November 5, 2003
03-45
_______________________________
PRODUCT
Tegretol tablets (Carbamazepine USP), 200 mg, 1000 tablet bottles. Rx only. Recall # D-008-4.
CODE
Lot 218D8264.
RECALLING FIRM/MANUFACTURER
Novartis Pharmaceuticals, Corp., by letter via fax on September 2, 2003. Firm initiated recall is ongoing.
REASON
Dissolution failure; stability (at 30-months).
VOLUME OF PRODUCT IN COMMERCE
3,622 bottles.
DISTRIBUTION
Nationwide
_________________________________
PRODUCT
a) Zyprexa tablets (olanzapine), 5 mg, 60 tablet bottles,
Rx only. Recall # D-014-4;
b) Zyprexa tablets (olanzapine), 10 mg, 60 tablet bottles,
Rx only. Recall D-015-4.
CODE
a) 6AA66A;
b) 6AH19A.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Rochester Drug Cooperative Inc., Rochester, NY, by letters dated September 22, 2003 and September 25, 2003. Firm initiated recall is ongoing.
Manufacturer: Unknown.
REASON
Counterfeit: An unknown number of bottles bearing these lot numbers are counterfeit, in that they have been repackaged, relabeled and/or may contain different strengths or mixed strength tablets differing from their labeled contents and/or bear extended expiration dates, as the source of the repacked and/or relabeled bottles is unknown.
VOLUME OF PRODUCT IN COMMERCE
500 (est) bottles.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Zyprexa tablets (olanzapine), 20 mg, 60 tablet bottles, Rx only. Recall # D-016-4.
CODE
Lot No. 7AA79A, Exp. 3/1/05.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Rochester Drug Cooperative Inc, Rochester, NY, by letter dated September 22, 2003. Firm initiated recall is ongoing.
Manufacturer: Unknown.
REASON
Counterfeit : An unknown number of bottles bearing these lot numbers are counterfeit, in that they have been repackaged, relabeled and/or may contain different strengths or mixed strength tablets differing from their labeled contents and/or bear extended expiration dates, as the source of the repacked and/or relabeled bottles is unknown.
VOLUME OF PRODUCT IN COMMERCE
12 bottles.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Lipitor tablets (Atorvastatin Calcium),10 mg, Rx only, 5000 TABLETS. Important - This package for pharmacy stock use. Recall # D-017-4.
CODE
Lot 16092V (exp. date 7/2004), QK Item # 64953.
RECALLING FIRM/MANUFACTURER
Recalling Firm: QK Healthcare, Inc., Ronkonkoma, NY, by telephone and faxed letter on September 29, 2003. Firm initiated recall is ongoing.
Manufacturer: Unknown.
REASON
Counterfeit: An unknown number of units bearing these lot numbers are counterfeit, in that they have been repackaged, relabeled and/or may contain different strengths or mixed strength tablets differing from their labeled contents and/or bear extended expiration dates, as the source of the repacked and/or relabeled bottles is unknown.
VOLUME OF PRODUCT IN COMMERCE
20 bottles of 5000 Tablets.
DISTRIBUTION
TX.
_______________________________
PRODUCT
Kaletra Capsules (Ritonavir/Lopinavir 33.3mg/133.3mg), 180 capsule bottles, Rx only. Recall # D-018-4.
CODE
Lot 852002E21, EXP 1 FEB 2004.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mid Atlantic Csc, Perryman, MD, by e-mail on September 25, 2003. Firm initiated recall is ongoing.
Manufacturer: Unknown
REASON
Counterfeit : An unknown number of bottles bearing these lot numbers are counterfeit, in that they have been repackaged, relabeled and/or may contain different strengths or mixed strength tablets differing from their labeled contents and/or bear extended expiration dates, as the source of the repacked and/or relabeled bottles is unknown.
VOLUME OF PRODUCT IN COMMERCE
71 bottles.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Kaletra capsules (lopinavir/ritonavir), 133.3/33.3mg, 180 capsule bottles, Rx Only. Recall # D-029-4.
CODE
Lot No. 852072E25 (Exp. 1JUN2004) and Lot No. 852002E21 (Exp. 12/03 or 02/04).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Midwest Drug Supply LLC by letter via fax on August 25, 2003. Firm initiated recall is ongoing.
Manufacturer: Unknown
REASON
Counterfeit: An unknown number of bottles bearing these lot numbers are counterfeit, in that they have been repackaged, relabeled and/or may contain different strengths or mixed strength tablets differing from their labeled contents and/or bear extended expiration dates, as the source of the repacked and/or relabeled bottles is unknown.
VOLUME OF PRODUCT IN COMMERCE
387 bottles.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Sufenta Injection, (Sufentanil Citrate), 50 mcg/mL (Sufentanil base),1 mL and 5 mL ampules, 10 ampules per carton; Rx Only. Recall # D-030-4.
CODE
Lot Number-1 mL ampule, 11522, Exp. 1/4 and 5 mL ampule, 11192, Exp. 01/04.
RECALLING FIRM/MANUFACTURER
Akorn, Inc., Decatur, IL by letter dated September 12, 2003. Firm initiated recall is ongoing.
REASON
Unapproved New Drug; These lots were manufactured with an active ingredient produced according to a drug master file method not cited in the approved New Drug Application.
VOLUME OF PRODUCT IN COMMERCE
24,460 ampules.
DISTRIBUTION
Nationwide and Puerto Rico.
_______________________________
PRODUCT
Senokot-S tablets (Sennosides 8.6 mg and Docusate Sodium 50 mg) tablets, 30 count bottles. Recall # D-007-4.
CODE
Lot No. PB11.
RECALLING FIRM/MANUFACTURER
The Purdue Frederick Company, Stamford, CT, by letter on August 27, 2003. Firm initiated recall is ongoing.
REASON
Subpotent (Sennosides).
VOLUME OF PRODUCT IN COMMERCE
45,420/30 count bottles.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
MORPHINE-SULFATE EXTENDED-RELEASE TABLETS, 15 mg, 100 TABLETS, Rx only, ENDO GENERIC PRODUCTS. Recall # D-031-4.
CODE
Lot TP168A, Exp. date 2/2006.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Endo Pharmaceutical, Inc., Garden City, NY, by letter on October 7, 2003.
Manufacturer: Bristol-Myers Squibb Company Princeton, New Jersey. Firm initiated recall is ongoing.
REASON
Mis-labeling: some tablets are not imprinted with an identification number, bearing the number "15" on each side. (Each tablet should be imprinted with the number "15" on one side and with the identification code "E652" on the other side).
VOLUME OF PRODUCT IN COMMERCE
22,608 bottles of 100s.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0023-4;
b) Platelets, Leukocytes Reduced. Recall # B-0024-4;
c) Fresh Frozen Plasma. Recall # B-0025-4.
CODE
a), b), and c) Unit 13FN86981.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southeastern Michigan Region, Detroit, MI, by letter dated March 5, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor taking the medication Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
MI.
_______________________________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced. Recall # B-0027-4.
CODE
Units 13P90716 (2 units), 13P90864, 13P90678, 13P90735, 13P90920 (2 units), 13P90021 (2 units), 13P90243 (2 units), 13P90318 (2 units), 13P90324 (2 units), 13P90358 (2 units), 13P90773 (2 units).
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southeastern Michigan Region, Detroit, MI, by letter dated February 22, 2003. Firm initiated recall is complete.
REASON
Blood products, collected during a period of apheresis machine validation, but were not properly quality control tested, were distributed.
VOLUME OF PRODUCT IN COMMERCE
19 units.
DISTRIBUTION
MI.
_______________________________
PRODUCT
Red Blood Cells, Leukoreduced. Recall # B-0042-4.
CODE
Unit 0138113.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on June 24, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose medical history screening was not complete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
_______________________________
PRODUCT
Red Blood Cells. Recall # B-0082-4.
CODE
Units D133050, E152877, E153128, F139550.
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center & Program, Seattle, WA, by telephone on May 20, 2002. Firm initiated recall is complete.
REASON
Blood products, with incomplete compatibility testing performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
WA.
_____________________________
PRODUCT
a) Red Blood Cells. Recall # B-0084-4;
b) Red Blood Cells, Leukocytes Reduced. Recall # B-0085-4;
c) Fresh Frozen Plasma. Recall # B-0086-4;
d) Recovered Plasma. Recall # B-0087-4.
CODE
a) and d) Unit number 53H68507;
b) and c) Unit number 53FM55608.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by telephone on December 17, 2002, by letter on December 30, 2002, and by facsimile on December 31, 2002. Firm initiated recall is complete.
REASON
Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a subsequent disclosure of previous positive hepatitis testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
MD, and CA.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0088-4;
b) Fresh Frozen Plasma. Recall # B-0089-4;
c) Recovered Plasma. Recall # B-0090-4.
CODE
a) Unit numbers 53M88168, 53M85906, and 53FM34305;
b) Unit number 53FM34305;
c) Unit number 53M88168.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by letter on June 10, 2003, and by facsimile on June 12, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a subsequent disclosure of previous positive hepatitis testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
MD, VA, D.C., and CA.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0091-4;
b) Fresh Frozen Plasma. Recall # B-0092-4;
c) Recovered Plasma. Recall # B-0093-4.
CODE
a) Units 32GE50021, 32KC26802, 32GE45669 and 32GE43957;
b) Units 32KC26802, and 32GE45669;
c) Units 32GE50021, and 32GE43957.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Badger-Hawkeye Region, Madison, WI, by facsimile on July 26, 2002, and by letters on August 5 and 6, 2002. Firm initiated recall is complete.
REASON
Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a subsequent disclosure of previous positive hepatitis testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units.
DISTRIBUTION
IL, WI, CA, and Switzerland.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0094-4;
b) Platelets. Recall # B-0095-4;
c) Fresh Frozen Plasma. Recall # B-0096-4;
d) Recovered Plasma. Recall # B-0097-4.
CODE
a) Unit numbers 8091084, 6411519, 6621471;
b) and c) Unit number 6621471;
d) Unit numbers 8091084 and 6411519.
RECALLING FIRM/MANUFACTURER
LifeSource Blood Services, Glenview, IL, by telephone on August 13, 2003, and by letter on August 15, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a subsequent disclosure of previous positive hepatitis testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units.
DISTRIBUTION
IL, and Switzerland.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0098-4;
b) Fresh Frozen Plasma. Recall # B-0099-4.
CODE
a) and b) Unit number 9829088.
RECALLING FIRM/MANUFACTURER
LifeSource Blood Services, Glenview, IL, by telephone on August 12, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for the antibody to hepatitis C virus (anti-HCV), but were collected from an ineligible donor based on the subsequent disclosure of a previous positive test for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0100-4;
b) Recovered Plasma. Recall # B-0101-4.
CODE
a) and b) Unit number 53L41074.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by letter on May 13, 2003, and by facsimile on May 15, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for the antibody to hepatitis C virus (anti-HCV), but were collected from an ineligible donor based on the subsequent disclosure of a previous positive test for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
D.C. and CA.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0103-4.
CODE
Unit number 8469416.
RECALLING FIRM/MANUFACTURER
South Florida Blood Banks, Inc., West Palm Beach, FL, by letter on July 18, 2002. Firm initiated recall is complete.
REASON
Blood product, that tested negative for hepatitis, but were collected from an ineligible donor due to a reported history of hepatitis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0104-4;
b) Recovered Plasma. Recall # B-0105-4.
CODE
a) and b) Unit number 17KX90143.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, North Central Region
St. Paul, MN, by facsimile on July 16, 2002, and by letter on July 22, 2002. Firm initiated recall is complete.
REASON
Blood products, that tested negative for hepatitis, but
were collected from an ineligible donor due to a reported
history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MN and CA.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0107-4.
CODE
Unit number 21KC50605.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pacific Northwest Region, Portland, OR, by letter on August 26, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OR.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0108-4.
CODE
Unit number 21KH73656.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pacific Northwest Region, Portland, OR, by letter on October 22, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KA.
_______________________________
PRODUCT
Red Blood Cells. Recall # B-0109-4.
CODE
Unit number 0804119.
RECALLING FIRM/MANUFACTURER
LifeShare, Inc, Elyria, OH, by letter on July 31, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH.
_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0110-4.
CODE
Unit number P0967901.
RECALLING FIRM/MANUFACTURER
South Bend Medical Foundation, Inc., South Bend, IN, by letter on June 27, 2003. Firm initiated recall is complete.
REASON
Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IN.
_______________________________
PRODUCT
Recovered Plasma. Recall # B-0111-4.
CODE
Unit number 3428912.
RECALLING FIRM/MANUFACTURER
LifeSource Blood Services, Glenview, IL, by facsimile on July 15, 2003. Firm initiated recall is complete.
REASON
Blood product, that tested negative for viral markers, but was collected from a donor that had been previously deferred, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Scotland.
_______________________________
PRODUCT
Source Plasma. Recall # B-0112-4.
CODE
Unit numbers G-68373-160, G-67245-160, G-66795-160, G-55196-160, G-54832-160, G-71773-160, G-71718-160, and G-57142-160.
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, Gainesville, FL, by facsimile on March 5, 2002. Firm initiated recall is complete.
REASON
Blood product tested negative for viral markers but was collected from an ineligible donor due to risk factors for increased incidence of infection with human immunodeficiency virus (HIV).
VOLUME OF PRODUCT IN COMMERCE
8 units.
DISTRIBUTION
CA, and Switzerland.
_______________________________
PRODUCT
Cryoprecipitated AHF. Recall # B-0113-4.
CODE
Unit number 8424272.
RECALLING FIRM/MANUFACTURER
South Florida Blood Banks, Inc., West Palm Beach, FL, by facsimile on March 13, 2003. Firm initiated recall is complete.
REASON
Blood product, that tested negative for viral markers, but was collected from an unsuitable donor due to body piercing, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
SC.
_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-0114-4.
CODE
Unit number M0842285.
RECALLING FIRM/MANUFACTURER
Community Blood Council of New Jersey, by facsimile on May 29, 2003. Firm initiated recall is complete.
REASON
Blood product, that tested negative for viral markers, but was collected from an unsuitable donor due to body piercing, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NJ.
_______________________________
PRODUCT
a) Platelets, Leukocytes Reduced. Recall # B-0115-4;
b) Fresh Frozen Plasma. Recall # B-0116-4.
CODE
a) Units 13GV02586, 13LG77668, 13GM72244;
b) Units 13LG77668, 13GM72244.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southeastern Michigan Region, Detroit, MI, by letter dated April 8, 2003. Firm initiated recall is complete.
REASON
Blood products, corresponding to a unit of clotted Red Blood Cells, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
MI.
_______________________________
PRODUCT
Source Plasma. Recall # B-0118-4.
CODE
Units 0590271028, 0590270883, 0590270628, 0590270528, 0590270375, 0590270770, 0590270218, 0590270096, 0590269876, 0590269656, 0590268510, 0590268348, 0590268230, 0590268096, 0590267966, 0590267799, 0590267709, 0590267382.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma Services, Inc., Allentown, PA, by facsimile dated December 10, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
18 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0119-4;
b) Platelets. Recall # B-0120-4.
CODE
a) and b) Unit FC000919.
RECALLING FIRM/MANUFACTURER
Community Blood Council of New Jersey, Trenton, NJ, by facsimile dated January 24, 2002. Firm initiated recall is complete.
REASON
Blood products, which tested negative for the antibody to the human T-lymphotropic virus type I/II (anti-HTLV-I/II), but were collected from a donor who previously tested repeatedly reactive for anti-HTLV-I/II with an indeterminate confirmation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NJ.
_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0121-4.
CODE
Unit 17KW44408.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, St. Paul, MN, by facsimile on July 2, 2002, or by letter dated July 15, 2002. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was taking the medication amantadine for the treatment of Parkinson's disease, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA, and MA.
_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-0131-4.
CODE
Units 53H93038, 53L45988.
RECALLING FIRM/MANUFACTURER
American Red Cross, Chesapeake Region, Baltimore, MD, by telephone on March 13, 2002, and by letters dated March 20, 2002 and August 5, 2002. Firm initiated recall is complete.
REASON
Blood products, in which the corresponding blood components were contaminated with Pseudomonas and implicated in a transfusion reaction, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MD and D.C.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0132-4.
CODE
Unit 32KR05894.
RECALLING FIRM/MANUFACTURER
American Red Cross, Madison, WI, by letter dated July 9, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.
_______________________________
PRODUCT
Osteochondral grafts Tissues. Recall # B-0143-4.
CODE
Tissue numbers 1740573, 1740575, 1740574.
RECALLING FIRM/MANUFACTURER
Regeneration Technologies, Inc., Alachua, FL, by letter dated May 9, 2003 and June 13, 2003. Firm initiated recall is complete.
REASON
Human tissues, collected from a donor who had engaged in high risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 tissues.
DISTRIBUTION
GA, NJ, and IL.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0160-4;
b) Platelets, Leukocytes Reduced. Recall # B-0161-4;
c) Recovered Plasma. Recall # B-0162-4.
CODE
a), b), and c) Unit 17GZ23966.
RECALLING FIRM/MANUFACTURER
American National Red Cross, North Central Region, St. Paul, MN, by letter dated August 13, 2002 and by Questionable Plasma Inquiry on August 12, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking the medication Lupron, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
MN.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0163-4.
CODE
Unit 2861319.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on July 29, 2002 and by letter dated August 1, 2002. Firm initiated recall is complete.
REASON
Red Cells, collected from a donor who had no hemoglobin check performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
_______________________________
PRODUCT
Source Plasma. Recall # B-0164-4.
CODE
Units 77N246, 77N333, 77N433, 770016, 770102, 770316, 878382, 88A867, 88A987, 88B054, 8GS774, 8GS901.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aventis Bio-Services, Inc., Knoxville, TX, by facsimile dated March 19, 2001.
Manufacturer: Aventis Bio-Services, Inc., Minneapolis, MN. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from a donor that subsequently admitted to multiple risk factors for increased incidence of infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units.
DISTRIBUTION
IL, and Germany.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0165-4.
CODE
Units 17KL70449, 17FH82660.
RECALLING FIRM/MANUFACTURER
American National Red Cross, North Central Region, St. Paul, MN, by telephone on May 26, 1999, and by letter dated February 28, 2003. Firm initiated recall is complete.
REASON
Blood products, incorrectly tested for the Kell antigen, and labeled Kell negative, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MN.
_______________________________
PRODUCT
Source Plasma. Recall # B-0166-4.
CODE
Unit 70531589.
RECALLING FIRM/MANUFACTURER
NABI Biopharmaceuticals, Scranton, PA, by facsimile dated October 25, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0167-4;
b) Platelets. Recall # B-0168-4;
c) Fresh Frozen Plasma. Recall # B-0169-4.
CODE
a), b) and C) Unit 5454162.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated August 26, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
TX.
_______________________________
PRODUCT
Red Blood Cells. Recall # B-0170-4.
CODE
Unit KS15425.
RECALLING FIRM/MANUFACTURER
Inova Health System, Blood Donor Services, Annandale, VA, by facsimile dated June 26, 2003. Firm initiated recall is complete.
REASON
Blood Product, collected from a donor who had Crohn's Disease, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0192-4;
b) Red Blood Cells, Leukocytes Reduced. Recall # B-0193-4;
c) Platelets, Pheresis, Leukocytes Reduced. Recall # B-
0194-4;
d) Fresh Frozen Plasma. Recall # B-0195-4;
e) Cryoprecipitated AHF. Recall # B-0196-4.
CODE
a) Units 803979, 8157697;
b) Units 8387398, 8395390, 8320642, 8235946;
c) Units (8456267, 8456224, 8391228, 8418723, 8418631
(A & B), 8093979;
d) Unit 8157697;
e) Units 8387398, 8320642, 8235946, 8395390.
RECALLING FIRM/MANUFACTURER
South Florida Blood Banks, Inc., West Palm Beach, Florida, by letters dated June 12, 2002, and March 13, 2003. Firm initiated recall is ongoing.
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
18 units.
DISTRIBUTION
FL, NY, and Hawaii.
_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-0198-4.
CODE
Unit 6145549.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on February 12, 2002, and by letter dated February 20, 2003. Firm initiated recall is complete.
REASON
Blood product, in which the corresponding blood component may have been contaminated with Staphylococcus aureus, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-0199-4.
CODE
Units 6160934, 6160940.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on January 27, 2003. Firm initiated recall is complete.
REASON
Blood products, in which the corresponding blood component was contaminated with Escherichia coli, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.
_______________________________
PRODUCT
Human Tissue. Recall # B-0200-4.
CODE
Unit CryoVein, Saphenous Vein; Model # V010, Serial # 8049220.
RECALLING FIRM/MANUFACTURER
CryoLife, Inc., Kennesaw, GA, by letter dated September 5, 2003. Firm initiated recall is ongoing.
REASON
Human tissue for transplantation, associated with a tissue in which the pre-processing culture detected microorganisms, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0201-4.
CODE
Units 9490445, 8484941, 8484959, 8490542, 8490408, 8484965, 8481828, 8484823, 8490448, 8484963, 8490464.
RECALLING FIRM/MANUFACTURER
South Florida Blood Banks, Inc., West Palm Beach, FL, by letter dated September 17, 2002. Firm initiated recall is complete.
REASON
Red Cells, collected from donors whose hematocrits were not properly determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units.
DISTRIBUTION
FL and SC.
_______________________________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced. Recall # B-0202-4.
CODE
Unit 1534130
RECALLING FIRM/MANUFACTURER
Florida Georgia Blood Alliance, Jacksonville, FL, by e-mail dated May 6, 2002. Firm initiated recall is complete.
REASON
Platelets, contaminated with coagulase negative Staphylocoocus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.
_______________________________
PRODUCT
Red Blood Cells. Recall # B-0203-4.
CODE
Unit T80527.
RECALLING FIRM/MANUFACTURER
HCSC Blood Center, Bethlehem, PA, by letter dated June 30, 2003. Firm initiated recall is complete.
REASON
Red Cells, that did not meet volume requirements for quality control, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.
_______________________________
PRODUCT
Red Blood Cells. Recall # B-0204-4.
CODE
Units 0567468, 6011834.
RECALLING FIRM/MANUFACTURER
Blood Bank of Delaware, Inc., Newark, DE, by letter dated February 26, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking the medication, Arava, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MD, and DE.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0205-4;
b) Platelets. Recall # B-0206-4.
CODE
a), and b) Units 94-63397.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by facsimile and letter on December 6, 2000. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to the use of the medication Permax, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TN, and CA.
_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0208-4.
CODE
Unit number V10448.
RECALLING FIRM/MANUFACTURER
HCSC Blood Center, Miller Memorial Blood Center, Bethlehem, PA, by letter on November 15, 2002. Firm initiated recall is complete.
REASON
Blood product, that was labeled leukoreduced but had an elevated white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0209-4;
b) Fresh Frozen Plasma. Recall # B-0210-4
CODE
a) Unit numbers 9232781, 9240761, and 9282808;
b) Unit number 9232781.
RECALLING FIRM/MANUFACTURER
Blood Bank of Delaware, Inc., Newark, DE, by telephone on June 25, 2002, and by letter on August 15, 2002. Firm initiated recall is complete.
REASON
Blood products, that tested negative for the antibodies to human T lymphotropic virus, types I and II (anti-HTLV-I/II), but were collected from an ineligible donor due to previous positive testing for anti-HTLV-I/II, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
DE, MD, and VA.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0211-4;
b) Red Blood Cells, Leukocytes Reduced. Recall # B-0212-4; c) Platelets. Recall # B-0213-4;
d) Cryoprecipitated AHF. Recall # B-0214-4;
e) Recovered Plasma. Recall # B-0215-4.
CODE
a) and c) Unit number 2012119;
b) and d) Unit numbers 2071963 and 0501304;
e) Unit numbers 2012119, 2071963,and 0501304.
RECALLING FIRM/MANUFACTURER
Blood Bank of Delaware, Inc., Newark, DE, by facsimile on September 11, 2002, and by letter on October 3, 2002. Firm initiated recall is complete.
REASON
Blood products, that tested negative for the antibody to hepatitis C virus (anti-HCV), but were collected from an ineligible donor based on the subsequent disclosure of a previous positive test for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units.
DISTRIBUTION
DE, and NJ.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0219-4;
b) Platelets. Recall # B-0220-4;
c) Fresh Frozen Plasma. Recall # B-0221-4.
CODE
a) Units L87489, L88457, L89419, L90475, L92380, R22276;
b) Units L88457, L89419;
c) Units L87489, L88457, L89419, L90475, L92380.
RECALLING FIRM/MANUFACTURER
South Bend Medical Foundation, South Bend, IN, by letters beginning on June 23, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from donors who were not properly reentered, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units.
DISTRIBUTION
IN.
_______________________________
PRODUCT
a) Red Blood Cells. Recall B-0223-4;
b) Recovered Plasma. Recall # B-0224-4.
CODE
a) and b) Unit 5207689.
RECALLING FIRM/MANUFACTURER
Florida Georgia Blood Alliance, Jacksonville, FL, by facsimile dated March 26, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking the medication Antabuse, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
FL.
_______________________________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced. Recall # B-0227-4.
CODE
Units 8380950A, 8380950B, 8390618A, 8390618B, 8453361A, 8453361B, 8385535A, 8385535B, 8385535C, 8494527A, 8494527B, 8476679A, 8475579B.
RECALLING FIRM/MANUFACTURER
South Florida Blood Banks, Inc., West Palm Beach, FL, by letter dated November 19, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking the medication Plavix, were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units.
DISTRIBUTION
NY, FL, SC, AL, and D.C.
_______________________________
PRODUCT
Source Plasma. Recall # B-0238-4.
CODE
Units 57529370, 57530154, 58078797, 61414761, 61418288, 61420014, 59806752, 59807933, 59810056, 60190963, 60193308, 60196750, 60198112, 60199584, 61861305.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Muskogee, Oklahoma, by facsimile dated November 1, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of IV drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
15 units.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Source Plasma. Recall # B-0239-4.
CODE
Unit G-75013-026.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Tuscaloosa, AL, by facsimile dated March 24, 2000. Firm initiated recall is complete.
REASON
Blood product, that tested negative for antibody to hepatitis C virus (anti-HCV), but was not properly quarantined after the receipt of subsequent repeatedly reactive anti-HCV results, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Source Plasma. Recall # B-0240-4.
CODE
Unit N-88349-022.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., DBA Seramed Bio Center, Lake Charles, LA, by facsimile transmission dated February 16, 2000. Firm initiated recall is complete.
REASON
Source Plasma, with an elevated ALT level, was distributed for further manufacture.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Source Plasma. Recall # B-0241-4.
CODE
Unit 776082.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., DBA Seramed Bio Center, Baton Rouge, LA, by facsimile dated November 18, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor, was distributed for further manufacture.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0245-4;
b) Recovered Plasma. Recall # B-0246-4.
CODE
a) and b) 49LJ51499.
RECALLING FIRM/MANUFACTURER
Recalling Firm: American National Red Cross, Southwest Region, Tulsa, OK, by telephone, and by letter dated April 19, 2001.
Manufacturer: American Red Cross Blood Services, Southwest Region, College Station, TX. Firm initiated recall is complete.
REASON
Blood products, which were not quarantined after receiving information concerning post donation illness, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
OK and Switzerland.
_______________________________
PRODUCT
Platelets, Leukocytes Reduced. Recall # B-0026-4.
CODE
Unit 13GE11683.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southeastern Michigan Region, Detroit, MI, by telephone on February 9, 2003. Firm initiated recall is complete.
REASON
Blood product, prepared from a donation that had discrepant start and stop collection times documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0029-4;
b) Platelets, Leukocytes Reduced. Recall # B-0030-4.
CODE
a) and b) Unit 13FV01370.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southeastern Michigan Region, Detroit, MI, by letter on March 19, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to the use of the medication Megace, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MI.
_______________________________
PRODUCT
Source Plasma. Recall # B-0031-4.
CODE
GCHYZZ, GCHYWP, GCHXSV.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Indianapolis, IN, by facsimile dated March 23, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from ineligible donors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
IL.
______________________________
PRODUCT
Source Plasma. Recall # B-0052-4.
CODE
Unit 00EWIG3310.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P. (formerly Community Bio-Services) Eau Claire, WI, by facsimile on March 27, 2001 and September 11, 2003. Firm initiated recall is complete.
REASON
Blood Product, collected from a donor whose health history screening was not adequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.
______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated. Recall # B-0083-4.
CODE
Unit number F86519.
RECALLING FIRM/MANUFACTURER
Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL, by telephone on July 1, 2003, and by letter on July 3, 2003. Firm initiated recall is complete.
REASON
Blood product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.
______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0102-4.
CODE
Unit numbers 16KJ06024, 16KJ06033, 16LG49556, 16GM24171, 16GM24229, 16KJ06002, and 16LL67719.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by telephone on February 27, 2003. Firm initiated recall is complete.
REASON
Blood products possibly exposed to unacceptable shipping temperatures were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units.
DISTRIBUTION
MD.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0117-4.
CODE
Unit 30773-6721.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fargo, ND., by telephone on April 17, 2003, and by letter dated May 16, 2003. Firm initiated recall is complete.
REASON
Red Blood Cells, that failed RBC recovery ratio, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Recovered Plasma. Recall # B-0122-4.
CODE
Unit 17KW44408.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, St. Paul, MN, by facsimile on July 2, 2002, or by letter dated July 15, 2002. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was taking the medication amantadine for the treatment of Parkinson's disease, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA, and MA.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0171-4;
b) Red Blood Cells, Leukocytes Reduced. Recall # B-0172-4;
c) Platelets. Recall # B-0173-4;
d) Fresh Frozen Plasma. Recall # B-0174-4;
e) Source Leukocytes. Recall # B-0175-4;
f) Recovered Plasma. Recall # B-0176-4.
CODE
a) Units 8007711, 7888797, 7949974, 7980710, 7927676,
7840881;
b) Units 8185452, 8284550, 8249731, 8376390, 8052558,
8036477, 8115659, 8175917, 8351319;
c) Units 8284550, 8185452, 8351319, 8052558, 8036477,
8376390, 8249731;
d) Units 8287550, 8007711, 7980710, 8153249, 8115659,
7949974, 7888797, 8185452, 8052555;
e) Unit 7840881;
f) Unit 7867323.
RECALLING FIRM/MANUFACTURER
South Florida Blood Banks, Inc., West Palm Beach, FL, by letter dated March 12, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had von Willebrand's Disease, were distributed.
VOLUME OF PRODUCT IN COMMERCE
33 units.
DISTRIBUTION
FL, CA, OH, NY, MA, MD, and D.C.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0197-4.
CODE
Units F67307, F67298.
RECALLING FIRM/MANUFACTURER
Central Illinois Community Blood Center, Springfield, IL, by facsimile transmission dated July 2, 2003. Firm initiated recall is complete.
REASON
Blood products, that lacked assurance of proper temperature storage, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL.
_______________________________
PRODUCT
Recovered Plasma. Recall # B-0207-4.
CODE
Unit 94-63397.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by facsimile and letter on December 6, 2000. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to the use of the medication Permax, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN, and CA.
_______________________________
PRODUCT
Source Plasma. Recall # B-0216-4.
CODE
Unit numbers XG0016663 and XG0018791.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Port Arthur, TX, by facsimile on June 29, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from a donor that did not answer medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IN.
_______________________________
PRODUCT
Source Plasma. Recall # B-0217-4.
CODE
Unit number CNG007147.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston, TX, by facsimile on March 15, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose responses to the health history screening questions were not recorded properly, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.
_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-0218-4.
CODE
Unit number 3700491.
RECALLING FIRM/MANUFACTURER
Florida Georgia Blood Alliance, Inc., Jacksonville, FL, by telephone on July 11, 2003. Firm initiated recall is complete.
REASON
Unlicensed blood product was distributed interstate.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MA.
_______________________________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced. Recall # B-0222-4.
CODE
Units 084C29330, 084M16756 (parts 1 & 2), 084M12262.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Northern California Region, Oakland, CA, by letter dated October 14, 2002. Firm initiated recall is complete.
REASON
Blood products, manufactured in expired collection bags, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Source Plasma. Recall # B-0225-4.
CODE
Unit F08620143.
RECALLING FIRM/MANUFACTURER
Tri-Cities Plasma Corporation, Johnson City, TN, by letter dated December 10, 2002. Firm initiated recall is complete.
REASON
Blood product, which tested negative for viral markers, but was collected from a donor whose health history was inadequately determined.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Source Plasma. Recall # B-0226-4.
CODE
Unit F02063143.
RECALLING FIRM/MANUFACTURER
Tri-Cities Plasma Corporation, Johnson City, TN, by facsimile dated December 10, 2002. Firm initiated recall is complete.
REASON
Blood product, which tested negative for viral markers, but was collected from a donor whose health history was inadequately determined.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Source Plasma. Recall # B-0244-4.
CODE
CJBRBQ, CJBRBY, CJBQZF, CJCDZV, CJBQTQ, CJBQRV, CJDBQX, CJCDXY, CJFBQN, CJBQDL, CJBQDS, CJCDTV, CJDBBM, CJDBBN,
CJCDTG, CJCZXZ, CJCZTY, CJCDPZ, CJBPJJ, CJCZGF, CJBYHP, CJCZGB, CJBPJQ.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., East Lansing, MI, by facsimile dated June 26, 2002. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor who did not answer all of the donor history questions, was distributed.
VOLUME OF PRODUCT IN COMMERCE
23 units.
DISTRIBUTION
IL.
_______________________________
PRODUCT
Pulse Generator Pacemaker, Integrity, Identity, and Verity. Recall # Z-0052-04.
CODE
Integrity ADx DR Model 5360 & 5366 Identity Adx DR model 5286, 5380, 5386 & 5480 Verity ADx DR 5256, 5356 & 5456.
RECALLING FIRM/MANUFACTURER
St. Jude Medical, Sylmar, CA, by letter dated July 31, 2003. Firm initiated recall is ongoing.
REASON
Under certain circumstances, pacemaker has a potential to deliver a short coupled pacing interval of approx. 300 msec (200ppm). It is also possible that a patient may experience (up to max of 12) shorter than anticipated pacing intervals.
VOLUME OF PRODUCT IN COMMERCE
775 implanted plus 211 sold.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
e.cam Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; all e.cam models: 4380213, 4380221, 5242826, 5977066, 5977074, 5984005, 5989079, 5989087, 5989095, 5991109, 5991117, 5992099, 7332625, 7332633, 7760809, 7760932, 7761161, 7823920, 7823938, 7823946, 7823953, 7823979. Recall # Z-0053-04.
CODE
Serial numbers 1 through 9091.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Hoffman Estates, IL, by letters dated August 27, 2003. Firm initiated recall is ongoing.
REASON
The detector's radial brake may not be applied properly, allowing unintended motion which could result in injury to the patient or operator.
VOLUME OF PRODUCT IN COMMERCE
2,386 units.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
a) Western Medica OPC Portable Oxygen Conserving Regulator,
Model OPC-830, 1/2 - 5 LPM, packaged under the Western
Medica label. Recall # Z-0054-04;
b) Western Medica OPC Portable Oxygen Conserving Regulator,
Model LIN-7005, 1/2 - 5 LPM, packaged under the Lincare
label. Recall # Z-0055-04;
c) Western Medica OPC Portable Oxygen Conserving Regulator,
Model MDL-7609, 1/2 - 5 LPM, packaged under the Medline
label. Recall # Z-0056-04.
CODE
a) Unit S/Ns beginning with "HE0010xxxxx"and "HE001100001"
thru "DHE001102881";
b) Unit S/Ns beginning with "DHE0010xxxxx" and
"DHE001100001" thru "DHE001102881";
c) Unit S/Ns beginning with "DHE0010xxxxx" and
"DHE001100001" thru "DHE001102881".
RECALLING FIRM/MANUFACTURER
Western a Scott Fetzer Co., Westlake, OH, letter on October 2, 2003. Firm initiated recall is ongoing.
REASON
The demand valve is defective and does not function as intended in the "Conservative Mode".
VOLUME OF PRODUCT IN COMMERCE
2,972.
DISTRIBUTION
Nationwide, China and Japan.
_______________________________
PRODUCT
a) FLEXICAIR(r) II, Low Airloss Therapy unit. This unit is
similar to MC3 but does not have the utility shelf above
the foodboard, patient scale or alternate CPR function
actuators. Recall # Z-0058-04;
b) FLEXICAIR MC3(r) Low Airloss Therapy unit.
Recall # Z-0059-04.
CODE
a) Model #13000, IBxxxxxx (where xxxxxxx is a 6-digit
number sequence);
b) MC3, Serial numbers: IC xxxxxx (where xxxxxxx is a
6-digit number sequence).
RECALLING FIRM/MANUFACTURER
Hill-Rom Manufacturing, Inc., Charleston, SC, by letter on August 27, 2003. Firm initiated recall is ongoing.
REASON
Reports of patient entrapment between mattress and side-rails.
VOLUME OF PRODUCT IN COMMERCE
2,339 units.
DISTRIBUTION
Nationwide, Canada, Austria, Germany and the U.K.
_______________________________
PRODUCT
a) Stat Profile Ultra Magnesium Sensor (In-vitro Diagnostic
used with the Stat Profile Ultra M analyzer) Part #
20394. Recall # Z-0060-04;
b) Stat Profile Critical Care Expres Ionized Magnesium
Sensor (In-vitro Diagnostic used with the Stat Profile
Critical Care Xpress Analyzer) Part # 37271. Recall #
Z-0061-04.
CODE
a) Lot Number Exp. Date 304716 2/29/04 304074 2/29/04
303798 1/31/04 303515 1/31/04 303479 1/31/04 303222
1/31/04 302808 12/31/03 302652 12/31/03 302267 12/31/03
301844 11/30/03 301443 11/30/03 301219 11/30/03 212490
b) Lot Number Exp. Date 304828 7/31/04 304543 7/31/04
304296 7/31/04 303793 6/30/04 303519 6/30/04 303401
6/30/04 302670 5/31/04 302242 5/31/04 301126 4/30/04
212130 3/31/04 211349 2/29/04.
RECALLING FIRM/MANUFACTURER
Nova Biomedical Corporation, Waltham, MA, by telephone beginning on September 26, 2003. Firm initiated recall is ongoing.
REASON
Degradation of the magnesium sensor could result in low ionized magnesium patient samples.
VOLUME OF PRODUCT IN COMMERCE
939 sensors.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
IMx Tacrolimus II Calibrators, list 3C10-10; the pack contains six 4.5-mL bottles, with Calibrator A having 0 ng/mL, Calibrator B having 3 ng/mL, Calibrator C having 6 ng/mL, Calibrator D having 12 ng/mL, Calibrator E having 20 ng/mL and Calibrator F having 30 U/mL. Recall # Z-0063-04.
CODE
List 3C10-10, lots 94165M100 and 94164M100.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL, by letters dated September 19, 2003 and October 7, 2003. Firm initiated recall is ongoing.
REASON
Invalid test results are being generated due to calibration errors when using calibrator lots 94165M100 and 94164M100.
VOLUME OF PRODUCT IN COMMERCE
2,677 kits.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
ACIST Automated Manifold (Transducer) Kit, Model BT2000, SKU #014613 (used with ACIST Contrast Management Systems (CMS2000) and E2000 Voyager Units). Recall # Z-0064-04.
CODE
Lot Numbers 0933A and 1003I.
RECALLING FIRM/MANUFACTURER
Acist Medical Systems, Eden Prairie, MN, by letters dated October 2, 2003. Firm initiated recall is ongoing.
REASON
Some of the automated manifold's 2.5 inch high-pressure lines for radiopaque contrast media, used in angiographic procedures, have separated where they are bonded to the manifold body of the device allowing contrast media to leak.
VOLUME OF PRODUCT IN COMMERCE
7,120 kits.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
CryoValve, Pulmonary Heart Valve, Donor #68830, Model #PV10. Recall # Z-0065-04.
CODE
Serial #8038836.
RECALLING FIRM/MANUFACTURER
Cryolife Inc., Kennesaw, GA, by letter on September 25, 2003. Firm initiated recall is ongoing.
REASON
Additional information obtained from the Outside Tissue Procurement Organization indicated that the donor's attending physician stated that the patient had pneumonia and it possibly might have been a systemic infection.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Bayer Rapidpoint 405 Blood Gas Analyzer. Recall # Z-0066-04.
CODE
Software Versions below 3.1.
RECALLING FIRM/MANUFACTURER
Bayer Corp., Medfield, MA, by telephone and letter dated September 26, 2003. Firm initiated recall is ongoing.
REASON
Potential for bias shift in p02 values due to air bubble in sample path.
VOLUME OF PRODUCT IN COMMERCE
494 units.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
Synchron CX4, CX5 and CX9 Pro Systems. Recall # Z-0067-04.
CODE
None provided.
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, Ca, by letter on September 29, 2003. Firm initiated recall is ongoing.
REASON
Motor driver boards may contain wrong type of microchip which does not have obstruction detection feature.
VOLUME OF PRODUCT IN COMMERCE
351.
DISTRIBUTION
Nationwide and Canada.
_______________________________
PRODUCT
Howell D.A.S.H. Extraction Balloon, DASH-8.5-12-15, with Multiple Sizing, Catheter: 6 FR./200 CM. , Shelf Life: 1 Year, Sterile, Disposable, Single Use Only. Recall # Z-0068-04.
CODE
Lots 1602780, 160281, 1602782, 1602784, 1602785, 1602786, 1602788, 1602789, 1602790, 1602791, 1602792, 1602793, 1602794, 1602795, 1602796, 1602797, 1602798, 1602799, 1602800, 1602801, 1602802, 1607143, 1607144, 1610890, 1611901, 1613669, 1613670, 1614712, 1615429, 1615745, 1617031, 1617649, 1618498, 1620684, 1620928., 1621381, 1621496, 1621691, 1621692, 1622879, 16254321, 1626364, 1626669, 1627928, 1628134, 1629489, 1630384, 1630385, 1633042, 1633043, 1620783, 1623781, 1624348, 1625245, 1627107, 1629245, 1630813, 1634319, 1633787, 1634878, and 1635692.
RECALLING FIRM/MANUFACTURER
Wilson-Cook Medical Inc., Winston-Salem, NC, by Fax or E-mail in August/September, 2002. Firm initiated recall is ongoing.
REASON
The product was labeled with a 5 year expiration date instead of a 1 year expiration date.
VOLUME OF PRODUCT IN COMMERCE
2,062 units.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
Remel Thayer Martin Agar (Improved), packaged in 10-packs (Cat. #01884), 15-packs (Cat. #01885), and 100 per case (Cat. #01886). Recall # Z-0069-04.
CODE
10 pack - Lot #384341, Exp. 11/03/2003; 15 pack - Lot #384342, Exp. 11/3/2003; 100/cs - Lot #384343
RECALLING FIRM/MANUFACTURER
Remel, Lenexa, KS, by letter dated October 2, 2003. Firm initiated recall is ongoing.
REASON
Some of the product lots exhibit no growth of quality control strains of Neisseria gonorrhoeae.
VOLUME OF PRODUCT IN COMMERCE
404/10-pks; 67/15-pks; 18/100-pk. Cs.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
a) Wire Driver Coupler, Model 7100-045, a component of
MicroAire Drill/Reamer Model 7500. Driver couplers are
reuseable medical devices, non-sterile, packed one per
box and labeled in part. Recall # Z-0043-04;
b) Pin Driver Coupler, component of MicroAire Drill\Reamer
Model 7500. Driver couplers are reuseable medical
devices, non-sterile, packed one per box and labeled in
part. Recall # Z-0043-04.
CODE
a) Serial numbers: 1007, 1008, 1009, 1010, 1011, 1012,
1013, 1014, 1015, 1016, 1017, 1018, 1019, 1020, 1021,
1022, 1024, 1025, 1026, 1027, 1028, 1029, 1030, 1031,
1032, 1033, 1034, 1035, 1036, 1037, 1038, 1039, 1042,
1043, 1044, 1045, 1047, 1049, 1050, 1051, 1052, 1053,
1054, 1055, 1056, 1057, 1058, 1059, 1060, 1061, 1062,
1064, 1065, 1066, 1068, 1069, 1070, 1071, 1072, 1073,
1074, 1075, 1076, 1079, 1082, 1083, 1084, 1087, 1088,
1089, 1090, 1094, 1095, 1096, 1097, 1099, 1100, 1101,
1102, 1103, 1104, 1105, 1106, 1107, 1108, 1109, 1110,
1112, 1113, 1114, 1115, 1117, 1118, 1119, 1120, 1121,
1122, 1124, 1126, 1127, 1128, 1129, 1130, 1132, 1133,
1134, 1135, 1136, 1137, 1138, 1139, 1140, 1141, 1142,
1143, 1144, 1145, 1146, 1162, 1163, 1164, 1165, 1166,
1167, 1168, 1169, 1170, 1171, 1172, 1173, 1175, 1176,
1177, 1178, 1179.
b) Serial numbers: 1007, 1008, 1009, 1010, 1011, 1012,
1013, 1014, 1016, 1021, 1022, 1023, 1024, 1025, 1026,
1027, 1028, 1030, 1031, 1032, 1034, 1035, 1036, 1038,
1039, 1040, 1041, 1042, 1043, 1046, 1047, 1048, 1049,
1051, 1052, 1053, 1054, 1057, 1058, 1059, 1060, 1061,
1062, 1065, 1066, 1067, 1068, 1069, 1070, 1071, 1072,
1073, 1074, 1075, 1076, 1077, 1078, 1079, 1080, 1081,
1082, 1083, 1084, 1085, 1086, 1087, 1088, 1089, 1090,
1091, 1093, 1095, 1096, 1097, 1098, 1099, 1100, 1101,
1102, 1103, 1104, 1105, 1106, 1107, 1108, 1109, 1110,
1111, 1113, 1114, 1115, 1116, 1119, 1120, 1121, 1122,
1123, 1124, 1125, 1126, 1127, 1128, 1129, 1130, 1131,
1132, 1133, 1134, 1135, 1136, 1137, 1138, 1139, 1140,
1141, 1142, 1143, 1144, 1145, 1146, 1149, 1150, 1151,
1152, 1153, 1155, 1156, 1157, 1158.
RECALLING FIRM/MANUFACTURER
MicroAire Surgical Instruments, Charlottesville, VA, by letter on September 23, 2003. Firm initiated recall is ongoing.
REASON
Wiring pin locking mechanism defective, potential to come apart in surgical site.
VOLUME OF PRODUCT IN COMMERCE
264.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
Premier Toxins A & B, Diagnostic Test Kits, Catalog No. 616096. Recall # Z-0062-04.
CODE
Lots 616096.095, 096, and 097. Expiration Date: 23 Jul 03.
RECALLING FIRM/MANUFACTURER
Meridian Bioscience, Inc., Cincinnati, OH, by letter on September 23, 2003. Firm initiated recall is ongoing.
REASON
The kits were packaged with incorrect dispensing pipettes.
VOLUME OF PRODUCT IN COMMERCE
1,077 kits.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
Co-op Zipper 25-50 MX (Item # 553) 50 pound bags. Recall # V-001-4.
CODE
91813553.
RECALLING FIRM/MANUFACTURER
Tennessee Farmers Cooperative, Jackson, TN, by telephone on August 1, 2003. Firm initiated recall is complete.
REASON
The product (swine feed) was analyzed and found not to contain Carbadox, the medicated component of the feed.
VOLUME OF PRODUCT IN COMMERCE
106-50 pound bags.
DISTRIBUTION
TN.
END OF ENFORCEMENT REPORT FOR NOVEMBER 5, 2003
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