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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December 5, 2007
07-49

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
Dole Hearts Delight" Salad sold in the U.S. and Canada with a "best if used by (BIUB)" date of September 19, 2007, and a production code of "A24924A" or "A24924B" stamped on the package. The "best if use by (BIUB)" code date can be located in the upper right hand corner of the front of the bag. The salad was sold in plastic bags of 227 grams in Canada and one-half pound in the U.S., with UPC code 0 71430 01038 9, Recall # F-052-8
CODE
"Best if used by (BIUB)" date of September 19, 2007, and a production code of "A24924A" or "A24924B" stamped on the package.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Dole Fresh Fruit Company, Westlake Village, CA, by email and Press Statement on September 17, 2007 and by telephone on September 24, 2007.
Manufacturer: Dole Fresh Vegetables, Inc., Springfield, OH. Firm initiated recall is ongoing.
REASON
The Canadian Food Inspection Agency found E. coli O157:H7 in the product.
VOLUME OF PRODUCT IN COMMERCE
755 cartons (6 X 8oz bags/carton)
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Organic Pastures brand Grade A Raw Cream 100% Pasture Glazed, 1 pint (470ml) plastic bottles with paper labels, Recall # F-056-8
CODE
SEP 14 through SEP 21
RECALLING FIRM/MANUFACTURER
Organic Pastures Dairy, Fresno, CA, by telephone beginning on September 7, 2007. Firm initiated recall is ongoing.
REASON
The California Department of Food and Agriculture detected Listeria monocytogenes in the product.
VOLUME OF PRODUCT IN COMMERCE
21 pint bottles
DISTRIBUTION
FL, HI, MN and WA

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
___________________________________
PRODUCT
100% Natural, La Estrellita Premium Enchilada Sauce, Net Wt. 16 oz., Mild, La Estrellita (Little Star), Recall # F-053-8
CODE
No manufacturing codes.
RECALLING FIRM/MANUFACTURER
La Estrellita Enterprises Inc., Brighton, CO., by visit beginning on May 22, 2007. Firm initiated recall is complete.
REASON
The product was inadequately processed to prevent growth of pathogens of public health significance.
VOLUME OF PRODUCT IN COMMERCE
Approximately 720 jars per year
DISTRIBUTION
CO
___________________________________
PRODUCT
Campbell's Chunky Baked Potato with Cheddar & Bacan Bits, 18.8 oz. (533 grams); UPC #51000 12804, Recall # F-054-8
CODE
Can Code: "JUL 08 2009 CT DT " BZ " 07097 XXXX" (XXXX represents military time). Case Code: "12804 08 JUL 09 TS"
RECALLING FIRM/MANUFACTURER
Recalling Firm: Campbells, Camden, NJ, by letter and telephone and press release on October 4, 2007.
Manufacturer: Campbell Soup Supply Company, LLC, Paris, TX. Firm initiated recall is ongoing.
REASON
Product may contain plastic fragments.
VOLUME OF PRODUCT IN COMMERCE
6,025 cases (72,300 units)
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III
___________________________________
PRODUCT
a) Top Ramen Oodles of Noodles Shrimp Flavor, 3.0 oz. The product is shipped
24 units per case/120 cases per pallet. UPC number 70662-01010-5., Recall # F-043-8;
b) Top Ramen Oodles of Noodles Picante Shrimp Flavor, 3.0 oz. The product is shipped
24 units per case/120 cases per pallet . UPC number 70662-01019-8. Recall # F-044-8;
c) Chow Mein Thai Peanut Flavor, 4.0 oz. The product is shipped 8 units per case/98
cases per pallet. UPC number 70662-08726-8, Recall # F-045-8;
d) Cup Noodle Salsa Picante Shrimp Flavor with Chile Limon, 2.25 oz. The product is
shipped 24 units per case/55 cases per pallet. UPC number 70662-03102-5.,
Recall # F-046-8;
e) Cup Noodle Shrimp Picante, 2.25 oz. The product is shipped 12 units per case/110
cases per pallet. UPC number 70662-03012-7, Recall # F-047-8;
f) Cup Noodle Chile Limon Flavor with Shrimp, 2.5 oz. The product is shipped 12 units
per case/110 cases per pallet. UPC number 70662-13009-4, Recall # F-048-8;
g) Thrifty Maid Shrimp Ramen, 3.0 oz. The product is shipped 24 units per case/120
cases per pallet. UPC number 21140-21771-4, Recall # F-049-8;
h) Kirkland Signature Cup Shrimp & Vegetable, 2.71 oz. The product is shipped 12 units
per case/110 cases per pallet. UPC number 62111-99221-6, Recall # F-050-8
CODE
a) Lot numbers are printed on the packages at the time of production, according to the
format and code for each product. The recall is underway on all production of the
shrimp cup of noodle products with production dates after 1/1/06 (production code
010107WS or 010107CS) through 7/17/07 (production code 071708WS or 071708CS).
The date codes are used to show the product Best By date;
b) Lot numbers are printed on the packages at the time of production, according to the
format and code for each product. The recall is underway on all production of the
shrimp cup of noodle products with production dates after 1/1/06 (production code
010107WS or 010107CS) through 7/17/07 (production code 071708WS or 071708CS).
The date codes are used to show the product Best By date;
c) Lot numbers are printed on the packages at the time of production, according to the
format and code for each product. The recall is underway on all production of the
shrimp cup of noodle products with production dates after 1/1/06 (production code
010107WS or 010107CS) through 7/17/07 (production code 071708WS or 071708CS).
The date codes are used to show the product Best By date;
d) Lot numbers are printed on the packages at the time of production, according to the
format and code for each product. The recall is underway on all production of the
shrimp cup of noodle products with production dates after 1/1/06 (production code
010107WS or 010107CS) through 7/17/07 (production code 071708WS or
071708CS). The date codes are used to show the product Best By date;
e) Lot numbers are printed on the packages at the time of production, according to the
format and code for each product. The recall is underway on all production of the
shrimp cup of noodle products with production dates after 1/1/06 (production code
010107WS or 010107CS) through 7/17/07 (production code 071708WS or 071708CS).
The date codes are used to show the product Best By date;
f) Lot numbers are printed on the packages at the time of production, according to the
format and code for each product. The recall is underway on all production of the
shrimp cup of noodle products with production dates after 1/1/06 (production code
010107WS or 010107CS) through 7/17/07 (production code 071708WS or 071708CS).
The date codes are used to show the product Best By date;
g) Lot numbers are printed on the packages at the time of production, according to the
format and code for each product. The recall is underway on all production of the
shrimp cup of noodle products with production dates after 1/1/06 (production code
010107WS or 010107CS) through 7/17/07 (production code 071708WS or 071708CS).
The date codes are used to show the product Best By date;
h) Lot numbers are printed on the packages at the time of production, according to the
format and code for each product. The recall is underway on all production of the
shrimp cup of noodle products with production dates after 1/1/06 (production code
010107WS or 010107CS) through 7/17/07 (production code 071708WS or 071708CS).
The date codes are used to show the product Best By date
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nissin Foods Co Inc USA, Gardena, CA, by e-mail on July 20, 2007.
Manufacturer: Nissin Foods USA Co Inc, Lancaster PA. Firm initiated recall is ongoing.
REASON
Product contains undeclared krill.
VOLUME OF PRODUCT IN COMMERCE
6,197,057 cases
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
Nicorette Original Stop Smoking Aid, (nicotine polacrilex gum), 2 mg, 130 pieces (Bonus 20 extra pieces), This product is protected in sealed blisters, For those who smoke less than 25 cigarettes a day, Retail UPC 3-07667-84515-0, Recall # D-050-2008
CODE
Lot Code/Expiry: 6K18N / 1/08 NDC: 000135-0229-04
RECALLING FIRM/MANUFACTURER
Recalling Firm: Glaxo Smithkline, Moon Township, PA, by letters on October 18, 2007.
Manufacturer: GlaxoSmithKline Consumer Healthcare LP, Hanover, PA. Firm initiated recall is ongoing.
REASON
Label error on declared strength; carton labeled to contain Nicorette 2 mg Original gum (130 ct) Bonus Pack actually contains Nicorette 4 mg Mint gum.
VOLUME OF PRODUCT IN COMMERCE
960 cartons
DISTRIBUTION
FL, OH, MI, PA and WV.
___________________________________
PRODUCT
NC Solution (anti-fungal solution), tolnaftate 1%, 15mL (1/2 oz), Recall # D-053-2008
CODE
Lot No. 207001, exp date: 2/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Astan Inc., Birmingham, AL, by telephone on October 26, 2007 and by letter on November 2, 2007.
Manufacturer: General Therapeutic Corp, Saint Louis, MI. Firm initiated recall is ongoing.
REASON
Unapproved New Drug; product contains DMSO.
VOLUME OF PRODUCT IN COMMERCE
4,402 units
DISTRIBUTION
AL, WA, IL, VA, NY
___________________________________
PRODUCT
a) Theophylline Extended-Release Capsules, USP, 200 mg, 100 Capsules,
NDC 0258-3634-01, Rx only; Recall # D-055-2008;
b) Theophylline Extended-Release Capsules, USP, 125 mg, 100 Capsules,
NDC 0258-3638-01, Rx only; Recall # D-056-2008
CODE
a) Lots 6B002 (exp. 1/09/08) and 6B004 (exp. 1/09/08);
b) Lot 6F004 (exp. 1/23/08)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Forest Laboratories, Inc., Commack, NY, by letters on November 7, 2007.
Manufacturer: Inwood Labs, Inwood, NY. Firm initiated recall is ongoing.
REASON
Failed USP dissolution test requirement.
VOLUME OF PRODUCT IN COMMERCE
Lot 6F004: 6652 bottles of 100; Lot 6B002: 9824 bottles of 100; Lot 6B004: 9706 bottles of 100
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
a) Demerol (Meperidine HCl Injection, USP), 25 mg/mL, 1 mL Carpuject Sterile
Cartridge Units with Luer Lock, Rx only, 10 Carpuject syringes per immediate
carton, 5 cartons per over-wrapped unit, 20 over-wrapped units per outer shipping
case, NDC 0409-1176-30, 10, Recall # D-048-2008;
b) HYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Carpuject Sterile Cartridge
Units with Luer Lock, NDC 0409-1312-30, 10 Carpuject syringes per immediate
carton, 5 cartons per over-wrapped unit, 20 over-wrapped units per outer shipping
case, Recall # D-049-2008
CODE
a) and b) Lot 54565LL, Exp. 1 JUN 2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira, Inc., Lake Forest, IL, by letters dated October 17, 2007.
Manufacturer: Hospira, Inc., McPherson, KA. Firm initiated recall is ongoing.
REASON
Mispacked. Correctly labeled prefilled Dermerol syringes are mispacked into cartons labeled as HYDROmorphone HCI injection.
VOLUME OF PRODUCT IN COMMERCE
36,101/10-Carpuject cartons
DISTRIBUTION
Nationwide and Guam
___________________________________
PRODUCT
Children's Claritin Allergy Oral Solution, (loratadine), 5mg/5mL - antihistimine, Non Drowsy - 24 hour relief, Ages 2-6+, 2 Fl Oz (60 mL) and 4 Fl Oz (120mL) bottles, Great Grape Taste, Item number 80463, 2 oz, and Item number 80465; 4 oz; UPC # 100-41100-80465-2, Recall # D-051-2008
CODE
Lot Number 6-FGH-800, exp Jun 08; Lot Number 6-FGH-802, exp. Sep 08; Lot Number 6-FGH-803, exp Sep 08. --- Lot Number 6-FGH-801 CASE
RECALLING FIRM/MANUFACTURER
Recalling Firm: Schering Plough Corporation, Summit, NJ, by letter on October 16, 2007.
Manufacturer: Schering Corp., Kenilworth, NJ. Firm initiated recall is ongoing.
REASON
Degradation Failure (3 month stability)
VOLUME OF PRODUCT IN COMMERCE
227,652 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Ibuprofen-200 Advanced Pain Relief Tablets, (ibuprofen) 200mg, 24, 50 and 100 count bottles, Recall # D-052-2008
CODE
Lot: HA09807
RECALLING FIRM/MANUFACTURER
Recalling Firm: Reese Pharmaceutical Company, Cleveland, OH, by letter on October 25, 2007.
Manufacturer: Interpharm, Inc., Hauppauge, NY. Firm initiated recall is ongoing.
REASON
Impurity (6 month stability)
VOLUME OF PRODUCT IN COMMERCE
15,720 tablets
DISTRIBUTION
AL, AR, CA, GA, IL, NC, NJ, PA, and TX
___________________________________
PRODUCT
Preferred Plus Pharmacy Cough Formula PE, Expectorant/Nasal Decongestant for adults and children, active ingredients (in each 5 mL tsp): Guaifenesin 100 mg and Phenylepherine HCL 5 mg, 4 fl.oz. bottle, NDC 66879-949-05, Recall # D-054-2008
CODE
Lot: D0738, exp. 04/09
RECALLING FIRM/MANUFACTURER
Medico Labs, Inc., Hamilton, NJ, by telephone on October 26, 2007 and by letter on October 29, 2007. Firm initiated recall is ongoing.
REASON
The Drug Facts panel on the product bottle incorrectly lists the nasal decongestant active ingredient as Pseudoephedrine HCL 30 mg; the product contains the nasal decongestant Phenylepherine HCl 5 mg as stated on the outer carton.
VOLUME OF PRODUCT IN COMMERCE
4,308 bottles
DISTRIBUTION
NY
___________________________________
PRODUCT
Penicillin G Procaine, Injectable Suspension, 1,200,000 units per 2mL, Rx only, packages of 10 and individual syringes, Recall # D-057-2008
CODE
Lot: 44175, exp. 03-2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: King Pharmaceuticals, Inc., Bristol, TN, by letter on October 12, 2007.
Manufacturer: King Pharmaceuticals, Inc., Rochester, MI. Firm initiated recall is ongoing.
REASON
Outer carton mislabeling.
VOLUME OF PRODUCT IN COMMERCE
16,660 units (in packages in 10 syringes)
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
a) Fresh Frozen Plasma, Recall # B-0096-08;
b) Red Blood Cells, Leukocytes Reduced, Recall # B-0097-08
CODE
a) Unit: 36KP15846;
b) Units: 36KP15848; 36KP15846
RECALLING FIRM/MANUFACTURER
American National Red Cross, Columbia, SC, by telephone on September 20, 2005 and follow-up letter on October 10, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
SC
___________________________________
PRODUCT
Antihemophilic Factor/von Willebrand Factor Complex (Human), Dried, Pasteurized Humate-P. The box is shipped in a box containing the following: 1 glass vial of Antihemophilic Factor/von Willebrand Factor Complex (Human); 1 glass vial of Sterile Diluent for Humate-P; 1 transfer needle for reconstitution; 1 disposable filter; 2 alcohol swabs; and directions for use. NDC numbers 0053-7620-05, NDC number 0053-7620-10, NDC number 0053-7620-20, NDC number 0053-7615-05,
NDC number 0053-7615-10, NDC number 0053-7615-20, Recall # B-0157-08
CODE
Lot number 39466611E exp 15/04/07;
Lot numbers 41166611A exp 28/06/07; 41566611A exp07/08/07; 41666611A exp 07/08/07; 41966611A exp 07/08/07;
Lot numbers 37566611G exp 03/12/06; 41366611A exp 31/08/07; 41466611A exp 01/09/07; 41766611A exp 08/09/07; 41866611A exp 09/09/07; 42166611A exp 27/09/07; 42266611A exp 04/10/07; and 42466611A exp 05/10/07;
Lot numbers 00166811A exp 22/06/06; 00466811A exp 16/07/06; 01766811A exp 08/11/07; 03166811A exp 09/12/07; 06166811A exp 09/05/08; 06166811B exp 09/05/08;06266811A exp 16/05/08; 06366811A exp 17/05/08; 08066811A exp 03/08/08; 08066811B exp 03/08/08; 09566811A exp 25/11/08; and 11366811A exp 13/01/09;
Lot numbers 00266811A exp 13/07/06, 00966811A exp 06/10/07, 01066811A exp 06/10/07, 01866811A exp 06/10/07, 02866811A exp 06/10/07, 02966811A exp 06/10/07, 03066811A exp 08/12/07, 03266811A exp 24/01/08, 03366811A exp 25/01/08, 04066811A exp 09/02/08, 04566811A exp 28/02/08, 05266811B exp 28/03/08, 05366811B exp 29/03/08 05466811A exp 04/04/08, 05566811A exp 05/04/08, 05666811A exp 11/04/08, 05766811A exp 12/04/08, 06066811A exp 27/04/08, 06066811B exp 27/04/08, 07166811A exp 15/06/08, 07266811A exp 16/06/08, 07366811A exp 24/06/08, 07666811A exp 21/07/08, 07766811A exp 22/07/08, 08166811A exp 19/09/08, 08266811A exp 20/09/08, 08766811A exp 12/10/08, 08766811B exp 12/10/08, 08866811A exp 13/10/08, 09366811A exp26/10/08, 09466811A exp 25/11/08, 10866811A exp 23/01/09, 10966811A exp 24/01/09, 11466811A exp 10/02/09, 12466811A exp 17/03/09;
Lot numbers 01166811A exp 27/10/07, 01266811A exp 28/10/07,
01366811A exp 01/11/07, 01466811A exp 02/11/07, 01566811A exp 03/11/07, 01666811A exp 04/11/07, 01966811A exp 10/11/07, 02066811A exp 11/11/07, 02166811A exp 15/11/07, 02266811A exp 16/11/07, 02366811A exp 17/11/07, 02466811A exp 18/11/07, 02566811A exp 22/11/07, 02666811A exp 23/11/07, 02766811A exp 24/11/07, 03466811A exp 26/01/08, 03566811A exp 27/01/08, 03766811A exp 01/02/08, 03866811A exp 07/02/08, 03966811A exp 08/02/08, 04166811A exp 15/02/08, 04266811A exp 16/02/08, 04366811A exp 17/02/08, 04466811A exp 17/02/08, 04666811A exp 01/03/08, 04766811A exp 02/03/08, 04866811B exp 07/03/08, 04966811B exp 08/03/08, 05066811B exp 14/03/08, 05166811B exp 15/03/08, 05866811A exp 25/04/08, 05966811A exp 26/04/08, 06466811A exp 23/05/08, 06566811A exp 07/06/08, 06666811A exp 08/06/08, 06766811A exp 09/06/08, 06866811A exp 10/06/08, 06966811A exp 13/06/08, 07066811A exp 14/06/08, 07466811A exp 14/07/08, 07566811A exp 15/07/08, 07866811A exp 01/08/08, 07966811A exp 02/08/08, 08366811A exp 30/09/08, 08466811A exp 30/09/08, 08566811A exp 10/10/08, 08666811A exp 11/10/08, 08966811A exp 17/10/08, 09066811A exp 18/10/08, 09166811A exp 24/10/08, 09266811A exp 25/10/08, 09666811A exp 28/11/08, 09766811A exp 29/11/08, 09866811A exp 30/11/08, 09966811A exp 01/12/08, 10166811A exp 09/12/08, 10266811A exp 12/12/08, 10366811A exp 13/12/08, 10466811A exp 22/12/08, 10566811A exp 22/12/08, 10666811B exp 12/01/09, 10766811B exp 12/01/09, 11066811A exp 12/01/09, 11166811A exp 12/01/09, 11266811A exp 12/01/09, 11566811A exp 12/01/09, 11666811A exp 12/01/09, 11766811A exp 12/01/09, 11866811A exp 12/01/09, 11966811A exp 12/01/09, 12066811A exp 12/01/09, 12166811A exp 12/01/09, 12366811A exp 12/01/09, 12566811A exp 10/03/09, 12966811A exp 24/03/09, 13466811A exp 05/04/09, and 13566811A exp 06/04/09;
RECALLING FIRM/MANUFACTURER
Csl Behring Llc, King of Prussia, PA, by telephone and letter on July 24, 2007 and by letters on July 27, 2007. Firm initiated recall is complete.
REASON
Humate-P, with possible damage to the blister (plastic film) packaging of the transfer sets, was distributed.
VOLUME OF PRODUCT IN COMMERCE
205,671 vials
DISTRIBUTION
Nationwide, Canada and Germany
___________________________________
PRODUCT
Teruflex®CPDA-1 Blood collection System with Blood Sampling Arm®, containing 63mL CPDA-1 anticoagulant, 450 mL (whole blood fill) volume, Recall # B-0160-08
CODE
Lot #: 070417GY Exp 2009-09
070418GV Exp 2009-09
070530GX Exp 2009-10
070531GV Exp 2009-10
070628GX Exp 2009-11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Terumo Medical Corp., Elkton, MD, by telephone on August 1, 2007 and by urgent product bulletin on August 6, 2007.
Manufacturer: Fujinomiya Factory Of Terumo Corp., Shizuoka, Japan. Firm initiated recall is ongoing.
REASON
Blood collection system is mislabeled for expiration date.
VOLUME OF PRODUCT IN COMMERCE
5 lots
DISTRIBUTION
PA, LA and FL
___________________________________
PRODUCT
AUSAB Quantitation Panel, List Number 1459-05, Recall # B-0161-08
CODE
Lot 46399M100
RECALLING FIRM/MANUFACTURER
Abbott Laboratories MPG, Abbott Park, IL, by letter dated June 25, 2007. Firm initiated recall is ongoing.
REASON
The AUSAB Quantitation Panel was found to read preparations of the W.H.O. reference material up to 61% higher when using Procedure A and up to 84% higher when using Procedure B for Lot Number 46399M100.
VOLUME OF PRODUCT IN COMMERCE
1 panel
DISTRIBUTION
Nationwide, Canada and Germany
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0192-08
CODE
FW84186
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by facsimile on December 28, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor who had traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0193-08
CODE
Unit: GN21681
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by facsimile on August 31, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI
___________________________________
PRODUCT
Red Blood Cells, Recall # B-0194-08
CODE
Unit: 6760121
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on November 15, 2006. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0233-08
CODE
Unit: 4811469
RECALLING FIRM/MANUFACTURER
Recalling Firm: Oklahoma Blood Institute – Sylvan N Goldman Center, Oklahoma City, OK, by fax on October 2, 2006.
Manufacturer: Oklahoma Blood Institute, Ardmore, OK. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY and Switzerland
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0243-08
CODE
Unit: 2334882
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by facsimile on January 2, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had sexual contact with a person who traveled to an HIV Group O risk area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0253-08
CODE
Unit: 2294873, Part A and Part B.
RECALLING FIRM/MANUFACTURER
Blood Bank of Delmarva, Inc., Newark, DE, by letter on August 14, 2007. Firm initiated recall is complete.
REASON
Blood products, which were labeled with incorrect platelet counts and product volumes, were distributed. Firm initiated recall is complete.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
DE
___________________________________
PRODUCT
eQueTM Automated Interview and Assessment, Recall # B-0260-08
CODE
Version 1.2.1
RECALLING FIRM/MANUFACTURER
Recalling Firm: Haemonetics Corp., Braintree, MA, issued notification letters by electronic mail on September 21, 2007.
Manufacturer: Fifth Dimension Info Systems, Edmonton, Canada. Firm initiated recall is complete.
REASON
Blood Donor Self Interview may not result in assessment of the donors suitability
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, WI and NJ
___________________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-0261-08
CODE
Unit: 71S962694
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Birmingham, AL, by facsimile on August 28, 2006. Firm initiated recall is complete.
REASON
Blood product, associated with a Red Blood Cell unit that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Abbott COMMANDER Flexible Pippetting Center (FPC); List #3A46; 510(k) #K894069, Recall # B-0162-08
CODE
All
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc., Irving, TX, by telephone and letter on August 17, 2007. Firm initiated recall is ongoing.
REASON
Blood device pippetor with arms that may be out of specification, resulting in samples potentially not being drawn and dispensed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
438 units
DISTRIBUTION
Nationwide, Canada and Japan
___________________________________
PRODUCT
a) Cryoprecipitated AHF, Recall # B-0268-08;
b) Red Blood Cells, Recall # B-0269-08;
c) Red Blood Cells Leukocytes Reduced, Recall # B-0270-08;
d) Plasma Frozen, Recall # B-0271-08;
e) Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0272-08;
f) Fresh Frozen Plasma, Recall # B-0273-08;
CODE
a) Units: 40FR29652, 40FR29654, 40FR29656, 40FR29661, 40FR29663, 40FR29665, 40FR29669, 40FW38020, 40FW38026, 40FW38032, 40FW38040, 40FW38048, 40FW38052, 40GF77726, 40GF77727, 40GF77730, 40GF77731, 40GF77733, 40GF77740, 40GF77742, 40GF77743, 40GF77744, 40GF77755, 40GF77756, 40GF77758, 40GF77762, 40GF77765, 40GF77766, 40GF77768, 40GL11341, 40GL11343, 40GL11349, 40GL11353, 40GL11356, 40GL11361, 40GL11400, 40GL11403, 40GL11407, 40GL11414, 40GL11415, 40GN17192, 40GN17194, 40GN17198, 40GN17201, 40GN17204, 40GN17205, 40GN17213, 40GN17214, 40GN17215, 40GN17223, 40GN17226, 40GN17227, 40GN17230, 40GN17231, 40GN17233, 40GN17234, 40GS86453, 40GS86462, 40GS86463, 40GS86473, 40GS86478, 40GS86482, 40GS86483, 40GS86487, 40GS86710, 40GS86719, 40GS86731, 40GS86739, 40GS86753, 40GS86758, 40GS86766, 40GS86770, 40GS86772. 40KE67669, 40KE67671, 40KE67674, 40KE67677, 40KE67679, 40KE67687, 40KE67691, 40KE67693, 40KE67700, 40KE67704, 40KE67707, 40KE67717, 40KE67718, 40KE67723, 40KE67724, 40KE67728, 40KE67729, 40KE67733, 40KE67737, 40KE67738, 40KE67859, 40KG09485, 40KG09486, 40KG09489, 40KG09493, 40KG09496, 40KG09500, 40KG09503, 40KG09504, 40KG09507, 40KG09508, 40KG09509, 40KG09512, 40KJ01035, 40LZ24794, 40LZ24801, 40LZ24807, 40LZ24811, 40LZ24814, 40LZ24816, 40LZ24819, 40LZ24821, 40LZ24823, 40LZ24824, 40LZ24825;

b) Units: 40 FF61065, 40FF61066, 40FF61069, 40FF61071, 40FF61073, 40FF61077, 40FF61083, 40FF61086, 40FF61088, 40FF61090, 40FF61093, 40FF61100, 40FR29663, 40FR29665, 40FW38012, 40GF77726, 40GF77727, 40GF77733, 40GF77740, 40GF77742, 40GF77743, 40GF77744, 40GF77755, 40GF77756, 40GF77758, 40GF77762, 40GF77765, 40GF77766, 40GF77768, 40GH77269, 40GH77287, 40GH77619, 40GJ65488, 40GJ65495, 40GJ65498, 40GJ65506, 40GJ65512, 40GJ65517, 40GL11343, 40GL11353, 40GL11356, 40GL11382, 40GN17192, 40GN17196, 40GN17198, 40GN17201, 40GN17204, 40GN17205, 40GN17208, 40GN17213, 40GN17215, 40GN17227, 40GN17229, 40GN17234, 40GR84905, 40GS86473, 40GS86478, 40GS86482, 40GS86739, 40GS86758, 40KE67669, 40KE67671, 40KE67674, 40KE67677, 40KE67679, 40KE67687, 40KE67691, 40KE67693, 40KE67695, 40KE67700, 40KE67704, 40KE67717, 40KE67718, 40KE67729, 40KE67733, 40KE67737, 40KE67867, 40LH26851, 40LH26867, 40LV11644, 40LV11646, 40LZ24807, 40LZ24816, 40LZ24821, 40LZ24824;

c) Units: 40FF61061, 40FF61063, 40FF61082, 40FF61085, 40FF61092, 40FF61096, 40FF61097, 40FR29646, 40FR29647, 40FR29650, 40FR29652, 40FR29654, 40FR29656, 40FR29661, 40FR29668, 40FR29669, 40FR29675, 40FR29678, 40FR29679, 40FW38015, 40FW38020, 40FW38026, 40FW38032, 40FW38048, 40FW38052, 40FW38056, 40GF77731, 40GH77271, 40GH77276, 40GH77309, 40GH77311, 40GH77314, 40GH77317, 40GH77324, 40GH77328, 40GH77598, 40GH77602, 40GH77615, 40GH77621, 40GH77643, 40GH77645, 40GH77657, 40GH77661, 40GH77664, 40GH77669, 40GH77676, 40GJ65490, 40GJ65500, 40GJ65502, 40GJ65504, 40GJ65509, 40GJ65514, 40GJ65518, 40GJ65581, 40GJ65586, 40GJ65588, 40GJ65591, 40GJ65593, 40GJ65594, 40GJ65603, 40GJ65605, 40GJ65609, 40GJ65613, 40GJ65614, 40GJ65616, 40GL11341, 40GL11349, 40GL11374, 40GL11378, 40GL11388, 40GL11393, 40GL11394, 40GL11400, 40GL11403, 40GL11407, 40GL11414, 40GL11415, 40GM05848, 40GN17210, 40GN17214, 40GN17223, 40GN17226, 40GN17230, 40GN17231, 40GN17233, 40GR84868, 40GR84879, 40GR84881, 40GR84895, 40GR84897, 40GR84909, 40GR84910, 40GR84914, 40GR84919, 40GR84929, 40GR84940, 40GR84941, 40GR84956, 40GR84957, 40GR84985, 40GR85004, 40GR85010, 40GS86451, 40GS86453, 40GS86462, 40GS86466, 40GS86471, 40GS86477, 40GS86487, 40GS86688, 40GS86706, 40GS86710, 40GS86719, 40GS86725, 40GS86731, 40GS86733, 40GS86753, 40GS86766, 40GS86770, 40GS86772, 40KC16416, 40KC16418, 40KC16425, 40KC16432, 40KC16437, 40KC16448, 40KC16455, 40KC16464, 40KC16472, 40KC16478, 40KC16484, 40KC16486, 40KE67707, 40KE67723, 40KE67724, 40KE67728, 40KE67738, 40KE67834, 40KE67850, 40KE67854, 40KE67858, 40KE67859, 40KE67860, 40KE67866, 40KG09325, 40KG09485, 40KG09486, 40KG09489, 40KG09493, 40KG09496, 40KG09500, 40KG09503, 40KG09504, 40KG09507, 40KG09508, 40KG09509, 40KG09512, 40KG09802, 40KG09814, 40KJ01035, 40LH26853, 40LH26857, 40LH26865, 40LH26868, 40LH26872, 40LH26874, 40LH26875, 40LV11638, 40LV11641, 40LV11653, 40LV11655, 40LV11657, 40LV11659, 40LV11661, 40LV11663, 40LV11665, 40LV11670, 40LV11671, 40LV11675, 40LV11679, 40LV11683, 40LW31117, 40LW31119, 40LW31122, 40LW31123, 40LW31125, 40LW31129, 40LW31134, 40LW31135, 40LW31136, 40LW31137, 40LW31166, 40LW31168, 40LW31171, 40LW31177, 40LW31182, 40LW31184, 40LW31191, 40LW31193, 40LW31196, 40LW31200, 40LW31206, 40LW31209, 40LW31214, 40LW31217, 40LW31220, 40LW31319, 40LW31321, 40LW31325, 40LW31327, 40LW31334, 40LW31335, 40LW31336, 40LW31341, 40LW31343, 40LW31345, 40LW31347, 40LW31350, 40LW31352, 40LW31358, 40LW31360, 40LW31362, 40LZ24793, 40LZ24794, 40LZ24801, 40LZ24811, 40LZ24823, 40LZ24825, 40KE67843;

d) Units: 40FF61061, 40FF61065, 40FF61082, 40FF61085, 40FF61086, 40FF61092, 40FF61096, 40FF61097, 40KC16464, 40LV11659, 40LV11671, 40LV11675, 40LV11679, 40LW31117, 40LW31177, 40LW31196, 40LW31220;

e) Units: 40FF61076, 40GL11372, 40GR84870, 40GS86458, 40KE67847, 40KE67856, 40KE67861, 40LW31332;

f) Units: 40GH77269, 40GH77271, 40GH77276, 40GH77287, 40GH77290, 40GH77309, 40GH77311, 40GH77615, 40GH77619, 40GH77621, 40GJ65488, 40GJ65490, 40GJ65495, 40GJ65498, 40GJ65500, 40GJ65502, 40GJ65504, 40GJ65506, 40GJ65509, 40GJ65512, 40GJ65514, 40GJ65517, 40GJ65518, 40GJ65594, 40GJ65603, 40GJ65609, 40GJ65613, 40GJ65614, 40GR84868, 40GR84870, 40GR84905, 40GR84909, 40GR84910, 40GR84919, 40KC16416, 40KC16418, 40KC16425, 40KC16432, 40KC16437, 40KE67843, 40LH26851, 40LH26857, 40LH26868, 40LH26872, 40LH26875, 40LW31125, 40LW31129, 40LW31134, 40LW31135, 40LW31136, 40LW31137, 40LW31319, 40LW31321, 40LW31335, 40LW31336, 40LW31343, 40LW31345, 40LW31347, 40LW31350, 40LW31352, 40LW31358, 40LW31360, 40LW31362 units 40LW31332 - parts 1, 2, 3 and 4, and 40LW31334 - parts 1, 2, 3 and 4;
RECALLING FIRM/MANUFACTURER
American National Red Cross HOA Blood Services Region, Peoria, IL, by letters dated May 10, 2007. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may compromise the sterility of the product, were distributed.
VOLUME OF PRODUCT IN COMMERCE
529 units
DISTRIBUTION
PA, NY, WI, MA, MO, NE and IL
___________________________________
PRODUCT
a) Platelets, Recall # B-0275-08;
b) Red Blood Cells, Leukocytes Reduced, Recall # B-0276-08
CODE
a) and b) Unit: 5960602
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on February 6, 2006 and by letter on February 22, 2006. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0277-08
CODE
Unit: 2665477
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on June 29, 2006 and by letter and electronic mail on July 5,, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor taking the medication Aricept, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX and Switzerland
___________________________________
PRODUCT
Red Blood, Recall # B-0283-08
CODE
Unit: FK62860
RECALLING FIRM/MANUFACTURER
Recalling Firm: Heartland Blood Centers, Aurora, IL, by telephone on August 10, 2007 and by letter on August 15, 2007.
Manufacturer: Heartland Blood Centers – Tinley Park, Tinley Park, IL. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0284-08
CODE
Unit: FK87327
RECALLING FIRM/MANUFACTURER
Heartland Blood Centers, Aurora, IL, by telephone on August 10, 2007 and by letter on August 15, 2007. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL
___________________________________
PRODUCT
Misys Laboratory" Blood Bank and Blood Donor Modules V6.0.1, Recall # B-0293-08
CODE
Blood Bank/Blood Donor 6.0.1 Blood Bank/Blood Donor is distributed with Misys Laboratory Version 6.1 and Version 6.2
RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems dba Misys Hospital Systems, Tucson, AZ, by e-mail on June 27, 2007. Firm initiated recall is ongoing.
REASON
Misys identified that under certain scenarios the count for tests with unacceptable results is inaccurate. This could lead to: The QA failure, "Unit status updated to inventory with unacceptable results on file", in Blood Product Testing Review (BTR) not being displayed. - This could result in a unit being released into inventory inappropriately if no active donor deferral(s) are on file (Misys Blood Donor). If the unit is inappropriately released into inventory, the QA failure, "Unacceptable Result on File", does not display in the following functions: - Blood Order Processing (BOP), Blood Product Issue (BPI), Blood Component Preparation (BCP), Blood Status Correction (BSC), or Blood Status Update (BSU).
VOLUME OF PRODUCT IN COMMERCE
252 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0297-08;
b) Platelets, Recall # B-0298-08
CODE
a) and b) Unit: 5943902
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone on June 21 - 22, 2007. Firm initiated recall is complete.
REASON
Blood products, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IL
___________________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-0303-08
CODE
Unit: 71S17420X
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Center, Inc., Gainesville, GA, by telephone and letter dated June 2, 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
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0304-08;
b) Plasma Frozen, Recall # B-0305-08
CODE
a) and b) Unit: 012FR01026
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Carolinas Blood Services, Charlotte, NC, by telephone on July28, 2007 and by letter dated August 9, 2007.
Manufacturer: American Red Cross Blood Services, Durham, NC. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC
___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0306-08;
b) Plasma Frozen, Recall # B-0307-08
CODE
a) and b) Unit: 003FV96175
RECALLING FIRM/MANUFACTURER
American National Red Cross, Douglasville, GA, by telephone on September 29, 2006 and by letter dated October 9, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0308-08
CODE
Units: 003GF31326, 003GP83001, 003GX37433, 003GZ86205, 003H40073
RECALLING FIRM/MANUFACTURER
American National Red Cross, Douglasville, GA, by telephone on September 28, 2006 and by letter dated October 5, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from donors who traveled to areas considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
GA
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0310-08
CODE
Unit: 2655238
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on September 13, 2005. Firm initiated recall is complete.
REASON
Blood product, which was labeled as leukoreduced, but was not tested to verify the White Blood Cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
___________________________________
PRODUCT
Platelets, Recall # B-0312-08
CODE
Unit: 1983766
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on August 8, 2006 and by letter dated August 18, 2006. Firm initiated recall is complete.
REASON
Blood product, associated with a red cell unit that was contaminated with Staphylococcus aureus, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
a) Platelets, Recall # B-0313-08;
b) Recovered Plasma, Recall # B-0314-08
CODE
a) and b) Unit: 2758544
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone or electronic mail on December 19, 2006 and by letter dated December 22, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had received a piercing within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX and Switzerland
___________________________________
PRODUCT
Misys Laboratory Blood Bank and Blood Donor Modules v6.0.1 and v6.0.2, Recall # B-0317-08
CODE
Misys Laboratory Blood Bank and Blood Donor Modules v6.0.1 and v6.0.2 distributed with Misys Laboratory v6.1, v6.2 and v6.3
RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems dba Misys Hospital Systems, Tucson, AZ, by e-mail on August 24, 2007. Firm initiated recall is ongoing.
REASON
Software, with a defect or glitch, was distributed.
VOLUME OF PRODUCT IN COMMERCE
260 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B0319-08
CODE
Units: 012LJ72060, 012LJ69569
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Carolinas Blood Services Region, Charlotte, NC, by telephone or electronic notification on April 5, 2007 and by letter dated April 11, 2007.
Manufacturer: American Red Cross Blood Services, Asheville, NC. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC and CA
___________________________________
PRODUCT
a)Cryoprecipitated AHF, Recall # B-0321-08;
b) Fresh Frozen Plasma, Recall # B-0322-08;
c) Red Blood Cells, Leukocytes Reduced, Recall # B-0323-08
CODE
a) Unit: 012FF47499;
b) Unit: 012FF45625;
c) Unit: 012FF45625; 012FF47499
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Carolinas Blood Services, Charlotte, NC, by telephone on July27, 2007 and by letter dated August 9, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0325-08
CODE
Unit: 003FJ94461
RECALLING FIRM/MANUFACTURER
American National Red Cross, Douglasville, GA, by telephone or electronic notification on December 15, 2006 and by letter dated December 22, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA and CA
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0326-08
CODE
Unit: 012Z69024
RECALLING FIRM/MANUFACTURER
American Red Cross Carolinas Blood Services Region, Charlotte, NC, by telephone or electronic notification on April 5, 2007 and by letter dated April 11, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA and TN
___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0328-08;
b) Recovered Plasma, Recall # B-0329-08
CODE
a) and b) Unit: 4355028
RECALLING FIRM/MANUFACTURER
Central Jersey Blood Center, Shrewsbury, NJ, by fax on April 28, 2006 and May 1, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NJ and CA
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0330-08
CODE
Unit; 12F79666
RECALLING FIRM/MANUFACTURER
American Red Cross Carolinas Blood Services Region, Charlotte, NC, by letter, electronic notification, or facsimile on July6, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA and NC
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0332-08
CODE
Unit: 012Z70816
RECALLING FIRM/MANUFACTURER
American Red Cross Carolinas Blood Services Region, Charlotte, NC, by telephone or electronic notification on July 13, 2007 and by letter dated July 26, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC and CA
___________________________________
PRODUCT
Platelets, Recall # B-0334-08
CODE
Unit: KP14078
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by fax on May 10, 2007. Firm initiated recall is complete.
REASON
Blood product, associated with a red cell component that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0338-08
CODE
Unit 2792754
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on February 20, 2007 and by letter dated March 2, 2007. Firm initiated recall is complete.
REASON
Blood product, which was collected in a manner that may have compromised the sterility of the collection system, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX and Switzerland
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0341-08
CODE
Unit: 71X41440X
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Montgomery Region, Montgomery, AL. by facsimile on April 21, 2006. Firm initiated recall is complete.
REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0342-08
CODE
Unit: 71X15322X
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Birmingham Region, Birmingham, AL. by facsimile on March 8, 2006. Firm initiated recall is complete.
REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall B-0343-08
CODE
Unit: 71X15756
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Birmingham Region, Birmingham, AL. by telephone on February 24, 2006. Firm initiated recall is complete.
REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Fresh Frozen Plasma, Recall B-0344-08
CODE
Unit: FV17650
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by fax on June 25, 2007. Firm initiated recall is complete.
REASON
Blood product, associated with a red cell component that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0346-08
CODE
Unit: FQ85903
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by fax on July 12, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who visited a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0347-08
CODE
Units: LP72132, (Split unit), KC33150 (Split unit)
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by fax on April 22, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who visited a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
WI
___________________________________
PRODUCT
a) Platelets, Recall # B-0364-08;
b) Red Blood Cells, Recall # B-0365-08
CODE
a) and b) Unit: 6731609
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Services, Elyria, OH, by facsimile on April 27, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0366-08;
b) Platelets, Recall # B-0367-08
CODE
a) and b) Unit: 4183281
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH, by letter dated June 6, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0368-08
b) Cryoprecipitated AHF, Recall # B-0369-08
CODE
a) and b) Units: 6730567
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Services, Elyria, OH, by facsimile on June 16, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who provided post donation information regarding a previous positive test for the Hepatitis C virus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH
___________________________________
PRODUCT
Red Blood Cells Apheresis, Leukocytes Reduced, Recall # B-0370-08
CODE
Unit: 182348794 (2 units)
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Cheyenne, WY, by letter dated June 5, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of Hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WY
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocyt4s Reduced, Recall # B-0387-08
CODE
Unit: 2786777 (Split unit)
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on February 15, 2007 and by letter dated February 26, 2007. Firm initiated recall is complete.
REASON
Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT
a) Platelets, Recall # B-0388-08;
b) Fresh Frozen Plasma, Recall # B-0389-08
CODE
a) and b) Unit: 2775376
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone and letter dated January 22, 2007. Firm initiated recall is complete.
REASON
Blood products, which were collected fro a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Robotic Disposable Tip (DiTi) Rack for use with the Abbott m2000sp (List 9K14-01) and m1000 (List 4J72-01) Automated Sample Preparation System. The racks are sold as a component of the instruments as well as replacement components. Each system contains two 200 microliter DiTi racks, two 1000 microliter ASPS reuse racks and nine 1000 microliter DiTi racks, and three racks are included in the m1000/M2000 Upgrade Kit, part 09K13-01. The individual replacement DiTi racks are sold one per carton: Robotic DiTi 200 Rack - Tecan Art. Nr. 613089, Abbott LN Nr 04J72-30; Robotic DITi 1000 Rack - Tecan Ref 613090, Abbott LN Nr 04J72-32; and Robotic DiTi Reuse 1000 ASPS Rack - Tecan Ref 613091, Abbott Ln Nr 04J72-34, Recall # B-0158-08
CODE
Part numbers: 9K14-01, 4J72-01, 9K13-01, 4J72-30, 4J72-32, 4J72-34
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Molecular, Des Plaines, IL, by letters dated June 12, 2007.
Manufacturer: Tecan Schweiz Ag, Mannedorf Zuerich, Switzerland. Firm initiated recall is ongoing.
REASON
The spring clips on the Disposable Tips (DiTi) Racks may have sharp protruding corners which may cause instrument user injury. The DiTi Racks were shipped with or independent of the m2000sp Instrument or the m1000 Instrument.
VOLUME OF PRODUCT IN COMMERCE
22 instruments in U.S.; 308 instruments, 111 racks internationally
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Pall Acrodose PL System, Pool and Store Set for Leukocyte -Reduced Platelets with a 1.5 Liter CLX HP Extended Storage Bag for Pooled Leukocyte-Reduced Platelets. This extended Storage Bag is not labeled properly. The Storage Bag has a white stick-on label labeled in part "*** LEUOKOCYTES REDUCED -- ___mL -- Number of units in pool ___. -- From CP2D Whole Blood -- Store at 20-24C. *** 12064 *** VOLUNTEER DONOR *** LOT REO2131 *** Pall Corporation -- East Hills, NY 11548, NY ***". --- The actual label should read "*** PLATELETS POOLED - 5d LEUKOCYTES REDUCED *** ___mL -- Number of units in pool ___. -- From CP2D Whole Blood -- Store at 20-24C. *** 12064 *** VOLUNTEER DONOR *** LOT REO2131 *** The Storage Bag also contains a section where the unit number and expiry date can be placed. This system is packages in a Tyvek header bag and includes one (1) system per unit pouch. There is also unit package insert which includes instructions for use. --- 510K # BR050074, Recall # B-0159-08
CODE
Lot Number: REO2131; Expiration Date: December 2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pall Biomedical Products Corp., East Hills, NY, by email, phone and letter on January 16, 2007.
Manufacturer: Ensatec, S.A. de C.V. Fraccionamineto El Florido, Tijuana/Tecate
Mexico. Firm initiated recall is complete.
REASON
The product name "PLATELETS POOLED -5d" does not appear on the label as required.
VOLUME OF PRODUCT IN COMMERCE
2,880 units
DISTRIBUTION
CT, OH
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0181-08
CODE
Unit: 4026169
RECALLING FIRM/MANUFACTURER
Recalling Firm: The Blood Connection, Inc., Piedmont, SC, by telephone on July 24, 2006/ Firm initiated recall is complete.
REASON
Blood product, documented as being out of controlled storage for more than 30 minutes, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
SC
___________________________________
PRODUCT
a) Fresh Frozen Plasma, Recall # B-0238-08;
b) Red Blood Cells, Leukocytes Reduced, Recall # B-0239-08;
c) Recovered Plasma, Recall # B-0240-08
CODE
a) Unit: 2151334;
b) Units: 2151334, 2244695;
c) Unit: 2244695
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by telephone on October 30, 2006, by letter dated November 2, 2006, or by facsimile on November 2, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking the medication Enbrel, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
TN and FL
___________________________________
PRODUCT
Recovered Plasma, Recall # B-0278-08
CODE
Unit: 2665477
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on June 29, 2006 and by letter and electronic mail on July 5,, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor taking the medication Aricept, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX and Switzerland
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0281-08
CODE
Unit: FW97994
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by facsimile on March 29, 2005. Firm initiated recall is complete.
REASON
Blood product, which may have been shipped under unacceptable temperatures, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0285-08
CODE
Unit: GW07035
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by telephone on March 15, 2005. Firm initiated recall is complete.
REASON
Blood product, which may have been stored under unacceptable storage conditions, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Cryoprecipitated AHF, Recall # B-0286-08
CODE
Unit: KQ66955
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by telephone on March 21, 2005. Firm initiated recall is complete.
REASON
Blood product, which may have been stored under unacceptable storage conditions, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated, Recall # B-0294-08
CODE
Units: 71S016651, 71S016663, and 71S126434
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by telephone and letter dated June 5, 2006. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly labeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
GA
___________________________________
PRODUCT
Red Blood Cells, Recall # B-0295-08
CODE
Unit: 71T459146
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by telephone and letter dated January 22, 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
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0296-08
CODE
Unit: 003H36514
RECALLING FIRM/MANUFACTURER
American National Red Cross, Douglasville, GA, by telephone on September 14, 2005. Firm initiated recall is complete.
REASON
Blood product, which was not manufactured in accordance with the manufacturer’s instructions, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0302-08
CODE
Unit: 8464482 (split unit)
RECALLING FIRM/MANUFACTURER
Atlanta Blood Services, Atlanta, GA, by telephone on October 5, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA
___________________________________
PRODUCT
Plasma Frozen, Recall # B-0309-08
CODE
Units: 012FC93282, 012LF22170, 012LF22169
RECALLING FIRM/MANUFACTURER
American Red Cross Carolinas Blood Services Region, Charlotte, NC, by telephone on August 31, 2007. Firm initiated recall is complete.
REASON
Blood products, which may have been out of controlled storage for longer than the acceptable time limit, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced Recall # B-315-08
CODE
Unit: 1995841 (2 units)
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on July 18, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells (Apheresis), Leukocytes Reduced, Recall # B-0316-08
CODE
Unit: 1979795 (2 units)
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on July 18, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with an elevated body temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT
Blood and Blood Products for Reprocessing, Recall # B-0320-08
CODE
Units: 012LJ72060, 012LJ69569
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Carolinas Blood Services Region, Charlotte, NC, by telephone or electronic notification on April 5, 2007 and by letter dated April 11, 2007.
Manufacturer: American Red Cross Blood Services, Asheville, NC. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC and CA
___________________________________
PRODUCT
Recovered Plasma, Recall # B-0324-08
CODE
Unit: 003FJ94461
RECALLING FIRM/MANUFACTURER
American National Red Cross, Douglasville, GA, by telephone or electronic notification on December 15, 2006 and by letter dated December 22, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA and CA
___________________________________
PRODUCT
Blood and Blood Products for Reprocessing, Recall # B-0327-08
CODE
Unit: 012Z69024
RECALLING FIRM/MANUFACTURER
American Red Cross Carolinas Blood Services Region, Charlotte, NC, by telephone or electronic notification on April 5, 2007 and by letter dated April 11, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA and TN
___________________________________
PRODUCT
Blood and Blood Products for Reprocessing, Recall # B-0331-08
CODE
Unit; 12F79666
RECALLING FIRM/MANUFACTURER
American Red Cross Carolinas Blood Services Region, Charlotte, NC, by letter, electronic notification, or facsimile on July 6, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA and NC
___________________________________
PRODUCT
Blood and Blood Products for Reprocessing, Recall # B-0333-08
CODE
Unit: 012Z70816
RECALLING FIRM/MANUFACTURER
American Red Cross Carolinas Blood Services Region, Charlotte, NC, by telephone or electronic notification on July 13, 2007 and by letter dated July 26, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC and CA
___________________________________
PRODUCT
Red Blood Cells, Recall # B-0335-08
CODE
Unit: 71S451992
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by telephone and fax on November 16, 206. Firm initiated recall is complete.
REASON
Blood product associated with a unit of Cryoprecipitated AHF that contained clots was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells (Apheresis), Leukocytes Reduced, Recall # B-0339-08
CODE
Unit: 71T10470
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers – Wiregrass Region, Dothan, AL, by facsimile on September 30, 2006. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from an associated blood component that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0340-08
CODE
Unit: 71Q521069
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by facsimile on January 19, 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
AL
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Recall # B-0345-08
CODE
Unit: LR96407
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by fax on May 30, 2007. Firm initiated recall is complete.
REASON
Blood product, associated with a red cell component that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 split unit
DISTRIBUTION
PA

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
a) Cyberonics Neuro Cyberonics Prothesis System NCP Bipolar Lead, Model #300;
Sterile, Single use only, Z-0171-2008;
b) Cyberonics VNS Therapy Bipolar Lead, Model #302; Sterile, Single use only,
Recall # Z-0172-2008;
c) Cyberonics VNS Therapy Perrennia Lead, Model #303; Sterile, Single use only,
Recall # Z-0173-2008
CODE
All manufactured and distributed leads.
RECALLING FIRM/MANUFACTURER
Cyberonics, Inc., Houston, TX, by correction notice in June of 2007. Firm initiated recall is ongoing.
REASON
Dissolution/Fractures to the leads of the VNS Therapy System.
VOLUME OF PRODUCT IN COMMERCE
56,189 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Capnostream20 Monitor with Nellcor Pulse Oximetry Module--Part Number:
CS 08657- Oridion Medical, Recall # Z-0177-2008;
b) Capnostream20 Monitor with Masimor Pulse Oximetry Module - Part Number: CS
08659 - Oridion Medical, Recall # Z-0178-2008
CODE
a) Serial Numbers: B200001085 B200001254 B200001163 B200001153 B200001150
B200001135 B200001133 B200001086 B200001105 B200001104 B200001103
B200001102 B200001101 B200001325 B200001258 B200001272 B200001275
B200001289 B200001290 B200001291 B200001323;
b) Serial Numbers: B300001003 B300001008 B300001018 B300001043 B300001044
B300001050
RECALLING FIRM/MANUFACTURER
Recalling Firm: Oridion Capnography Inc., Needham Heights, MA, by letters dated, August 21, 2007.
Manufacturer: Oridion Medical 1987 Ltd., Jerusalem, Israel. Firm initiated recall is ongoing.
REASON
Handle Cracking - Cracks in the handle will lead to disconnection of the handle from the monitor, causing the monitor to fall.
VOLUME OF PRODUCT IN COMMERCE
27 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Edwards Lifesciences LifeStent FlexStar Bilary Stent System Application, Model EX080801CD; 8 MM stent, 80 CM Delivery System, Recall # Z-0179-2008
CODE
Lot: FR6K0319
RECALLING FIRM/MANUFACTURER
Edwards Lifesciences, Llc, Irvine, CA, by letter dated March 15, 2007. Firm initiated recall is complete.
REASON
Failure to deploy.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Pilling® Center-Action Forceps with Insulated Shafts- Serrated Grasping Jaws,
Catalog Number: 505015, Non Sterile, Rx Only, (ALLIG GRASPING FCPS 30 CM
INSUL), Recall # Z-0266-2008;
b) Pilling® Center-Action Forceps with Insulated Shafts- Elongated Cup Biopsy Jaws,
Catalog Number: 505039, Non Sterile, Rx Only, (30 CM), Recall # Z-0267-2008;
c) Pilling® Center-Action Forceps with Insulated Shafts- Circular Cup Biopsy Jaws,
Catalog Number: 505045, Non Sterile, Rx Only, (30 CM), Recall # Z-0268-2008
CODE
a) Date Codes: WW5, XX5, NN6, RR6, TT6, XX6, MM7, NN7, OO7, QQ7 and SS7;
b) Date Codes: WW5, MM6 and SS7;
c) Date Codes: UU5, MM6, OO7, RR7 and SS7
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teleflex Medical, Durham, NC, letter on/about November 1/2007.
Manufacturer: Rai Wenzier Gmbh, Balgheim, Germany, Federal Republic of. Firm initiated recall is ongoing.
REASON
The specified insulation is not present on the shaft of the devices, leaving a risk of arcing and/or damage to surrounding tissue.
VOLUME OF PRODUCT IN COMMERCE
235 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Siemens ECAT ACCEL, Catalog No. 3545584, PET/CT Scanner,
Recall # Z-0269-2008;
b) Siemens ECAT ART, Catalog No.. 3545584, PET/CT Scanner,
Recall # Z-0270-2008;
c) Siemens ECAT EXACT 47, Catalog No. 1788772, PET/CT Scanner,
Recall # Z-0271-2008;
d) Siemens ECAT EXACT HR 47, Catalog No. 2956261, PET/CT Scanner,
Recall # Z-0272-2008;
e) Siemens ECAT EXACT HR+, Catalog No. 3548083, PET/CT Scanner,
Recall # Z-0273-2008
CODE
a) Serial Numbers: 101014, 1303, 1305, 1309, 1310, 1311, 1314, 301089, 301092, 301111, 3600211-00-001003, 3600211-00-001041, 3600211-00-001110, 3600211-00-001122, 3600211-00-0101001, 3600211-00-0101004, 3600211-00-0101005, 3600211-00-0101006, 3600211-00-0101008, 3600211-00-0101012, 3600211-00-0101015, 3600211-00-0101016, 3600211-00-0101017, 3600211-00-0201007, 3600211-00-0201022, 3600211-00-0201023, 3600211-00-0201024, 3600211-00-0201025, 3600211-00-0201026, 3600211-00-0201027, 3600211-00-0201029, 3600211-00-0201031, 3600211-00-0201032, 3600211-00-0201033, 3600211-00-0201035, 3600211-00-0201036, 3600211-00-0201037, 3600211-00-0201038, 3600211-00-0201039, 3600211-00-0201040, 3600211-00-0201041, 3600211-00-0201042, 3600211-00-0201043, 3600211-00-0201045, 3600211-00-0201049, 3600211-00-0201050, 3600211-00-0201051, 3600211-00-0201052, 3600211-00-0201053, 3600211-00-0201054, 3600211-00-0201055, 3600211-00-0201056, 3600211-00-0201057, 3600211-00-0201058, 3600211-00-0201060, 3600211-00-0201061, 3600211-00-0201062, 3600211-00-0201063, 3600211-00-0201064, 3600211-00-0201065, 3600211-00-0201066, 3600211-00-0201067, 3600211-00-0201069, 3600211-00-0201070, 3600211-00-0201071, 3600211-00-0201072, 3600211-00-0201079, 3600211-00-0201080, 3600211-00-0201084, 3600211-00-0201090, 3600211-00-0201091, 3600211-00-0201093, 3600211-00-0201095, 3600211-00-0201103, 3600211-00-0201104, 3600211-00-0201106, 3600211-00-0201115, 3600211-00-0201120, 3600211-00-0301073, 3600211-00-0301075, 3600211-00-0301076, 3600211-00-0301077, 3600211-00-0301078, 3600211-00-0301083, 3600211-00-0301085, 3600211-00-0301086, 3600211-00-0301087, 3600211-00-0301094, 3600211-00-0301096, 3600211-00-0301098, 3600211-00-0301099, 3600211-00-0301100, 3600211-00-0301102, 3600211-00-0301107, 3600211-00-0301108, 3600211-00-0301109, 3600211-00-0401112, 3600211-00-0401113, 3600211-00-0401114, 3600211-00-0401116, 3600211-00-0401117, 3600211-00-201034, 3600211-00-201046, 3600211-00-301097, 3600211-00-301105, 401118;

b) Serial Numbers: 3600066-00-0001001, 3600066-00-0001002, 3600066-00-0001005, 3600066-00-0001007, 3600066-00-0001008, 3600066-00-0001010, 3600066-00-0001013, 3600066-00-0001014, 3600078-00-0001003, 3600082-00-0001002, 3600084-00_0001005, 3600084-00-0001005, 3600090-00-0001001, 3600090-00-0001002, 3600090-00-0001003, 3600090-00-0201005, 3600090-00-0201006, 3600099-00-001001, 3600099-00-001006, 3600099-00-001009, 3600099-00-0201002, 3600099-00-0201003, 3600099-00-0201004, 3600099-00-0201005, 3600099-00-0201007, 3600099-00-0201008, 3600099-00-0201010, 3600099-00-0201012, 3600099-00-0301013, 3600099-00-0301014, 3600099-00-0301016, 3600099-00-0301017, 3600099-00-0301018, 3600099-00-0301019, 3600099-00-0301020, 3600099-00-0301021, 3600099-00-0301022, 3600099-00-0301023, 3600099-00-0301024, 3600099-00-0301025, 3600099-00-0301026, 3600099-00-0301027, 3600099-00-0301028;

c) Serial Numbers: 045-001002, 058-001003, 059-001005, 088-001046, 1003, 201021, 301076, 301083, 3200965-00-0001038, 3201933-00-0201036, 3600036-01-0001001, 3600037-03-0001002, 3600037-03-0001003, 3600037-03-0001004, 3600045-00-0001001, 3600045-00-0001008, 3600056-00-0001001, 3600057-00-0001001, 3600058-00-0001002, 3600058-00-0001004, 3600058-00-0001005, 3600062-00-0001002, 3600062-00-0001004, 3600062-01-0001001, 3600063-00-0001003, 3600065-00-0001001, 3600072-00-0001001, 3600072-00-0001002, 3600072-00-0001003, 3600072-00-0001004, 3600072-00-0001005, 3600072-00-0001007, 3600072-00-0001008, 3600072-00-0001009, 3600072-00-0001010, 3600072-00-0001011, 3600072-00-0001012, 3600072-00-0001013, 3600072-00-0001014, 3600072-00-0001015, 3600072-00-0001016, 3600072-00-0001017, 3600072-00-0001018, 3600072-00-0001019, 3600072-00-0001020, 3600072-00-0001021, 3600072-00-0001022, 3600072-00-0001023, 3600072-00-0001024, 3600072-00-0001025, 3600072-00-0001028, 3600079-00-0001001, 3600079-00-0001003, 3600079-00-0001004, 3600079-00-0001005, 3600079-00-0001006, 3600079-00-0001009, 3600079-00-0001010, 3600079-00-0001011, 3600079-00-0001012, 3600079-00-0001013, 3600079-00-0001014, 3600079-00-0001015, 3600079-00-0001017, 3600079-00-0001018, 3600079-00-0001019, 3600079-00-0001020, 3600085-00-0001001, 3600085-00-0001003, 3600088-00/001058, 3600088-00-0001001, 3600088-00-0001002, 3600088-00-0001004, 3600088-00-0001005, 3600088-00-0001006, 3600088-00-0001008, 3600088-00-0001010, 3600088-00-0001012, 3600088-00-0001013, 3600088-00-0001015, 3600088-00-0001017, 3600088-00-0001018, 3600088-00-0001019, 3600088-00-0001020, 3600088-00-0001021, 3600088-00-0001022, 3600088-00-0001023, 3600088-00-0001024, 3600088-00-0001025, 3600088-00-0001029, 3600088-00-0001030, 3600088-00-0001034, 3600088-00-0001035, 3600088-00-0001037, 3600088-00-0001038, 3600088-00-0001040, 3600088-00-0001044, 3600088-00-0001046, 3600088-00-0001049, 3600088-00-0001050, 3600088-00-0001051, 3600088-00-0001052, 3600088-00-0001054, 3600088-00-0001056, 3600088-00-0001058, 3600088-00-0001060, 3600088-00-0001061, 3600088-00-0001065, 3600089-00-0001009, 3600097-00-0101001, 3600097-00-0101002, 3600097-00-0101003, 3600097-00-0101005, 3600097-00-0101006, 3600097-00-0101007, 3600097-00-0101008, 3600097-00-0101009, 3600097-00-0101010, 3600097-00-0101013, 3600097-00-0101014, 3600097-00-0101015, 3600097-00-0101018, 3600097-00-0101019, 3600097-00-0101020, 3600097-00-0101021, 3600097-00-0101022, 3600097-00-0101024, 3600097-00-0101026, 3600097-00-0101027, 3600097-00-0101029, 3600097-00-0101030, 3600097-00-0101031, 3600097-00-0101032, 3600097-00-0101034, 3600097-00-0101035, 3600097-00-0101037, 3600097-00-0101042, 3600097-00-0101056, 3600097-00-0101059, 3600097-00-0101074, 3600097-00-0101075, 3600097-00-0101081, 3600097-00-0201036, 3600097-00-0201039, 3600097-00-0201040, 3600097-00-0201043, 3600097-00-0201044, 3600097-00-0201045, 3600097-00-0201046, 3600097-00-0201047, 3600097-00-0201049, 3600097-00-0201050, 3600097-00-0201051, 3600097-00-0201052, 3600097-00-0201054, 3600097-00-0201055, 3600097-00-0201057, 3600097-00-0201058, 3600097-00-0201060, 3600097-00-0201061, 3600097-00-0201062, 3600097-00-0201066, 3600097-00-0201068, 3600097-00-0301069, 3600097-00-0301072, 3600097-00-0301073, 3600097-00-0301077, 3600097-00-0301079, 3600097-00-0301080;

d) Serial Numbers: 3600041-00-0001001, 3600050-000001, 3600050-00-0001001, 3600050-00-0001002, 3600050-00-0001004, 3600059-00-0001001, 3600059-00-0001002, 3600059-00-0001006;

e) Serial Numbers: 070-001012, 070-001021, 070-001022, 070-001024, 080-001014, 1001, 1005, 1009, 101007, 1011, 1026, 3600063-00-0001002, 3600063-00-0001004, 3600063-00-0001005, 3600063-00-0001007, 3600063-00-0001008, 3600070-00-0001001, 3600070-00-0001003, 3600070-00-0001006, 3600070-00-0001007, 3600070-00-0001008, 3600070-00-0001013, 3600070-00-0001015, 3600070-00-0001016, 3600070-00-0001017, 3600070-00-0001018, 3600070-00-0001019, 3600070-00-0001023, 3600070-01-0001001, 3600070-01-001002, 3600070-01-001004, 3600070-01-001006, 3600070-01-001008, 3600070-01-001011, 3600070-01-001017, 3600070-01-001020, 3600070-01-001027, 3600070-01-001037, 3600070-01-001043, 3600070-01-001063, 3600076-00-0001001, 3600076-00-0001002, 3600076-00-0001003, 3600080-00-0001002, 3600080-00-0001003, 3600080-00-0001004, 3600080-00-0001006, 3600080-00-0001007, 3600080-00-0001008, 3600080-00-0001009, 3600080-00-0001010, 3600080-00-0001011, 3600080-00-0001012, 3600080-00-0001013, 3600080-00-0001016, 3600086-00-0001002, 3600086-00-0001003, 3600086-00-0001004, 3600089-00-0001002, 3600089-00-0001003, 3600089-00-0001004, 3600089-00-0001005, 3600089-00-0001006, 3600089-00-0001007, 3600089-00-0001008, 3600089-00-0001010, 3600089-00-0001011, 3600089-00-0001012, 3600089-00-0001013, 3600089-00-0001014, 3600089-00-0001017, 3600089-00-0001018, 3600089-00-0001019, 3600089-00-0001021, 3600089-00-0001022, 3600098-00-0101002, 3600098-00-0101003, 3600098-00-0101004, 3600098-00-0101005, 3600098-00-0101006, 3600098-00-0101008, 3600098-00-0101009, 3600098-00-0101010, 3600098-00-0101012, 3600098-00-0101013, 3600098-00-0101015, 3600098-00-0101016, 3600098-00-0101017, 3600098-00-0101018, 3600098-00-0101019, 3600098-00-0101020, 3600098-00-0101021, 3600098-00-0101022, 3600098-00-0101023, 3600098-00-0101024, 3600098-00-0101025, 3600098-00-0101026, 3600098-00-0101027, 3600098-00-0101030, 3600098-00-0201028, 3600098-00-0201029, 3600098-00-0201031, 3600098-00-0201032, 3600098-00-0201033, 3600098-00-0201034, 3600098-00-0201035, 3600098-00-0201036, 3600098-00-0201037, 3600098-00-0201038, 3600098-00-0201039, 3600098-00-0301040, 3600098-00-0401044, 3800098-00-0201034, 401045, 9501006, 9601002, 9801029
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Knoxville, TN, by letter dated June 15, 2007. Firm initiated recall is ongoing.
REASON
Incorrect Decay Correction Results - ECAT System's software versions 7.2.2 and 7.4 calculate the decay correction for emission data incorrectly, while performing whole-body studies with all transmissions followed by all emissions.
VOLUME OF PRODUCT IN COMMERCE
441 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Zimmer Durom Hip Resurfacing Systems, Femoral Component 54 Code T;
Catalog No.: 01.00211.154, Recall # Z-0275-2008;
b) Zimmer Durom Hip Resurfacing Systems, Femoral Component 46 Code L;
Catalog No.: 01.00211.146, Recall # Z-0276-2008
CODE
a) and b) Lot 2376766
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zimmer Inc., Warsaw, IN, by letter dated September 26, 2007.
Manufacturer: Zimmer Gmbh, Winterthur, Switzerland. Firm initiated recall is ongoing.
REASON
Mislabeled as to size; 54mm package contains 46 mm device and vice versa.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Odyssey Femoral Holder/Driver, Part Number K001-7410, Non-sterile, 1 each, Recall # Z-0290-2008
CODE
Lot Numbers: 047367193, 067380510, and 077414021
RECALLING FIRM/MANUFACTURER
Wright Medical Technology, Inc., Arlington, TN, by letters on October 4, 2007. Firm initiated recall is ongoing.
REASON
Breakage. Breaking of the connecting foot that is on the distal surface of the instrument.
VOLUME OF PRODUCT IN COMMERCE
66 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Pioneer Quantum Spinal Rod System, MIS Yoke Manipulator, Long Slot, non-sterile; Cat # 51-YOKEMAN-L, Recall # Z-0291-2008
CODE
Lot: 013886
RECALLING FIRM/MANUFACTURER
Pioneer Surgical Technology, Marquette, MI, by letter dated October 10, 2007. Firm initiated recall is ongoing.
REASON
The pins may come out of the instrument and, if this happens, they could fall into/remain in the patient.
VOLUME OF PRODUCT IN COMMERCE
19 units
DISTRIBUTION
CA, FL, MI, and NC
___________________________________
PRODUCT
Toshiba-Interventional Angiography System, Infinix i, Model DFP-8000D, equipped with Digital Radiography System with Software version 3.4er000, Recall # Z-0293-2008
CODE
Serial numbers: B5522165, W1C0562187, W1C0572197, W1C0572202, W1C0622275, W1C0622270, A3632065, A3622066, W1C0456192, W1C0632284, W1D0722373, W1D0742386, B5512160, W1C0592213, W1C0592215, A4562099, W1C05Z2254, B4582113, W1C0642289, W1D0697015, W1C0552182, W1C05X2224, W1D0742387
RECALLING FIRM/MANUFACTURER
Recalling Firm: Toshiba America Medical Systems, Inc., Tustine, CA, by letters beginning on October 2, 2007.
Manufacturer: Toshiba Corp. Medical Engineering Ctr., Nasu Works, Otawara-Shi, Tochigi, Japan. Firm initiated recall is ongoing.
REASON
System Lock-up: When performing DAS One Shot, the system may lockup due to a software timing error.
VOLUME OF PRODUCT IN COMMERCE
23 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Medtronic 0-arm Imaging System, Product Catalog Number: B1-700-00027, (software version 3.0), Recall # Z-0294-2008
CODE
System Serial Numbers: 103, 104, 109, 117, 119 (Germany) 125, and 144 (Canada)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Navigation, Inc., Louisville, CO, by letter on October 17, 2007.
Manufacturer : Medtronic Navigation, Inc., Littleton, MA
REASON
Reversed Instrument Position: a defect in the software version 3.0 causes an error in the position of surgical instruments and relative motion are reversed 180' on the StealthStation image. (If the StealthStation is not used, or if the patient orientation is prone or supine, the problem does not occur)
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Xoran MiniCAT for ENT. This device is a cone beam CT scan for sinue, temporal bones and maxillofacial imaging, Recall # Z-0296-2008
CODE
Serial numbers ENT00009, ENT00051, ENT00084, ENT00086 and ENT00088
RECALLING FIRM/MANUFACTURER
Xoran Technologies, Inc., Ann Arbor, MI, by visit between July 25, 2006 and August 10, 2007. Firm initiated recall is complete.
REASON
The hard drive may crash, resulting in loss of data from patient CT scans.
VOLUME OF PRODUCT IN COMMERCE
5 systems
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS III
___________________________________
PRODUCT
a) Lick Your Chops Natural Healthy Pet Food Chicken and Brown Rice Dinner for cats
Net Wt. 5.5 oz., UPC 0-32976-26966-2, Recall # V-012-2008;
b) Lick Your Chops Natural Healthy Pet Food Lamb & Brown Rice Dinner for cats Net.
Wt. 5.5 oz.; UPC 0-32976-55967-1, Recall # V-013-2008;
c) Lick Your Chops Natural Healthy Pet Food Seafood & Brown Rice Dinner for cats
Net. Wt. 5.5 oz.; UPC 0-32976-55970-1, Recall # V-014-2008;
d) Lick Your Chops Natural Healthy Pet Food Turkey & Brown Rice Dinner for cats Net.
Wt. 5.5 oz.; UPC 0-32976-55972-5, Recall # V-015-2008
CODE
a) Formula code 16CC, Exp 3/27/2010;
b) Formula Code: 16CL, Expiration 3/27/2010;
c) Formula Code: 16CS, Expiration 3/27/2010;
d) Formula Code: 16CT, Expiration 3/27/2010;
RECALLING FIRM/MANUFACTURER
Menu Foods, Inc., Pennsauken, NJ, by telephone and letter on November 14, 2007. Firm initiated recall is complete.
REASON
Product may contain non-protein nitrogen compounds.
VOLUME OF PRODUCT IN COMMERCE
2,168 cases
DISTRIBUTION
PA and Canada
___________________________________
PRODUCT
a) Atlantis Tropical Fish Flake Food, 0.42 oz, 0.88 oz, and 2.25 oz, Recall # V-016-2008;
b) Atlantis Goldfish Flake Food, 0.42 oz, 0.75 oz, and 2.15 oz, Recall # V-017-2008;
c) Atlantis Tropical Fish Color Enhancer Flake Food, 0.88 oz, Recall # V-018-2008;
d) Atlantis Betta Food, 1.2 oz, Recall # V-019-2008
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sergeant's Pet Care Products Inc., Omaha, NB, by letters dated May 30, 2007.
Manufacturer: Five Eels Industry Corp., Taipei, Taiwan, Republic Of China. Firm initiated recall is ongoing.
REASON
Finished product tropical fish food was found by the Georgia Dept of Ag and the recalling firm to contain melamine, an unapproved feed additive.
VOLUME OF PRODUCT IN COMMERCE
18,791 cases
DISTRIBUTION
Nationwide and Internationally

END OF ENFORCEMENT REPORT FOR DECEMBER 5, 2007

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