November 12, 2003
03-46
______________________________
PRODUCT
Lipitor tablets (Atorvastatin Calcium), 10 mg, Rx only, 5,000 tablet bottles, Important - This package for pharmacy stock use. Recall # D-032-4.
CODE
Lot # 16092V.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Valley Drug Company, Inc., Youngstown, OH, by fax on October 4, 2003.
Manufacturer: Unknown. FDA initiated recall is complete.
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
20 bottles of 5,000 tablets each.
DISTRIBUTION
NY.
______________________________
PRODUCT
ProHance injection, pre-filled single dose syringes (gadoteridol injection),
279.3mg/mL, 10mL and 17mL syringes. Recall # D-033-4.
CODE
| Lot Number | Exp. Date | Syringe Fill Volume 10 or 17 mL. |
|---|---|---|
| 3A24160 | 1/31/2006 | 17 |
| 2L22102 | 12/31/2005 | 17 |
| 2K21712 | 11/30/2005 | 17 |
| 2J21003 | 10/31/2005 | 17 |
| 2I32955 | 9/30/2005 | 17 |
| 2I17317 | 9/30/2005 | 10 |
| 2H16614 | 8/31/2005 | 17 |
| 2H15874 | 8/31/2005 | 17 |
| 2F17315 | 6/30/2005 | 10 |
| 2F12961 | 6/30/2005 | 17 |
| 2C08707 | 3/31/2005 | 17 |
| 2B07323 | 2/28/2005 | 17 |
| 2B07322 | 2/28/2005 | 17 |
| 2B06887 | 2/28/2005 | 17 |
| 2B06354 | 2/28/2005 | 10 |
| 2B06353 | 2/28/2005 | 10 |
| 2B05899 | 2/28/2005 | 17 |
| 1J00355 | 10/31/2004 | 17 |
| 1I22325 | 9/30/2004 | 17 |
| 1H20014 | 8/31/2004 | 17 |
| 1G19656 | 7/31/2004 | 17 |
| 1G19572 | 7/31/2004 | 17 |
| 1G18241 | 7/31/2004 | 17 |
| 1G18456 | 7/31/2004 | 10 |
| 1G17795 | 7/31/2004 | 17 |
| 1D17792 | 4/30/2004 | 17 |
_______________________________
PRODUCT
INDOMETHACIN Capsules, 25 MG, 60 capsule plastic bottles, RX ONLY. Recall # D-036-4.
CODE
Lot # 2I3981BB EXP 7/2004.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Direct Dispensing, Inc., Miami, FL, by telephone, and letter on September 23, 2003.
Manufacturer: Mylan Pharamceuticals, Morgantown, WV.
FDA initiated recall is ongoing.
REASON
Label Mix-up: bottles labeled as containing 25 mg strength capsules actually contain 50 mg capsules.
VOLUME OF PRODUCT IN COMMERCE
400 bottles.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
a) Estrace tablets (estradiol tablets, USP) 0.5mg,
physician samples, 7 and 21 count boxes, Rx Only, NOT AN
ORAL CONTRACEPTIVE. Recall # D-037-4;
b) Estrace tablets (estradiol tablets, USP) 1mg, physician
sample, 7 and 21 count boxes, Rx Only. NOT AN ORAL
CONTRACEPTIVE! Recall # D-038-4;
c) Estrace tablets (estradiol tablets, USP) 2mg, physician
sample, 7 and 21 count boxes, Rx Only. NOT AN ORAL
CONTRACEPTIVE! Recall # D-039-4.
CODE
a), b), and c) 64-GCA07.
RECALLING FIRM/MANUFACTURER
Bristol-Myers Squibb Company, Princeton, N.J., by letter on August 18, 2003. Firm initiated recall is ongoing.
REASON
Dissolution failure.
VOLUME OF PRODUCT IN COMMERCE
106,871 blisters.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Oxygen, USP, Compressed, cylinders, sizes-H, E, D, C, ML 6 and M6, Rx. Recall # D-040-4.
CODE
All Lots.
RECALLING FIRM/MANUFACTURER
Classic Medical Inc., St. Clair Shores, MI, by firm visit. Firm initiated recall is ongoing.
REASON
Good Manufacturing Practice Deviations (GMPs); including but not limited to, failure to perform purity analysis.
VOLUME OF PRODUCT IN COMMERCE
Pending determination (estimate 50 cylinders).
DISTRIBUTION
MI.
_______________________________
PRODUCT
a) NuLYTELY, Powder for Reconstitution, (PEG 33350, Sodium
Chloride, Sodium Bicarbonate and Potassium Chloride for
Oral Solution), Rx only, disposable jug.
Recall # D-041-4;
b) NuLYTELY, Powder for Reconstitution, Cherry Flavor,
(PEG 33350, Sodium Chloride, Sodium Bicarbonate and
Potassium Chloride for Oral Solution), Rx only,
Disposable jug. Recall # D-042-4;
c) NuLYTELY, Powder for Reconstitution, Lemon-Lime
(PEG 33350, Sodium Chloride, Sodium Bicarbonate and
Potassium Chloride for Oral Solution), Rx only,
disposable jug. Recall # D-043-4;
d) NuLYTELY, Powder for Reconstitution, Orange Flavor,
(PEG 33350, Sodium Chloride, Sodium Bicarbonate and
Potassium Chloride for Oral Solution), Rx only,
disposable jug. Recall # D-044-4.
CODE
a) Lot Number: N3E005 Exp. Date: 5/06;
b) Lot Number: C3G020 Exp. Date: 7/05;
c) Lot Number: L3F014 Exp Date: 6/05;
d) Lot Numbers: R3G011 Exp. Date: 7/05 and R3E009,
Exp. Date: 5/05.
RECALLING FIRM/MANUFACTURER
Braintree Laboratories, Inc., Braintree, MA, by letter dated September 25, 2003. Firm initiated recall is ongoing.
REASON
Product overfill: double one ingredient (PEG-3350).
VOLUME OF PRODUCT IN COMMERCE
69,744 bottles.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
TRASYLOL Injection (aprotinin), 200mL vial, Rx only. Recall # D-049-4.
CODE
Batch Number: 250076L Expiration Date: 2/2004.
RECALLING FIRM/MANUFACTURER
Bayer Corporation, West Haven, CT, by letter dated October 6, 2003. Firm initiated recall is ongoing.
REASON
Particulates: Delayed formation of a precipitate (stability).
VOLUME OF PRODUCT IN COMMERCE
2,649 vials.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Levoxyl tablets, (Levothyroxine, Sodium Tablets, USP), 25mcg, 100 count bottles, Rx only. Recall # D-050-4.
CODE
Lot No. 7478, expiration 11/03.
RECALLING FIRM/MANUFACTURER
King Pharmaceuticals, Inc., Bristol, TN, by letter dated October 10, 2003. Firm initiated recall is ongoing.
REASON
Subpotency: Stability failure (18 month CRT-controlled room temperature).
VOLUME OF PRODUCT IN COMMERCE
24,872 units.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Sterile Diluent for Humulin L, Humulin U and Lente Iletin, Lilly, 10 ml. vial. Warning: Use ONLY with insulins listed on side panel. PROFESSIONAL PACKAGE NOT TO BE SOLD. Recall # D-053-4.
CODE
7RE39M and 7RT38M.
RECALLING FIRM/MANUFACTURER
Eli Lilly and Company, Indianapolis, IN, by letter on October 3, 2003. Firm initiated recall is ongoing.
REASON
Particulates: vials exhibit white particulates/ white precipitate on vial wall which does not resuspend.
VOLUME OF PRODUCT IN COMMERCE
6,814 vials.
DISTRIBUTION
Nationwide, Canada and Japan.
_______________________________
PRODUCT
Mentax(r) cream (butenafine HCL), 1%, Topical Antifungal Cream 1%, 12.2 gram tubes, Physician Sample, Rx only, For topical Dermatologic Use Only. Recall # D-034-4.
CODE
Lot RBER, Expiration date Jan-04.
RECALLING FIRM/MANUFACTURER
Bertek Pharmaceuticals, Inc., Durham, NC, by letter on November 14, 2002. Firm initiated recall is complete.
REASON
Stability failure, sodium benzoate (18 month test point).
VOLUME OF PRODUCT IN COMMERCE
506,736 units.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Metoclopramide Injection, USP, 10 mg (5 mg/mL), 2 mL single dose, Flip top glass vial, Preservative Free, Rx only, For I.V. or I.M. use. Recall # D-035-4.
CODE
89-297-DK, 89-364-DK, 90-364-DK, 90-012-DK, 90-013-DK,
90-414-DK, 90-498-DK, 91-095-DK, 91-317-DK, 92-093-DK,
92-435-DK, 92-591-DK, 92-529-DK, 92-530-DK, 92-644-DK,
93-039-DK, 93-040-DK, 93-164-DK, 93-450-DK, 94-031-DK,
94-500-DK, 94-407-DK, 94-441-DK, 95-369-DK, 95-427-DK,
96-661-DK, 96-663-DK, 01-163-DK, 01-403-DK; 01-404-DK,
02-498-DK, 02-590-DK, 02-071-DK, 02-135-DK, 03-238-DK,
03-281-DK, 03-338-DK, 03-377-DK, 04-539-DK, 04-097-DK,
04-119-DK, 05-161-DK, 05-411-DK.
RECALLING FIRM/MANUFACTURER
Abbott International, Abbott Park, IL, by letter on September 17, 2003. Firm initiated recall is ongoing.
REASON
Discoloration: solution discolored due to known degradent.
VOLUME OF PRODUCT IN COMMERCE
9,158,500.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Indigo Carmine Injection, Indigotindisulfonate Sodium Injection USP, 0.8% Solution; 5 mL ampoules, 10 per carton; Rx only, For Intravenous or Intramuscular use. Recall # D-052-4.
CODE
Lot number 61013, Expiration date 06/05.
RECALLING FIRM/MANUFACTURER
Akorn, Inc., Buffalo Grove, IL, by letter on September 29, 2003. Firm initiated recall is ongoing.
REASON
The lot was manufactured from active (drug) pharmaceutical ingredient which failed to meet assay specifications.
VOLUME OF PRODUCT IN COMMERCE
41,420 ampules.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Source Plasma. Recall # B-0125-4.
CODE
Units G76921160, G77197160, G79879160, G82492160, G82852160, G83232160, G83504160, G85222160, G86682160, and G87074160.
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, Gainesville, FL, by facsimile on April 17, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had received a tattoo, was distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Platelets. Recall # B-0130-4.
CODE
Unit K35025.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Grand Rapids, MI, by telephone and letter on July 29, 2003. Firm initiated recall is complete.
REASON
Blood product, which was not tested for CMV, but was labeled as negative for CMV, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.
_______________________________
PRODUCT
Red Blood Cells. Recall # B-0136-4.
CODE
Unit 6707979.
RECALLING FIRM/MANUFACTURER
Lifeshare, Inc., Elyria, OH, by letter dated July 31, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH.
_____________________________
PRODUCT
a) Red Blood Cells. Recall # B-0137-4;
b) Red Blood Cells Leukocytes Reduced. Recall # B-0138-4;
c) Platelets. Recall # B-0139-4;
d) Fresh Frozen Plasma. Recall # B-0140-4.
CODE
a), c), and d) Unit 1923283;
b), and d) Unit 5612270.
RECALLING FIRM/MANUFACTURER
Florida Georgia Blood Alliance, Inc., Jacksonville, FL, by telephone on August 7, 2002. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was at risk for Creuztfeldt Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
FL, GA, and HI.
_______________________________
PRODUCT
Red Blood Cells. Recall # B-0141-4.
CODE
Unit C26697.
RECALLING FIRM/MANUFACTURER
HCSC Blood Center, Bethlehem, PA, by letters dated July 18 and December 29, 2002, or by facsimile on July 29, 2002. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA, and NJ.
_______________________________
PRODUCT
Platelets Pheresis. Recall #B-0144-4.
CODE
Unit numbers P1018364A and P1018364B.
RECALLING FIRM/MANUFACTURER
Community Blood Council of New Jersey, Trenton, NJ, by facsimile on March 4, 2002. Firm initiated recall is complete.
REASON
Blood products, labeled with the incorrect expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NJ.
_______________________________
PRODUCT
Platelets. Recall # B-0145-4.
CODE
Unit number M0842247.
RECALLING FIRM/MANUFACTURER
Community Blood Council of New Jersey, Trenton, NJ, by facsimile on May 28, 2003. Firm initiated recall is complete.
REASON
Blood product, that tested negative for the antibody to hepatitis C virus (anti-HIV), but was collected from an ineligible donor based on a previous positive test for anti-HIV, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NJ.
_______________________________
PRODUCT
a) Red Blood Cells. Recall B-0146-4;
b) Fresh Frozen Plasma. Recall # B-0147-4.
CODE
a) and b) Unit number M0837444.
RECALLING FIRM/MANUFACTURER
Community Blood Council of New Jersey, Trenton, NJ, by facsimile on April 8, 2002. Firm initiated recall is complete.
REASON
Blood products, that tested negative for the human immunodeficiency virus (anti-HIV), but were collected from a donor that previously tested repeatedly reactive for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NJ.
_______________________________
PRODUCT
Human Tissue for Transplantation, Corneas. Recall # B-0148-4.
CODE
Tissue numbers 03-0145 OD and 03-0145 OS.
RECALLING FIRM/MANUFACTURER
Northwest Lions Eye Bank, Seattle, WA, by electronic mail on May 16, 2003, and by letters on May 19 and 20, 2003. Firm initiated recall is ongoing.
REASON
Human tissue for transplantation, that tested negative for viral markers, but was procured from a donor that participated in behavior known to increase risk of infection with human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues.
DISTRIBUTION
WA, and Japan.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0149-4;
b) Red Blood Cells, Leukocytes Reduced. Recall # B-0150-4;
c) Cryoprecipitated AHF. Recall # B-0151-4;
d) Fresh Frozen Plasma. Recall # B-0152-4;
e) Recovered Plasma. Recall # B-0153-4.
CODE
a), c), and e) Unit number 49LH44383;
b), and d) Unit numbers 49LH46086 and 49LF49471.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Waco, TX, by telephone , facsimile, and letter beginning February 2, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on use of an experimental medication, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
TX and Switzerland.
_______________________________
PRODUCT
Red Blood Cells. Recall # B-0154-4.
CODE
Units numbers 8015606, 7023927, and 8015912.
RECALLING FIRM/MANUFACTURER
Wellmont Health System, Kingsport, TN, by electronic mail on April 24, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested reactive for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
TN and VA.
_______________________________
PRODUCT
Platelets. Recall # B-0157-4.
CODE
Unit numbers 8015881, 8015880, 8015877, 8015879, 8015876, and 8015874.
RECALLING FIRM/MANUFACTURER
Community Blood Centers of South Florida, Lauderhill, FL, by facsimile on August 6, 2002. Firm initiated recall is complete.
REASON
Blood products, labeled with the incorrect expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
FL.
_______________________________
PRODUCT
Platelets. Recall # B-0158-4.
CODE
Unit numbers 8016092, 8016096, and 8016095.
RECALLING FIRM/MANUFACTURER
Community Blood Centers of South Florida, Lauderhill, FL, by facsimile on August 21, 2002. Firm initiated recall is complete.
REASON
Blood products, labeled with the incorrect expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
FL.
_______________________________
PRODUCT
Platelets Pheresis, LeukocytesReduced Irradiated. Recall # B-0178-4.
CODE
Unit number 9560800 (distributed as two split products).
RECALLING FIRM/MANUFACTURER
Community Blood Centers of South Florida, Lauderhill, FL, by facsimile on October 19, 2001. Firm initiated recall is complete.
REASON
Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
FL.
_______________________________
PRODUCT
Platelets Pheresis. Recall # B-0179-4.
CODE
Unit number 9575551 (distributed as two split products).
RECALLING FIRM/MANUFACTURER
Community Blood Centers of South Florida, Lauderhill, FL, by facsimile on January 11, 2002. Firm initiated recall is complete.
REASON
Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
FL.
_______________________________
PRODUCT
Platelets. Recall # B-0180-4.
CODE
Unit number 9559825.
RECALLING FIRM/MANUFACTURER
Community Blood Centers of South Florida, Lauderhill, FL, by facsimile on October 29, 2001. Firm initiated recall is complete.
REASON
Blood product, that tested reactive for hepatitis B surface antigen (HbsAg), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.
_______________________________
PRODUCT
Platelets. Recall # B-0181-4.
CODE
Unit number 9421376.
RECALLING FIRM/MANUFACTURER
Community Blood Centers of South Florida, Lauderhill, FL, by letter on March 20, 2001. Firm initiated recall is complete.
REASON
Blood product, that tested negative for antibodies to human immunodeficiency virus (anti-HIV), but was collected from a donor that previously tested repeatedly reactive for anti-HIV, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NY.
_______________________________
PRODUCT
Red Blood Cells. Recall # B-0182-4.
CODE
Unit number 4190641.
RECALLING FIRM/MANUFACTURER
Florida Georgia Blood Alliance, Inc., Jacksonville, FL, by telephone on October 26, 1999. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that did not answer one of the medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.
_______________________________
PRODUCT
Red Blood Cells. Recall # B-0183-4.
CODE
Unit number 4194318.
RECALLING FIRM/MANUFACTURER
Florida Georgia Blood Alliance, Inc., Jacksonville, FL, by telephone on May 17, 2000. Firm initiated recall is complete.
REASON
Blood product collected from an unsuitable donor due to a history of residing in an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0230-4;
b) Fresh Frozen Plasma. Recall # B-0231-4.
CODE
a) Unit numbers 4182545, 4188080, and 2912856.
b) Unit number 4182545.
RECALLING FIRM/MANUFACTURER
Florida Georgia Blood Alliance, Inc., Jacksonville, FL, by facsimile on June 26, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to behavior known to increase risk of infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
FL.
_______________________________
PRODUCT
Human Tissue for Transplantation, Corneas. Recall # B-0232-4.
CODE
Tissue numbers 2003-05-2013 and 2003-05-2014.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Heartland Lions Eye Banks, Columbia, MO, by telephone and electronic mail on October 2, 2003.
Manufacturer: Heartland Lions Eye Banks - Illinois Branch, Springfield, IL. Firm initiated recall is complete.
REASON
Human tissue for transplantation, that tested negative for hepatitis prior to distribution, but was subsequently found to test repeatedly reactive for antibodies to hepatitis B core antigen (anti-HBc) by a different facility, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues.
DISTRIBUTION
CT, and TX.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0233-4.
CODE
Unit number 84J54234.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northern California Region, Oakland, CA, by letter on May 21, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Source Plasma. Recall # B-0234-4.
CODE
Unit numbers 0590269936 and 0590270024.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Allentown, PA, by facsimile on December 19, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for new variant Creutzfeldt-Jacob disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Source Plasma. Recall # B-0235-4.
CODE
Unit numbers 0590268570, 0590268759, 0590268871, 0590269122, 0590269331, 0590269577, 0590269690, 0590269858, 0590269975, 0590270199, 0590270421, 0590270922, and 0590271007.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Allentown, PA, by facsimile on December 19, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for new variant Creutzfeldt-Jacob disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Source Plasma. Recall # B-0237-4.
CODE
Unit numbers FXTCBG, FXTBYL, FXTBTN, FXTBQP, FXTBHG, FXTBCV, FXSZYL, FXSZXF, FXSZTZ, FXSZTF, FXQQLV, FXQPMX, FXQNQC, FXQMSR, FXQLZC, FXQLBP, FXMVDK, FXPMGY, FXPKLJ, FXPJNY, FXPHHD, FXPGNG, FXPFMD, FXPDTD, FXMSZH, FXMSXM, FXPBLX, FXNZVX, FXMSNR, FXNYXT, FXMSJH, FXMSGG, FXMSBR, FXMBKB, FXMBFG, FXMBCB, FXLZXN, FXLZWC, FXLZRW, FXLZQL, FXLLRY, FXLLCX, FXLJVS, FXDYXC, BRZVVS, FXBCFB, FXBBZM, FXBBWL, FXBBSJ, FXBBNN, BRZPMC, BRZPDW, BRZMVF, BRZMKK, BRZKXY, BRZKPF, BRZHZZ, and BRZHPT.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aventis Bio-Services, Inc., Knoxville, TN, by facsimile on June 11, 2003.
Manufacturer: Aventis Bio-Services, Inc., Akron, OH. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from a donor that was subsequently determined to have multiple risk factors for increased incidence of infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
58 units.
DISTRIBUTION
IL, Germany, and Italy.
_______________________________
PRODUCT
Whole Blood. Recall # B-0243-4.
CODE
Units 21R66000, 21R69719, 21R70465, 21FR11923, and 21R69784.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Portland, OR, by telephone on April 24, 2002 and by letter dated May 8, 2002. Firm initiated recall is complete.
REASON
Blood product, which was labeled with an incorrect volume, was distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
OR, and WA.
_______________________________
PRODUCT
Source Plasma. Recall # B-0247-4.
CODE
Unit number G-78807-026.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Tuscaloosa, AL, by telephone on May 27, 2000. Firm initiated recall is complete.
REASON
Blood product, untested for viral markers, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0248-4.
CODE
Unit number 6484134 (distributed as two split products).
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Beaumont, TX, by telephone on January 2, 2002, and by letter on January 18, 2002. Firm initiated recall is complete.
REASON
Blood products, that were labeled leukoreduced but had an elevated white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0249-4.
CODE
Unit number LE44687.
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence, RI, by letter on July 15, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that did not have a hematocrit or hemoglobin test during the donor screening process, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
RI.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0250-4;
b) Platelets Pheresis, Leukocytes Reduced. Recall # B-0251-4.
CODE
a) and b) Unit number FM68763.
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence, RI, by letter on July 21, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MA and RI.
_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0252-4.
CODE
Unit numbers LE39919 and LE27908.
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence, RI, by letter on June 10, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MA.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0253-4;
b) Platelets. Recall # B-0254-4.
CODE
a) Unit numbers FC2001420 and FC2004365;
b) Unit number FC2001420.
RECALLING FIRM/MANUFACTURER
Community Blood Council of New Jersey, Trenton, NJ, by facsimile on August 5, 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
3 units.
DISTRIBUTION
NJ.
_______________________________
PRODUCT
Human Corneas Tissues. Recall # B-0255-4.
CODE
Tissue numbers 2003-08-2023 and 2003-08-2024.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Heartland Lions Eye Banks, Columbia, MO, by telephone and by letter dated October 6, 2003.
Manufacturer: Heartland Lions Eye Banks - Illinois Branch, Springfield, IL. Firm initiated recall is complete.
REASON
Human tissue for transplantation, that tested negative for hepatitis prior to distribution, but were subsequently found to test repeatedly reactive for antibodies to hepatitis B core antigen (anti-HBc) by a different facility, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues.
DISTRIBUTION
KS, and MO.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0256-4.
CODE
Unit 16GM28953.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Central Ohio Region, Columbus, OH, by telephone on August 15, 2003. Firm initiated recall is complete.
REASON
Blood product, incorrectly tested for syphilis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH.
_______________________________
PRODUCT
a) Platelets. Recall # B-0257-4;
b) Platelets, Irradiated. Recall # B-0258-4;
c) Platelets, Leukocytes Reduced. Recall # B-0259-4;
d) Fresh Frozen Plasma. Recall # B-0260-4;
e) Plasma, Frozen within 24 Hours. Recall # B-0261-4.
CODE
a) 001E39064, 001E47143, 001E51108, 001FC07937,
001FF36217, 001FF37100, 001FF38545, 001FF38839,
001FF39924, 001FF41099, 001FW04484, 001FW04550,
001FW04905, 001FW09051, 001FW09863, 001FW10028,
001GC28693, 001GC49072, 001GJ37006, 001GJ42638,
001GL39726, 001GL43091, 001GL50113, 001GL53398,
001GL61247, 001GN38524, 001GN41998, 001GY32342,
001GY37305, 001GY43608, 001GY43609, 001GY44147,
001GY44477, 001GY48591, 001GY49687, 001GY50873,
001GY51177, 001GY52859, 001GY52866, 001GY59939,
001GY63709, 001GY63928, 001KF42950, 001KF45334,
001KF45525, 001KF52363, 001KF54414, 001KF54620,
001KF55524, 001KF55793, 001KF55971, 001KF56065,
001KF56298, 001KF56676, 001KF60385, 001KF70497,
001KH30159, 001KH31694, 001KH36292, 001KH45219,
001KH45554, 001KH45556, 001KH45710, 001KH46144,
001KH46536, 001KH47164, 001KH47511, 001KH47829,
001KH47949, 001KH48063, 001KH48114, 001KH48132,
001KH48524, 001KH50613, 001KH51002, 001KH51364,
001KH52387, 001KH56072, 001KJ30535, 001KJ31401,
001KJ32494, 001KJ35056, 001KJ36220, 001KJ36873,
001KJ38776, 001KJ39013, 001KJ40161, 001KJ40765,
001KJ42214, 001KJ42828, 001KJ45068, 001KK50357,
001KK54217, 001KK58753, 001KK59625, 001KK61561,
001KK62868, 001KK64602, 001KK65199, 001KK65422,
001KK65746, 001KK66370, 001KK66401, 001KK66504,
001KK66800, 001KK66826, 001KK67140, 001KK67152,
001KK67175, 001KK67200, 001KK67841, 001KK67883,
001KK67884, 001KK68159, 001KK69014, 001KK70230,
001KK70530, 001KK70878, 001KK71399, 001KK71445,
001KK73687, 001KK75705, 001KT39618, 001KT51449,
001KT52428, 001KT53852, 001KT55373, 001KT56803,
001KT57003, 001KT57100, 001KT58048, 001KT58204,
001KT58956, 001KT59200, 001KT59735, 001KT60094,
001KX40897, 001KX47337, 001KX48516, 001KX49494,
001KX52292, 001KX53246, 001KX53829, 001KX55218,
001KX55252, 001KX55412, 001KX55468, 001KX55705,
001KX55762, 001KX55923, 001KX56351, 001KX56383,
001KX56420, 001KX57719, 001KX57942, 001KX64350,
001KX64706, 001KX65125, 001KY13906, 001KY14917,
001KY19520, 001LC31431, 001LC32523, 001LC32806,
001LC35361, 001LC35861, 001LE23513, 001LE25506,
001LE27003, 001LE27182, 001LH39428, 001LN16559,
001LN22600, 001LN22993, 001LN28866, 001LP30014,
001LP37998, 001LS27681, 001LS28653, 001LS32975,
001LT25078, 001LT25492, 001LV41608, 001LV42374,
001LW19499, 001LW22480, 001LW22747, 001LW23390,
001LW23447, 001LW25082, 001Q41288, 001Q41964,
001Q41971, 001Q42317, 001Q42457, 001Q42468,
001Q43467, 001Q43685, 001Q44662, 001Q46859,
001Q48143, 001Q48363, 001Q48440, 001Q48441,
001Q48481, 001Q48637, 001Q48882, 001Q49016,
001Q49459, 001Q49543, 001Q50067, 001Q50585,
001Q54407, 001W79733, 001W79796, 001W82240,
001W83685, 001W83909, 001W84973, 001W85223,
001W85365, 001W85615, 001W85669, 001W85844,
001W86073, 001W86387, 001W86680, 001W86765,
001W89792, 001W91754, 001Y31072, 001Y34226,
001Y35745, 001Y35770 , 001Y36563, 001Y36803,
001Y39044, 01FW12575, 01FW13087, 01GN59581,
01KH59836, 01KH60374, 01KH63741, 01KH65066,
01KJ49404, 01KK77332, 01KK79160, 01KK79829,
01KM14706, 01KM15667, 01KX70726, 01KX71952,
01LE27383, 01LT35513, 01LT41087, 01LV48868,
01LW28635, 01LY18827, 01Q59726, 01Q59738,
01W00103, 01W00681, 01Y41220, 01Y41233,
01Y41556, 01Y42697, 01Y45655, 01Y46543;
b) Units 001E46341, 001FC05136, 001FF32765, 001FF38791,
001GY33613, 001KF44812, 001KF50715, 001KH31689,
001KH39704, 001KK66971, 001Q48352, 001Q55419,
001W93012, 001Y26561, 01Y41440;
c) Unit 001KF49427;
d) Units 01E51108, 001FC05136, 001FF36217, 001FF38545,
001FF38791, 001FF41099, 001FW04550, 001FW09863,
001FW10028, 001GJ42638, 001GL50113, 001GY44240,
001GY45232, 001GY49687, 001GY50873, 001GY51177,
001GY52859, 001GY52866, 001GY59939, 001KF45334,
001KF54620, 001KF55524, 001KF55793, 001KF55976,
001KF56946, 001KF60385, 001KH31521, 001KH31689,
001KH39704, 001KH45219, 001KH45554, 001KH45556,
001KH45710, 001KH46144, 001KH46250, 001KH46536,
001KH47164, 001KH47663, 001KH47829, 001KH48114,
001KH48132, 001KH48524, 001KH51002, 001KH56072,
001KJ31401, 001KJ34897, 001KJ35041, 001KJ35051,
001KJ39670, 001KJ39943, 001KJ40161, 001KJ40714,
001KJ40765, 001KJ42198, 001KJ42828, 001KJ45068,
001KK64397, 001KK65746, 001KK66370, 001KK66408,
001KK66504, 001KK66826, 001KK66971, 001KK67152,
001KK67200, 001KK67841, 001KK67883, 001KK67884,
001KK67893, 001KK68159, 001KK70252, 001KK70530,
001KK71399, 001KK71445, 001KT48199, 001KT55373,
001KT58204, 001KT59735, 001KX53729, 001KX53829,
001KX55252, 001KX55705, 001KX55725, 001KX55762,
001KX57942, 001KY19520, 001LC28753, 001LC32806,
001LC35361, 001LC35861, 001LE22560, 001LE25506,
001LH39428, 001LP37998, 001LS27681, 001LS28653,
001LS32975, 001LV41608, 001LV42374, 001LW22480,
001LW25082, 001Q45630, 001Q48334, 001Q48481,
001Q48882, 001Q49016, 001Q49543, 001Q50585,
001Q54407, 001W74640, 001W75332, 001W82240,
001W83685, 001W83828, 001W83909, 001W84178,
001W84592, 001W84891, 001W84897, 001W85223,
001W85365, 001W85615, 001W85669, 001W85844,
001W86765, 001W90908, 001W91754, 001Y34226,
001Y36089, 001Y36480, 001Y36563, 001Y40054;
e) Units 001GG58310, 001GY63709, 001KF70497,
001KX64350, 001KX65125, 001LE27003, 001LE27182,
001LN26296, 001LN28866, 001W93012, 01FW13087,
01GN57109, 01GN59579, 01GN59581, 01KH59836,
01KH59891, 01KH63741, 01KH64318, 01KH65066,
01KJ49404, 01KJ51104, 01KK77929, 01KK78820,
01KX70559, 01KX70726, 01KX71784, 01KX71952,
01KX71959, 01LH51291, 01LS40072, 01LT35513,
01LT41087, 01LV48868, 01LW26719, 01LW28635,
01Q56811, 01Q60630, 01Q60704, 01W00078,
01W00103, 01W00681, 01Y41556, 01Y42697,
01Y45655.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, New York-Penn Region, West Henrietta, NY, by letters dated January 17, 2003 and April 8, 2003. Firm initiated recall is complete.
REASON
Blood products, corresponding to units of clotted Red Blood Cells, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 269 units;
b) 15 units;
c) 1 unit;
d) 132 units;
e) 44 units.
DISTRIBUTION
NY, PA, and MA.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0262-4;
b) Platelets. Recall # B-0263-4;
Fresh Frozen Plasma. Recall # B-0264-4.
CODE
a), b), and c) Unit M16959.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Inc., Richmond, VA, by letter dated June 23, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for variant Creutzfeldt Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
VA.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0265-4.
CODE
Unit 6622677.
RECALLING FIRM/MANUFACTURER
West Tennessee Regional Blood Center, Inc., Jackson, TN, by letter dated March 8, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who visited a malarial endemic region, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.
_______________________________
PRODUCT
Source Plasma. Recall # B-0269-4.
CODE
Unit numbers 0181083739, 0181084704, 0181084963, 0181085355, 0181086373, 0181086639, 0181087018, 0181087260, 0181087560, 0181087677, 0181088254, 0181088514, 0181088761, 0181089069, 0181089433, and 0181088020.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Columbus, OH, by facsimile on April 16, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for new variant Creutzfeldt-Jacob Disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Source Plasma. Recall # B-0270-4.
CODE
Unit numbers 0181089405, 0181088890, 0181088668, 0181088367, 0181088196, 0181087847, 0181087661, 0181087106, 0181086905, 0181086203, 0181085956, 0181085588, 0181085240, and 0181084550.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Columbus, OH, by facsimile on May 15, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for new variant Creutzfeldt-Jacob disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
14 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0271-4.
CODE
Unit number 042KW17622.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northern Ohio Region, Cleveland, OH, by telephone and letter on August 18, 2003. Firm initiated recall is complete.
REASON
Blood product, that was labeled leukoreduced but was not tested for white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH.
_______________________________
PRODUCT
Source Plasma. Recall # B-0123-4.
CODE
Units 0078567, 0078893, 0079136, 0079405, 0079667, 0080436, 0080922, 0081128, 0081302, 0081450, 0081632, 0081799, 0081942, 0082275, 0082390, 0082763, 008310, 0083087, 0083381, 0083540, 0083859, 0084019, and 0084524.
RECALLING FIRM/MANUFACTURER
DCI Biologicals Carbondale, LLC, Carbondale, IL, by facsimile on July 21, 2003. Firm initiated recall is complete.
REASON
Blood product, that was collected from a donor who had undergone surgery, was distributed.
VOLUME OF PRODUCT IN COMMERCE
23 units.
DISTRIBUTION
NY and NC.
_______________________________
PRODUCT
Source Plasma. Recall # B-0124-4.
CODE
Units G27321160 and G26939160.
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, Gainesville, FL, by facsimile on November 26, 2001. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had undergone surgery, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
Switzerland.
_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced. Recall # B-0126-4;
b) Platelets Irradiated. Recall # B-0127-4;
c) Platelets Pheresis Leukocytes Reduced. Recall # B-0128-4.
CODE
a) Units 0165693, 0165728, 016529, 0165731, 016539,
0165745, 0165747, 0165749, 0165750, 0165828, 0165831,
and 0165834;
b) Unit 0165693;
c) Units 0165722, 0165724A, 0165724B, and 0165912.
RECALLING FIRM/MANUFACTURER
Marquette General Hospital, Inc., Marquette, MI, by telephone on March 10, 2003. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly tested for infectious diseases, but subsequently were re-test and found negative for infectious diseases, were distributed.
VOLUME OF PRODUCT IN COMMERCE
17 units.
DISTRIBUTION
MI.
_______________________________
PRODUCT
Red Blood Cells. Recall # B-0129-4.
CODE
Unit J44291.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Saginaw, MI, by facsimile on July 31, 2003.
REASON
Blood product, which was collected from a donor with an elevated body temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.
_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0135-4.
CODE
Units 9284453, 9284454, 9284455, 9284456, and 9284457.
RECALLING FIRM/MANUFACTURER
Blood Bank of Delaware, Inc., Newark, DE, by telephone on July 29, 2002, or by letters dated July 30, and September 4, 2002. Firm initiated recall is complete.
REASON
Blood product, which was shipped at unacceptable temperatures, was distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
DE, MD, and TX.
_______________________________
PRODUCT
Recovered Plasma. Recall # B-0142-4.
CODE
Unit C26697.
RECALLING FIRM/MANUFACTURER
HCSC Blood Center, Bethlehem, PA, by letters dated July 18 and December 29, 2002, or by facsimile on July 29, 2002. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA, and NJ.
_______________________________
PRODUCT
Red Blood Cells. Recall # B-0155-4.
CODE
Unit number 9673486.
RECALLING FIRM/MANUFACTURER
Community Blood Centers of South Florida, Lauderhill, FL, by facsimile on January 31, 2002. Firm initiated recall is complete.
REASON
Blood product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.
_______________________________
PRODUCT
Whole Blood. Recall # B-0156-4.
CODE
Unit number 9560492.
RECALLING FIRM/MANUFACTURER
Community Blood Centers of South Florida, Lauderhill, FL, by facsimile on June 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
FL.
_______________________________
PRODUCT
Red Blood Cells. Recall # B-0159-4.
CODE
Unit numbers 8016092, 8016094, and 8016097.
RECALLING FIRM/MANUFACTURER
Community Blood Centers of South Florida, Lauderhill, FL, by facsimile on August 21, 2002. Firm initiated recall is complete.
REASON
Blood products, labeled with the incorrect expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
FL.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0184-4.
CODE
Unit number 5340205.
RECALLING FIRM/MANUFACTURER
Florida Georgia Blood Alliance, Inc., Jacksonville, FL, by telephone on May 23, 2002. Firm initiated recall is complete.
REASON
Blood product, that was labeled as leukoreduced but failed quality control testing due to an elevated white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # 0185-4;
b) Platelets, Leukocytes Reduced. Recall # 0186-4;
c) Fresh Frozen Plasma. Recall # 0187-4;
d) Plasma. Recall # 0188-4;
e) Red Blood Cells, for further manufacture into non-
injectable products. Recall # 0189-4;
f) Red Blood Cells, for further manufacture.
Recall # 0190-4;
g) Recovered Plasma. Recall # 0191-4.
CODE
a) Unit numbers 042K58582, 042R67007, 042K58077,
042FG00479, 042FG00484, 042FW08604, 042FW08605, 042S95164, 042T16011, 042Y34246, 042FE78536, 042FS78802, 042FY41828, 042K58085, 042Q78671, 042T16014, 042T17021, 042X69807, 042FG00443, 042Y35350, 042FG00474, 042R67008, 042FS78801, 042FG00206, 042FG00324, 042FG00442, 042FG00446, 042FG00448, 042FG00483, 042FM35981, 042FS78800, 042FT31291, 042FT31294, 042FT31335, 042FT31337, 042FW08615, 042FX21670, 042FX21980, 042FY41830, 042G41864, 042G41870, 042G41874, 042G41876, 042G41884, 042J46570, 042J46571, 042J46577, 042J46582, 042J46586, 042K58083, 042L14424, 042L14426, 042Q78661, 042Q78662, 042Q78665, 042Q78666, 042Q78674, 042Q78764, 042Q78765, 042Q78669, 042R67830, 042R67833, 042R67834, 042S95179, 042T16029, 042T16031, 042T17016, 042T17018, 042T17019, 042T17024, 042T17049, 042T17053, 042T17067, 042X70027, 042X70933, 042X70943, 042Y35956, 042Y35962, 042Y35965, 042S95172, 042FE78542, 042FM35983, 042FY41805, 042T17014, 042T17022, 042X69963, 042Y35335, 042FG00475, 042FS78816, 042G41878, 042K58591, 042Q78749, 042FW08608, 042FW08614, 042FX21675, 042K58601, 042Q78663, 042Y34240, 042Y34242, 042Y34248, 042Y34256, 042K58064, 042FG99793, 042FG99814, 042FS78803, 042FY41792, 042G41881, 042K58585, 042T17052, 042Y35332, 042Y35364, 042T17059, 042X70099, 042Y35344, 042FE78550, 042J46584, 042T17041, 042T17050, 042X70925, 042Y36206, 042FY41826, 042K58612, 042X71409, 042Y36189, 042FG00320, 042L14423, 042Y34236, 042Y34218, 042Y34229, 042FG00204, 042FT31331, 042FT31330, 042FT31350, 042K58863, 042Q78761, 042Q78763, 042Y34227, 042FG00198, 042FG00462, 042FG00476, 042FS78814, 042FY41790, 042J46578, 042K58067, 042K58080, 042K58589, 042L14431, 042L14432, 042L14434, 042R67829, 042R67849, 042S95141, 042S95143, 042T17060, 042X70620, 042Y36182, 042FX21690, 042X70622, 042Y36201, 042Y35329, 042R67836, 042FT31343, 042Y34233, 042FG99801, 042J46588, 042FM35979, 042FT31353, 042FX21677, 042K58072, 042R67837, 042S95166, 042S95177, 042Y35958, 042T17066, 042FG99813, 042FM35991, 042FX21960, 042J46583, 042K58058, 042K58592, 042Q78668, 042Q78766, 042Q78768, 042T16016, 042T16044, 042X70052, 042X70937, 042Y35346, 042Y36147, 042Y36177, 042Y36181, 042FT31341, 042FX21672, 042FX21673, 042X70953, 042X70963, 042FG00465, 042FG00466, 042FG00469, 042FS78808, 042Y36210, 042K58866, 042FX21687, 042Q78660, 042X70619, 042Y35322, 042Y35333, 042FE78537, 042FS78828, 042FT31324, 042L14435, 042Q78659, 042Q78672, 042Q78673, 042FE78540, 042FG00463, 042FG99792, 042FX21688, 042FX21971, 042FX22000, 042G41863, 042K58020, 042K58028, 042K58060, 042K58586, 042Q78675, 042R67846, 042R67848, 042S95140, 042T17056, 042T17064, 042X69977, 042X70926, 042X70947, 042X71398, 042X71419, 042Y35326, 042Y35338, 042Y35349, 042Y35963, 042FG00464, 042X69793, 042Y35363, 042FY41784, 042K58590, 042K58606, 042K58608, 042X70124, 042Y34253, 042Y36154, 042L14436, 042S95144, and 042S95175;
b) Unit numbers 042FT31341, 042FY41784, 042FY41805,
042J46570, 042J46582, 042K58064, 042Y34246,
042Y35322, 042Y35329, 042Y35333, 042Y35335,
042FM35991, 042FS78802, 042FW08608, 042FW08609,
042FW08614, 042FX21690, 042Y35346, 042K58072,
042R67848, 042FY41792, 042FE78536, 042FE78537,
042FE78540, 042FE78542, 042FE78550, 042FG00462,
042FG00463, 042FG00464, 042FG00465, 042FG00466,
042FG00469, 042FG00475, 042FG00476, 042FG00479,
042FG00483, 042FG00484, 042FG99792, 042FG99813,
042FG99814, 042FS78803, 042FS78808, 042FS78828,
042FT31294, 042FT31330, 042FT31337, 042FT31343,
042FT31350, 042FT31353, 042FX21687, 042FX21966,
042FX21971, 042K58067, 042K58077, 042K58080,
042K58083, 042K58085, 042K58582, 042K58585,
042K58586, 042K58589, 042K58590, 042K58591,
042K58592, 042K58601, 042K58606, 042K58608,
042K58612, 042K58863, 042L14431, 042L14432,
042L14436, 042S95141, 042S95144, 042S95165,
042S95172, 042S95175, 042S95177, 042S95179,
042T16029, 042T16031, 042T16044, 042T17014,
042T17016, 042T17019, 042T17021, 042T17022,
042T17024, 042T17049, 042T17050, 042X69793,
042X69807, 042X69963, 042X70027, 042X70099,
042X70926, 042X70947, 042X70963, 042X71354,
042X71358, 042X71372, 042X71393, 042X71397,
042X71398, 042X71407, 042X71409, 042X71410,
042Y34227, 042Y34229, 042Y34236, 042Y34242,
042Y34248, 042Y34253, 042Y34256, 042Y35344,
042Y35349, 042Y35363, 042Y35364, 042Y36177,
042Y36181, 042Y36182, 042Y36189, 042Y36201,
042Y36210, 042X70124, 042FT31324, 042FT31331,
042FY41795, 042FY41818, 042FY41820, 042X70052,
042Y35338, 042Y34218, 042T16014, 042Y35320,
042Y36154, 042FG99811, 042FS78827, 042T16011,
042X70933, 042T16016, 042Y35350, 042Y36147,
042FY41812, 042FY41815, 042S95136, 042X70026,
042Y36187, 042X71416, 042FY41790, 042FG99810,
042FT31323, 042FY41803, 042R67846, 042R67847,
042X70937, 042X71419, 042Y35326, 042Y35332,
042FG99801, 042FT31291, 042FY41797, 042X70925, and
042X70943;
c) Unit numbers 042FE78550, 042K58077, 042K58083,
042K58085, 042S95165, 042Y35320, 042Y35322,
042Y35332, 042Y35333, 042FE78540, 042FX21980,
042S95172, 042Y35344, 042FW08614, 042Y36154,
042FE78536, 042FE78542, 042FG00462, 042FG00464,
042FG99792, 042FG99793, 042FM35991, 042FW08609,
042S95136, 042S95177, 042X69977, 042Y34246,
042Y35364, 042Y36177, 042FG99801, 042K58028,
042Y35349, 042FE78537, 042J46570, 042J46571,
042X70026, 042X70027, 042FG99810, 042K58020,
042K58067, 042K58072, 042Y35326, 042Y35363,
042X70099, 042X69793, 042FM35983, 042K58080,
042S95141, 042X70052, 042FG99811, 042K58058,
042FG99813, 042Y36181, 042FG99814, 042FS78827,
042J46578, 042Y34227, 042Y34229, 042Y34256,
042FS78828, 042Y35329, 042Y35338, 042Y36147,
042FT31353, 042S95144, 042S95175, 042S95179,
042FS78808, 042K58612, 042S95140, 042Y35335,
042FT31350, 042X69807, 042X70124, 042Y34236, and
042Y34242;
d) Unit numbers 042G41863, 042Y35958, 042FX21690, and
042Q78671;
e) Unit numbers 042FS78805 and 042S95136;
f) Unit numbers 042FG99810, 042FG99811, 042FS78827,
042FW08609, 042FY41799, 042K58034, 042R67006, and
042Y36187;
g) Unit numbers 042FG00320, 042FS78799, 042FS78800,
042FS78801, 042FS78816, 042FW08605, 042FX21960,
042J46584, 042J46588, 042K58034, 042L14434,
042L14435, 042Q78761, 042T17018, 042T17067,
042X70620, 042X70953, 042Y35956, 042FG00198,
042FG00204, 042FG00206, 042FG00324, 042FG00441,
042FG00442, 042FG00443, 042FG00446, 042FG00448,
042FG00463, 042FG00465, 042FG00466, 042FG00469,
042FG00476, 042FG00479, 042FG00483, 042FG00484,
042FM35979, 042FM35981, 042FS78802, 042FS78803,
042FS78805, 042FT31291, 042FT31323, 042FT31324,
042FT31330, 042FT31331, 042FT31335, 042FT31337,
042FT31341, 042FT31343, 042FW08604, 042FW08608,
042FW08615, 042FX21670, 042FX21672, 042FX21673,
042FX21675, 042FX21677, 042FX21687, 042FX22000,
042FY41784, 042FY41790, 042FY41792, 042FY41805,
042FY41812, 042FY41815, 042FY41817, 042FY41818,
042FY41820, 042FY41828, 042FY41830, 042G41864,
042G41870, 042G41874, 042G41876, 042G41878,
042G41881, 042G41884, 042J46577, 042J46582,
042J46583, 042J46586, 042K58064, 042K58582,
042K58585, 042K58586, 042K58589, 042K58590,
042K58591, 042K58592, 042K58601, 042K58606,
042K58608, 042K58863, 042K58866, 042L14423,
042L14424, 042L14426, 042L14431, 042L14432,
042L14436, 042Q78659, 042Q78660, 042Q78661,
042Q78662, 042Q78663, 042Q78666, 042Q78668,
042Q78669, 042Q78672, 042Q78673, 042Q78674,
042Q78675, 042Q78749, 042Q78763, 042Q78764,
042Q78765, 042Q78766, 042Q78768, 042R67006,
042R67007, 042R67008, 042R67829, 042R67830,
042R67833, 042R67834, 042R67836, 042R67837,
042S95164, 042S95166, 042T16011, 042T16014,
042T16016, 042T16029, 042T16031, 042T16044,
042T17014, 042T17016, 042T17019, 042T17021,
042T17022, 042T17024, 042T17049, 042T17050,
042T17052, 042T17053, 042T17056, 042T17059,
042T17060, 042T17066, 042X70619, 042X70622,
042X70925, 042X70926, 042X70933, 042X70937,
042X70943, 042X70947, 042X70963, 042Y34218,
042Y34233, 042Y34248, 042Y34253, 042Y35346,
042Y35350, 042Y35962, 042Y35963, 042Y35965,
042Y36182, 042Y36187, 042Y36189, 042Y36201,
042Y36206, and 042Y36210.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northern Ohio Region, Cleveland, OH , by telephone, letter, and facsimile on February 20, 25, and 26, 2003, March 24 and 25, 2003, April 21, 2003, and May 30, 2003. Firm initiated recall is complete.
REASON
Blood products, that were collected by an employee who was observed on at least one occasion to collect blood in a manner that may compromise the sterility of the product, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 253 units;
b) 164 units;
c) 76 units;
d) 4 units;
e) 2 units;
f) 8 units;
g) 173 units.
DISTRIBUTION
Nationwide and Switzerland.
_______________________________
PRODUCT
a) Platelets. Recall # B-0228-4;
b) Fresh Frozen Plasma. Recall # B-0229-4.
CODE
a) Unit number 5651860;
b) Unit numbers 5651858, 5651859, 5651860, 5651861,
5651864, 5651867, 5651870, and 5651881.
RECALLING FIRM/MANUFACTURER
Florida Georgia Blood Alliance, Inc., Jacksonville, FL, by telephone and letter on November 1, 2001. Firm initiated recall is complete.
REASON
Blood products, prepared more than eight hours after collection of the corresponding unit of Whole Blood, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units.
DISTRIBUTION
FL, NY, and GA.
_______________________________
PRODUCT
Red Blood Cells. Recall # B-0236-4.
CODE
Unit number 2452053.
RECALLING FIRM/MANUFACTURER
Department of the Army, Frank R. Camp Memorial Blood Center, U.S. Army Medical Department Activity, Fort Knox, KY, by facsimile on May 12, 2003. Firm initiated the recall is complete.
REASON
Blood product, that did not have the complete amount of additive solution included, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NJ.
_______________________________
PRODUCT
Source Plasma. Recall # B-0242-4.
CODE
Units CQVYZZ, CQVYRX, and CQVKBH.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Louisville, KY, by facsimile on July 8, 2003. 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
3 units.
DISTRIBUTION
IL and Germany.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0266-4;
b) Platelets. Recall # B-0267-4;
c) Plasma. Recall # B-0268-4.
CODE
a), b) and c) Unit number 53FN85322.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by letter on May 31, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor due to use of the medication Propecia, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
MD and D.C.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0272-4;
b) Plasma. Recall # B-0273-4.
CODE
a) Unit numbers 53GE72112, 53GE72411, 53GE72412, 53L50195,
53C23125, 53FX89724, 53FX89731, 53FX89732, 53FH00827,
53FH00829, 53FH00830, 53C25707, 53C25708, 53FC21909, and
53G63413;
b) Unit numbers 53GE72070, 53GE72112, 53GE72411, 53GE72412,
53GF45253, 53FH00827, 53FH00830, 53L54836, 53Q99047,
53C25707, 53C25708, 53FC21909, and 53G63413.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by telephone on January 30, 2003, and by letter on February 3, 2003. Firm initiated recall is complete.
REASON
Blood products, manufactured from units of Whole Blood more than 8 hours after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
28 units.
DISTRIBUTION
MD, PA, VA, and D.C.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0274-4.
CODE
Unit number 53F41535.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by telephone on October 11, 2002. Firm initiated recall is complete.
REASON
Blood product, that tested out of specification for hematocrit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MD.
_______________________________
PRODUCT
Sonotrode Probe, a straight nephroscopy probe with a 3.5 mm diameter and 362 mm working length; an accessory to the Richard Wolf Model 2271 Ultrasound Generator Unit 2271. Model 8963.535. Recall # Z-0081-04.
CODE
Lot number M000580.
RECALLING FIRM/MANUFACTURER
Richard Wolf Medical Instruments Corp., Vernon Hills, IL, by telephone on October 9, 2003 and follow-up visits. Firm initiated recall is ongoing.
REASON
The sonotrode tube could become blocked by the stone fragments, causing overheating and damage to the device.
VOLUME OF PRODUCT IN COMMERCE
10 probes.
DISTRIBUTION
NE, OR, MN, and IL.
_______________________________
PRODUCT
a) Concentric brand Concentric Retriever(tm) X5 Percutaneous
Catheter Model REF 90035. Recall # Z-0085-04;
b) Concentric brand Concentric Retriever(tm) X6 Percutaneous
Catheter Model REF 90037. Recall # Z-0086-04.
CODE
a) and b) Lot numbers: 31494 or lower.
RECALLING FIRM/MANUFACTURER
Concentric Medical Inc, Mountain View, CA, by letters on September 24, 2003, and follow-up letters on October 17, 2003. Firm initiated recall is ongoing.
REASON
The device has the potential for tip breakage during use.
VOLUME OF PRODUCT IN COMMERCE
97 Units.
DISTRIBUTION
MA, GA, NY, OH, MO, and CA.
_______________________________
PRODUCT
Digital Fluorographic System model DFP-2000A. Recall # Z-0100-04.
CODE
All serial numbers, all codes.
RECALLING FIRM/MANUFACTURER
Toshiba American Medical Systems, Inc., Tustin, CA, by service representative visit starting on May 27, 2003. Firm initiated recall is ongoing.
REASON
Images display with wrong patient demographics.
VOLUME OF PRODUCT IN COMMERCE
471.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
a) Arrow Howes multi-lumen central venous catheterization
kit 7 Fr x 20 cm. Catalog number AK-25703.
Recall # Z-0082-04;
b) Arrow central venous catheterization kit, 14 ga x 20 cm.
Catalog number AK-04700. Recall # Z-0083-04;
c) Cannon catheter hemodialysis catheterization set, 15 Fr
x 36 cm. Catalog number CC-03600. Recall # Z-0084-04.
CODE
a) Lot number RF3066892;
b) Lot number RF3067086;
c) Lot number RF3066991.
RECALLING FIRM/MANUFACTURER
Arrow International, Inc., Reading, PA, by letter dated September 16, 2003. Firm initiated recall is ongoing.
REASON
Wrong product in box.
VOLUME OF PRODUCT IN COMMERCE
4,754 units.
DISTRIBUTION
Nationwide.
END OF ENFORCEMENT REPORT FOR NOVEMBER 12, 2003
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Hypertext created by clb 2003-NOV-12.