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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.
January 30, 2008
08-05
___________________________________
PRODUCT
Rudy's PAPAYA, unsulphured, net wt 7.0 oz (198.4g) in cellophane packages. UPC 078134005789, Recall # F-154-8
CODE
Best Before APR08
RECALLING FIRM/MANUFACTURER
Rudy's Confections, Inc. Miami, FL, by visit beginning on October 1, 2007. Firm initiated recall is ongoing.
REASON
The product contains undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
107 cases
DISTRIBUTION
FL
___________________________________
PRODUCT
a) Protica Nutritional Research Profect Protein Beverage Grapefruit Mango in 2.9 oz
single serve plastic vial like containers. The product is shipped in cases that contain
12 containers. Recall # F-155-8;
b) Protica Nutritional Research Profect Protein Beverage Fresh Citrus Berry in 2.9 oz
single serve plastic vial like containers. The product is shipped in cases that contain
12 containers. Recall # F-156-8;
c) Protica Nutritional Research Profect Protein Beverage Blue Raspberry Swirl in 2.9 oz
single serve plastic vial like containers. The product is shipped in cases that contain
12 containers. Recall # F-157-8;
d) Protica Nutritional Research Profect Protein Beverage Cool Melon Splash in 2.9 oz
single serve plastic vial like containers. The product is shipped in cases that contain
12 containers. Recall # F-158-8;
e) Protica Nutritional Research Profect Protein Beverage Passion Fruit in 2.9 oz single
serve plastic vial like containers. The product is shipped in cases that contain 12
containers. Recall # F-159-8;
f) Protica Nutritional Research Profect Protein Beverage Ruby Melon Twist in 2.9 oz
single serve plastic vial like containers. The product is shipped in cases that contain
12 containers. Recall # F-160-8;
g) Protica Nutritional Research Profect Protein Beverage Fuzzy Peach Nectar in 2.9 oz
single serve plastic vial like containers. The product is shipped in cases that contain
12 containers. Recall # F-161-8;
h) Protica Nutritional Research Profect Protein Beverage Orange Pineapple in 2.9 oz
single serve plastic vial like containers. The product is shipped in cases that contain
12 containers. Recall # F-162-8
CODE
Best By 04/01/2009
RECALLING FIRM/MANUFACTURER
Protica, Inc., Horsham, PA, by e-mail on December 7, 2007. FDA initiated recall is ongoing.
REASON
The products list whey and casein protein as ingredients but do not list milk as the source of the whey and casein as required by Food Allergen Labeling and Consumer Protection Act.
VOLUME OF PRODUCT IN COMMERCE
19,818 cases (12 containers/case)
DISTRIBUTION
The product is sold directly to consumers via internet purchasing.
___________________________________
PRODUCT
a) Perphenazine Tablets, USP, 8 mg, 100 and 500 tablets, Rx only, NDC 0603-5092-21
and NDC 0603-5092-28, NDC 54738-552-01, Recall # D-083-2008;
b) Perphenazine Tablets, USP, 16 mg, 100 tablets, Rx only, NDC 0603-5093-21 and
NDC 54738-553-01, Recall # D-084-2008
CODE
a) 100 count: T019G07D, exp 07/09 and T019G07C, exp 07/09;
500 count: T019G07B, exp 07/09 and T019G07A, exp 07/09;
b) 100 count: T049F07A, exp 06/09; T020G07B, exp 07/09; and, T020G07A, exp 07/09
RECALLING FIRM/MANUFACTURER
Vintage Pharmaceuticals LLC, Huntsville, AL, by letter on January 8, 2008. Firm initiated recall is ongoing.
REASON
Tablet separation; cracking and splitting of tablets.
VOLUME OF PRODUCT IN COMMERCE
20,402 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Children's Dimetapp Cold & Chest Congestion Syrup, active ingredients (in each
5 mL tsp): Phenylephrine HCl 5 mg and Guaifenesin 100 mg, 4 fl. oz. bottles, OTC,
Recall # D-087-2008;
b) Robitussin Cough & Cold CF Syrup, active ingredients (in each 5 mL tsp):
Dextromethorphan HBr 10 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg;
4 fl. oz., 8 fl. oz. and 12 fl. oz. bottles, OTC, Recall # D-088-2008;
c) Robitussin Cough & Congestion Syrup, active ingredients (in each 5 mL tsp):
Dextromethorphan HBr 10 mg and Guaifenesin 200 mg; 4 fl. oz. and 8 fl. oz. bottles,
OTC, Recall # D-090-2008;
d) Robitussin Cough DM Syrup, active ingredients (in each 5 mL tsp):
Dextromethorphan HBr 10 mg and Guaifenesin 100 mg; 4 fl. oz., 8 fl. oz, and
12 fl. oz. bottles, OTC, Recall # D-091-2008;
e) Robitussin-CF Syrup, active ingredients (in each 5 mL tsp): Dextromethorphan HBr
10 mg; Guaifenesin 100 mg, Pseudoephedrine HCl 30 mg; 4 fl. oz., 8 fl. oz., and
12 fl. oz. bottles, OTC, Recall # D-092-2008;
f) Robitussin PE Syrup, active ingredients (in each 5 mL tsp): Pseudoephedrine HCl
30 mg and Guaifenesin 100 mg; 4 fl. oz. and 8 fl. oz. bottles, OTC, Recall # D-093-
2008;
g) Robitussin Head & Chest Congestion PE Syrup, active ingredients (in each 5 mL tsp):
Phenylephrine HCl 5mg and Guaifenesin 100 mg; 4 fl. oz. bottles, OTC,
Recall # D-094-2008;
h) Robitussin Sugar Free Cough Syrup, active ingredients (in each 5 mL tsp):
Dextromethorphan HBr 10 mg and Guaifenesin 100 mg; 4 fl. oz. bottles, OTC,
Recall # D-095-2008
CODE
a) All lots with expiration date May 2009;
b) All lots with expiration dates January 2008 to August 2009;
c) All lots with expiration dates May 2008 to August 2010;
d) All lots with expiration dates October 2007 to August 2010;
e) and f) All lots within expiration;
g) All lots with expiration dates January 2008 to April 2009;
h) All lots with expiration dates October 2007 to February 2010
RECALLING FIRM/MANUFACTURER
Richmond Division of Wyeth, Richmond, VA, by letters on October 26, 2007, November 2, 2007 and November 9, 2007. Firm initiated recall is ongoing.
REASON
Dosing cups packaged with the product lack the 1/2 teaspoon mark for dosing children 2 to 6 yrs of age.
VOLUME OF PRODUCT IN COMMERCE
1,822,132 bottles/month (D-089-2008 is a Class III and volume is included in this figure)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Lithium Carbonate Extended Release Tablets, USP, 450 mg, 90 and100 count bottles, Rx only, NDC 0143-1277-01, Recall # D-085-2008
CODE
100 count bottle; Lot number 62395C, Exp. Date 3/2008,
90 count bottle; Lot number 62395B, Exp. Date 3/2008
RECALLING FIRM/MANUFACTURER
West-Ward Pharmaceutical Corp, Eatontown, NJ, by letter on December 26, 2007. Firm initiated recall is ongoing.
REASON
Failed USP Dissolution Specification; 18 month stability.
VOLUME OF PRODUCT IN COMMERCE
156 bottles of 100 count.
DISTRIBUTION
Nationwide and PR
___________________________________
PRODUCT
Budeprion SR (Bupropion HCl) Extended-Release Tablets, 150 mg, 100-tablet bottles, Rx only, NDC 0093-5502-01, Recall # D-086-2008
CODE
Lots: 7050091, 7050101, 7050961, 7050971, 7050981, 7050991, 7051001, 7051011, 7051021, 7051031, 7051041, 7051051, 7051061, 7051071, 7051081, 7051091; expiry 5/2009 for all lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, North Wales, PA, by letter on November 28, 2007.
Manufacturer: Impax Laboratories Inc, Hayward, CA. Firm initiated recall is ongoing.
REASON
Product does not meet time-release dissolution specifications.
VOLUME OF PRODUCT IN COMMERCE
187,455/100-tablet bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Robitussin Chest Congestion Guaifenesin Syrup, active ingredient (in each 5 mL tsp): Guaifenesin 100 mg; 4 fl. oz. and 8 fl. oz. bottles, OTC, Recall # D-089-2008
CODE
All lots with expiration dates October 2007 to August 2010
RECALLING FIRM/MANUFACTURER
Richmond Division of Wyeth, Richmond, VA, by letters on October 26, 2007, November 2, 2007 and November 9, 2007. Firm initiated recall is ongoing.
REASON
Dosing cups packaged with the product lack the 1/2 teaspoon mark for dosing children 2 to 6 yrs of age.
VOLUME OF PRODUCT IN COMMERCE
1,822,132 bottles/month (D-087-2008 – D-295-08 are Class II and volume is included in this figure)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0186-08
CODE
49GG24827
RECALLING FIRM/MANUFACTURER
Recalling Firm: American National Red Cross SW Region –HT, Tulsa, OK, by telephone, fax and electronically starting February 3, 2007.
Manufacturer: American Red Cross Blood Services-SW Region, College Station, TX. 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
OK
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0390-08;
b) Platelets, Recall # B-0391-08
CODE
a) Units: 614896, 615402, 615871;
b) Unit: 615871
RECALLING FIRM/MANUFACTURER
Avera McKennan Hospital & University Health Center, Sioux Falls, SD, by letter dated June 23, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking the drug Finasteride, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
SD, IA
___________________________________
PRODUCT
SoftBank II version 23.1, 23.1.1.x . , 23.1.2.x With Softscape 1.2.0.x, Recall # B-0505-08
CODE
Version 23.1, 23.1.1.x, 23.1.2.x with Softscape 1.2.0.x
RECALLING FIRM/MANUFACTURER
SCC Soft Computer, Clearwater, FL, by Task Management Notification and telephone on September 19, 2007. Firm initiated recall is ongoing.
REASON
Software, with a glitch or defect, was distributed.
VOLUME OF PRODUCT IN COMMERCE
100 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0524-08
CODE
Unit: 49GP32183
RECALLING FIRM/MANUFACTURER
American National Red Cross SW Region – HT, Tulsa OK, by facsimile on October 31, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK
___________________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-0525-08
CODE
Unit: 49Q82400
RECALLING FIRM/MANUFACTURER
American National Red Cross SW Region – HT, Tulsa OK, by telephone on April 3, 2007 and by facsimile on April 5, 2007. Firm initiated recall is complete.
REASON
Blood product, associated with a red cell unit that contained a clot, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0526-08
CODE
Unit: 49GV28430
RECALLING FIRM/MANUFACTURER
American National Red Cross SW Region – HT, Tulsa OK, by telephone on July 26, 2005 and by facsimile on July 27, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0528-08;
b) Plasma Frozen, Recall # B-0529-08
CODE
a) and b) Unit: 49KE05316
RECALLING FIRM/MANUFACTURER
American National Red Cross SW Region – HT, Tulsa OK, by letter dated December 13, 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
a) Plasma Frozen, Recall # B-0530-08;
b) Recovered Plasma, Recall # B-0531-08
CODE
a) Unit: 49LG88881;
b) Units: 49KM13808, 49LE07403, 49LG87391
RECALLING FIRM/MANUFACTURER
Recalling Firm: American National Red Cross SW Region – HT, Tulsa OK, by telephone and facsimile on October 31, 2006.
Manufacturer: American Red Cross Blood Services - SW Region, Waco, TX. Firm initiated recall is complete.
REASON
Blood products, which tested negative for Hepatitis, but were collected from a donor who previously tested positive for the Hepatitis B Surface Antigen HbsAg), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
TX, CA, and Switzerland
___________________________________
PRODUCT
a) Platelets, Recall # B-0532-08;
b) Fresh Frozen Plasma, Recall # B-0533-08;
c) Red Blood Cells Leukocytes Reduced, Recall # B-0535-08
CODE
a), b), and c) Unit: 5808077
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile beginning August 2, 2006. Firm initiated recall is complete.
REASON
Blood products, which tested negative for the human immunodeficiency virus (HIV), but were collected from a donor who previously tested positive for HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TX, NJ
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0545-08;
b) Platelets, Recall # B-0547-08;
c) Fresh Frozen Plasma, Recall # B-0548-08
CODE
a) Units: G36040, G36056, G36058, G36066, G36130, G36398, G36482, G36493, G36495, G36506, G36508, G36512, G36633, G36635, G36636, G36685, G36710, G36713, G36722, G36723, G36730, G36753, G36754, G36755, G36771, G36776, G36777, G36780, G36781, G36800, G36808, G36814, G36815, G36816, G36819, G36936, G36939, G37009, G37021, G37159, G37168, G37202, G37221, G37231, G37299, G37372, G37378, G37389, G37442, G37463, G37465, G37624, G37625, G37690, G37695, G37706, G37720, G37724, G37752, G37757, G37810, G37815, G37818, G37853, G37856, G37886, G37888, G37988, G38002, G38075, G38095, G38134, G38176, G38191, G38200, G38208, G38249, G38274, G38355, G38365, G38367, G38370, G38372, G38373, G38374, G37381, G38383, G38384, G38385, G38393, G38394, G38398, G38401, G38407, G38408, G38409, G38414, G38421, G38426, G38430, G38436, G38440, G38466, G38467, G38472, G38473, G38474, G38475, G38476, G38477, G38478, G38479, G38488, G38491, G38502, G38507, G38527, G38530, G38532, G38533, G38536, G38540, G38542, G38543, G38546, G38549, G38550, G38555, G38558, G38560, G38567, G38570, G38577, G38659, G38670, G38686, G38688, G38694, G38744, G38770, G38819, G38919, G39240, G39383, G39385, G39386, G39631, G39659, G38649, G38016, G38497, G38641;
b) Units: G36776, G36777, G36780, G38389, G38393, G38507, G38516;
c) Units: G36489, G36508, G36534, G36630, G36669, G36681, G37089
RECALLING FIRM/MANUFACTURER
The Good Samaritan Hospital, Lebanon, PA, by letter dated May 24, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
166 units
DISTRIBUTION
PA, MD
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0566-08
CODE
Unit: 18FN14890
RECALLING FIRM/MANUFACTURER
American National Red Cross Great Lakes Region, Lansing, MI, by telephone on June 2, 2006 and by letter dated June 16, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0570-08
CODE
Unit: 003R39182
RECALLING FIRM/MANUFACTURER
The American National Red Cross – Southern Region, Douglasville, GA, by telephone on January 8, 2007, electronic notification on January 11, 2007, or by letter dated January 19, 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
GA, CA
___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0573-08;
b) Plasma, Frozen, Recall # B-0574-08
CODE
a) and b) Unit: 003LJ42934
RECALLING FIRM/MANUFACTURER
The American National Red Cross – Southern Region, Douglasville, GA, by telephone on November 15, 2006, and by letter dated November 21, 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
Cryoprecipitated AHF, Recall # B-0575-08
CODE
Unit: 0235466
RECALLING FIRM/MANUFACTURER
The Blood Connection, Inc., Piedmont, SC, by telephone and facsimile on November 9, 2006. Firm initiated recall is complete.
REASON
Blood product, associated with a red cell unit that contained a clot, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
SC
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0577-08
CODE
Unit: 4146601
RECALLING FIRM/MANUFACTURER
Indiana Blood Center, Indianapolis, IN, by telephone on August 13, 2007 and by letter on August 23, 2007. Firm initiated recall is complete.
REASON
Blood product, with positive bacterial detection testing, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN
___________________________________
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced, Irradiated, Recall # B-0578-08;
b) Platelets Pheresis, Leukocytes Reduced, Recall # B-0579-08
CODE
a) Unit: 4146478, Part A;
b) Unit: 4146478, Part B
RECALLING FIRM/MANUFACTURER
Indiana Blood Center, Indianapolis, IN, by telephone on August 5, 2007 and letter on September 5, 2007. Firm initiated recall is complete.
REASON
Blood products, with positive bacterial detection testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IN
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0580-08
CODE
Unit: 72C244232
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by telephone and facsimile on August 7, 2007. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0581-08
CODE
Unit: 72C368450
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by facsimile on August 15, 2007. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0590-08
CODE
Unit: 49GL26462
RECALLING FIRM/MANUFACTURER
American National Red Cross SW Region – HT, Tulsa, OK, by fax and e-mail on April 17, 2007 and April 18, 2007. 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
TX
___________________________________
PRODUCT
a) Cryoprecipitated AHF, Recall # B-0594-08;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0595-08
CODE
a) and b) Unit: 1003687
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter dated April 28, 2005. 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
VA, MN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0596-08
CODE
Unit: 182393210
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter dated March 13, 2006.
Manufacturer: Blood Systems, Inc., Cheyenne, WY. 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
TX
___________________________________
PRODUCT
Source Plasma, Recall # B-0598-08
CODE
Units: 0490589001, 0490586391
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Grand Prairie, TX, by fax on June 26, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose scheduled physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC
___________________________________
PRODUCT
a) Platelets, Recall # B-0599-08;
b) Fresh Frozen Plasma, Recall # B-0600-08
CODE
a) and b) Unit: 1289028
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter dated June 27, 2005. Firm initiated recall is complete.
REASON
Blood products, associated with a red cell component that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MN
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0601-08;
b) Fresh Frozen Plasma, Recall # B-0602-08
CODE
a) and b) Unit: FL02533
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Blood Donor Services, Sterling, VA, by letter dated February 8, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had previously tested reactive for Hepatitis C (HCV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
VA
___________________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-0603-08
CODE
Unit: 1346886
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letters dated December 5, 2005 and February 24, 2006. 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
MN
___________________________________
PRODUCT
Cryoprecipitated AHF, Recall # B-0604-08
CODE
Unit: 1191624
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter dated April 4, 2005. Firm initiated recall is complete.
REASON
Blood product, associated with a plasma component that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN
___________________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-0606-08
CODE
Unit: 1286652
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter dated April 28, 2005. 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
MN
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0610-08;
b) Fresh Frozen Plasma, Recall # B-0611-08
CODE
a) and b) Unit: 22GE98379
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by telephone on September 17, 2007 and fax on September 24, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0620-08
CODE
Unit: J90674
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Grand Rapids, MI, by facsimile on June 7, 2007. Firm initiated recall is complete.
REASON
Blood product, which tested negative for hepatitis, but was collected from a donor who previously tested positive for the antibody to hepatitis B core antigen (anti-HBc) on two separate occasions, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-624-08
CODE
Unit: 72C056571
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by telephone and facsimile on August 16, 2007. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0625-08;
b) Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0626-08;
c) Blood and Blood Products for Reprocessing, Recall # B-0627-08
CODE
a) Unit: 4550729;
b) and c) 5895747
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute – Sylvan N Goldman Center, Oklahoma City, OK, by electronic mail or facsimile on December 12, 2006 and December 18, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
OK, NJ, Switzerland
___________________________________
PRODUCT
a) Fresh Frozen Plasma, Thawed, Recall # B-0628-08;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0629-08
CODE
a) and b) Unit: 1935891
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by facsimile on December 15, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0630-08
CODE
Unit: 0635258
RECALLING FIRM/MANUFACTURER
West Tennessee Regional Blood Center, Inc., Jackson, TN, by facsimile on April 6, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
Platelets, Recall # B-0631-08
CODE
Unit: 5376224
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood Center, Inc., Long Island City, NY, by telephone on May 13, 2005 and by facsimile on May 16, 2005.
Manufacturer: New York Blood Center, Inc., Westbury, NY. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm scrub procedure was performed incorrectly, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT
Red Blood Cells, Recall # B-0632-08
CODE
Unit: 5423242
RECALLING FIRM/MANUFACTURER
New York Blood Center, Inc., Long Island City, NY, by telephone on August 9, 2005 and by letter dated August 11, 2005. 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
NY
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0633-08;
b) Recovered Plasma, Recall # B-0634-08
CODE
a) and b) Units: M98637, M46467
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by facsimile or electronic notification on October 21, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who provided post donation information regarding multiple high-risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
GA, TN, Switzerland
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0635-08;
b) Fresh Frozen Plasma, Recall # B-0636-08;
c) Red Blood Cells Leukocytes Reduced, Recall # B-0637-08;
d) Plasma Frozen, Recall # B-0638-08;
CODE
a) Units: 004V28109, 004Z32935, 004Z31812;
b) Units: 004V28109, 004Z32935;
c) Units: 004KQ59814, 004KS11249, 004KQ62282, 004KT91337, 004E02802;
d) Unit: 004Z31812;
RECALLING FIRM/MANUFACTURER
ARC Blood Services, New England Region, Dedham, MA, by telephone, facsimile, or electronic notification on February 23, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
MA, NY, CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0640-08
CODE
Unit: 4799422
RECALLING FIRM/MANUFACTURER
Recalling Firm: Oklahoma Blood Institute - Sylvan N Goldman Center, Oklahoma City, OK, by facsimile on October 5, 2006.
Manufacturer: Oklahoma Blood Institute Tulsa Center, Tulsa, 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
OK
___________________________________
PRODUCT
a) Platelets, Recall # B-0644-08;
b) Red Blood Cells, Leukocytes Reduced, Recall # B-0645-08
CODE
a) and b) Unit: 2777024
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on January 16, 2007 and letter on February 8, 2007. Firm initiated recall is complete.
REASON
Blood products, which was collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0648-08
CODE
Unit: 49GC20833
RECALLING FIRM/MANUFACTURER
American National Red Cross SW Region – HT, Tulsa, OK, by telephone on June 8, 2007 and facsimile on June 13, 2007. 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
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0661-08
CODE
Unit: 22FQ49756
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by letter dated August 23, 2007. 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
PA
___________________________________
PRODUCT
Red Blood Cells, Recall # B-0665-08
CODE
Unit: 4181504
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH, by letter on April 4, 2006. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0666-08;
b) Recovered Plasma, Recall # B-0667-08
CODE
a) and b) Unit: V00786
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by facsimile and electronic mail on September 13, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL and Israel
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0668-08
CODE
Units: Y62847, Y37803
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by facsimile on November 14, 2006. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA, AL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0669-08
CODE
Unit: 2246297
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by letter dated December 27, 2005. Firm initiated recall is complete.
REASON
Blood product, possibly contaminated with air during collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KY
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0670-08;
b) Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0671-08;
c) Recovered Plasma, Recall # B-0672-08
CODE
a) Units: Y95783; K56698; K42114; N60617; N47361; L91914; L40116; L15784;
N33594; N24082 and N14809;
b) Unit: K83843;
c) Units: K83843; K56698; K42114; N60617; N47361; Y95783; L91914; L40116;
L15784; N33594, N24082 and N14809
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by facsimile on August 23, 2006. Firm initiated recall is complete.
REASON
Blood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
24 units
DISTRIBUTION
TN, GA, NY and Israel
___________________________________
PRODUCT
a) Platelets, Recall # B-0673-08;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0674-08
CODE
a) and b) Unit: Y71402
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by facsimile on September 21, 2006. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN, GA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0675-08
CODE
Unit: LH54991
RECALLING FIRM/MANUFACTURER
Rhode Island Blood Center, Providence, RI, by telephone and letter on March 27, 2007. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-0677-08
CODE
Unit: 1317421
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by telephone on June 23, 2005. Firm initiated recall is complete.
REASON
Blood product, associated with a unit of red blood cells that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN
___________________________________
PRODUCT
Recovered Plasma, Recall # B-0187-08
CODE
49GG24827
RECALLING FIRM/MANUFACTURER
Recalling Firm: American National Red Cross SW Region –HT, Tulsa, OK, by telephone, fax and electronically starting February 3, 2007.
Manufacturer: American Red Cross Blood Services, SW Region, College Station, TX. 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
CA
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B--0438-08
CODE
Unit: 1618344 (split unit)
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center UC Medical Center, Cincinnati, OH, by letters dated March 22, 2006. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to an area considered as endemic for leishmania, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH
___________________________________
PRODUCT
Source Leukocytes, Recall # B-0534-08
CODE
Unit: 5808077
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile beginning August 2, 2006. Firm initiated recall is complete.
REASON
Blood product, which tested negative for the human immunodeficiency virus (HIV), but was collected from a donor who previously tested positive for HIV, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX, NJ
___________________________________
PRODUCT
Source Plasma, Recall # B-0546-08
CODE
Units: G36033, G36034, G36040, G36058, G36059, G36060, G36062, G36065, G36066, G36129, G36130, G36132, G36133, G36134, G36159, G36163, G36173, G36175, G36232, G36256, G36259, G36398, G36447, G36449, G36452, G36482, G36483, G36504, G36510, G36511, G36514, G36517, G36519, G36521, G36527, G36548, G36568, G36585, G36586, G36595, G36597, G36598, G36599, G36600, G36615, G36617, G36620, G36621, G36622, G36623, G36624, G36625, G36627, G36629, G36633, G36634, G36635, G36636, G36663, G36667, G36670, G36672, G36673, G36674, G36677, G36680, G36682, G36683, G36685, G36708, G36710, G36711, G36712, G36713, G36716, G36718, G36721, G36728, G36734, G36736, G36737, G36739, G36740, G36741, G36743, G36744, G36745, G36746, G36749, G36752, G36753, G36754, G36757, G36760, G36761, G36764, G36768, G36771, G36772, G36776, G36777, G36780, G36781, G36788, G36789, G36792, G36796, G36799, G36800, G36801, G36802, G36804, G36808, G36812, G36814, G36815, G36816, G36819, G36820, G36825, G36838, G36839, G36840, G36843, G36845, G36847, G36848, G36851, G36852, G36853, G36854, G36860, G36862, G36866, G36867, G36883, G36886, G36890, G36893, G36902, G36905, G36923, G36924, G36927, G36930, G36936, G36938, G36947, G36954, G36956, G36957, G36966, G36969, G36975, G36976, G36977, G36978, G36980, G36983, G36987, G36989, G36990, G36992, G36993, G36995, G36996, G36999, G37000, G37002, G37003, G37004, G37009, G37014, G37018, G37019, G37021, G37023, G37025, G37045, G37048, G37053, G37054, G37057, G37061, G37062, G37063, G37064, G37066, G37067, G37068, G37069, G37070, G37076, G37079, G37080, G37081, G37083, G37101, G37108, G37112, G37115, G37121, G37126, G37130, G37139, G37144, G37146, G37147, G37151, G37159, G37160, G37162, G37164, G37165, G37166, G37168, G37171, G37174, G37178, G37187, G37189, G37192, G37201, G32703, G37206, G37212, G37217, G37218, G37220, G37221, G37222, G37224, G37229, G37232, G37235, G37255, G37256, G37258, G37267, G37270, G37275, G37281, G37282, G37283, G37285, G37295, G37299, G37303, G37312, G37313, G37315, G37318, G37319, G37337, G37341, G37343, G37349, G37350, G37352, G37356, G37358, G37359, G37366, G37372, G37375, G37378, G37381, G37384, G37388, G37390, G37392, G37398, G37408, G37414, G37434, G37437, G37441, G37442, G37450, G37452, G37465, G37466, G37484, G37493, G37503, G37505, G37507, G37510, G37513, G37514, G37515, G37517, G37522, G37523, G37526, G37527, G37536, G37537, G37539, G37545, G37547, G37548, G37550, G37556, G37558, G37563, G37565, G37566, G37567, G37570, G37574, G37575, G37576, G37577, G37579, G37581, G37582, G37583, G37589, G37590, G37594, G37597, G37598, G37600, G37602, G37605, G37606, G37608, G37611, G37612, G37613, G37617, G37618, G37623, G37626, G37640, G37642, G37645, G37646, G37649, G37650, G37651, G37656, G37658, G37663, G37666, G37667, G37670, G37673, G37674, G37681, G37684, G37686, G37687, G37689, G37690, G37691, G37694, G37695, G37698, G37699, G37701, G37704, G37705, G37706, G37707, G37708, G37719, G37720, G37722, G37723, G37724, G37725, G37726, G37727, G37728, G37729, G37730, G37731, G37734, G37737, G37739, G37742, G37757, G37774, G37781, G37789, G37799, G37801, G37816, G37817, G37822, G37828, G37829, G37835, G37836, G37838, G37849, G37850, G37854, G37858, G37864, G37865, G37866, G37870, G37880, G37881, G37882, G37884, G37886, G37887, G37891, G37893, G37899, G37907, G37910, G37912, G37913, G37916, G37917, G37918, G37928, G37931, G37932, G37933, G37935, G37938, G37940, G37942, G37943, G37946, G37947, G37948, G37951, G37952, G37954, G37956, G37958, G37959, G37960, G37961, G37963, G37965, G37969, G37971, G37974, G37975, G37976, G37977, G37985, G37986, G37987, G37988, G37989, G37990, G37992, G37995, G37999, G38000, G38002, G38003, G38005, G38010, G38013, G38014, G38016, G38017, G38045, G38046, G38047, G38053, G38055, G38059, G38064, G38066, G38068, G38070, G38073, G38077, G38078, G38081, G38085, G38094, G38098, G38110, G38111, G38115, G38117, G38118, G38123, G38124, G38125, G38127, G38128, G38134, G38135, G38136, G38144, G38145, G38147, G38151, G38154, G38157, G38159, G38166, G38169, G38170, G38171, G38176, G38177, G38181, G38183, G38184, G38188, G38191, G38197, G38198, G38200, G38202, G38206, G38208, G38212, G38213, G38217, G38221, G38225, G38230, G38233, G38240, G38243, G38246, G38247, G38249, G38274, G38276, G38278, G38280, G38281, G38284, G38285, G38287, G38289, G38290, G38293, G38296, G38298, G38303, G38307, G38308, G38214, G38351, G38352, G38355, G38357, G38359, G38361, G38367, G38368, G38370, G38372, G38373, G38374, G38375, G38376, G38379, G38380, G38381, G38383, G38384, G38389, G38394, G38408, G38409, G38413, G38414, G38417, G38420, G38426, G38429, G38440, G38451, G38457, G38475, G38476, G38477, G38479, G38480, G38497, G38502, G38507, G38510, G38516, G38527, G38530, G38540, G38541, G38542, G38544, G38546, G38550, G38552, G38555, G38557, G38558, G38559, G38560, G38561, G38565, G38568, G38570, G38577, G38578, G38579, G38585, G38619, G38620, G38621, G38624, G38627, G38632, G38633, G38640, G38641, G38645, G38648, G38649, G38653, G38657, G38659, G38661, G38662, G38663, G38665, G38672, G38686, G38688, G38690, G38692, G38694, G38699, G38701, G38704, G38710, G38714, G38718, G38721, G38724, G38727, G38729, G38734, G38735, G38737, G38738, G38740, G38742, G38743, G38744, G38745, G38748, G38753, G38755, G38758, G38765, G38766, G38767, G38769, G38770, G38771, G38775, G38782, G38787, G38791, G38792, G38793, G38795, G38797, G38800, G38802, G38805, G38807, G38810, G38819, G38820, G38821, G38827, G38833, G38842, G38845, G38851, G38863, G38865, G38881, G38890, G38893, G38896, G38905, G38907, G38909, G38917, G38919, G38923, G38924, G38928, G38934, G38936, G38937, G38938, G38950, G38988, G38991, G38997, G38999, G39204, G39206, G39208, G39209, G39210, G39211, G39217, G39222, G39226, G39232, G39240, G39248, G39250, G39252, G39254, G39264, G39266, G39269, G39273, G39280, G39285, G39292, G39302, G39305, G39306, G39312, G39313, G39314, G39315, G39325, G39326, G39336, G39359, G39360, G39373, G39381, G39383, G39385, G39386, G39387, G39393, G39398, G39399, G39400, G39402, G39403, G39417, G39433, G39434, G39435, G39440, G39444, G39445, G39446, G39451, G39452, G39453, G39457, G39465, G39466, G39470, G39471, G39475, G39476, G39478, G39483, G39484, G39490, G39503, G39505, G39507, G39513, G39514, G39518, G39524, G39526, G39538, G39539, G39540, G37008, G37677, G37937, G38407, G38478
RECALLING FIRM/MANUFACTURER
The Good Samaritan Hospital, Lebanon, PA, by letter dated May 24, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
796 units
DISTRIBUTION
PA, MD
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0563-08;
b) Platelets, Recall # B-0564-08;
c) Recovered Plasma, Recall # B-0565-08
CODE
a), b) and c) Unit: T26465
RECALLING FIRM/MANUFACTURER
Recalling Firm: Michigan Community Blood Centers, Grand Rapids, MI, by facsimile or electronic notification on June 15, 2007.
Manufacturer: Michigan Community Blood Center, Traverse City, MI. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of surgery within the previous 12 months, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
MI, Switzerland
___________________________________
PRODUCT
Recovered Plasma, Recall # B-0567-08
CODE
Unit: T26608
RECALLING FIRM/MANUFACTURER
Recalling Firm: Michigan Community Blood Centers, Grand Rapids, MI, by facsimile on April 4, 2007.
Manufacturer: Michigan Community Blood Center, Traverse City, MI. Firm initiated recall is complete.
REASON
Blood product, which tested negative for human immunodeficiency virus (HIV), but was collected from a donor who previously tested positive for HIV, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0568-08;
b) Platelets, Recall # B-0569-08
CODE
a) and b) Unit: T26492
RECALLING FIRM/MANUFACTURER
Recalling Firm: Michigan Community Blood Centers, Grand Rapids, MI, by facsimile on March 13, 2007.
Manufacturer: Michigan Community Blood Center, Traverse City, MI. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking antibiotics, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI
___________________________________
PRODUCT
Recovered Plasma, Recall # B-0571-08
CODE
Unit: 003R39182
RECALLING FIRM/MANUFACTURER
The American National Red Cross – Southern Region, Douglasville, GA, by telephone on January 8, 2007, electronic notification on January 11, 2007, or by letter dated January 19, 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
GA, CA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0576-08
CODE
Units: 32KP67646 (Part A), 32KP67646 (Part B, 32KP67649, 32KP67657, 32KP67660
RECALLING FIRM/MANUFACTURER
American National Red Cross HOA Blood Services Region, Peoria, IL, by telephone on July 30, 2007 and letter on August 2, 2007. Firm initiated recall is complete.
REASON
Blood products, which were exposed to unacceptable temperatures during shipment, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
IL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0582-08
CODE
Unit: 1471426
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on September 19, 2006 and by letter and electronic mail on September 27, 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
1 unit
DISTRIBUTION
TX and Switzerland
___________________________________
PRODUCT
a) Cryoprecipitated AHF, Recall # B-0583-08;
b) Plasma Cryoprecipitated Reduced, Recall # B-0584-08;
c) Fresh Frozen Plasma, Recall # B-0585-08;
d) Red Blood Cells Leukocytes Reduced, Recall # B-0586-08;
CODE
a) Units: 71S481770; 71S481500; 71S648304; 71S373979;
b) Units: 71S648304; 71S64841X; 71S373979;
c) Units: 71S147884; 71S368619;
d) Units: 71S648304, 71S648297, 71S80649X and 71S898643;
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Birmingham Region, Birmingham, AL, by facsimile on August 14, 2006 and August 15, 2006. Firm initiated recall is complete.
REASON
Blood products, processed more than eight hours after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
AL
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0588-08;
b) Recovered Plasma, Recall # B-0589-08
CODE
a) and b) Unit: 55K54464
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Ozark-Arkansas Region, Little Rock, AR, by telephone and letter on July 12, 2006. Firm initiated recall is complete.
REASON
Blood products, that were not quarantined after information was received concerning post-donation illness, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AR, CA
___________________________________
PRODUCT
Recovered Plasma, Recall # B-0591-08
CODE
Unit: 49GL26462
RECALLING FIRM/MANUFACTURER
American National Red Cross SW Region – HT, Tulsa, OK, by fax and e-mail on April 17, 2007 and April 18, 2007. 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
CA
___________________________________
PRODUCT
Red Blood Cells, Recall # B-0597-08
CODE
Unit: 1304415
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by fax on May 9, 2005. Firm initiated recall is complete.
REASON
Blood product, associated with a plasma component that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN, IL
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0605-08
CODE
Units: 04LP73715, 04LM89653, 04LP73713, 04LM89653, 04LP73715
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by telephone on July 8, 2007 and letter dated July 12, 2007. Firm initiated recall is complete.
REASON
Blood products, lacking assurance of having been maintained at an acceptable temperature during shipping, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
PA, NJ
___________________________________
PRODUCT
Red Blood Cells, Recall # B-0608-08
CODE
Unit: 1272135
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by telephone on February 9, 2005. Firm initiated recall is complete.
REASON
Blood product, incorrectly labeled as negative for the Kell antigen, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0612-08
CODE
Unit: 1341469
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter dated November 24, 2005. Firm initiated recall is complete.
REASON
Blood product, associated with a plasma component that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL, MN
___________________________________
PRODUCT
Red Blood Cells, Recall # B-0614-08
CODE
Unit: 1362217
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter dated December 19, 2005. Firm initiated recall is complete.
REASON
Blood product, associated with a plasma component that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN
___________________________________
PRODUCT
Red Blood Cells, Recall # B-0616-08
CODE
Unit: 1359554
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter dated October 24, 2005. Firm initiated recall is complete.
REASON
Blood product, associated with a plasma component that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN
___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0618-08;
b) Blood and Blood Products for Reprocessing, Recall # B-0619-08
CODE
a) and b) Unit: J15400
RECALLING FIRM/MANUFACTURER
Recalling Firm: Michigan Community Blood Centers, Grand Rapids, MI, by facsimile on April 27, 2007 or by electronic notification on April 30, 2007.
Manufacturer: Michigan Community Blood Centers, Bay City, MI. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had surgery within the 12 months prior to donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI and Switzerland
___________________________________
PRODUCT
Recovered Plasma, Recall # B-0639-08
CODE
Units: 004KQ59814, 004KS11249, 004KQ62282, 004KT91337, 004E02802
RECALLING FIRM/MANUFACTURER
ARC Blood Services, New England Region, Dedham, MA, by telephone, facsimile, or electronic notification on February 23, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma, Recall # B-0641-08
CODE
Unit: 4799422
RECALLING FIRM/MANUFACTURER
Recalling Firm: Oklahoma Blood Institute - Sylvan N Goldman Center, Oklahoma City, OK, by facsimile on October 5, 2006.
Manufacturer: Oklahoma Blood Institute Tulsa Center, Tulsa, 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
Switzerland
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0642-08;
b) Cryoprecipitated AHF, Recall # B-0643-08
CODE
a) and b) Unit: LM37595
RECALLING FIRM/MANUFACTURER
Rhode Island Blood Center, Providence, RI, by telephone and letter on August 20, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had major surgery within twelve months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
RI, NY
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0646-08
CODE
Unit: Y16167
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by facsimile on October 18, 2005. Firm initiated recall is complete.
REASON
Blood product, manufactured from Whole Blood unit that was stored at an incorrect temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-0647-08
CODE
Unit: 49GC20833
RECALLING FIRM/MANUFACTURER
American National Red Cross SW Region – HT, Tulsa, OK, by telephone on June 8, 2007 and facsimile on June 13, 2007. 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
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0657-08;
b) Fresh Frozen Plasma, Recall # B-0658-08;
c) Platelets Leukocytes Reduced, Recall # B-0659-08
CODE
a), b) and c) Unit: LY25397
RECALLING FIRM/MANUFACTURER
Rhode Island Blood Center, Providence, RI, by fax dated September 25, 2007 and by telephone and fax on September 27, 2007. Firm initiated recall is complete.
REASON
Quality Control and Distribution/Distribution of product that did not meet specifications.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
MA, RI
___________________________________
PRODUCT
Recovered Plasma, Recall # B-0660-08
CODE
Unit: 22FQ49756
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by e-mail dated August 17, 2007. 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
CA
___________________________________
PRODUCT
Biomet Straight Magnum Inserter Handle, a preparatory instrument used for acetabular component insertion; REF # or Catalog Number: S313141. (Systems affected by this action include M2a-Magnum, Regenerex, Acetabular Revision Shell and M2a-38), Recall # Z-0115-2008
CODE
Lots: 095112 and 474660
RECALLING FIRM/MANUFACTURER
Biomet, Inc., Warsaw, IN, by letter dated September 4, 2007. Firm initiated recall is complete.
REASON
Binding: The instrument was manufactured incorrectly and its use may result in binding to the acetabular component and cause the implant to not release following impaction.
VOLUME OF PRODUCT IN COMMERCE
22 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
AmniSure ROM Test, Fetal Membrane Rupture Test for In-Vitro Diagnostic Use, Model: FMRT-1, Recall # Z-0120-2008
CODE
Lot Number/ Exp. Date A7003, 01/2009. A7002, 11/2008, A7001, 10/2008, A6005, 04/2008, A6004, 01/2008, A6003, 09/2007, and A6002-3, 09/2007
RECALLING FIRM/MANUFACTURER
AmniSure International LLC, Cambridge, MA, by letter dated October 1, 2007. Firm initiated recall is ongoing.
REASON
Weak true positive/false negative results: weak true positive or false negatives in ruptured fetal membranes may occur due to a "hook effect"
VOLUME OF PRODUCT IN COMMERCE
170,000 kits
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Abbott AxSYM AUSAB Reagent Pack, List No: 3C74-20, 100 tests, an in-vitro test for Antibody to Hepatitis B Surface Antigen (Anti-HBs), Recall # Z-0127-2008
CODE
Lot Numbers: 49535M100 and 55451M200
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Abbott Park, IL, by letter dated October 1, 2007. Firm initiated recall is ongoing.
REASON
Incorrect results: Reagents in these lots were manufactured with an incorrect ratio of 2 key components, which could result in both false reactive and false nonreactive specimens.
VOLUME OF PRODUCT IN COMMERCE
1,722 packs
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Intuitive Surgical EndoWrist, 8 mm, PK Dissecting Forceps for use with the da Vinci and da Vinci S Surgical systems, Part Numbers: 400214-02, 400214-03, 420214-02 and 420214-03, Recall # Z-0258-2008
CODE
All instruments manufactured till 03/21/07
RECALLING FIRM/MANUFACTURER
Intuitive Surgical, Inc., Sunnyvale, CA, by letter on January 9, 2008. Firm initiated recall is ongoing.
REASON
Mislabeling-electrical isolation requirements: devices were incorrectly labeled with a CF symbol not their proper BF Symbol on the instrument housing. (All instruments meeting the CF isolation requirements are suitable for direct cardiac application, while instruments meeting BF isolation requirements are not suitable for direct cardiac application)
VOLUME OF PRODUCT IN COMMERCE
1,136 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Advanced Medical Optics (AMO), VISX WaveScan WaveFront System (software). Part Number 0070-1478, Recall # Z-0365-2008
CODE
Serial Numbers: 75447, 75448, 76086, 75389, 70170, 76092, 76004, 76020, 76070, 76128, 75391, 75413, 75416, 75417, 75423, 75441, 75442, 76043, 76046, 76048, 76082, 76091, 76121, 76144, 76147, 75419, 76122, 75257, 75385, 75386, 76003, 76022, 76111, 76018, 75390, 76050, 76098, 75420, 76071, 76075, 76114, 75411, 75425, 76123, 76124, 76136, 75384, 75421, 76002, 76023, 75449, 76084, 76119, 76085, 76033, 76036, 76083, 76076, 76052, 76089, 76067, 75444, 75450, 76047, 76099, 76146, 76026, 75424, 76095, 75410, 76106, 75392, 75409, 75428, 75452, 76025, 76032, 76045, 76053, 76097, 70213, 70256, 70316, 70776, 75358, 75418, 75430, 75431, 75432, 76042, 76044, 76049, 76051, 76077, 76078, 76108, 76109, 76116, 76126, 76141, 76035, 76087, 76112, 75398, 76115, 76013, 76120, 76057, 75387, 76021, 76125, 76127, 76130, 76135, 75422, 76069, 75415, 76110, 76137, 76161, 76163, 70419, 70869, 75403, 76096, 76142, 70304, 70160, 70250, 70666, 70753, 70890, 75028, 75402, 75405, 75426, 75429, 75436, 76007, 76027, 76029, 76031, 76037, 76065, 76068, 76073, 78074, 76079, 76103, 76117, 76139, 76140, 76143, 76150, 76151, 76153, 76155, 76156, 76157, 76159, 76160,76162, 70272, 70280, 70297, 70706, 70872, 75297, 75359, 75404, 76059, 76061, 76063, 76081, 76149, 75397, 75399, 70541, 70774, 70904, 75412, 75437, 76017, 70043, 70394, 75401, 75439, 76066, 76080, 76088, 76148, 76058, 76090, 70271, 70353, 70398, 70409, 70734, 76006, 76009, 76028, 76154, 76158, 76145, 70855, 76038, 76062, 75433, 70864, 75394, 75434, 76138, 71704, 70217, 70485, 70491, 70690, 75281, 76104, 75406, 75414, 75427, 76015, 70286, 70440, 70476, 70765, 70882, 75400, 75446, 76005, 75388, 76024, 76039, 76129, 70588, 70603, 75445, 76040, 70597, 70175, 70178, 76094, 70759, 70336, 70637, 75230, 76093, 76105, 75121, 76019, 76056, 76060, 70333, 70341, 70365, 70379, 70428, 75113, 76001, 76054, 70691, 75109, 76107, 70299, 75234, 70554, 70653, 75236, 76011, 76152, 70474, 70495, 70542, 75440, 76101, 76118, 76113, 75435, 76012, 70031, 70032, 70036, 70092, 70227, 70580, 70608, 70721, 75172, 75395, 75408, 75443, 75451, 76016, 76030, 76034, 76072, 76100, 76064, 70080, 70221, 70283, 75328, 75396, 75438, 75407, 70159, 70241, 70350, 76008, 76010, 76014, 70650, 70732, 76055, 76102, 70457, and 76041
RECALLING FIRM/MANUFACTURER
Visx, Inc., Santa Clara, CA, by letter on May 30, 2007. Firm initiated recall is ongoing.
REASON
Erroneous Treatment Calculations - Two software caused errors; in combination, in the WaveScan System Software, will result in an erroneous treatment calculation (overcorrection) in patients. (1) Installation of software for a certain brand of computer (Dedicated Computing LLC) can cause a software registry setting for an algorithm that identifies image reflection to be erroneously set in the "off" position upon installation on these specific computers, and (2) Software error in the WaveScan System application produces erroneous treatment calculations.
VOLUME OF PRODUCT IN COMMERCE
329 systems
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Depuy TK2 Compression Hip Screw trauma plate, Standard Barrel, 135 Degree,
4H-92.6mm, sterile; REF 8315-35-004, Recall # Z-0434-2008;
b) Depuy TK2 Compression Hip Screw trauma plate, Short Barrel, 135 DEG,
4H-92.6mm, sterile; REF 8315-35-104, Recall # Z-0435-2008
CODE
a) Lot: DHDB73;
b) Lot: DHDB6P
RECALLING FIRM/MANUFACTURER
Recalling Firm: Depuy Orthopaedics, Inc., Warsaw, IN, by letter dated October 30, 2007.
Manufacturer: DePuy ACE S.a.R.L., Le Locle, Switzerland. Firm initiated recall is ongoing.
REASON
Mis-etched/labeled as to barrel length: the lot with the short barrel was etched and labeled as a standard barrel and the lot with the standard barrel was etched and labeled as a short barrel.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Oxy Serve II Oxygen Conserving Regulator, Model Number: MCRB-870-6, Recall # Z-0529-2008
CODE
Lot 051101 - (Serial #'s: 001009, 001010, 001012, 001017, 001019, 001023, 001025, 001027, & 001029) -- Lot 05111 - (Serial #: 001049)-- Lot 051121 (Serial #'s: 001022, 001015, 001026, 530002, 530004, 001013, 001014, 001016, & 001034)-- Lot 051130 (Serial #'s: 530003, 001011, 001018, 001021, 001024, 001031, 001033, 001035, 001037, 001038, 001039, & 001050) -- Lot 051202 (Serial # 001044)-- Lot 063759 (Serial #'s: 001206, 001054, 001055, 001056, 001073, 001077, 001164, 001168, 001180, 001191, 001207, 001078, 001166, 001154, 001178, 001169, 001170, 001174, 001153, 001155, 001157, 001171, 001175, 001177, 001182, 001200, 001203, 001208, 001140, & 001165) Lot 063426 (Serial # 001093, 001101, 001111, 001128, 001106, 001114, 001076, 001112, 001074, 001084, 001092, 001124, 001126, 001134, 001137, 001141, 001142, 001167, 001069, 001057, 001099, 001130, 001135, 001150, 001118, 001139, 001075, 001052, 001117, 001119, 001176, 001061, 001053, 001103, 0011363, 001108, 001067, 001110, 001070, 001136, 001098, 001121, 001113, 001051, 001063, 001082, 001071, 001116, 001064, 001066, 001095, 001109, 001085, 001087, 001088, 001089, 001090, 001091, 001094, 001096, 001125, 001127, 001144, & 001145)
RECALLING FIRM/MANUFACTURER
Superior Products, Inc., Cleveland, OH, by letter on or about October 19, 207. Firm initiated recall is ongoing.
REASON
Leakage: Device was leaking oxygen.
VOLUME OF PRODUCT IN COMMERCE
108 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Terumo Ultrasonic air sensor, 3/8" by 3/32" (9.5 mm x 2.4 mm), Red, for use on
Terumo perfusion systems 1, 8000 and 9000; Catalog No: 5773, Recall # Z-0530-
2008;
b) Terumo ultrasonic air sensor, 1/4" by 1/16" (6.4 mm x 1.6 mm), Black, for use on
Terumo perfusion systems 1, 8000 and 9000; Catalog No: 5785, Recall # Z-0531-
2008;
c) Terumo Ultrasonic air sensor, 1/4" by 3/32" (6.4 mm x 2.4 mm), Gold, for use on
Terumo perfusion systems 1, 8000 and 9000; Catalog No: 5791, Recall # Z-0532-2008
CODE
a) Serial Numbers: 1988 through 4450, 4452 through 4457, 4459 through 4485, 4487
through 4500, 4502 through 4525, 4527 through 4545 and 4551;
b) Serial Numbers: 1106 through 1370 and 1376;
c) Serial Numbers: 1091 through 1307
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by letter dated September 14, 2007. Firm initiated recall is ongoing.
REASON
False Alarms: The air sensor may malfunction and trigger false alarms, and may continue to alarm thus preventing the device from being reset.
VOLUME OF PRODUCT IN COMMERCE
2,826 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Benchmark, Slide Staining System, Catalog Number: N750-BMK-FS,
Recall # Z-0537-2008;
b) Benchmark XT, Slide Staining System, Catalog Number: N750-BMKXT-FS,
Recall # Z-0538-2008;
c) Benchmark LT, Slide Staining System, Catalog Number: N750-BMKLT-FS,
Recall # Z-0539-2008;
d) Discovery, Slide Staining System, Catalog Number: N750-DIS-FS,
Recall # Z-0540-2008;
e) Discovery XT, Slide Staining System, Catalog Number: N750-DISXT-FS,
Recall # Z-0541-2008
CODE
a) Serial Numbers: #810000-822654;
b) Serial Numbers: #710000-711289;
c) Serial Numbers: #610000-610266;
d) Serial Numbers: #810000-811666;
e) Serial Numbers: #710000-711288
RECALLING FIRM/MANUFACTURER
Ventana Medical Systems, Inc., Tucson, AZ, by letters dated September 30, 2005, June 27, 2006 and September 29, 2006. Firm initiated recall is ongoing.
REASON
Leaking Carboys/Safety Updates: The Ventana Staining Platform includes one or more carboys that may have the potential to leak if the spigot is either improperly installed or not fully closed.
VOLUME OF PRODUCT IN COMMERCE
2,871 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) VNUS 7F ClosureFAST Catheter, Order #: CF7-7-60 (60 cm working length),
Recall # Z-0542-2008;
b) VNUS 7F ClosureFAST Catheter, Order # ClF7-7-100 (100 cm working length),
Recall # Z-0543-2008
CODE
a) Lot #s: 319484, 274119, 274900, 275146, 275637, 276054, 277311, 277775, 278742, 279181, 279614, 279880, 279938, 280314, 280315, 280316, 285851, 286800, 287108, 287566, 288293, 292135, 292432, 293002, 293275, 293276, 293830, 293832, 294657, 294881, 294882, 295263, 296973, 298603, 299607, 299929, 300573, 301032, 301354, 302329, 302628, 303250, 303712, 303723, 304640, 304698, 305533, 305894, 306571, 306834, 307366, 307561, 307938, 307951, 308465, 309081, 309441, 309741, 309782, 310338, 310401, 310408, 310920, 311185, 312220, 312241, 312334, 313084, 313104, 313373, 313530, 313792, 314079, 314241, 314548, 314655, 315253, 315389, 315751, 315765, 315913, 315922, 316405, 316652, 316653, 316947, 317041, 317342, 317421, 318802, 319117, and 319253;
b) Lot #s: 269157, 269653, 269937, 273326, 277761, 286201, 286565, 287746, 288012, 288336, 288984, 289027, 289757, 291483, 295539, 295786, 296215, 296218, 296974, 298602, 299406, 301347, 301352, 302596, 303252, 304271, 305063, 305550, 306673, 306823, 307368, 308780, 308782, 312677, 312735, 313529, 314828, 314829, 314829, 315084, 315381, 317485, 317827, 317889, 317972, 317979, 318124, 318259, 318556, and 318610
RECALLING FIRM/MANUFACTURER
VNUS Medical Technologies, Inc., San Jose, CA, by letter dated August 6, 2007. Firm initiated recall is ongoing.
REASON
Instructions for Use change: Instructions for Use have been changed to include a modified placement recommendation.
VOLUME OF PRODUCT IN COMMERCE
22,937 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) ProTime Microcoagulation System Instrument, Catalogue Number: PROTIMEPRO,
Recall # Z-0546-2008;
b) ProTime Microcoagulation System Instrument, Catalogue Number: PROTIMEPST,
Recall # Z-0547-2008;
c) ProTime Microcoagulation System Instrument: Catalogue Number: PROTIMEINT,
Recall # Z-0548-2008
CODE
All instruments with Serial Number V56560 or lower
RECALLING FIRM/MANUFACTURER
Recalling Firm: International Technidyne Corp., Piscataway, NJ, by letter on November 19, 2007.
Manufacturer: V Tech Communications Limited, Tai Po, Hong Kong. Firm initiated recall is ongoing.
REASON
An increase in the frequency of non-conformance reports (NCMR) for certain displayed error messages.
VOLUME OF PRODUCT IN COMMERCE
5,910 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) ACAT 1 Series Intra-Aortic Balloon Pumps, Catalog # IAP-0100,
Recall # Z-0549-2008;
b) AutoCAT 2 Series Intra-Aortic Balloon Pumps Catalog No: IAP-0400, IAP-0435,
IAP-0500, and IAP-0535, Recall # Z-0550-2008
CODE
a) Serial Numbers: 070511A, 070512A, 070513A, 070514A, 070515A, 070516A, 070517A, 070518A, 070519A, 070520A, 070521A, 070522A, 070523A, 070524A, 070525A, 070601A, 070602A, 070603A, 070604A, 070605A, 10708A, 70206A, 70207A, 70208A, 70209A, 70210A, 70301A, 70302A, 70303A, 70304A, 70305A, 70401A, 70402A, 70403A, 70404A, 70405A, 70501A, 70502A, 70503A, 70504A, 70505A, 70506A, 70507A, 70508A, 70509A, 70510A, and 90305A;
b) Serial Numbers: 070405V, 070411V, 070412V, 070413V, 070415V, 070416V, 070420V, 070421V, 070422V, 070423W, 070424V, 070426V, 070501V, 070502W, 070503W, 070510V, 070512W, 070513V, 070514W, 070518V, 070520W, 070522W, 070523W, 070524V, 070525W, 070526V, 070527V, 070528W, 070529V, 070530W, 070531W, 070532W, 070533W, 070534W, 070535W, 070536W, 070537V, 070538V, 070539V, 070540W, 070601W, 070602W, 070603V, 070604V, 070605W, 070606W, 070607W, 70608W, 070609W, 070610W, 070611W, 070612W, 070613W, 070614W, 070615W, 070616W, 070617W, 070618W, 070619W, 70620W, 070621W, 070622W, 070623W, 070624W, 070625W, 070626W, 070627W, 70628W, 070629W, 070630W, 070631W, 070632W, 070633W, 070634W, 070635W, 070636W, 070637W, 070638W, 070639W, 070640W, 070641W, 070642W, 070643W, 070644V, 070645W, 070646V, 070647V, 070648V, 070649W, 070650V, 31122V, 41146W, 51007W, 60930W, 60939W, 70111W, 70112W, 70113V, 70114W, 70115W, 70116V, 70117W, 70118W, 70119W, 70120W, 70121W, 70122W, 70123W, 70124V, 70125W, 70126V, 70127W, 70128V, 70129W, 70130W, 70131W, 70132W, 70133W, 70134W, 70135W, 70136W, 70137W, 70138W, 70139W, 70140W, 70141V, 70142W, 70143W, 70144W, 70145W, 70146W, 70147W, 70148W, 70149W, 70150W, 70201W,70202W, 70203W, 70204W, 70205W, 70206W, 70207W, 70208W, 70209W, 70210W, 70211W, 70212W, 70213W, 70214W, 70215W, 70216W, 70217W, 70218W, 70219W, 70220W, 70221V, 70222V, 70223W, 70224V, 70225W, 70226V, 70227W, 70228W, 70229V, 70230V, 70231W, 70232V, 70233W, 70234V, 70235V, 70236V, 70237W, 70238W, 70239W, 70240W, 70301W, 70302W, 70303W, 70304W, 70305W, 70306W, 70307W, 70308W, 70309W, 70310W, 70311W, 70312V, 70313W, 70314W, 70315V, 70316W, 70317W, 70318W, 70319V, 70320W, 70401W, 70402W, 70403W, 70404W, 70406W, 70407W, 70408W, 70409W, 70410W, 70414W, 70417W, 70418W, 70419W, 70425W, 70427W, 70428W, 70429W, 70430W, 70504W, 70505W, 70506V, 70507W, 70508W, 70509W, 70511W, 70515W, 70516W, 70517W, 70519W, and 70521V
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arrow International, Inc., Reading, PA, by letter dated November, 2007.
Manufacturer: Arrow International, Inc., Everett, MA. Firm initiated recall is complete.
REASON
Leak may occur in the helium drive system for the IABP.
VOLUME OF PRODUCT IN COMMERCE
272 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Abbott, Accelerator Device Manager (ADM); List Number: 08H74-01, Recall # Z-0551-2008
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories, Inc., Irving, TX, by letters on October 25, 2007.
Manufacturer: P.G.P. s.a., Brussels, Belgium. Firm initiated recall is ongoing.
REASON
Sample/Patient Mis-identification: Two issues identified related to the ACCELERATOR Decision Manager (ADM), to include: 1) Sample Identification (SID) and/or Patient Identification (PID) numbers that contain more than 12 characters are truncated to the final 12 characters by the ADM; 2) for SIDs using alpha characters that are case sensitive, SIDs with lower case characters are transmitted by the ADM as upper case characters. Both issues have the potential for sample results to be associated with the incorrect patient.
VOLUME OF PRODUCT IN COMMERCE
19 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
AADCO Rayshield Frame Mounted Overhead X-Ray Barrier; Models: E3051AR S-568, 60 x 80 cm Frame Mounted Barrier with Cut-out, E3051AS S-568HL, 60 x 80 cm Frame Mounted Barrier with Cut-out and lamp, E3051AT S-634, 30 x 40 cm Frame Mounted Barrier, E3051AW S-645S, 40 x 50 cm Frame Mounted Barrier, E3051AY S-634HL, 30 x 40 cm Frame Mounted Barrier with lamp, and E3051AZ S-645SHL, 40 x 50 cm Frame Mounted Barrier with lamp, Recall # Z-0552-2008
CODE
Serial Numbers: 03028006 03028007 03028008 03029004 03029005 03029011 03037001 03050001 03050002 03050006 03055001 03055002 03057030 03063006 03071001 03073001 03078007 03083043 03086001 03087023 03097003 03098001 03099001 03101001 03104001 03113001 03114001 03114002 03118001 03126002 03132001 03134001 03135002 03140001 03147002 03149002 03154001 03154001 03156004 03160003 03160004 03167003 03168002 03178001 03188001 03188003 03197001 03197002 03240002 03240003 03241001 03276004 03281001 03287001 03287002 03287003 03288003 03301007 03316001 03316002 03316003 03343006 03343010 03346001 03346002 03349001 03349002 03357003 03357004 03357005 03357006 03363001 04006001 04014004 04020001 04020003 04026001 04029001 04033001 04033003 04034001 04034003 04035001 04042001 04044001 04050001 04050002 04050003 04062001 04064001 04065001 04068001 04068002 04069003 04069006 04075001 04076001 04084125 04104001 04118001 04128001 04131001 04131002 04132001 04138001 04138002 04139001 04142001 04154002 04163001 04163002 04173005 04174001 04189001 04196001 04208001 04212002 04222001 04223001 04226003 04229001 04229004 04229006 04240001 04243001 04252001 04257001 04267001 04267002 04268001 04278001 04279001 04288001 04294005 04294007 04303001 04308001 04308003 04313001 04317001 04317002 04327001 04327002 04328004 04338001 04342001 04342002 04343002 04344001 04344004 04344011 04344012 04349001 04350006 04352001 04356002 04362005 04365001 04365002 05004001 05039001 05040003 05041004 05041005 05046001 05054002 05063009 05070001 05073002 05075001 05075003 05082004 05083002 05088003 05096001 05096002 06024006 06026001 06032001 06038001 06039001 06039002 06046003 06046004 06055004 06058001 06079001 06082001 06097001 06100001 06100002 06100003 06100005 06100006 06102003 06103001 06103002 06110001 06115001 06128001 06130001 06136001 06136002 06136003 06143003 06151001 06151002 06151004 06156001 06165002 06187003 06206001 06213001 06213002 06213003 06216004 06228001 06228003 06229003 06235001 06235002 06237002 06241001 06248001 06256002 06256005 06264001 06268001 06268003 06268004 06270002 06271001 06277002 06317001 06318001 06318004 06325001 06326002 06334001 06335004 06340002 07010004 07010005 07015001 07015002 07044001 07047003 07058001 07059001 07061001 07072001 07073001 07080001 07081011 07085002 07099001 07099002 07142001 07169001 07178002 07226001and 0727400 (not inclusive data goes back to 2003)
RECALLING FIRM/MANUFACTURER
Aadco Medical, Inc., Randolph, VT, by letter dated November 1, 2007. Firm initiated recall is ongoing.
REASON
Screws may become loose from the mounted shield compromising stability
VOLUME OF PRODUCT IN COMMERCE
324 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Baxter Single Day INFUSOR Portable Elastomeric Infusion System, Product Code: 2C1071KJP; 2mL/hr with Tubing Flow Restrictor; 12 units per case; Recall # Z-0588-2008
CODE
Lot Numbers: 07E037, 07E038, 07E039, 07E055, 07E056, 07E057, 07F015, 07F029, 07F030, 07F039, 07G003, 07G004, 07G043, 07H004, 07H005, 07H006, 07H035, 07H036, 07H037, 07H057, 07H059, 07H061, 07H074, 07J016, 07J018, 07J052, 07J054, and 07K020
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letter on November 30, 2007.
Manufacturer: Baxter Healthcare Corporation, Medication Delivery Division, Irvine, CA. Firm initiated recall is ongoing.
REASON
Leaking: leaks at the tubing flow restrictor connection to either the coupler or the male luer during filling.
VOLUME OF PRODUCT IN COMMERCE
86,192 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) BD Vacutainer Push Button Blood collection sets with Pre-Attached Holder;
Catalog Number: 367352: 21G x 3/4" x 12"; 0.8 x 19mm x 305mm, Wingset
PBBCS, Recall # Z-0589-2008;
b) BD Vacutainer Push Button Blood collection Sets with Pre-Attached Holder;
Catalog Number: 368656; 23 g X12 " PBBCS w/PAH (Pre-attached),
Recall # Z-0590-2008
CODE
a) Lot #’s: 7117874, 7157882, 7159943, 7180478, 7215299, 7215300, 7324340,
and 7234341;
b) Lot #'s: 6090251R, 6094839, 6111757R, 6121669, 6121676, 6138669, 6146186R,
6152710, 6151443, 6160625, 6164839, 6171015, 6174156, 6178381, 7018205,
7025868, 7026017, 7033728, 7093399, 7093400, 7093403, 7106969, 7106970,
7106971, 7106972, 7113647, 7113648, 7124156, 7124157, 7131786, 7141678,
7141679, 7141680, 7150272, 7162775, 7167155, 7169403, 7172215, 7177261,
and 7208536
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ, by letters on December 10, 2007.
Manufacturer: BD Preanalytical Solutions, Sumter, SC. Firm initiated recall is ongoing.
REASON
Safety Mechanism Failure: the safety mechanism of the BD Vacutainer Push Button Collection Set with Pre-attached holder cannot be activated; thus the needle cannot retract into the rear barrel.
VOLUME OF PRODUCT IN COMMERCE
976,100 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Hoana LifeBed Patient Vigilance System, (Intelligent Medical Vigilance System),Model Number: 010135-01, Recall # Z-0592-2008
CODE
All Serial Numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hoana Medical, Honolulu, Hawaii, by letter and visit on November 7, 2007.
Manufacturer: Sanmina-SCI Corporation, San Jose, CA. Firm initiated recall is complete.
REASON
Bed Exit Failure: Failure to recognize “Bed Exit” when the feature is active due to a software anomaly.
VOLUME OF PRODUCT IN COMMERCE
216 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Tucker Embryo Catheter, Stylet, for use with Embryo Transfer Catheter, 23 cm,
Sterile, Single Use Only, Order #: ftr 223, Recall # Z-0662-2008;
b) Tucker Embryo Catheter, Stylet, for use with Embryo Transfer Catheter, 20 cm,
Sterile, Single Use Only, Order #: ftr 220, Recall # Z-0663-2008;
c) Tucker Embryo Catheter with URM Tip, Embryo Transfer Catheter, 20 cm,
Order #: ftr120, Recall # Z-0664-2008;
d) Tucker Embryo Catheter with URM Tip, Embryo Transfer Catheter, 23 cm,
Order #: ftr123, Recall # Z-0665-2008;
e) Tucker Embryo Catheter for Trial Transfer, 20 cm, Order #: ftr320,
Recall # Z-0666-2008;
f) Morton IUI Catheter, Sterile, Single Use Only, Order #: ftr510,
Recall # Z-0667-2008
CODE
All units shipped before August 17, 2007
RECALLING FIRM/MANUFACTURER
Fertility Technology Resources, Inc., Marietta, GA, by telephone starting September 13, 2007 and by letter on October 9, 2007. Firm initiated recall is ongoing.
REASON
Expiration Date for Sterility; The 5 year dating could not be validated/supported for sterility assurance.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Organogenesis Apligraf, interactive wound and burn dressing, Recall # Z-0675-2008
CODE
Lot Numbers: GS0711.20.01.2A and GS0711.22.01.2A
RECALLING FIRM/MANUFACTURER
Organogenesis, Inc., Canton, MA, by telephone on December 26, 2007, letter on December 27, 2007 and by fax on December 31, 2007. Firm initiated recall is ongoing.
REASON
Contamination: Apligraf units were reported to have contamination in the agarose nutrient medium of some units retained at Organogenesis. Preliminary tests show a gram negative rod (bacillus) organism.
VOLUME OF PRODUCT IN COMMERCE
177 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) StelKast Proven Knee System - Tibial Half Block Augmentation and Screw.
Part Number SC2287-1-5, Size 1, Thickness 5 mm, Recall # Z-0479-2008;
b) StelKast Proven Knee - Tibial Half Block Augmentation and Screw. Part Number
SC2287-2-5, Size 2 Thickness 5 mm, Recall # Z-0480-2008;
c) StelKast Proven Knee - Tibial Half Block Augmentation and Screw. Part Number
SC2287-3-5, Size 3, Thickness 5 mm, Recall # Z-0481-2008;
d) StelKast Proven Knee - Tibial Half Block Augmentation and Screw.
Part Number SC2287-4-5, Size 4, Thickness 5 mm, Recall # Z-0482-2008;
e) StelKast Proven Knee - Tibial Half Block Augmentation and Screw.
Part Number: SC2287-5-5, Size 5, Thickness 5 mm, Recall # Z-0483-2008;
CODE
a) Lot Numbers: 14888-122005, 16052-032706, and 18549-091807;
b) Lot Numbers: 14890-111605, 17084-110706, and 17942-091807;
c) Lot Numbers: 14892-122005, 16156-032706, and 17943-091807;
d) Lot Numbers: 14894-122005, 16040-010906, 16054-031406, 17945-043007, and
17945-050107;
e) Lot Numbers: 14896-122005, 16042-010906, 16048-031406, 16056-031406, and
16157-031406
RECALLING FIRM/MANUFACTURER
StelKast Co., McMurray, PA, by telephone on October 5, 2007 and by letter on October 9, 2007. Firm initiated recall is complete.
REASON
The screws may fracture.
VOLUME OF PRODUCT IN COMMERCE
207 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Symphony Staining System (High Volume Stainer), KPA, Model Number 2200000, Recall # Z-0553-2008
CODE
Lot #: 910044, 910020, 910041, 910060, 910038, 910008, 910048, 910029, 910057, 910006, 910027, 910049, 910036, 910011, 910014, 910056, 910022, 910019, 910016, 910046, 910042, 910007, 910053, 910031, 910021, 910037, 910077, 910032, 910023, 910028, 910034, 910054, 910025, 910045, 910001, 910002, 910015, 910017, 910018, 910026, 910030, 910043, 910004, 910024, 910003, 910047, PP-018, 910040, 910033, 910058, 910059, 910009, 910010, 910013, PP-017
RECALLING FIRM/MANUFACTURER
Ventana Medical Systems Inc., Tucson, AZ, by telephone starting in November 2007. Firm initiated recall is ongoing.
REASON
Fluid Leaks-The T fitting located in the Symphony Clear system of the Symphony High Volume Slide Stainer needs to be larger to securely hold the tubing in place to eliminate any possible fluid leak due to the tubing movement.
VOLUME OF PRODUCT IN COMMERCE
55 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
3M ESPE Unitek Stainless Steel Permanent Molar Crowns, Product Code: 900321, Made in U.S.A, Recall # Z-0569-2008
CODE
Code Information: Lot #: P060928
RECALLING FIRM/MANUFACTURER
Recalling Firm: 3M Company / Medical Division, South St Paul, MN, by telephone and letter on October 22, 2007.
Manufacturer: 3M Espe Dental Products, Irvine, CA. Firm initiated recall is ongoing.
REASON
Mislabeled: Unitek Stainless Steel Permanent Molar Crowns were placed in packaging which incorrectly identified the product as Unitek Stainless Steel Primary Molar Crowns.
VOLUME OF PRODUCT IN COMMERCE
975 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
AngioSculpt PTCA Scoring Balloon Catheter, Catalog (REF) Number: 2027-2510, size 2.5 mm x 10 mm, Recall # Z-0591-2008
CODE
Lot number: F07090015
RECALLING FIRM/MANUFACTURER
AngioScore Inc., Fremont, CA, by letters on November 9, 2007. Firm initiated recall is ongoing.
REASON
Mis-labeling: Product labeling on product pouch indicates wrong size, the correct size is on the product carton.
VOLUME OF PRODUCT IN COMMERCE
114 units
DISTRIBUTION
Nationwide
END OF ENFORCEMENT REPORT FOR JANUARY 30, 2008
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