December 10, 2003
03-50
_______________________________
PRODUCT
Wheat Montana Farms & Bakery Bagels Wild Blueberry Net Wt 1 lb. 4 oz. (567g). Six bagels packaged in a flexible plastic bag closed with a colored bread tag. Recall # F-037-4.
CODE
1014-Yellow Tag, 1016-Red Tag, 1017-Blue Tag, 1018-White Tag, 1020-Orange Tag, 1021-Yellow Tag, 1023-Red Tag, 1024-Blue Tag, 1025-White Tag, 1027-Orange Tag, 1028-Yellow Tag. 1014 is nine days from the month and day the product was manufactured. For example, 10/14/03 would be the pull date for product manufactured on 10/6/2003.
RECALLING FIRM/MANUFACTURER
Wheat Montana Bakery Inc., Three Forks, MT, by telephone and letter on October 22, 2003. Firm initiated recall is ongoing.
REASON
The product contains undeclared colors - FD&C Yellow #6, FD&C Red #3, and FD&C Blue #1.
VOLUME OF PRODUCT IN COMMERCE
1,582 Packages.
DISTRIBUTION
MT.
______________________________
PRODUCT
Germack Nut Co. brand Trail Mix in 1 lb. clear bag. Recall # F-038-4.
CODE
Production code numbers of 328, 330 and 331.
RECALLING FIRM/MANUFACTURER
Germack Pistachio Company, Detroit, MI, by letters on September 16, 2003. Michigan State initiated recall is ongoing.
REASON
The product contains undeclared color, FD&C Yellow #6.
VOLUME OF PRODUCT IN COMMERCE
3,276 packages.
DISTRIBUTION
Nationwide.
____________________________
PRODUCT
Lipitor tablets (Atorvastatin Calcium), 10 mg, Rx only, 5000 Tablets. Important
- This package for pharmacy stock use. Recall # D-072-4.
CODE
Lot 1609V Expiration July 2004.
RECALLING FIRM/MANUFACTURER
Breckenridge Trading Company, Berlin, CT, by letter on November 4, 2003. FDA
initiated recall is ongoing.
REASON
Counterfeit product.
VOLUME OF PRODUCT IN COMMERCE
20/5000 bottles.
DISTRIBUTION
OH.
_______________________________
PRODUCT
a) The Skin Culture One Day Peeling Treatment.
6 Treatments: 6 Cerate 39XXX, 6 Normalizer Applicators,
Jar. Recall # D-024-4;
b) Skin Culture 2 Peeling Treatment, Skin Creams, The 6 Day
Cosmetic Facial Treatment Kit. Recall # D-025-4;
c) Skin Culture 3 Peeling Treatment, Skin Creams. The 6 Day
Cosmetic Facial Treatment Kit. Recall # D-026-4;
d) Skin Culture 4 Peeling Treatment, Skin Creams. The 6 Day
Cosmetic Facial Treatment Kit. Recall # D-027-4.
CODE
a) Lots 11132, and 11829;
b) Lot 27652;
c) Lot 28132;
d) Lot 37522.
RECALLING FIRM/MANUFACTURER
Skin Culture Institute, Inc., New York, NY, by letter and fax on October 1, and October 2, 2003. FDA initiated recall is ongoing.
REASON
Misbranding: Product fails to contain declared ingredient Resorcinol and is subpotent for its sulfur ingredient.
VOLUME OF PRODUCT IN COMMERCE
Approximately 4,000 jars.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Novocol Octocaine 50 Lidocaine Hydrochloride 2% with Epinephrine 1:50,000 Injection (Lidocaine Hydrochloride and Epinephrine Injection, USP). 50 cartridges/1.8 mL, For Dental Block and Infiltration Only, Rx Only. Also sold under brands as: Henry Schein Lidocaine HCI 2% and Epinephrine 1:50,000 Injection, Super-Dent Lidocaine Hydrochloride 2% and Epinephrine 1:50,000. Recall # D-045-4.
CODE
Lot No/Exp date: 2058 (12/03), 2058A (12/03), 2073 (12/03), 2073A (12/03), 2079 (1/04), 2094 (1/04), 2094A (1/04), 2094B (1/04), 2116A (1/04), 2150 (4/04), and 2150A (04/04). Lot No 2095 was shipped to foreign accounts only.
RECALLING FIRM/MANUFACTURER
Septodont Inc., New Castle, DE, by letter dated October 6, 2003. Firm initiated recall is ongoing.
REASON
Subpotent for Epinephrine ingredient.
VOLUME OF PRODUCT IN COMMERCE
32,748 boxes.
DISTRIBUTION
Nationwide, Armenia, Chile, and Taiwan.
_______________________________
PRODUCT
Pert Plus, 2 in 1 Dandruff Control Shampoo plus Conditioner (Pyrithione zinc 1.0%), 13.5 Fl. Oz. (400 mL), 12 bottles per case. Recall # D-071-4.
CODE
Lot Numbers: 32765395XA and 32885395XA.
RECALLING FIRM/MANUFACTURER
The Proctor & Gamble Company, Cincinnati, OH, by telephone on October 27, 2003. Firm initiated recall is ongoing.
REASON
Subpotent for Pyrithione Zinc ingredient.
VOLUME OF PRODUCT IN COMMERCE
1,374 cases.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Removed. Recall # B-0305-4;
b) Platelets, Leukocytes Removed. Recall # B-0306-4;
c) Fresh Frozen Plasma. Recall # B-0307-4;
d) Recovered Plasma. Recall # B-0308-4.
CODE
a) Unit 13FV19511, 13FV16184;
b) and c) Unit 13FV19511;
d) Unit 13FV16184.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southeastern Michigan Region, Detroit, MI, by telephone on May 23, 2003, by letters dated June 6 or June 13, 2003, and by facsimile dated May 23, 2003, and August 11, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported being exposed to Hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
MI, and PA.
_______________________________
PRODUCT
a) Red Blood Cells, Leukoreduced. Recall # B-0310-4;
b) Recovered Plasma. Recall # B-0311-4.
CODE
a) and b) Unit 13FN89020.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southeastern Michigan Region, Detroit, MI, by telephone and fax on April 25, 2003, by letter on April 29, 2003 and by fax on June 13, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor taking the drug Evista, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MI.
_______________________________
PRODUCT
Red Blood Cells. Recall # B-0312-4.
CODE
Unit numbers: 1425795 and 1425864.
RECALLING FIRM/MANUFACTURER
Department of the Army, Womack Army Medical Center, Fort Bragg, NC, by letters dated January 23, 2002. Firm initiated recall is complete.
REASON
Blood products, which had an unsuitable sample submitted for viral testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX, and NC.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0313-4;
b) Fresh Frozen Plasma. Recall # B-0314-4.
CODE
a) Unit numbers: F139674, F139692, F139694, F139755, and
F139931;
b) Unit numbers: F139674, F139692, F139694, F139748,
F139755, and F139757.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center, Seattle, WA, by telephone on May 24, 2002, and May 30, 2002.
Manufacturer: Puget Sound Blood Center, Everett, WA. Firm initiated recall is complete.
REASON
Whole blood units, collected in 450 mL blood bags using 500 mL bag collection parameters, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units.
DISTRIBUTION
WA, and OR.
_______________________________
PRODUCT
Platelets Pheresis. Recall # B-0316-4.
CODE
Unit number 55FP18630.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Ozarks - Arkansas Region, Little Rock, AR, by telephone and letter on October 23, 2001. Firm initiated recall is complete.
REASON
Blood product, corresponding to a blood product that was possibly contaminated with Staphylococcus sp. Bacteria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Removed. Recall # B-0324-4;
b) Platelets, for Further Manufacture. Recall # B-0325-4;
c) Recovered Plasma. Recall # B-0326-4.
CODE
a), b), and c) Unit FG72999.
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence, RI, by facsimile and letter dated August 26, September 2, and September 9, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had received a tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
MA, RI, and Switzerland.
_______________________________
PRODUCT
Source Plasma. Recall # B-0340-4.
CODE
Units G-05177-139, G05362-139, G-06046-139, G-06207-139.
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, Mobile, AL, by facsimile dated July 11, 2002. Firm initiated recall is complete.
REASON
Source Plasma, that tested negative for antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), but were collected from a donor that subsequently tested anti-HIV by PCR reactive, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
Spain.
_______________________________
PRODUCT
Source Plasma. Recall # B-0341-4.
CODE
Units G-35465-139, G-35681-139, G-37746-139, G-38387-139,
G-38673-139, G-40367-139, G-40781-139, G-43934-139,
G-44045-139, G-49388-139, G-49621-139.
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, Mobile, AL, by facsimile dated February 28, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor due to behavior associated with an increased risk of infection with the human immunodeficiency virus (HIV) or the hepatitis B virus (HBV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units.
DISTRIBUTION
Spain.
_______________________________
PRODUCT
Source Plasma. Recall # B-0343-4.
CODE
Unit numbers 69292460, 69289514, 69279386, 69275999, 69271342, 69263231, 69261695, 69254116, 69252006, 69246098, 69244131, 69239182, 69236723, 69231261, 69211720, 69203664, 69197703, 69195143, 69189326, 69186837, 69180903, and 69178726.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Evansville, IN, by facsimile on September 19, 2002. Firm initiated recall is complete.
REASON
Blood products 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
22 units.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Source Plasma. Recall # B-0344-4.
CODE
Unit numbers 69158070, 69152740, 69149467, 69144295, 69140495, 69135439, 69132476, 69127441, 69123986, 69119125, 69116919, 69105425, 69103247, 69099014, 69096358, 69091995, 69089435, 69085420, 69083365, 69079733, 69076176, 69073519, and 69069512.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Evansville, IN, by facsimile on May 22, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to possible previous incarceration, were distributed.
VOLUME OF PRODUCT IN COMMERCE
23 units.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Source Plasma. Recall # B-0345-4.
CODE
Unit numbers 0181090015, 0181089703, 0181089401, 0181089172, 0181088815, 0181088543, 0181088321, 0181088052, 0181087656, 0181087416, 0181087133, 0181086834, 0181086584, 0181085724, 0181085047, 0181084848, 0181084386, 0181084056, and 0181083713.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Columbus, OH, by facsimile on June 2, 2003. Firm initiated recall is complete.
REASON
Problem: 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
19 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Whole Blood. Recall # B-0346-4.
CODE
Unit KC23347.
RECALLING FIRM/MANUFACTURER
HCSC Blood Center, Reading, PA, by telephone on October 18, 2000. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had not completed a CJD increased risk question, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.
_______________________________
PRODUCT
Red Blood Cells. Recall # B-0347-4.
CODE
Unit V05609.
RECALLING FIRM/MANUFACTURER
HCSC Blood Center, Bethlehem, PA, by telephone on August 29, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a polycythemic donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Removed. Recall # B-0348-4;
b) Plasma. Recall # B-0349-4;
c) Cryoprecipitated AHF. Recall # B-0350-4.
CODE
a), b), and c) Unit number: 22LJ67814.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by letter dated July 11, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking the medication, Imuran, for the treatment of Crohn's Disease, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
PA, and NJ.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0352-4;
b) Recovered Plasma. Recall # B-0353-4.
CODE
a) and b) Unit 34G85284.
RECALLING FIRM/MANUFACTURER
American Red Cross, New England Region, Dedham, MA, by facsimile transmission dated July 21, 2003, and by letter dated July 22, 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
NH.
_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0354-4.
CODE
Unit 36FP18739 (part 2).
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, River Valley Region, Louisville, KY, by telephone on September 3, 2003, and by letter dated September 16, 2003. Firm initiated recall is complete.
REASON
Blood product, in which the corresponding blood component was contaminated with Staphylococcus epidermidis and implicated in a transfusion reaction, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IN.
_______________________________
PRODUCT
Red Blood Cells, Irradiated. Recall # B-0355-4.
CODE
Unit V01039.
RECALLING FIRM/MANUFACTURER
HCSC Blood Center, Bethlehem, PA, by letter dated September 18, 2003. Firm initiated recall is complete.
REASON
Blood product, for which documentation of irradiation was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NJ.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0356-4.
CODE
Unit number FK76098.
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence, RI, by telephone on July 25, 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
MA.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0357-4.
CODE
Unit number FK75119.
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence, RI, by telephone on September 4, 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
RI.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0358-4;
b) Fresh Frozen Plasma. Recall # B-0359-4.
CODE
a) and b) Unit number 33GV44557.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Connecticut Region, Farmington, CT, by letter on August 15, 2003. Firm initiated recall is complete.
REASON
Blood products, 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), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CT.
_______________________________
PRODUCT
Source Plasma. Recall # B-0362-4.
CODE
Unit numbers 0590270897, 0590270641, 0590270384, 0590270107, 0590270002, and 0590269782.
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
6 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0363-4;
b) Red Blood Cells Deglycerolized. Recall # B-0364-4;
c) Platelets. Recall # B-0365-4;
d) Fresh Frozen Plasma. Recall # B-0366-4;
e) Cryoprecipitated AHF. Recall # B-0367-4;
f) Buffy Coat. Recall # B-0368-4;
g) Platelets, For Further Manufacturing into Non-
injectables. Recall # B-0369-4;
h) Recovered Plasma. Recall # B-0370-4.
CODE
a) Units 21S49030, 21S42252, 21S28365, 21S10340,21F76736,
21F68637, 21F43891, 21F31994, 21H09760, 21F04938,
21F92129, 21G83174, 21F72825, 21F66606, 21F38665,
21F30365, 21F21493, 21F09896, 21F01585, 21J30215,
21F78607, 21F47201, 21F36976, 21F28175, 21F06739,
21F98607, 21F92198, 21F78622, 21F56321, and 21F51357;
b) Unit 21F19704;
c) Units 21S49030, 21F84330, 21F68637, 21F31994, 21H09760,
21F72825, 21F66606, 21F38665, 21F30365, 21F21493,
21F09896, 21F01585, 21F47201, 21F36976, 21F19704,
21F06739, 21F98607, 21F92198, and 21F56321;
d) Units 21S10340, 21F68637, 21F31994, 21H09760, 21F92129,
21F72825, 21F66606, 21F21493, 21F09896, 21F01585,
21J30215, 21F47201, 21F36976, 21F28175, 21F19704,
21F06739, 21F98607, 21F78622, 21F56321, and 21F51357
e) Unit 21F04938;
f) Units 21F72825, 21F09896, and 21F01585;
g) Units 21S28365 and 21S10340;
h) Units 21S49030, 21S42252, 21S28365, 21F04938, 21G83174, 21F76736, and 21F43891.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Pacific Northwest Region, Portland, OR, by facsimile on March 8, 2001, May 4, 2001, and June 21, 2002, and by letters dated March 13, 2001, and April 23, 2001. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who admitted to having a history of viral hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 30 units;
b) 1 unit;
c) 19 units;
d) 21 units;
e) 1 unit;
f) 3 units;
g) 2 units;
h) 7 units.
DISTRIBUTION
OR, WA, CA, and Switzerland.
_______________________________
PRODUCT
Source Plasma. Recall # B-0371-4.
CODE
Unit numbers: 0530328359, 0530327758.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Lexington, KY, by facsimile dated December 20, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not respond to the questions regarding risk factors for variant Creutzfeldt-Jakob (vCJD) disease, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0380-4.
CODE
Unit number 13FW09470.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southeastern Michigan Region, Detroit, MI, by telephone on August 27, 2003, and by letter on September 16, 2003. Firm initiated recall is complete.
REASON
Blood product, manufactured from a unit of Whole Blood more than 8 hours after collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.
_______________________________
PRODUCT
Source Plasma. Recall # B-0381-4.
CODE
Unit numbers FW092022, FW091806, FW090219, FW090821, FW090621, FW091175, and FW091431.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Fort Wayne, IN, by facsimile on December 19, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to use of the medication Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units.
DISTRIBUTION
England.
_______________________________
PRODUCT
Human Tissue for Transplantation, Femoral Vein.
Recall #B-0388-4.
CODE
Model number V060, serial number 8042362.
RECALLING FIRM/MANUFACTURER
Cryolife, Inc., Kennesaw, GA, by letter on October 24, 2003. Firm initiated recall is complete.
REASON
Human tissue for transplantation, associated with tissue that was found to test positive for microorganisms at a different facility, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 tissue.
DISTRIBUTION
FL.
_______________________________
PRODUCT
Source Plasma. Recall # B-0389-4.
CODE
Unit numbers: G-16318-070, G-16893-070, G-17190-070,
G-17654-070.
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, Vancouver, WA, by facsimile, dated August 28, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was permanently deferred at another center for unreliable information regarding a tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
Spain.
_______________________________
PRODUCT
Source Plasma. Recall # B-0338-4.
CODE
Unit number: 02GMIB3026.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, Walker, MI, by facsimile on July 24, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose medical history questions were not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Austria.
_______________________________
PRODUCT
Source Plasma. Recall # B-0351-4.
CODE
Unit number: 02RMIA6006.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, Grand Rapids, MI, by facsimile dated December 30, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.
_______________________________
PRODUCT
Platelets, Leukocytes Reduced. Recall # B-0360-4.
CODE
Unit number 33GM19732.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Connecticut Region, Farmington, CT, by letter on September 19, 2003. Firm initiated recall is complete.
REASON
Blood product, manufactured from a unit of Whole Blood that had a discrepant collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CT.
_______________________________
PRODUCT
Plasma. Recall # B-0361-4.
CODE
Unit number 04GK60233.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by telephone on July 31, 2003, and by letter on August 5, 2003. Firm initiated recall is complete.
REASON
Blood product, stored at an incorrect temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MA.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0372-4.
CODE
Unit number 9580555.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Beaumont, TX, by telephone on March 31, 2003, and by facsimile on April 3, 2003. Firm initiated recall is complete.
REASON
Blood product, that was not properly quarantined after the donor of the product reported a post donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.
_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Removed. Recall # B-0373-4.
CODE
Unit number: 7789458.
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Indianapolis, IN, by telephone on October 20, 2003, and by letter on October 22, 2003. Firm initiated recall is complete.
REASON
Leukoreduced product, that had a white blood cell count performed using a sample exceeding the time frame requirement for analysis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IN.
_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-0393-4.
CODE
Unit number: 20GR15206.
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Boise, ID, by telephone on August 9, 2002.
Manufacturer: American Red Cross Blood Services, Great Falls, MT. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who failed to answer the question whether any vaccinations had been received in the past four weeks, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MT.
_______________________________
PRODUCT
Calculator/Data Processing Module for Clinical Use. Recall
# Z-0007-04.
CODE
Versions 5.2, 5.23, and 5.3.
RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Tucson, AZ, by facsimile on August 12, 2003. Firm initiated recall is ongoing.
REASON
Software defect. Clinical Laboratory results failing quality assurance were filed directly to a patient's chart without review.
VOLUME OF PRODUCT IN COMMERCE
479.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
FastPack Total Testosterone Immunoassay. Device to
determine quantitative total testosterone in human serum.
Catalog #: 25000009. Recall # Z-0090-04.
CODE
Lots: 0307042, 0308019, and 0308020.
RECALLING FIRM/MANUFACTURER
Qualigen Inc., Carlsbad, CA, by letter starting September 24, 2003. Firm initiated recall is ongoing.
REASON
Kits may produce results that are falsely elevated.
VOLUME OF PRODUCT IN COMMERCE
81.
DISTRIBUTION
Nationwide and Switzerland.
_______________________________
PRODUCT
Misys Laboratory System. Recall # Z-0151-04.
CODE
Versions 5.2, 5.23, 5.3 up to 5.3.2.
RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Tucson, AZ, by fax on July 7, 2003. FDA initiated recall is ongoing.
REASON
Software defect causes orders to be lost under certain conditions of use. A typographical error at the Accept/Modfy/Reject prompt will cause the order not to be processed by the system.
VOLUME OF PRODUCT IN COMMERCE
473.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
100 inch (254 cm) 15 Drop Administration Set with FlowSafe Flow Controller and Max Y Connector, 50 per box. Product No. MFS102. Recall # Z-0152-04.
CODE
Lots D316302 and D323912.
RECALLING FIRM/MANUFACTURER
Maximus Medical Products Inc, Costa Mesa, CA,
REASON
Mislabeled with wrong drop size drip chamber specification.
VOLUME OF PRODUCT IN COMMERCE
63 cases.
DISTRIBUTION
CO, and PA.
_______________________________
PRODUCT
a) Midwest Tradition PB Non-Fiber Optic High Speed
Handpiece with Push Button Chuck (4 tube connection),
catalog #790044. Recall # Z-0154-04;
b) Midwest Tradition PB Fiber Optic High Speed Handpiece
with Push Button Chuck (5 tube connection), catalog
#790045 and 790045T. Recall # Z-0155-04;
c) Midwest XGT High Speed Handpiece with Fiber Optics and
Push Button Chuck, catalog #790000. Recall # Z-0156-04;
d) Midwest Tradition PB High Speed Handpiece with Push
Button Chuck, catalog #790042. Recall # Z-0157-04.
CODE
a) Chuck manufacturing lot numbers 7/15/03, 7/25/03,
8/12/03, 8/14/03; handpiece serial numbers 52038725
through 52429358. Not all units in the serial number
range were affected. 230 units were sold new with
affected chucks and 259 units were repaired with the
affected chucks.
b) Chuck manufacturing lot numbers 7/15/03, 7/25/03,
8/12/03, 8/14/03; handpiece serial numbers 52336288
through 52429923. Not all units in the serial number
range were affected. 446 units were sold new with
affected chucks and 252 units were repaired with the
affected chucks.
c) Chuck manufacturing lot numbers 7/15/03, 7/25/03,
8/12/03, 8/14/03; handpiece serial numbers 60007550,
60009370, 110298025 and 600000215 through 600018298. Not
all units in the serial number range were affected. 388
units were repaired with the affected chucks.
d) Chuck manufacturing lot numbers 7/15/03, 7/25/03,
8/12/03, 8/14/03; handpiece serial numbers 52327547,
52343124, 52372259, 52417392.
RECALLING FIRM/MANUFACTURER
DentSply-Professional Division, Des Plaines, IL, by telephone and letters on October 14-16, 2003. Firm initiated recall is ongoing.
REASON
Small Cracks in the dental handpiece's chuck could allow the dental burs to drift out of the chuck over time.
VOLUME OF PRODUCT IN COMMERCE
1,579 chuck assemblies.
DISTRIBUTION
Nationwide, Canada and Mexico.
_______________________________
PRODUCT
a) UHF Cardiac Pigtail non-wirebraid, 7F, 110 cm,
Angiographic Catheter, Sterile, Merit Medical. Catalog
Number7779-10. Recall # Z-0158-04;
b) UHF Grollman Pigtail Long Tip Non-wirebraid, 7FG, 110
cm, Angiographic Catheter, Sterile, Merit Medical.
Catalog Number 5614-A0. Recall # Z-0159-04.
CODE
a) Lots G270628, G283744, G260778;
b) Lot G260778.
RECALLING FIRM/MANUFACTURER
Merit Medical Systems, Inc, South Jordan, UT, by sales representatives on November 5-7, 2003. Firm initiated recall is complete.
REASON
Angiographic catheter tips may separate during use.
VOLUME OF PRODUCT IN COMMERCE
442 units.
DISTRIBUTION
FL, MI, NY, PA, TN, and TX.
______________________________
PRODUCT
a) Reusable Catheter Passer (40 cm) SP01. One stainless
steel catheter passer with T handle. Catalog number
SP01. Recall # Z-0160-04;
b) Reusable Catheter Passer (60 cm) SP02. One stainless
steel catheter passer with T handle. Catalog number
SP02. Recall # Z-0161-04.
CODE
a) Lot numbers H0359, J0107, and J0493;
b) Lot numbers H0266, H0464, H0565, H0650, I0195, J0288,
J0108, J0494, K0701, and K0929.
RECALLING FIRM/MANUFACTURER
Vygon US LLC, Norristown, PA, by letters on September 9, 2003. Firm initiated recall is complete.
REASON
Mislabeled as sterile.
VOLUME OF PRODUCT IN COMMERCE
29 units.
DISTRIBUTION
NY, TX, UT, and Internationally.
_______________________________
PRODUCT
URO PRO Plus Digital Urology Imaging System. Recall # Z-0162-04.
CODE
Serial Numbers: UR2003-006 UR2001-006 UR2002-010 UR2003-004 UR2001-2R03.
RECALLING FIRM/MANUFACTURER
Medstone International, Inc., Aliso Viejo, CA, by safety alert on July 29, 2003 and August ll, 2003. Firm initiated recall is complete.
REASON
X-ray tube arm and collimator fell and fractured patient's ribs.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
NM, NV, WA, and CA.
_______________________________
PRODUCT
ICON 25 hCG Test Kit. Recall # Z-0163-04.
CODE
Lot hCG030303.
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by letter on October 31, 2003. FDA initiated recall is ongoing.
REASON
False negative urine results are being observed at an increasing rate.
VOLUME OF PRODUCT IN COMMERCE
9,040.
DISTRIBUTION
Nationwide and Canada.
_______________________________
PRODUCT
AEROSET Immunoglobulin M, list number 1E01-01.
Recall # Z-0165-04.
CODE
All lots.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories Diagnostic Div., South Pasadena, CA,
REASON
Assay may produce falsely low IgM results without error codes when testing specimens contain elevated serum paraproteins associated with various myeloma or other malignancies.
VOLUME OF PRODUCT IN COMMERCE
205.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
Portex Spinal Tray with 25G Whitacre Needle. Kit contains Bupivacaine in Dextrose, Epinephrine,Lidocaine, Lidocaine in Dextrose and Tetracaine. Catalog Number: 15545-20. Recall # Z-0166-04.
CODE
Lot number: K203631 Exp. Date: 2004-08.
RECALLING FIRM/MANUFACTURER
Portex Inc., Keene, NH, by letter on October 10, 2003. Firm initiated recall is ongoing.
REASON
Spinal trays labeled as containing a Whitacre 25g x 3.5' needle actually contain a Quincke 25g x 3.5' needle.
VOLUME OF PRODUCT IN COMMERCE
2,600 units.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
CeyoValve Pulmonary Valve & Conduct. Model Number PV00. Recall # Z-0167-04.
CODE
Serial Number 8041312.
RECALLING FIRM/MANUFACTURER
Cryolife, Inc., Kennesaw, GA, by letter on November 4, 2003. Firm initiated recall is ongoing.
REASON
CryoLife received information that an allograft associated with the donor had been linked to a complaint of an alleged positive pre-implant culture. Specifically Clostridium baratii was detected on the pre-implant culture performed at the implanting hospital site.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MO.
_______________________________
PRODUCT
Paradigm Model 511 Insulin Infusion Pumps. Recall # Z-0168-04.
CODE
All.
RECALLING FIRM/MANUFACTURER
Medtronic MiniMed, Northridge, CA, by letter on August 29, 2003 and September 12, 2003. Firm initiated recall is complete.
REASON
Water ingresses into the device when in prolonged contact with water causing device to malfunction.
VOLUME OF PRODUCT IN COMMERCE
61,000.
DISTRIBUTION
Nationwide and Canada.
_______________________________
PRODUCT
Ambulatory infusion pump. Model 511. Recall # Z-0169-04.
CODE
All.
RECALLING FIRM/MANUFACTURER
Medtronic MiniMed, Northridge, CA, by letter on February 15, 2002, and in the "Positive Pumping Newsletter winter (2002/2003) edition. Firm initiated recall is ongoing.
REASON
Non delivery of insulin by pump after electrostatic discharge.
VOLUME OF PRODUCT IN COMMERCE
17,000.
DISTRIBUTION
Nationwide, Canada and possibly International.
END OF ENFORCEMENT REPORT FOR DECEMBER 10, 2003
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Hypertext created by clb 2003-DEC-10.