Recall # B-1277-11

1) and 2) Unit: 12X45280

The American National Red Cross, Carolinas Region, Charlotte, NC, by letter dated August 13, 2009. Firm initiated recall is complete.

Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.

2 units

NC

Red Blood Cells Leukocytes Reduced. Recall # B-1279-11

Unit: 032GM25543

The American National Red Cross, Madison, WI, by facsimile on October 3, 2007. Firm initiated recall is complete.  

Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.

1 unit

MA, CA

1) Red Blood Cells Leukocytes Reduced. Recall # B-1282-11;

2) Platelets Pheresis Leukocytes Reduced. Recall # B-1283-11

1) Units: 032LF76057; 032LJ25213;

2) Units: 032LF76057; 032LX79431

Recalling Firm: The American National Red Cross, Madison, WI, by fax and electronic notification on August 1, 2007. 

Manufacturer: American Red Cross - Dubuque Facility, Dubuque, IA. Firm initiated recall is complete.

Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.

4 units

WI, CA, MI, ME

Red Blood Cells Leukocytes Reduced. Recall # B-1285-11

Units: W115910048804; W115910056611

Central California Blood Center, Fresno, CA, by electronic mail and facsimile on March 29, 2011. Firm initiated recall is complete.

REASON                                                                                                                             

Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.

2 units

CA, Austria

Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1286-11

Unit: W051510130501

Recalling Firm: Memorial Blood Centers, Saint Paul, MN, by letter on January 27, 2011.  

Manufacturer: Memorial Blood Centers, Minneapolis, MN. Firm initiated recall is complete.

Blood product, did not meet the acceptable product specifications for release, was distributed.

1 unit

MN

 

Red Blood Cells Leukocytes Reduced. Recall # B-1213-11

Unit: W035211026107O

Carter BloodCare/ WE & Lela I Stewart Blood Center, Inc., Tyler, TX, by telephone on February 7, 2011. Firm initiated recall is complete. 

Blood product, collected from a donor with an incorrect documented body temperature, was distributed.

1 unit

TX

Recovered Plasma. Recall # B-1218-11

Unit: 012GK53420

Recalling Firm: The American National Red Cross, Carolinas Region, Charlotte, NC, by electronic notification and telephone on July 13, 2007. 

Manufacturer: Whole Blood Collections-Fixed Site-Carolinas Region, Johnson City, Johnson City, TN. Firm initiated recall is complete.  

Blood product, collected from a donor for which donor suitability was not adequately determined, was distributed.

1 unit

CA, NC

Recovered Plasma. Recall # B-1246-11 

Units: W0352103357069; W035208244377V

Carter BloodCare, Bedford, TX, by telephone on February 7, 2011, by letter February 25, 2011, and by e-mail on February 28, 2011. Firm initiated recall is complete.

Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.

2 units

Austria, TX

Recovered Plasma. Recall # B-1278-11

Unit: 032GM25543

The American National Red Cross, Madison, WI, by facsimile on October 3, 2007. Firm initiated recall is complete. 

Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.

1 unit

MA, CA

Source Plasma. Recall # B-1280-11

Units: 3560048567, 3560049517, 3560057110, 3560057709, 3560060858, 3560042587, 3560044361, 3560048246, 3560049171, 3560036229, 3560037060, 3560037881, 3560038743, 3560039516, 3560040474, 3560041293, 3560042291, 3560043241, 3560044184, 3560045441, 3560045959, 3560046987, 3560047835, 3560049408, 3560049904, 3560051291, 3560053582, 3560054489, 3560056920, 3560057237, 3560061016, 3560061957, 3560063241, 3560065291, 3560066106, 3560067446, 3560068475, 3560069330, 3560070512, 3560071422, 3560073224, 3560074282, 3560075311, 3560080096, 3560042753, 3560043642, 3560044407, 3560045392, 3560048033, 3560048719, 3560050535, 3560051228, 3560052413, 3560052975, 3560054216, 3560054956, 3560056152, 3560056868, 3560058106, 3560058755, 3560059950, 3560063967, 3560064676, 3560066032, 3560066883, 3560068031, 3560068682, 3560070088, 3560070692, 3560072062, 3560073012, 3560074104, 3560075258, 3560076385, 3560077961, 3560079650, 3560080647, 3560082414, 3560083005, 3560085442, 3560032245, 3560033046, 3560033990, 3560034929, 3560035754, 3560075476, 3560076236, 3560081636, 3560082640, 3560083577, 3560049910, 3560050796, 3560044440, 3560044983, 3560046164, 3560046857, 3560048420, 3560048839, 3560051374, 3560052329, 3560053393, 3560054121, 3560055578, 3560056482, 3560057390, 3560058417, 3560059936, 3560060705, 3560062003, 3560062555, 3560042711, 3560064834, 3560067056, 3560077882, 3560081520, 3560082589, 3560032601, 3560033091, 3560034798, 3560035409, 3560039135, 3560040400, 3560040876, 3560042430, 3560042996, 3560044031, 3560048696, 3560049645, 3560050495, 3560051909, 3560052840, 3560061847, 3560062631, 3560064180, 3560064931, 3560066439, 3560067859, 3560068645, 3560070029, 3560048039, 3560051828, 3560057043, 3560069189, 3560069953, 3560073912, 3560074661, 3560075928, 3560076789, 3560078836, 3560079297, 3560080671, 3560081651, 3560082720, 3560084551, 3560040556, 3560041217, 3560042424, 3560043007, 3560043991, 3560044516, 3560049040, 3560037757, 3560038317, 3560043307, 3560050968, 3560053521, 3560054670, 3560037601, 3560038213, 3560039396, 3560040253, 3560041042, 3560042194, 3560044972, 3560045632, 3560046675, 3560047423, 3560049837, 3560050483, 3560052447, 3560053054, 3560054284, 3560055049, 3560045601, 3560057386, 3560070268, 3560070996, 3560072355, 3560073056, 3560034051, 3560034747, 3560035650, 3560036297, 3560039953, 3560040481, 3560042303, 3560039319, 3560039920, 3560041116, 3560041753, 3560044618, 3560045307, 3560046404, 3560047143, 3560048312, 3560048987, 3560050248, 3560052325, 3560053018, 3560054169, 3560054833, 3560056465, 3560057673, 3560058355, 3560059462, 3560060144, 3560042754, 3560043234, 3560044300, 3560045120, 3560046136, 3560046826, 3560048307, 3560049023, 3560057116, 3560057744, 3560030714, 3560031509, 3560032250, 3560033048, 3560033929, 3560034749, 3560036260, 3560050119, 3560053808, 3560057913, 3560039110, 3560040108, 3560057227, 3560058922, 3560062970, 3560064372, 3560064972, 3560034181, 3560034607, 3560041191, 3560046861, 3560047369, 3560048561, 3560049466, 3560050468, 3560055250, 3560060690, 3560061777, 3560033205, 3560033591, 3560034632, 3560035228, 3560036152, 3560036804, 3560037809, 3560038484, 3560039730, 3560040247, 3560041489, 3560041996, 3560047985, 3560049216, 3560049916, 3560051099, 3560052932, 3560057880, 3560058713, 3560064993, 3560065723, 3560043224, 3560044218, 3560044815, 3560046260, 3560047279, 3560045647, 3560046333, 3560057071, 3560061815, 3560063781, 3560068338, 3560077583, 3560079545, 3560080229, 3560081550, 3560082209, 3560030512, 3560031257, 3560033459, 3560045372, 3560046357, 3560047585, 3560060619, 3560069227, 3560069937, 3560073322, 3560032743, 3560033310, 3560034273, 3560034910, 3560036320, 3560037536, 3560038188, 3560039341, 3560040032, 3560060903, 3560062202, 3560066218, 3560067304, 3560072559, 3560073158, 3560074554, 3560046725, 3560048761, 3560051833, 3560066047, 3560047644, 3560049181, 3560045631, 3560045812, 3560047734, 3560048814, 3560049615, 3560050728, 3560051320, 3560052597, 3560053213, 3560054473, 3560055166, 3560056508, 3560057156, 3560058268, 3560058940, 3560060117, 3560060862, 3560062067, 3560062839, 3560064212, 3560064880, 3560066172, 3560067090, 3560068198, 3560069591, 3560071722, 3560082055, 3560082522, 3560084583, 3560043275, 3560049882, 3560050966, 3560053519, 3560054669, 3560060664, 3560046820, 3560084423, 3560032525, 3560033072, 3560034174, 3560035785, 3560036329, 3560040616, 3560045602, 3560046063, 3560051989, 3560053027, 3560056745, 3560059099, 3560060280, 3560061486, 3560062260, 3560064901, 3560065403, 3560040516, 3560040978, 3560046364, 3560047071, 3560048301, 3560048873, 3560050210, 3560050834, 3560052523, 3560052923, 3560048196, 3560048790, 3560050020, 3560050732, 3560051859, 3560052938, 3560054063, 3560054748, 3560055953, 3560056657, 3560057903, 3560058587, 3560059747, 3560060460, 3560061697, 3560062407, 3560065341, 3560066165, 3560067484, 3560068187, 3560071876, 3560072644, 3560073964, 3560074756, 3560076154, 3560076972, 3560078156, 3560078875, 3560080146, 3560080871, 3560082120, 3560040798, 3560041306, 3560042783, 3560043460, 3560045744, 3560046996, 3560049445, 3560050383, 3560051332, 3560052227, 3560062807, 3560063700, 3560065230, 3560066472, 3560067374, 3560068450, 3560069321, 3560070488, 3560071380, 3560072552, 3560073490, 3560074679, 3560075644, 3560077037, 3560077702, 3560079014, 3560079668, 3560081185, 3560033088, 3560036543, 3560032269, 3560039095, 3560039567, 3560043129, 3560044391, 3560045105, 3560046852, 3560052702, 3560053345, 3560054563, 3560055128, 3560030254, 3560030688, 3560031721, 3560032201, 3560033344, 3560033821, 3560036538, 3560037037, 3560039172, 3560039649, 3560040913, 3560041997, 3560043450, 3560047731, 3560049725, 3560050971, 3560051934, 3560054692, 3560055247, 3560056359, 3560057012, 3560058295, 3560058902, 3560044939, 3560047931, 3560048437, 3560050501, 3560051712, 3560052327, 3560053504, 3560057378, 3560058020, 3560061819, 3560065500, 3560066333, 3560071660, 3560032486, 3560033256, 3560034084, 3560036084, 3560041087, 3560041696, 3560042834, 3560043487, 3560044538, 3560045186, 3560047073, 3560048352, 3560049067, 3560072443, 3560073704, 3560078767, 3560040985, 3560041986, 3560045094, 3560045613, 3560031318, 3560031733, 3560037303, 3560038198, 3560044284, 3560049800, 3560050500, 3560051683, 3560052343, 3560053629, 3560054622, 3560030055, 3560030457, 3560033255, 3560033632, 3560039601, 3560040331, 3560030999, 3560031535, 3560032702, 3560033338, 3560047376, 3560047792, 3560051634, 3560052479, 3560053992, 3560054917, 3560055875, 3560056838, 3560059763, 3560060613, 3560062593, 3560035999, 3560036541, 3560037893, 3560038521, 3560039597, 3560040212, 3560043694, 3560045009, 3560045496, 3560047318, 3560048161, 3560050094, 3560050814, 3560051960, 3560052634, 3560054160, 3560054858, 3560056061, 3560056740, 3560059817, 3560030550, 3560030771, 3560048252, 3560049013, 3560051264, 3560051496, 3560053099, 3560053696, 3560055009, 3560044552, 3560051343, 3560066021, 3560066687, 3560068397, 3560084569, 3560036073, 3560036670, 3560037617, 3560038346, 3560039394, 3560040153, 3560042866, 3560045040, 3560046735, 3560047474, 3560048689, 3560041048, 3560062841, 3560063750, 3560065838, 3560067609, 3560068235, 3560039136, 3560040061, 3560044105, 3560044938, 3560046435, 3560043355, 3560043942, 3560049924, 3560050768, 3560029940, 3560030834, 3560041235, 3560041736, 3560048592, 3560049523, 3560051556, 3560052079, 3560053978, 3560048213, 3560049017, 3560051442, 3560052041, 3560053327, 3560054610, 3560055721, 3560056463, 3560057723, 3560058451, 3560059527, 3560060274, 3560061469, 3560062209, 3560064528, 3560065547, 3560066818, 3560069653, 3560070467, 3560071696, 3560072527, 3560073773, 3560074579, 3560077435, 3560078359, 3560079631, 3560080417, 3560032887, 3560033426, 3560034349, 3560035056, 3560036008, 3560036652, 3560037641, 3560038401, 3560039347, 3560040069, 3560041176, 3560041830, 3560042963, 3560043644, 3560044646, 3560045386, 3560046455, 3560047221, 3560048276, 3560049025, 3560050181, 3560050915, 3560052408, 3560052976, 3560054265, 3560054955, 3560056147, 3560056823, 3560058145, 3560058767, 3560059929, 3560060711, 3560061921, 3560062708, 3560063909, 3560064619, 3560066031, 3560066908, 3560068061, 3560068738, 3560070776, 3560072093, 3560072778, 3560074201, 3560074939, 3560076449, 3560077113, 3560081023, 3560082330, 3560083056, 3560040530, 3560044231, 3560053540, 3560054138, 3560057268, 3560057941, 3560059104, 3560060158, 3560061358, 3560062080, 3560063347, 3560064089, 3560065792, 3560066640, 3560068826, 3560069404, 3560072340, 3560072988, 3560038077, 3560039065, 3560039656, 3560044304, 3560045010, 3560046100, 3560046727, 3560036569, 3560037035, 3560046681, 3560047945, 3560049019, 3560030975, 3560032403, 3560057192, 3560060825, 3560030762, 3560031138, 3560032297, 3560032785, 3560034373, 3560049931, 3560050594, 3560051639, 3560047088, 3560048574, 3560034734, 3560035305, 3560036254, 3560037876, 3560038641, 3560039609, 3560040347, 3560042103, 3560043154, 3560043842, 3560044892, 3560045611, 3560046686, 3560047382, 3560048527, 3560049311, 3560050411, 3560051175, 3560052242, 3560052962, 3560054206, 3560055162, 3560056057, 3560057105, 3560057994, 3560058965, 3560059819, 3560060854, 3560061797, 3560062805, 3560063736, 3560064840, 3560065855, 3560036019, 3560036544, 3560037658, 3560038295, 3560039312, 3560039954, 3560041391, 3560042131, 3560043202, 3560043829, 3560046393, 3560047035, 3560048183, 3560048853, 3560050215, 3560051169, 3560052006, 3560053050, 3560053888, 3560054795, 3560056020, 3560056782, 3560057985, 3560058704, 3560059842, 3560060647, 3560061747, 3560063807, 3560065883, 3560066781, 3560067984, 3560068728, 3560069803, 3560070624, 3560034497, 3560035030, 3560035983, 3560037389, 3560038003, 3560039098, 3560039596, 3560043027, 3560044546, 3560045308, 3560046645, 3560047447, 3560044424, 3560045143, 3560046257, 3560046926, 3560049819, 3560050593, 3560051761, 3560052436, 3560077657, 3560078310, 3560079644, 3560080282, 3560040458, 3560041097, 3560042903, 3560044276, 3560044918, 3560040768, 3560029919, 3560030525, 3560031425, 3560031950, 3560033145, 3560033619, 3560034698, 3560035215, 3560036549, 3560037603, 3560038255, 3560047153, 3560047608, 3560048876, 3560049487, 3560050807, 3560051415, 3560052773, 3560053240, 3560054663, 3560032797, 3560033323, 3560034292, 3560034926, 3560035887, 3560036494, 3560037515, 3560039216, 3560034824, 3560036001, 3560049808, 3560050772, 3560048283, 3560048983, 3560046746, 3560047395, 3560049682, 3560030616, 3560030904, 3560032120, 3560032557, 3560033705, 3560034185, 3560042376, 3560044081, 3560045664, 3560046076, 3560047441, 3560048260, 3560049334, 3560051509, 3560052155, 3560047738, 3560048102, 3560029959, 3560030562, 3560034066, 3560034650, 3560037375, 3560038004, 3560041171, 3560041939, 3560043031, 3560044756, 3560045258, 3560047262, 3560048370, 3560049039, 3560050299, 3560050994, 3560052157, 3560055536, 3560056129, 3560063166, 3560064365, 3560079561, 3560044592, 3560047131, 3560050925, 3560051512, 3560039390, 3560043284, 3560048514, 3560049680, 3560049960, 3560051778, 3560052375, 3560053690, 3560054381, 3560055530, 3560061869, 3560062648, 3560045663, 3560045877, 3560049617, 3560050235, 3560053959, 3560054657, 3560050168, 3560050757, 3560068130, 3560069723, 3560071107, 3560071566, 3560073473, 3560074638, 3560075646, 3560046711, 3560050692, 3560047867, 3560049443, 3560037628, 3560038199, 3560049900, 3560051633, 3560038319, 3560038834, 3560034748, 3560035524, 3560037131, 3560037696, 3560038197, 3560039308, 3560040004, 3560033104, 3560034105, 3560030743, 3560031759, 3560034133, 3560037136, 3560038915, 3560045942, 3560032868, 3560033699, 3560034457, 3560035323, 3560040858, 3560041305, 3560043123, 3560085231, 3560085725, 3560086749, 3560087704, 3560039099, 3560040494, 3560041366, 3560063155, 3560064087, 3560038193, 3560038822, 3560054468, 3560058304, 3560060824, 3560063013, 3560066276, 3560069842, 3560071209, 3560078877, 3560079807, 3560080914, 3560039054, 3560040110, 3560056232, 3560056845, 3560057976, 3560058838, 3560060001, 3560065202, 3560066017, 3560067557, 3560068656, 3560034035, 3560040979, 3560053460, 3560054456, 3560055636, 3560056353, 3560057551, 3560058285, 3560059397, 3560060122, 3560041253, 3560041724, 3560047938, 3560049844, 3560057445, 3560058473, 3560065538, 3560078110, 3560033154, 3560033894, 3560034930, 3560035899, 3560036608, 3560037932, 3560048867, 3560049508, 3560051120, 3560052297, 3560053040, 3560054294, 3560054813, 3560056160, 3560056974, 3560047113, 3560048623, 3560049567, 3560050531, 3560051695, 3560053481, 3560054477, 3560055712, 3560056402, 3560058201, 3560058785, 3560059975, 3560060646, 3560061928, 3560062613, 3560063961, 3560064634, 3560065908, 3560066730, 3560067914, 3560068764, 3560070593, 3560032221, 3560032674, 3560033968, 3560034542, 3560035640, 3560036233, 3560037258, 3560037800, 3560039199, 3560039850, 3560041092, 3560041627, 3560049823, 3560050874, 3560051706, 3560057931, 3560058660, 3560059851, 3560060622, 3560061796, 3560062570, 3560063794, 3560064694, 3560065868, 3560066842, 3560068043, 3560039918, 3560040786, 3560042331, 3560043253, 3560044556, 3560045303, 3560046448, 3560047130, 3560048251, 3560048922, 3560050167, 3560051016, 3560052124, 3560052819, 3560054570, 3560055508, 3560056531, 3560057736, 3560058454, 3560059467, 3560060207, 3560061484, 3560062169, 3560065087, 3560065864, 3560068036, 3560068663, 3560070452, 3560039618, 3560040638, 3560041911, 3560042508, 3560044189, 3560046185, 3560047229, 3560048020, 3560049146, 3560049718, 3560051285, 3560053689, 3560055579, 3560056645, 3560015136, 3560015474, 3560016354, 3560016749, 3560041035, 3560041634, 3560042803, 3560043445, 3560044526, 3560045212, 3560046321, 3560047004, 3560060851, 3560061347, 3560062778, 3560063335, 3560064761, 3560065364, 3560067492, 3560068190, 3560069405, 3560070194, 3560071492, 3560072300, 3560047599, 3560048185, 3560051162, 3560051417, 3560053269, 3560053827, 3560055882, 3560058987, 3560060018, 3560060887, 3560061961, 3560062925, 3560063921, 3560064817, 3560071230, 3560072014, 3560073289, 3560074218, 3560075435, 3560076439, 3560077637, 3560078400, 3560079540, 3560080362, 3560047905, 3560048656, 3560051538, 3560052123, 3560053348, 3560053998, 3560057114, 3560057848, 3560059055, 3560060336, 3560061994, 3560062501, 3560074797, 3560075599, 3560077255, 3560078715, 3560079567, 3560081450, 3560083126, 3560084749, 3560046766, 3560047407, 3560049733, 3560050455, 3560052001, 3560052733, 3560053755, 3560054591, 3560055752, 3560056360, 3560059762, 3560060655, 3560063920, 3560051767, 3560052493, 3560055573, 3560056378, 3560057666, 3560058639, 3560102791, 3560041458, 3560032274, 3560033391, 3560034153, 3560034947, 3560035738, 3560036552, 3560037347, 3560038209, 3560039028, 3560039957, 3560041121, 3560041905, 3560042924, 3560043527, 3560044585, 3560045267, 3560046413, 3560047189, 3560048334, 3560049036, 3560050115, 3560050827, 3560051908, 3560052716, 3560053880, 3560054629, 3560055862, 3560056524, 3560057735, 3560058372, 3560059491, 3560060288, 3560061432, 3560062226, 3560063417, 3560064174, 3560048053, 3560048476, 3560049743, 3560050412, 3560051611, 3560052340, 3560055387, 3560056063, 3560060996, 3560061661, 3560063253, 3560063998, 3560065294, 3560066132, 3560067435, 3560068596, 3560069373, 3560070870, 3560071466, 3560072874, 3560080468, 3560081065, 3560082431, 3560036053, 3560040751, 3560041823, 3560042543, 3560043508, 3560044315, 3560045192, 3560046050, 3560047065, 3560047844, 3560049047, 3560049751, 3560050805, 3560052596, 3560053484, 3560054504, 3560055337, 3560056411, 3560057298, 3560058688, 3560059438, 3560061047, 3560062092, 3560063009, 3560064070, 3560065072, 3560066329, 3560067284, 3560068365, 3560069186, 3560070279, 3560071236, 3560072403, 3560073295, 3560074438, 3560075390, 3560076620, 3560077568, 3560078663, 3560079515, 3560080999, 3560081843, 3560083301, 3560083783, 3560034461, 3560035492, 3560035917, 3560037287, 3560037901, 3560040378, 3560040599, 3560042276, 3560042689, 3560048732, 3560049287, 3560051273, 3560051421, 3560053149, 3560053250, 3560055038, 3560055289, 3560056744, 3560057174, 3560047623, 3560048126, 3560051372, 3560052245, 3560054180, 3560055183, 3560057468, 3560057966, 3560059500, 3560061550, 3560063137, 3560064276, 3560074200, 3560074887, 3560076392, 3560077133, 3560081236, 3560082719, 3560083261, 3560040371, 3560040926, 3560042011, 3560042627, 3560043702, 3560044364, 3560045609, 3560046154, 3560047288, 3560047969, 3560049221, 3560049831, 3560051184, 3560051679, 3560052969, 3560053640, 3560054779, 3560055335, 3560056709, 3560038247, 3560039355, 3560040046, 3560041163, 3560041858, 3560042888, 3560043510, 3560044481, 3560045229, 3560049887, 3560051195, 3560051741, 3560053049, 3560054403, 3560054913, 3560056298, 3560057433, 3560058794, 3560059205, 3560060637, 3560073918, 3560074850, 3560077178, 3560078119, 3560078990, 3560079946, 3560081045, 3560082076, 3560083066, 3560047987, 3560048915, 3560051791, 3560052761, 3560054246, 3560055711, 3560057693, 3560058505, 3560061554, 3560062298, 3560063604, 3560064335, 3560066285, 3560067352, 3560069522, 3560071284, 3560072609, 3560073833, 3560074459, 3560076022, 3560076906, 3560080087, 3560080739, 3560081965, 3560038221, 3560039356, 3560040041, 3560041158, 3560041856, 3560042876, 3560043509, 3560044643, 3560045350, 3560046475, 3560037732, 3560039452, 3560040202, 3560041203, 3560042179, 3560044740, 3560045692, 3560047749, 3560048342, 3560050280, 3560053536, 3560054322, 3560055531, 3560056237, 3560057456, 3560058501, 3560059676, 3560060411, 3560061629, 3560062396, 3560065728, 3560066506, 3560039304, 3560039917, 3560041119, 3560041754, 3560044620, 3560045309, 3560046405, 3560047158, 3560048317, 3560048988, 3560050553, 3560051202, 3560052347, 3560053021, 3560054172, 3560054838, 3560056467, 3560057676, 3560058357, 3560059466, 3560060145, 3560066343, 3560067250, 3560068391, 3560069719, 3560070442, 3560071525, 3560072902, 3560074905, 3560077173, 3560079532, 3560081654, 3560082725, 3560083573, 3560034393, 3560037228, 3560037711, 3560039481, 3560040116, 3560041245, 3560042497, 3560043902, 3560045431, 3560046905, 3560047801, 3560049099, 3560049679, 3560050997, 3560053403, 3560054961, 3560055263, 3560057856, 3560060058, 3560061745, 3560062713, 3560039291, 3560039878, 3560040987, 3560041678, 3560043118, 3560043727, 3560045203, 3560045925, 3560047014, 3560047589, 3560049200, 3560049470, 3560051152, 3560051350, 3560053125, 3560054584, 3560055690, 3560056388, 3560058365, 3560059601, 3560060156, 3560061503, 3560062166, 3560063824, 3560064545, 3560066102, 3560066705, 3560068281, 3560068941, 3560070236, 3560070919, 3560072393, 3560074029, 3560075857, 3560076730, 3560081948, 3560082652, 3560038337, 3560048204, 3560048882, 3560050681, 3560051514, 3560052376, 3560053262, 3560054231, 3560055482, 3560056540, 3560057786, 3560060074, 3560060917, 3560061918, 3560063161, 3560064213, 3560065135, 3560066263, 3560067217, 3560068295, 3560069133, 3560070206, 3560071202, 3560072341, 3560073367, 3560074535, 3560075405, 3560076624, 3560079757, 3560080477, 3560042736, 3560043288, 3560045107, 3560045895, 3560046793, 3560047724, 3560048694, 3560050884, 3560051426, 3560052803, 3560053635, 3560054989, 3560055445, 3560057780, 3560058784, 3560060043, 3560060726, 3560062024, 3560062706, 3560063740, 3560064606, 3560066155, 3560066798, 3560068138, 3560068672, 3560073176, 3560076560, 3560044329, 3560045233, 3560046037, 3560047031, 3560047848, 3560048914, 3560049742, 3560050981, 3560051771, 3560052752, 3560053683, 3560054624, 3560055539, 3560056585, 3560057857, 3560058544, 3560059679, 3560060403, 3560061644, 3560062735, 3560063584, 3560064450, 3560065707, 3560083461, 3560032755, 3560033330, 3560035470, 3560036860, 3560038166, 3560040755, 3560041847, 3560042593, 3560043563, 3560044331, 3560045289, 3560046104, 3560046988, 3560048018, 3560049123, 3560064636, 3560064980, 3560069010, 3560070253, 3560071741, 3560072714, 3560074312, 3560074896, 3560076487, 3560077126, 3560078518, 3560078904, 3560080181, 3560080968, 3560082189, 3560082888, 3560084109, 3560045073, 3560045780, 3560046663, 3560048270, 3560055840, 3560056566, 3560063471, 3560065444, 3560067656, 3560071412, 3560072555, 3560075905, 3560076792, 3560038038, 3560038675, 3560039698, 3560040563, 3560041402, 3560042335, 3560043201, 3560044067, 3560044886, 3560045798, 3560046684, 3560047670, 3560048523, 3560049565, 3560050651, 3560051427, 3560052286, 3560053203, 3560054176, 3560055121, 3560056042, 3560057016, 3560057972, 3560058976, 3560059941, 3560060835, 3560061761, 3560062801, 3560063732, 3560064809, 3560065836, 3560066955, 3560067882, 3560068872, 3560070086, 3560073003, 3560074051, 3560075125, 3560042643, 3560043254, 3560044232, 3560044850, 3560046015, 3560046625, 3560048012, 3560048703, 3560049840, 3560050578, 3560051796, 3560052494, 3560053660, 3560054342, 3560055564, 3560056268, 3560058931, 3560059561, 3560061199, 3560061917, 3560063044, 3560063978, 3560065257, 3560066085, 3560067255, 3560067904, 3560069600, 3560070342, 3560072992, 3560074623, 3560076457, 3560078393, 3560040210, 3560040950, 3560041964, 3560042757, 3560043968, 3560044713, 3560045777, 3560046597, 3560047548, 3560048431, 3560049607, 3560050349, 3560051789, 3560052191, 3560054400, 3560055048, 3560056303, 3560056947, 3560058893, 3560059735, 3560061009, 3560061681, 3560062931, 3560063640, 3560065720, 3560066519, 3560067818, 3560068514, 3560069786, 3560070566, 3560071858, 3560073229, 3560073939, 3560076072, 3560076991, 3560078147, 3560038116, 3560039776, 3560041528, 3560042645, 3560054259, 3560055022, 3560056284, 3560056925, 3560058075, 3560059624, 3560060793, 3560062321, 3560063854, 3560065293, 3560066873, 3560068018, 3560071146, 3560072605, 3560076089, 3560076941, 3560047080, 3560048187, 3560048869, 3560052643, 3560053239, 3560054493, 3560055130, 3560056401, 3560057290, 3560058305, 3560059089, 3560060165, 3560061086, 3560062087, 3560063010, 3560064095, 3560065038, 3560066221, 3560067203, 3560068244, 3560069169, 3560071210, 3560072359, 3560073274, 3560074411, 3560075425, 3560076696, 3560077595, 3560078587, 3560079509, 3560080563, 3560081497, 3560082908, 3560083476, 3560045046, 3560045840, 3560046779, 3560049522, 3560050451, 3560051358, 3560052265, 3560053315, 3560054506, 3560055346, 3560056368, 3560057279, 3560058307, 3560059161, 3560060114, 3560061024, 3560062104, 3560063094, 3560064179, 3560065106, 3560066224, 3560067201, 3560068269, 3560069138, 3560070269, 3560071265, 3560072419, 3560073290, 3560074442, 3560075880, 3560076669, 3560077859, 3560053927, 3560038018, 3560039366, 3560040865, 3560041507, 3560042688, 3560044147, 3560046165, 3560049060, 3560050261, 3560051411, 3560055846, 3560057464, 3560058123, 3560059637, 3560060384, 3560061977, 3560062703, 3560063721, 3560065560, 3560066464, 3560067764, 3560068366, 3560071125, 3560071697, 3560073733, 3560074699, 3560076107, 3560076742, 3560077965, 3560078640, 3560080098, 3560080836, 3560039584, 3560040189, 3560041287, 3560041968, 3560043092, 3560043664, 3560044809, 3560045466, 3560046596, 3560047278, 3560048429, 3560049141, 3560050348, 3560051054, 3560052871, 3560054060, 3560054749, 3560055948, 3560056659, 3560057896, 3560058576, 3560059744, 3560060456, 3560061695, 3560062409, 3560063662, 3560064476, 3560065748, 3560066547, 3560069124, 3560069899, 3560071182, 3560071871, 3560073261, 3560073962, 3560075397, 3560076150, 3560077558, 3560078157, 3560079500, 3560080147, 3560083684, 3560083909, 3560084686, 3560052188, 3560032494, 3560033269, 3560034228, 3560034886, 3560035848, 3560036452, 3560041608, 3560042510, 3560043385, 3560044201, 3560045973, 3560046913, 3560047803, 3560048758, 3560049685, 3560050695, 3560051416, 3560052507, 3560053263, 3560054394, 3560055292, 3560056300, 3560057220, 3560058537, 3560058961, 3560061002, 3560062389, 3560064985, 3560065715, 3560067158, 3560067804, 3560069092, 3560069777, 3560071162, 3560071821, 3560073227, 3560073935, 3560075337, 3560076065, 3560077492, 3560078106, 3560079418, 3560080081, 3560081378, 3560082061, 3560039541, 3560040745, 3560042281, 3560044310, 3560045221, 3560046005, 3560047007, 3560047838, 3560049064, 3560050186, 3560050788, 3560052259, 3560053181, 3560054821, 3560056082, 3560056683, 3560058033, 3560058598, 3560060103, 3560060610, 3560062046, 3560062571, 3560064034, 3560065001, 3560066537, 3560067186, 3560068579, 3560070620, 3560071895, 3560072659, 3560074007, 3560074759, 3560076193, 3560077021, 3560078163, 3560078881, 3560080153, 3560080867, 3560041303, 3560049622, 3560050040, 3560051321, 3560052091, 3560053173, 3560053977, 3560055063, 3560055632, 3560056980, 3560057553, 3560058901, 3560059412, 3560060808, 3560061318, 3560062758, 3560063295, 3560064893, 3560065351, 3560067099, 3560067485, 3560069129, 3560069799, 3560071190, 3560071878, 3560073253, 3560073973, 3560075625, 3560076182, 3560077718, 3560078725, 3560079719, 3560041317, 3560042279, 3560043098, 3560043970, 3560044821, 3560045734, 3560046609, 3560047552, 3560048660, 3560049430, 3560050360, 3560051322, 3560052686, 3560053209, 3560054515, 3560055191, 3560056349, 3560056978, 3560058275, 3560058892, 3560060127, 3560042632, 3560043493, 3560044669, 3560045366, 3560046319, 3560047195, 3560048305, 3560048825, 3560050052, 3560050749, 3560051879, 3560052576, 3560053983, 3560054442, 3560055627, 3560056343, 3560057614, 3560058274, 3560059574, 3560060131, 3560061353, 3560062111, 3560063298, 3560064046, 3560065387, 3560066214, 3560067529, 3560068272, 3560069457, 3560070190, 3560071509, 3560072329, 3560073585, 3560074393, 3560075777, 3560076646, 3560077869, 3560047637, 3560048569, 3560050601, 3560051529, 3560053950, 3560055821, 3560056588, 3560057806, 3560059179, 3560059901, 3560061080, 3560062093, 3560063114, 3560064314, 3560065175, 3560066331, 3560067392, 3560069315, 3560070017, 3560071370, 3560072086, 3560075612, 3560076383, 3560079690, 3560081632, 3560082322, 3560042943, 3560043560, 3560044801, 3560045454, 3560046943, 3560047812, 3560048776, 3560049782, 3560050720, 3560051847, 3560052528, 3560053712, 3560054408, 3560057246, 3560057893, 3560059385, 3560060449, 3560061686, 3560062399, 3560063652, 3560064378, 3560065742, 3560066531, 3560067809, 3560068525, 3560069781, 3560070550, 3560073563, 3560074335, 3560075738, 3560076590, 3560082108, 3560082825, 3560047405, 3560047872, 3560049193, 3560049783, 3560051182, 3560053056, 3560068752, 3560069206, 3560050131, 3560051780, 3560057355, 3560058406, 3560063518, 3560064348, 3560065692, 3560066473, 3560071109, 3560071837, 3560073220, 3560049834, 3560050512, 3560051796, 3650053691, 3560054204, 3560056246, 3560063370, 3560064188, 3560079865, 3560042606, 3560043104, 3560044406, 3560044950, 3560046214, 3560047260, 3560048027, 3560049296, 3560050654, 3560051165, 3560052543, 3560053116, 3560054241, 3560070912, 3560072187, 3560052551, and 3560053223

Recalling Firm: Talecris Plasma Resources, Inc., Research Triangle Park, NC, by fax between February 25, 2009 and August 28, 2010.

Manufacturer: Talecris Plasma Resources, Inc., San Antonio, TX. Firm initiated recall is complete.

Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed.

2,228 units

NC

Platelets Pheresis Leukocytes Reduced. Recall # B-1281-11

Unit: 032KP65882

The American National Red Cross, Madison, WI, by facsimile on May 30, 2007. Firm initiated recall is complete.

Blood product, for which the quality control testing was incomplete, was distributed.

1 unit

PA

Recovered Plasma. Recall # B-1284-11

Units: 032LF76057; 032LJ25213; 032LX79431; 032LX79431

Recalling Firm: The American National Red Cross, Madison, WI, by fax and electronic notification on August 1, 2007. 

Manufacturer: American Red Cross - Dubuque Facility, Dubuque, IA. Firm initiated recall is complete.

Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.

4 units

WI, CA, MI, ME

 

LANTIS Commander, LANTIS Commander 6.1, LANTIS 8.3 Commander, LANTIS System, LANTIS 6.1 Complete, LANTIS 6.1 Essential, LANTIS 8.3 Complete and LANTIS 8.3 Essential. Electronic patient records management system.  Model Product Number LANTIS COMMANDER 4503178 LANTIS System 5835991 LANTIS Commander 6.1 5493072 LANTIS 6.1 Complete 8147527 LANTIS 6.1 Essential 8147535 LANTIS 8.3 Complete 8147543 LANTIS 8.3 Essential 8147550 LANTIS 8.3 Commander 8148178. Recall # Z-2151-2011

Model number only

Recalling Firm: Siemens Medical Solutions USA, Inc., Concord, CA, by letter on March 23, 2011.

Manufacturer: Impac Medical Systems Inc., Sunnyvale, CA. Firm initiated recall is ongoing.

There is a potential safety issue in regard to data transfer between LANTIS OIS system and the hospital Information System (HIS) when the HL7 (ADT) interfact is used.

47

Nationwide

 

1) Argon Medical Devices Catheter Introducer Kit, PCI 5 Kit 7F, Part Number 496183, Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier. For percutaneous introduction of catheters. Recall # Z-2083-2011;

 

2) Argon Medical Devices, Catheter Introducer Kit, Argon PCI Kit with Feather Dilator - Pediatric, 4F, Part Number 496308, Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier. For percutaneous introduction of catheters. Recall # Z-2084-2011;

 

3) Argon Medical Devices Catheter Introducer Kit, PCI Kit with Feather Dilator - Pediatric, 6F, Part Number 496310, Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier. For percutaneous introduction of catheters. Recall # Z-2085-2011;

 

4) Argon Medical Device Catheter Introducer Kit, Argon PCI Kit with Feather Dilator - Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier. For percutaneous introduction of catheters. Part Number 496311. Recall # Z-2086-2011;

 

5) Argon Medical Devices Catheter Introducer Kit, One-Piece/Tuohy-Borst Catheter Introducer Tray 8F, Part number 497444. Recall # Z-2087-2011;

 

6) Argon Medical Devices Arterial Line Kit/1 20ga x 6", Part Number 498100, Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier. Recall # Z-2088-2011;

 

7) Argon Medical Devices, Arterial Line Kit, Arterial Catheter Mini Kit 20gax6in, Part Number 498101, Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier. Recall # Z-2089-2011;

 

8) Argon Medical Devices, Arterial Line Kit/1 18ga x 6", Part Number 498104, Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier. Recall # Z-2090-2011;

 

9) Argon Medical Devices, Arterial Line Kit/1, 20ga x 3", Part Number 498106, Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier. Recall # Z-2091-2011;

 

10) Argon Medical Devices Arterial Line Kit/1, 18ga x 3", Part Number 498110, Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier. Recall # Z-2092-2011;

 

11) Argon Medical Devices, Arterial Line Kit, 20ga x 3", Part Number 498411B, Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier. Recall # Z-2093-2011;

 

12) Argon Medical Devices Arterial Line Kit, 20ga x 1.75", Part Number 498418, Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier. Recall #Z-2094-2011;

 

13) Argon Medical Devices, Arterial Line Kit, Arterial Catheter Mini Kit, 20GX3in, Part Number 498435, Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier. Recall # Z-2095-2011;

 

14) Argon Medical Devices, Arterial Line Kit, 18ga x 6", Part Number 498443, Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier. Recall # Z-2096-2011;

 

15) Argon Medical Devices, Catheter Introducer Kit 5F, Part Number 496190A, Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier. For percutaneous introduction of catheters. Recall # Z-2097-2011;

 

16) Argon Medical Devices, Arterial Line Kit, Part Number 498410B, 20gax6", Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier. Recall #Z-2098-2011;

 

17) Argon Medical Devices Arterial Line Kit, 18ga x 6", Part Number 498412B, Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier. Recall # Z-2099-2011;

 

18) Argon Medical Devices, Arterial Line Kit 20ga x 3", Part Number 498421B, Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier. Recall #Z-2100-2011;

 

19) Argon Medical Devices, Arterial Line Kit/1, 18ga x 6", Part Number 498447, Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier. Recall # Z-2101-2011

1) Lot number: 99767488;

2) Lot number: 99767641;

3) Lot number: 99767643;   

4) Lot number: 99768100;

5) Lot number: 99766895;

6) Lots numbers: 99767185, 99767266, and 99768223;

7) Lot number: 99767264;

8) Lot numbers: 99767186 and 99768103;

9) Lot numbers: 99767187 and 99767388;

10) Lot numbers: 99768048 and 99768520;

11) Lot number: 99767966;

12) Lot number: 99738059;

13) Lot number: 99738059;

14) Lot number: 99767778;

15) Lot number: 99766894;

16) Lot number: 99766894;

17) Lot number: 99767958;

18) Lot number: 99766896;

19) Lot number: 99767634

Argon Medical Devices, Inc., Athens, TX, by letter dated March 14, 2011. Firm initiated recall is ongoing.

Packaging for sterile tray has the potential to have a hole which could compromise sterility for the products inside.

5,780 units

Nationwide, Japan, Australia, Canada, Singapore, and the Netherlands

UniCel DxH 800 Coulter Cellular Analysis System Part Number: 629029 The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides: - Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood - Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF). Recall # Z-2128-2011

All serial numbers, SW version 1.1.3.0

Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter dated October 20, 2010. 

Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is ongoing.

Body Fluids results may be incorrectly interpreted by the Laboratory Information System (LIS). Body Fluid results ~ 1,000 celis/uL are reported using the US numeric separators to demark thousandths places (comma, ",") and partial units (decimal, "."). An LIS that uses non-US formats could interpret the comma as a partial units separator, which could lead to reporting erroneously low body fluid results. For example, if the LIS format uses commas to denote partial units, the figure transmitted as "1,586" (one thousand five hundred eighty-six) could be interpreted at the LIS as "1,6" (one and six tenths). IMPACT: Specimens with Body Fluid results ~1000 cells/uL could be reported erroneously low in the LIS. The impact of erroneously low results could be most severe in relation to cerebral spinal fluid (CSF) analysis. This could potentially result in a misdiagnosis or a delay in diagnosis that could affect patient management leading to permanent injury. A long-term delay in the diagnosis of an acute event may result in neurological sequelae such as acute meningitis or cerebral hemorrhage.

422 units

Nationwide and Internationally

Catheter Insertion Kit (containing, Under pad, PVP Pad, BZK Prep Pad, Sterile Lubricating Jelly, Vinyl Gloves and Poly Zipper Bag). Intended usage: Kit components to be used during Intermittent Urinary Catheterizations. Catalog Reference number: 6100A. Recall # Z-2133-2011

Lot numbers: 8315, 9317, 0317, 9G176, 0C046, 0G226, 0K186, 1A316, 8316, 9318, 0318, 9G206, 0C086, 0G236, 0K196, 1B016, 8317, 9320, 0319, 9G236, 0C096, 0G246, 0K206, 1B026, 8319, 9321, 0320, 9G286, 0C106, 0G296, 0K226, 1B036, 8320, 9324, 0321, 9G296, 0C186, 0G306, 0K236, 1B046, 8321, 9325, 0322, 9H066, 0C196, 0H216, 0K246, 1B056, 8324, 9326, 0323, 9H076, 0C206, 0H226, 0K256, 1B076, 8325, 9327, 0324, 9H086, 0C226, 0H266, 0K286, 1B186, 8326, 9328, 0325, 9H126, 0C236, 0H276, 0K296, 1B196, 8327, 9329, 0326, 9H176, 0C256, 0H286, 0K306, 1B176, 8329, 9340, 0327, 9H236, 0C266, 0I166, 0L036, 1B196, 8340, 0301, 0328, 9H246, 0C276, 0I176, 0L046, 1B216, 8341, 0302, 0329, 9H256, 0D076, 0I186, 0L066, 1B226, 8342, 0303, 0330, 0A186, 0D086, 0I206, 0L076, 1B236, 9301, 0304, 0331, 0A196, 0D096,0I256, 0L086, 1C016, 9302, 0305, 0332, 0A206, 0D106, 0I276, 0L096, 1C026, 9304, 0306, 1302, 0A216, 0D126, 0J236, 0L226, 1C036, 9305, 0307, 1303, 0A226, 0E086, 0J256, A196 and 1C046

Apogee Medical, Inc., Youngsville, NC, by letter dated March 23, 2011. FDA initiated recall is ongoing.

Kits contain PVP (Providone Iodine) prep pads that are being recalled by the Triad Group due to possible micro contamination, Elizabethkingia meningoseptica.

5,503,430 units

Nationwide

Baxter Single Day Infusor 2 mL/h Portable Elastomeric Infusion System; an Rx sterile disposable drug delivery system; REF 2C1071KJP The Infusor device is indicated for patients requiring slow, continuous intravenous, intra-arterial, epidural, or subcutaneous administration of medications; a) Product code 2C1071KJP, b) product code 2C1073KJP. Recall # Z-2146-2011

a) and b) Lot 10H054

Recalling Firm: Baxter Healthcare Corp., Round Lake, by letters dated March 15, 2011.

Manufacturer: Baxter Healthcare Corp., Irvine, CA. Firm initiated recall is ongoing.

Some of the Single Day Infusor System 2 mL/h have a foil over-pouch that was incorrectly labeled as the Half Day Infusor System 5 mL/h, product code 2C1073KJP, lot 10H054.

3,696 units

Nationwide, Mexico and Spain

UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029 The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a: (1) Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood; (2) Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial). Recall # Z-2148-2011

All Serial Numbers

Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter dated February 11, 2011.

Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is ongoing.

The recall was initiated because: The DxH 800 may fail to meet the carryover specification for NRBC% when the WBC is greater than 50 X 10 to the 3rd power cells/micro L (50 X 10 to the 9th power cells/L) Beckman Coulter indicated the NRBC% carryover is unlikely to have clinical impact.

566 units

Nationwide and Internationally

Siemens brand ACUSON S2000, Model 10434730, ABVS ultrasound systems; Affected sub-components Numbers: (1) 10434968, Boom Welding; (2) 10434969, Arm Welding; The S2000 Automated Breast Volume Scanner (ABVS) Ultrasound System for imaging the breast allows volumetric acquisition of the breast image. It provides the operator with the option of using a controlled user independent automated scan motion. The resulting 3D display information enables comprehensive image review by the medical professional. In particular, the coronal plane is scanned, which is not easily accessible with hand-held ultrasound transducers. Recall # Z-2150-2011

Serial Numbers: 1) 250157, 250162, 250163, 250164, 250166, 250167 and 250169; 2) 250171, 250173, 250177

Siemens Medical Solutions USA, Inc., Mountain View, CA, by telephone and e-mail on March 28, 2011. Firm initiated recall is complete.

The weld connecting the ABVS arm to the system base has the potential to fail, causing the arm to fall off of the unit.

10 units

Nationwide, Portugal, Germany, Russia, Estonia, Brazil, France, and Saudi Arabia

Allied Healthcare Products Inc. CarbO2Lime Carbon Dioxide Absorbent Granules for Canister Refill, Non-Hygroscopic Soda Lime USP-NF, Type: High Moisture (12% to 19%), Granule Size: 4 to 10 Mesh (4.8-2.0mm), packaged in 5-gal. pails, #55-01-0003; prepacked canisters (12 canisters/case), #55-01-0005; and replacement bags (12 bags/case), #55-01-0006, RX. The product is a non-hygroscopic soda lime compound that is specially formulated to absorb carbon dioxide from the respiratory gas stream in anesthesia applications. Recall # Z-2152-2011

Lot numbers C06910, C12410, C13810, C14410, C15510, C16210, C16610, C16810, C17210, C17410, C17610, and C17910

Recalling Firm: Allied Healthcare Products Inc., Saint Louis, MO, by letters dated August 10, 2010.

Manufacturer: Allied Healthcare Products, Inc., Stuyvesant Falls, NY. Firm initiated recall iscomplete.

The granules do not absorb as long as expected in the anesthesia machines.

949 pails, 335/12-canister cases, and 706/12-refill bag cases

Nationwide, Canada and Grenada

 

VARIANT nbs Sickle Program Resin Update CD-ROM; Model Number:250-3020, included in 250-3000; The VARIANT nbs Sickle Cell Program is intended 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(HPLC). The VARIANT nbs Sickle Cell Program is intended for Professional use only. Recall # Z-1984-2011

Resin Update CD-ROM, 250-3020 lot # AA 00092 goes with Reorder Pack Lot No. 50392618 Resin Update CD-ROM, 250-3020 lot # BA 00092 goes with Reorder Pack Lot No 50300210. Resin Update CD-ROM, 250-3020 lot # CA 00092 Reorder Pack Lot No 50300645 & 50300650. Expiration date: 05/31/2011, 06/30/2011, 08/31/2011 PIN No. 250-3000

Bio-Rad, Laboratories Inc., Hercules CA, by letters on April 14, 2011 and update on May 13, 2011. Firm initiated recall is ongoing.

The affected resin Update CD-ROMs cause all user-defined settings in the Setup/Test/Data Setup sub screen and Set/Test/Pattern Setting sub screen to be overwritten when the Update Kit procedure is performed.

658 units

Nationwide and Internationally

SharpointTM 4-0 Black Monofilament Non-Absorbable Nylon 18"/DS24mm Reverse Cutting Edged Needle. Intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, opthalmic, and neurological procedures. Product Code - AC-0584D. Recall # Z-2138-2011

Lot number M446840

Surgical Specialties Corp., Reading, PA, by letter on March 30, 2011. Firm initiated recall is ongoing.  

Mislabeled - a number of units of the product labeled as 4-0 Black Mono Nylon suture product contain a 4-0 Black Braided Silk suture.

2,628 units

Nationwide and Australia