Enforcement Report

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

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November 7, 2007
07-45

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS - CLASS I
___________________________________
PRODUCT
a) Majesty brand Cantaloupes further labeled "Five Crowns Marketing Brawley,
    and "SHIPPING IN SEASON FROM CALIFORNIA AND ARIZONA." The
    cantaloupes were packaged 15 per case, Recall # F-030-8;
b) Cut fruit products in 5 lb. plastic buckets under the following label: Northwestern
     Fruit Company Inc. Each bucket is labeled with the product name, weight and code
     number. Varieties included cantaloupe cubed, cantaloupe peeled/sliced, deluxe fruit
     mix, cantaloupe/pineapple mix, cantaloupe peeled/halved, c/h/p fruit mix, breakfast
     blend, and cantaloupe small cubed, Recall # F-031-8
CODE
a) Lot: # 23409;
b) Products were coded as 5, 6, 8, 9 or 11 (based on day processed July 5 – 11)
RECALLING FIRM/MANUFACTURER
Northwestern Fruit Co., Saint Paul, MN, by telephone on July 13, 2007. Firm initiated recall is complete.
REASON
The Minnesota Department of Agriculture found a sample of the whole cantaloupes contaminated with Salmonella. A portion of the whole cantaloupes was further processed into cut fruit products.
VOLUME OF PRODUCT IN COMMERCE
130 cases
DISTRIBUTION
MN and WI
___________________________________
PRODUCT
a) Smoked salmon spread in 7 oz. plastic tub labeled Jensen's Seattle Style Wild
    Smoked Salmon Spread Lemon Dill and Onion, Recall # F-032-8;
b) Smoked Salmon Spread in 7 oz. plastic tub labeled PCC NATURAL MARKETS
    smoked salmon SPREAD all-natural (Label does not declare manufacturer or
    distributor), Recall # F-033-8
CODE
a) Sell by 10/14 07, 10/15 07, 10/20 07;
b) Sell by 9/29 07
RECALLING FIRM/MANUFACTURER
Recalling Firm: Jensen's Old Fashioned Smokehouse Inc., Seattle, WA, by visit on September 1, 2007, by telephone, press release and e-mail on September 7, 2007, and by telephone and press release on October 2, 2007.
Manufacturer: Carso’s Pasta Company, Lynnwood, WA. Firm initiated recall is complete.
REASON
Product is contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
1,548 tubs
DISTRIBUTION
WA
___________________________________
PRODUCT
a) Buffalo Chicken Sandwich, plu 3707, Net Wt. 5.5 oz. (156g); fresh, refrigerated
    sandwiches in plastic wrappers, 12 sandwiches per case, under the following labels:
    a) All Seasons Services Inc. Buffalo Chicken,
    b) All Seasons Market Dynamic Vending Buffalo Chicken,
    c) Ala Carte Buffalo Chicken,
    d) Betty's Kitchen Buffalo Chicken,
    e) Fresh Options Buffalo Chicken,
    f) Fresh Cafe Buffalo Chicken,
    g) Fresh Selections Buffalo Chicken,
    h) Buffalo Chicken, Sheehan Bros.
    i) Sodexho Buffalo Chicken, Sodexho,
    j) The Lunch Box Buffalo Chicken,
    UPC 0 65875 63707 2, Recall # F-034-8;
b) Italian Asiago Sandwich, plu 3770, Net Wt. 9.25 oz. (262g); fresh, refrigerated
    sandwiches, 12 sandwiches per case, sold in vending machines and convenience
    stores in plastic wrappers under the following labels:
    a) All Seasons Services Inc. Italian Asiago,
    b) All Seasons Market Dynamic Vending Italian Asiago,
   c) Ala Carte Italian Asiago,
   d) Betty's Kitchen Italian Asiago,
    e) Fresh Options Italian Asiago,
    f) Fresh Cafe Italian Asiago,
    g) Fresh Selections Italian Asiago,
    h) Italian Asiago,
    i) Sodexho Italian Asiago,
    j) The Lunch Box Italian Asiago,
    UPC 0 65875 63770 6, Recall # F-035-8;
c) Cuban Sandwich, plu 3795, Net Wt. 9 oz. (255g); fresh, refrigerated sandwiches, 12
     sandwiches per case, sold in vending machines and convenience stores in plastic
     wrappers under the following labels:
    a) All Seasons Services Inc. Cuban Sandwich ,
    b) All Seasons Market Dynamic Vending Cuban Sandwich ,
    c) Ala Carte Cuban Sandwich,
    d) Betty's Kitchen Cuban Sandwich,
    e) Fresh Options Cuban Sandwich,
    f) Fresh Cafe Cuban Sandwich,
    g) Fresh Selections Cuban Sandwich,
    h) Cuban Sandwich,
    i) Sodexho Cuban Sandwich,
     j) The Lunch Box Cuban Sandwich,
    UPC 0 65875 63795 9, Recall # F-036-8
CODE
a) plu #3707, Expiration date 073007;
b) plu 3770, Expiration date 073007;
c) plu 3795, Expiration date 073007
RECALLING FIRM/MANUFACTURER
Imperial Food Service, South Elgin, IL, by letter dated July 25, 2007. Firm initiated recall is complete.
REASON
The sandwiches are contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
588 cases
DISTRIBUTION
IL, IN, MI, MO, OH, and WI

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS - CLASS II
___________________________________
PRODUCT
Market Pantry 100% Juice, vegetable, flavored from concentrate with added ingredients, packaged in 64-fl. oz. bottles, 6 bottles/case, Recall # F-029-8
CODE
Best By: 26JUL2008MCF, 16AUG2008MCF, 27AUG2008MCF, and 05SEP2008MCF
RECALLING FIRM/MANUFACTURER
Mrs Clark’s Foods LC, Ankeny, IA, by e-mail letter on October 1, 2007. Firm initiated recall is ongoing.
REASON
One of the seasoning ingredients contains wheat and is not declared on the label.
VOLUME OF PRODUCT IN COMMERCE
3,649/6-bottle cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
White plastic 7 1/2" x 2" bag containing: Outside Package label: ***naturabella***Nino Dusanzo***Toothbrush Set*** Inside packaging: two clear toothbrushes of approx 61/4 long and two toothpaste tubes approx 2 1/2 long with the picture of a blue color toothbrush and the words in red color "Dentifrice" "Dentifricio" "Toothpaste" in the front and back of the tube, Recall # F-037-8
CODE
None
RECALLING FIRM/MANUFACTURER
Certejenas, Inc., Cidra, PR, by visit beginning on June 18, 2007. Firm initiated recall is ongoing.
REASON
Toothpaste contains diethylene glycol (DEG)
VOLUME OF PRODUCT IN COMMERCE
60,000 sets
DISTRIBUTION
PR

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
Methylprednisolone Acetate Injectable Suspension, USP 80 mg/ml. The product is shipped as 25 single unit vials or 40 twenty-five unit vials, Recall # D-028-2008
CODE
Lot number: 07J704 exp 1/31/2009 and Lot number: 07K702 exp 1/31/2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: TEVA Pharmaceuticals USA, Inc., Sellersville, PA, by letter on September 26, 2007.
Manufacturer: Teva Parenteral Medicines Inc., Irvine, CA,. Firm initiated recall is ongoing.
REASON
Lack of assurance of sterility.
VOLUME OF PRODUCT IN COMMERCE
80,254 vials
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Top Care brand Tussin DM, cough suppressant expectorant for children and adults,
    alcohol free, active ingredients (in each 5 mL teaspoonful): Dextromethorphan HBr
    10 mg and Guaifenesin 100 mg, 8 fl. oz.. bottles, NDC 36800-359-34, OTC,
    Recall # D-031-2008
b) Good Neighbor Pharmacy brand Tussin DM, cough suppressant expectorant for
    children and adults, alcohol and sugar free, active ingredients (in each 5 mL
    teaspoonful): Dextromethorphan HBr 10 mg and Guaifenesin 100 mg, 4 fl. oz.. bottles,
    NDC 24385-578-26, OTC, Recall # D-032-2008
CODE
a) Lot 7HK0118, exp. 06/09;
b) Lot 7HK0044, exp. 06/09
RECALLING FIRM/MANUFACTURER
L. Perrigo, Co., Allegan, MI, by telephone on or about September 6, 2007. Firm initiated recall is ongoing.
REASON
Some dosing cups packaged with product lack the ½ teaspoon mark for dosing children 2 to 6 years of age which could result in administration of twice the recommended dose of dextromethorphan.
VOLUME OF PRODUCT IN COMMERCE
23,664 bottles (total number of bottles distributed for Recall # D-029-032-2008)
DISTRIBUTION
IL, MI, and PA
___________________________________
PRODUCT
Sunburst CHOLESTRIX Red Rice Yeast Extract, Standardized to contain 1.35% Lovastatin, A Dietary Supplement, 90 Vegetable Capsules, Product #489 90. UPC 6 40313 48901 9, Recall # D- D-033-2008
CODE
Lot 5142 (exp. 8/11)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sunburst Biorganics Inc., Baldwin, NY, by telephone on August 14, 2007.
Manufacturer: Bactolac Pharmaceutical, Inc., Hauppauge, NY. Firm initiated recall is ongoing.
REASON
Unapproved new drug marketed without an approved NDA/ANDA containing Lovastatin, the active pharmaceutical ingredient in Mevacor.
VOLUME OF PRODUCT IN COMMERCE
488 bottles (90 capsules per bottle)
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
Nutropin AQ Injection (somatropin (rDNA origin), 10 mg in per vial, 2 mL vials, Rx only, Recall # D-015-2008
CODE
Lot number N58562, expiration date 10/31/08, and lot number N63479, expiration date 03/31/2009
RECALLING FIRM/MANUFACTURER
Genentech, Inc., South San Francisco, CA, by letter dated July 23, 2007. Firm initiated recall is complete.
REASON
Mislabeled. Secondary carton may lack labeling of expiration date and lot number.
VOLUME OF PRODUCT IN COMMERCE
8,709 vials
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Major brand Children's Mucus Relief Expectorant/Guaifenesin liquid, grape flavor,
    active ingredient (in each 5 mL tsp): Guaifenesin 100 mg, 4 fl. oz.. bottles,
    NDC 0904-5814-20, OTC, Recall # D-029-2008;
b) Children's Expectorant/Cough Suppressant liquid, cherry flavor, alcohol free, active
    ingredients (in each 5 mL tsp): Dextromethorphan HBr 5 mg and Guaifenesin 100 mg,
    4 fl. oz . bottles. Packaged under the following brand names: 1) Major brand Children's
    Mucus Relief Cough, distributed by Major Pharmaceuticals, Livonia, MI (NDC 0904-
    5815-20); 2) Walgreens brand Children's Cough, (NDC 0363-0419-26); 3) Rite Aid
    brand Children's Mucus Relief Cough, Recall # D-030-2008
CODE
a) Lot 7HK0065, exp. 06/09;
b) Lots 7HK0062, exp. 06/09 and 7HK0063, exp. 03/09
RECALLING FIRM/MANUFACTURER
L. Perrigo, Co., Allegan, MI, by telephone on or about September 6, 2007. Firm initiated recall is ongoing.
REASON
Some dosing cups packaged with product lack the ½ teaspoon mark for dosing children 2 to 6 years of age.
VOLUME OF PRODUCT IN COMMERCE
23,664 bottles ((total number of bottles distributed for Recall # D-029-032-2008))
DISTRIBUTION
IL, MI, and PA
___________________________________
PRODUCT
Respi-Tann, Carbetapentane Citrate 20mg and Pseudoephedrine HCl 30mg Tannate Suspension per each 5mL, 16 fl oz, Rx only, Recall # D-034-2008
CODE
Lot number on shipping carton: EPS006, exp 06/09; Lot number on unit bottle: EPS0D6
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ani Pharmaceuticals, Woodlawn, MD, by letter on October 1, 2007.
Manufacturer: ANIP Acquisition Company, Gulfport, MS. Firm initiated recall is ongoing.
REASON
Lot number on unit bottle is incorrect.
VOLUME OF PRODUCT IN COMMERCE
1,632 units
DISTRIBUTION
TN
___________________________________
PRODUCT
Otozone Otic Drops (Chloroxylenol 1mg/ Hydrocortisone 10mg/Pramoxine HCI 10mg); Rx only, Recall # D-035-2008
CODE
Lot # 60411
RECALLING FIRM/MANUFACTURER
Elge, Inc., Rosenberg, TX, by telephone and letter on October 5, 2007. Firm initiated recall is ongoing.
REASON
Stability data does not support expiration date. Product failed Prammoxine during stability.
VOLUME OF PRODUCT IN COMMERCE
4,890 units
DISTRIBUTION
TN
___________________________________
PRODUCT
a) Gabapentin Tablets, 600 mg, 100 & 500 tablet bottles, Rx only, NDC 63304-592-01
     and 63304-592-05, Recall # D-036-2008;
b) Gabapentin Tablets, 800 mg, 100 & 500 tablet bottles, Rx only, NDC 63304-593-01
     and 63304-593-05, Recall # D-037-2008
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ranbaxy Pharmaceuticals, Inc., Princeton, NJ, by letters on October 24, 2007.
Manufacturer: Ranbaxy Laboratories, Limited, Simour District, India. Firm initiated recall is ongoing.
REASON
Product may exceed impurity specification for Related Substances during shelf life.
VOLUME OF PRODUCT IN COMMERCE
73,286,200 tablets
DISTRIBUTION
Nationwide and PR

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-0087-08
CODE
Unit: 040FP27245
RECALLING FIRM/MANUFACTURER
American National Red Cross Heart of America Region, Peoria, IL, by telephone on April 11, 2007 and fax on April 13, 2007. Firm initiated recall is complete.
REASON
Blood product, with incomplete documentation of the irradiation process, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL
___________________________________
PRODUCT
Platelets Leukocytes Reduced Irradiated, Recall # B-0176-08
CODE
Unit: 19GQ16247
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN,
by telephone on October 16, 2006 and follow-up letter dated October 24, 2006. Firm initiated recall is complete.
REASON
Blood product, collected in a manner that may have compromised the sterility of the collection system, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
Plasma Cryoprecipitate Reduced, Recall # B-0199-08
CODE
Unit: 71T274348
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by telephone and facsimile on November 8, and November 16, 2006. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which an associated blood component contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL and AL

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0088-08
CODE
Unit: 36FT06782
RECALLING FIRM/MANUFACTURER
American National Red Cross, Columbia, SC, by telephone on October 7, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for leishmaniasis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
SC
___________________________________
PRODUCT
Cryoprecipitated AHF, Recall # B-0093-08
CODE
Recall # 4027818
RECALLING FIRM/MANUFACTURER
The Blood Connection, Inc, Piedmont, SC, by telephone and follow-up letter on September 19, 2006. Firm initiated recall is complete.
REASON
Blood product, manufactured from plasma frozen more than 8 hours after collection, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
Red Blood Cells, Recall # B-0094-08
CODE
Unit: FK21393
RECALLING FIRM/MANUFACTURER
Heartland Blood Centers, Aurora, IL, by telephone on April 24, 2007 and letter on May 3, 2007. Firm initiated recall is complete.
REASON
Blood product, which did not have red cell preservative solution added but which was labeled AS-5, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL
___________________________________
PRODUCT
Red Blood Cells, Recall # B-0095-08
CODE
Unit: FK10919
RECALLING FIRM/MANUFACTURER
Heartland Blood Centers, Aurora, IL, by telephone on February 20, 2007 and letter on April 3, 2007. Firm initiated recall is complete.
REASON
Blood product, which did not have red cell preservative solution added but which was labeled AS-5, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0177-08
CODE
7165238 #1, 7165238 #2 (split product)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Oklahoma Blood Institute - Sylvan N Goldman Center, Oklahoma City, OK, by fax on December 14, 2006.
Manufacturer: Oklahoma Blood Institute, Northwest Oklahoma Blood Institute, Enid, OK. Firm initiated recall is complete.
REASON
Blood Products, collected from a donor who received Varicella Zoster vaccine less than 28 days before donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY
___________________________________
PRODUCT
Red Blood Cells, Recall # B-0196-08
CODE
Unit: 71S962239
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by telephone and facsimile on November 15, 2006. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which an associated blood component contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0197-08
CODE
Unit: 71T316319
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by telephone and facsimile on October 24, 2006. Firm initiated recall is complete.
REASON
A consignee reported discovery of fibrin strands in a fresh frozen plasma product; the product was returned and destroyed. The fibrin strands were not discovered at component production, pre-distribution inspection, or upon consignee acceptance. A market withdrawal was issued for the distributed co-components.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA

__________________________________
PRODUCT
Red Blood Cells, Recall # B-0198-08
CODE
Unit: 71T472875
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by telephone and facsimile on November 16, 2006 and January 17, 2007. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which an associated blood component contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells, Recall # B-0200-08
CODE
Unit: 71T274348
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by telephone and facsimile on November 8, and November 16, 2006. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which an associated blood component contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL and AL
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-0201-08
CODE
Unit: 71T203349
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by telephone and facsimile on October 23, 2006. Firm initiated recall is complete.
REASON
Blood product, which was incorrectly labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0202-08
CODE
Unit: 71T004232
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by telephone on December 27, 2006 and January 28, 2007. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which an associated blood component contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
Bio-logic System Corp --Telescoping Camera Pole Assembly (part number 585-CYBPSM and 580-VIDPOL) and assemblies (580IPCART and 580 PNCART; The Model 580-VIDPOL is used with the 580-PNCART that is wired for use with a Panasonic Camera. The pole is also a subassembly of the 585-CYBPSM with wires used in the 580-IPCART wired for the use with an Ipela Camera. Both carts are a component of the Ceegraph/Sleepscan Netlink with Video, Recall Z-0001-2008
CODE
No serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bio-Logic Systems Corp., Mundelein, IL, by letters dated July 26, 2007.
Manufacturer: TLK Industries Inc., Palatine, IL. Firm initiated recall is ongoing.
REASON
Bio-logic System Corp Camera Pole may weaken and detach at the base of the telescoping camera pole during transport causing pole to break at the welded base and fall.
VOLUME OF PRODUCT IN COMMERCE
311 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Medtronic Export XT Aspiration Catheter, 6F Model Numbers: G146200USB (US Distribution) G1452006B (Outside US), Recall # Z-0063-2008
CODE
All lot numbers
RECALLING FIRM/MANUFACTURER
Medtronic, Inc., Danvers, MA, by letter dated August 29, 2007. Firm initiated recall is ongoing.
REASON
Additional Warning in Instructions for Use for guide wire management. Complaints of wire lumen tearing during use or band marker becoming dislodged.
VOLUME OF PRODUCT IN COMMERCE
13,940 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Biomet --DCM AGC Molded Tibial Implant (12 mm x 80 mm)-- Biomet
    Orthopedics , Interlok finish/posterior stabilized, 12 mm thick x 80 mm wide,
    UHMWPE/CO-CR-MO alloy, sterile; REF 155364, Recall # Z-0076-2008;
b) Biomet Orthopedics DCM AGC Molded Tibial Component, 12 mm thick x 80 mm,
    UHMWPE/CO-CR-MO alloy, sterile; REF 155116, Recall # Z-0077-2008
CODE
a) Lot 311500; exp. 2012-02.
b) Lot 918930; exp. 2012-02.
RECALLING FIRM/MANUFACTURER
Biomet, Inc., Warsaw, IN, by telephone on or about July 24, 2007 and letter dated August 31, 2007. Firm initiated recall is complete.
REASON
Incorrect Product -- Mislabeled as to size. An 18 mm x 65 mm tibula implant is enclosed in a package labeled as 12 mm x 80 mm.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
IA, SD, Brazil and Chile
___________________________________
PRODUCT
Spectra Optia apheresis system, a blood component separator. Part No. 61000, Recall # Z-0078-2008
CODE
Serial #’s: 1P00100 to 1P00141
RECALLING FIRM/MANUFACTURER
Gambro BCT, Inc., Lakewood, CO, by telephone beginning September 17, 2007 and letters on September 22, 2007. Firm initiated recall is ongoing.
REASON
Under specific conditions, apheresis machine could return up to 60 mL. of air to the patient.
VOLUME OF PRODUCT IN COMMERCE
15 units
DISTRIBUTION
Nationwide, Canada, Australia, Europe
___________________________________
PRODUCT
ReUnion Fracture Stem Humeral Component - PureFix HA; Shoulder prosthesis. Distal Diameter - 7 to 15mm; Hydroxylapatite coated; Titanium Plasma Spray; Product No. 5351-4507 to 5351-4515; 5351-4608. 5351-4610 and 5351-4612, Recall # Z-0080-2008
CODE
All lot codes
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters on May 9, 2007 and November 1, 2007. Firm initiated recall is complete.
REASON
The plasma spray may delaminate from the proximal portion of the humeral stem.
VOLUME OF PRODUCT IN COMMERCE
232 units
DISTRIBUTION
OH
___________________________________
PRODUCT
a) Brilliance CT Systems, 40 slice configuration. Computed tomography scanner,
     Model No. 728231, Recall # Z-0110-2008;
b) Brilliance CT Systems 64 slice configuration. Computed tomography scanner.
    Model No. 728235, Recall # Z-0111-2008
CODE
a) and b) Version 2.2.1
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter dated May 25, 2007.
Manufacturer: Philips Medical Systems Technolo, Haifa, Israel. Firm initiated recall is ongoing.
REASON
Two potential artifacts may appear in some images from head scans on the Brilliance 40/64 systems. These artifacts may lead to misdiagnosis.
VOLUME OF PRODUCT IN COMMERCE
1,037 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Boston Scientific Radial Jaw Large Capacity Biopsy Forceps, Sterile, 240 mm.
    Box of 20 UPN Number: M00513321 REF: 1332-20, Recall # Z-0116-2008;
b) Boston Scientific Radial Jaw Large Capacity Biopsy Forceps with Needle, Sterile,
    240 mm. Box of 20 UPN Number: M00513331 REF: 1333-20,
    Recall # Z-0117-2008;
c) Boston Scientific Radial Jaw Large Capacity Biopsy Forceps with Needle, Sterile,
    240 mm. Box of 40 UPN Number: M00513332 REF: 1333-40, Recall # Z-0118-2008;
CODE
a) Lot Number: 8990184;
b) Lot Numbers: 8984691, 9005322, 9005726, 9005727;
c) Lot Numbers: 8984687, 8984688, 8984689, 8990186, 9003394, 9003396,
    9005718, 9005719, 9017283
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corporation, Marlborough, MA, by letter on August 28, 2007.
Manufacturer: Boston Scientific Corporation, Global Park, Heredia,Costa Rica. Firm initiated recall is ongoing.
REASON
Device lacked manufacturing finishing process resulting in scope damage.
VOLUME OF PRODUCT IN COMMERCE
1,519 boxes
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III
___________________________________
PRODUCT
Bio-Rad Laboratories-MONOLISA Anti-HBc IGM EIA kit, an in-vitro diagnostic test kit, Catalog # 26174, Recall # Z-0065-2008
CODE
Lot: 131BHH
RECALLING FIRM/MANUFACTURER
Bio-Rad Laboratories, Redmond, WA, by letters on September 5, 2007 and September 19, 2007. Firm initiated recall is complete.
REASON
Incorrect Instructions. The packages insert states to add 100L of conjugate; it should state to add 100uL.
VOLUME OF PRODUCT IN COMMERCE
46 kits
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Olympus Single Use Mechanical Lithotriptor, Model Number BML-V232QR-26,
    Recall # Z-0105-2008;
b) Olympus Single Use Mechanical Lithotriptor, Model number BML-V232QR-30,
    Recall # Z-0106-2008;
c) Olympus Single Use Mechanical Lithotriptor, Model number BML-V242QR-30,
    Recall # Z-0107-2008;
d) Olympus Single Use Mechanical Lithotriptor, Model number BML-201Q,
    Recall # Z-0108-2008
CODE
a) Model number BML-V232QR-26: Lot numbers 75K, 76K, and 77K.
b) Model number BML-V232QR-30: Lot numbers 75K, 76K, and 77K;
c) Model number BML-V242QR-30: Lot numbers 75K, 76K, and 77K;
d) Model number BML-201Q: Lot numbers 76K and 77K
RECALLING FIRM/MANUFACTURER
Recalling Firm: Olympus America Inc., Center Valley, PA, by letter dated September 20, 2007.
Manufacturer: Aomori Olympus Co Ltd, Aomori, Japan. Firm initiated recall is ongoing.
REASON
Slider knob does not move smoothly causing the user difficulty in advancing the coil sheath.
VOLUME OF PRODUCT IN COMMERCE
482 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Boston Scientific-Renegade Hi-Flo Microcatheter Kit, UPN Material Number: MOO1183030,Catalog Number: 18-303, Recall # Z-0109-2008
CODE
Lot Numbers: 9218692; 9218628; 9218451
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corporation, Marlborough, MA, by letter dated September 10, 2007.
Manufacturer: Boston Scientific Cork, Ltd., Cork, Ireland. Firm initiated recall is ongoing.
REASON
Incorrect Guidewire: Product may incorrectly contain a 135 cm length Transend-18 guidewire instead of the kit labeled 165 cm length Transend-18 guidewire.
VOLUME OF PRODUCT IN COMMERCE
153 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Harleco May and Grunwald's Stain; 0.17% w/v; Methanol Solution UN1230; Item # 660/75 1 liter and Item 660/85 /4 liter poly bottles, Recall # Z-0133-2008
CODE
Lot: 7161, Exp. Date: 31 Jan 09
RECALLING FIRM/MANUFACTURER
EMD Chemicals, Inc., Gibbstown, NJ, by letter dated July 30, 2007. Firm initiated recall is ongoing.
REASON
Batch Out of Specifications. The Batch (Lot) was incorrectly released after being rejected for out of specification of high azure and eosin absorbance at the end of the run and particulate matter at the end of the run.
VOLUME OF PRODUCT IN COMMERCE
26 units (1 liter), 1 unit (4 liter)
DISTRIBUTION
US and Canada

END OF ENFORCEMENT REPORT FOR NOVEMBER 7, 2007

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