April 16, 2003
03-16
_________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0410-3;
B) Fresh Frozen Plasma. Recall # B-0411-3.
CODE
a) 42G39702, 42X62136, 42W28305, 42FJ09119, 42FJ09128;
b) 42Q76487, 42G39702, 42X62136, 42W28305, 42FJ09119,
42FJ09128.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Cleveland, OH, by telephone or letter on August 29, 2002, September 26 and 27, 2002, and October 2, 2002. Firm initiated recall is complete.
REASON
Blood products, corresponding to Platelets that were implicated in a transfusion reaction and positive for Escherichia coli, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 5 units;
b) 6 units.
DISTRIBUTION
OH.
_________________________________
PRODUCT
Source Plasma. Recall # B-0666-3.
CODE
G-92677-030, G-99578-030, G-99995-030, G-05303-030,
G-06063-030, G-06820-030, G-07024-030, G-08464-030,
G-09008-030, G-09260-030, G-09781-030, G-10128-030,
G-10738-030, G-11015-030, G-11384-030, G-11670-030,
G-12021-030, G-12290-030, G-12719-030, G-12999-030,
G-13317-030, F-00119-030, F-00560-030, F-00873-030,
F-01239-030.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Alpha Therapeutic Corporation, Los Angeles, CA., by facsimile dated December 12, 2002.
Manufacturer: Alpha Therapeutic Corporation, Youngstown, OH. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
25 units.
DISTRIBUTION
NC and Spain.
_________________________________
PRODUCT
Cornea. Recall # B-0714-3.
CODE
ID number 2003-01-2012.
RECALLING FIRM/MANUFACTURER
Heartland Lions Eye Bank, Columbia, OH., by telephone and by letter on February 4, 2003. Firm initiated recall is complete.
REASON
Human cornea, collected from a donor with discordant Hepatitis B Virus test result, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 tissue.
DISTRIBUTION
MO.
_________________________________
PRODUCT
Source Plasma. Recall # B-0731-3.
CODE
Unit numbers 00SWIA2622, 00SWIA3354, 00SWIA3583, 00SWIA4162, 00SWIA5584, 00SWIA5882, 00SWIA6999, 00SWIA7615, 00SWIB0212, 00SWIB1272, 00SWIB1855, 00SWIB3389, 00SWIB3588, 00SWIB4829, 00SWIB5089, 00SWIB5865, 00SWIC0242, 00SWIC2977, 00SWIC3289, 00SWIC4019, 00SWIC4553, 00SWIC5680, 00SWIC6316, 00SWIC9376, 00SWID6969, 00SWID7436, 00SWID8031, 00SWIE6420, 01SWIA1677, and 01SWIA4074.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Community Bio-Resources, Inc., Hoover, AL, by facsimile on March 23, 2001.
Manufacturer: Community Bio-Resources, Inc. (now known as BioLife Plasma Services, L.P.), Sheboygan, WI. Firm initiated recall is complete.
REASON
Blood products 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
30 units.
DISTRIBUTION
Austria.
_________________________________
PRODUCT
Red Blood Cells, Leukoreduced. Recall # B-0740-3.
CODE
Unit 18FT60375.
RECALLING FIRM/MANUFACTURER
American Red Cross/Great Lakes Region, Lansing, MI., by letter dated July 15, 2002. Firm initiated recall 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
MI.
_________________________________
PRODUCT
a) Red Blood Cells, Leukoreduced. Recall # B-0742-3;
b) Liquid Plasma. Recall # B-0743-3.
CODE
a) and b) Unit 18226-4565.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Cheyenne, WY., by letter or fax dated September 11 or 12, 2002. Firm initiated recall is ongoing.
REASON
Blood products, collected from a donor whose health history screening was not adequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
AZ and VA.
_________________________________
PRODUCT
a) Red Blood Cell, Leukoreduced. Recall # B-0746-3;
b) Red Blood Cells. Recall # B-0747-3;
c) Recovered Plasma. Recall # B-0748-3.
CODE
a) Units 12GE59530, 12GE57901, 12KE69479, 12GE53417,
12GH97160, 12GH95057, 12GE49248;
b) Unit 12GE47945;
c) Units 12GE59530, 12GE57901, 12KE69479, 12GE53417,
12GH97160, 12GH95057, 12GE49248, 12GE47945.
RECALLING FIRM/MANUFACTURER
American Red Cross, Carolinas Regional Blood Services, Charlotte, NC, by letter dated July 29, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of Multiple Sclerosis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 7 units;
b) 1 unit;
c) 8 units.
DISTRIBUTION
AL, CA, NC and Switzerland.
_________________________________
PRODUCT
Platelets, Irradiated. Recall # B-0749-3.
CODE
Unit number G05352.
RECALLING FIRM/MANUFACTURER
Tacoma-Pierce County Blood Bank, Cascade Regional Blood Services, Tacoma, WA, by telephone on February 1, 2002 and by letter on March 13, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to recent ingestion of aspirin, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WA.
_________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0753-3.
CODE
Unit number V38930.
RECALLING FIRM/MANUFACTURER
Tacoma-Pierce County Blood Bank, Cascade Regional Blood Services, Tacoma, WA, by telephone and letter on March 22, 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
WA.
_________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0754-3.
CODE
Unit numbers LE02356, FK64681, and LE10477.
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc, dba: Rhode Island Blood Center, Providence, RI, by letter on December 16, 2002. 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
3 units.
DISTRIBUTION
RI.
_________________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-0755-3.
CODE
Unit number FG65545.
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc, dba: Rhode Island Blood Center, Providence, RI, by telephone on December 6, 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 risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
RI.
_________________________________
PRODUCT
a) Red Blood Cells. Recall # B-0761-3;
b) Red Blood Cells, leukocytes Reduced. Recall # B-0762-3;
c) Platelets, Pooled (1 pool). Recall # B-0763-3.
CODE
a) Unit number 0857951;
b) Unit number 0883232;
c) Pool number 0081666.
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, OH, by letter dated September 4, 2002.
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, 1 pool.
DISTRIBUTION
OH.
_________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0764-3;
b) Platelets. Recall # B-0765-3.
CODE
a) and b) unit number 01Q57350.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New York-Penn Region, West Henrietta, NY, by letter on June 18, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on living in an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NY.
_________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0766-3;
b) Recovered Plasma. Recall # B-0767-3.
CODE
a) and b) 01GN58178.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New York-Penn Region, West Henrietta, NY, by facsimile and electronic mail on June 14, and 19, 2002. Firm initiated recall is complete.
REASON
Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NY, and CA.
_________________________________
PRODUCT
Source Plasma. Recall # B-0769-3.
CODE
Unit numbers GFDRQM, CBZCBC, CBYYBN, CBYXQB, CBMZDS, CBMYYC, CBMXBV, CBMWRX, CBMVNB, and CBMVBZ.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aventis Bio-Services, Inc., Knoxville, TN, by facsimile on January 7, 2003.
Manufacturer: Aventis Bio-Services, Inc., Columbus, OH. Firm initiated recall is complete.
REASON
Blood products, that tested negative for antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2) and hepatitis B surface antigen (HBsAg), but were collected from a donor subsequently determined to have previously tested reactive for HIV and HBV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units.
DISTRIBUTION
IL.
_________________________________
PRODUCT
Source Plasma. Recall # B-0770-3.
CODE
Unit numbers 46421265, 46422330, 46427694, 46430205, 55973984, 55976299, 55979764, 56721812, 56725117, 56727340, 56450965, 56453430, 56458961, 58292235, 58294000, 58299821, 58302484, and 58308639.
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services L.P., Deerfield, IL, by facsimile on November 7, 2001.
Manufacturer: BioLife Plasma Services L.P., Dayton, OH. Firm initiated recall is complete.
REASON
Blood products, collected from a donor that was not tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
18 units.
DISTRIBUTION
CA.
_________________________________
PRODUCT
Red Blood Cells, Leukoreduced. Recall # B-0778-3.
CODE
Units 04KF56293, 04KF53542.
RECALLING FIRM/MANUFACTURER
American Red Cross, New England Region, Dedham, MA, by letter dated November 18, 2002. Firm initiated recall 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 NY.
_________________________________
PRODUCT
Red Blood Cells. Recall # B-0780-3;
Platelets. Recall # B-0781-3;
Recovered Plasma. Recall # B-0782-3;
Fresh Frozen Plasma. Recall # B-0783-3.
CODE
a) and b) Units 04P959310, 71C106262;
c) Unit 04P959310;
d) Unit 71C106262.
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Center, Gainesville, FL, by e-mail on January 2, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on a history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 2 units;
b) 2 units;
c) 1 unit;
d) 1 unit.
DISTRIBUTION
FL.
_________________________________
PRODUCT
Red Blood Cells, Leukoreduced. Recall # B-0785-3.
CODE
Unit number 40FZ27478.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Heart of America Region, Peoria, IL, by telephone on January 24, 2003, and by letter dated January 30, 2003. Firm initiated recall is complete.
REASON
Blood product was not irradiated properly but was distributed with labeling that indicated that the unit had been irradiated.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.
_________________________________
PRODUCT
a) Red Blood Cells. Recall # B-0787-3;
b) Platelets. Recall # B-0788-3;
c) Fresh Frozen Plasma. Recall # B-0789-3;
d) Recovered Plasma. Recall # B-0790-3.
CODE
a) Units 71C43146-4, 71C93756-7;
b) and c) Unit 71C93756-7;
d) Unit 71C43146-4.
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Center, Gainesville, FL, by electronic mail on March 27, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who lived in an HIV Group O risk area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
FL.
_________________________________
PRODUCT
Red Blood Cells. Recall # B-0792-3.
CODE
Unit number FE79325.
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Blood Donor Services, Annandale, VA, by telephone on July 1, 2002, and by letter on July 3, 2002. Firm initiated recall is complete.
REASON
Blood product collected from a donor that did not answer one of the history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV).
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0795-3;
b) Platelets. Recall # B-0796-3;
c) Cryoprecipitated AHF. Recall # B-0797-3;
d) Plasma, Cryoprecipitate Reduced. Recall # B-0798-3.
CODE
a), b), c), and d) Unit number 0108892.
RECALLING FIRM/MANUFACTURER
LifeShare, Inc., Elyria, OH, by telephone and facsimile on January 27, 28, and 31, 2003. 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), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
OH, and PA.
_________________________________
PRODUCT
Recovered Plasma. Recall # B-0799-3.
CODE
Unit number 53GF44774.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by facsimile on October 4, 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), were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_________________________________
PRODUCT
Platelets. Recall # B-0800-3.
CODE
Unit numbers 1956309, 1956410, 1956642, and 1958948.
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Centers, Inc., Lexington, KY, by letter dated January 23, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to recent ingestion of aspirin, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
KY.
_________________________________
PRODUCT
Cryoprecipitated AHF. Recall # B-0801-3;
Plasma, Cryoprecipitate Reduced. Recall # B-0802-3.
CODE
a) and b) Unit number 29KL25570.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Mid-Atlantic Region, Norfolk, VA, by letter dated August 15, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor due to a history of jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
VA, and NC.
_________________________________
PRODUCT
Source Plasma. Recall # B-0803-3.
CODE
Unit numbers G-94688-032, G-94916-032, G-97348-032, G-97564-032, G-97985-032, and G-98185-032.
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, Charleston, WV, by facsimile on October 23, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on ear piercing within the previous twelve months, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
NC.
_________________________________
PRODUCT
Source Plasma. Recall # B-0805-3.
CODE
Units BYDQMT, BYDRZM, BYD SGM, BYDSTG, BYDTBM, BYDVHQ, BYDVST, BYDWGB, BYDWNL, BYDXBY, BYDXKK, BYDZYF, BYFBKD, and BYFBYK.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Charlotte, NC, by letter dated May 31, 2002. Firm initiated recall is complete.
REASON
Blood products, which tested negative for hepatitis B surface antigen (HbsAg) but were collected from a donor who previously tested repeatedly reactive for HbsAg, were distributed.
VOLUME OF PRODUCT IN COMMERCE
14 units.
DISTRIBUTION
IL, and Germany.
_________________________________
PRODUCT
Source Plasma. Recall # B-0806-3.
CODE
Unit numbers 0530326764, 0530328571, 0530328103, 0530327750, 0530327159, 0530326531, 0530326248, 0530325600, 0530324765, 0530324071, 0530323763, 0530322826, 0530322737, 0530322048, 0530321819, 0530321207, 0530320917, 0530320329, 0530319966, 0530319296, 0530319029, 0530318163, 0530317792, 0530317387, 0530317032, 0530316602, 0530316061, 0530315591, 0530315136, 0530314782, 0530314302, 0530313989, 0530313434, 0530313092, 0530312601, 0530311787, 0530328774, 0530328253, 0530327934, 0530327387, 0530327145, 0530328031, 0530327183, 0530327474, 0530326853, 0530326281, 0530326025, 0530325242, 0530324868, 0530323703, 0530321871, 0530321369, 0530320934, 0530320080, 0530327845, 0530327272, 0530326849, 0530328729, 0530328430, 0530328333, 0530327721, 0530326912, 0530328792, 0530328057, 0530327573, 0530328366, 0530322145, 0530321750, 0530320919, 0530328448, 0530327282, 0530328550, 0530328893, 0530328476, 0530328381, 0530328227, 0530327128, 0530328187, 0530328267, 0530327703, 0530327188, 0530326760, 0530328456, 0530328240, 0530327423, 0530327175, 0530326671, 0530326133, 0530325438, 0530321794, 0530326185, 0530324728, 0530323292, 0530322509, 0530322225, 0530321559, 0530320762, 0530319001, 0530318445, 0530315757, 0530315243, 0530314899, 0530314422, 0530313902, 0530313532, 0530313048, 0530312701, 0530312271, 0530324760, 0530324403, 0530323921, and 0530317793.
RECALLING FIRM/MANUFACTURER
Recalling Firm: ZLB Bioplasma, Inc., Boca Raton, FL, by facsimiles between November 19, 2002, and December 20, 2002.
Manufacturer: ZLB Bioplasma, Inc., Lexington, KY. Firm initiated recall is complete.
REASON
Blood products, collected from donors 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
112 units.
DISTRIBUTION
NC.
_________________________________
PRODUCT
Red Blood Cells. Recall # B-0820-3.
CODE
Unit number 9296847.
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on April 25, 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
LA.
_________________________________
PRODUCT
Red Blood Cells. Recall # B-0821-3.
CODE
Unit number 9288868.
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone and facsimile on October 9, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from a donor that did not answer 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
1 units.
DISTRIBUTION
LA, and Switzerland.
_________________________________
PRODUCT
Red Blood Cells. Recall # B-0823-3.
CODE
Unit number 9338626.
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on August 7, 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
LA.
_________________________________
PRODUCT
Red Blood Cells. Recall # B-0416-3.
CODE
Units W95041, W95039, W95529, R73771.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Inc., Richmond, VA, by telephone on October 2, 2002, and by letter dated October 18, 2002. Firm initiated recall is complete.
REASON
Blood products, corresponding to pooled Platelets that were implicated in a transfusion reaction, and tested positive for gram negative rods, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
VA.
_________________________________
PRODUCT
Platelet, Pheresis (Split unit). Recall # B-0713-3.
CODE
Unit 084C 25909.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Northern California Region, Oakland, CA, by telephone on April 27, 2000, and by letter dated May 10, 2000. Firm initiated recall is complete.
REASON
Blood products, which were not manufactured within the acceptable time frame from collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.
_________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0732-3.
CODE
Unit number KC12768.
RECALLING FIRM/MANUFACTURER
BloodSource -Sacramento (formerly the Sacramento Medical Foundation Blood Center), Sacramento, CA, by telephone on December 11, 2000. 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
CA.
_________________________________
PRODUCT
a) Red Blood Cells. Recall # B-0733-3;
b) Red Blood Cells, Leukocytes Reduced. Recall # B-0734-3;
c) Red Blood Cells, Washed. Recall # B-0735-3;
d) Red Blood Cells, Irradiated. Recall # B-0736-3.
CODE
a) Unit numbers 01FC06931, 01FC07185, 01FC07186, 01FC07187,
01FC07188, 01FC07189, 01FC07192, 01GC46602, 01GC48268, 01GC48269, 01GC49000, 01GC49001, 01GC49002, 01GG34436, 01GG47315, 01GG47631, 01GG50523, 01GG51552, 01GG51553, 01GG51554, 01GG51555, 01GG51602, 01GG51603, 01GG53257, 01GG53545, 01GG53546, 01GG57558, 01GG57564, 01GJ40204, 01GJ40205, 01GL33738, 01GL41669, 01GL44448, 01GL45317, 01GL45318, 01GL45319, 01GL45320, 01GL50131, 01GL50132, 01GL51865, 01GL55946, 01GL55949, 01GL56146, 01GL56410, 01GL56411, 01GN40247, 01GN41540, 01GN41541, 01GN42670, 01GN42677, 01GN43225, 01GN43226, 01GN46659, 01GN49749, 01GN49750, 01GN49751, 01GY41249, 01GY45037, 01GY48353, 01GY51551, 01GY51980, 01GY51981, 01GY51982, 01GY52493, 01GY52713, 01GY52714, 01GY52715, 01GY52716, 01GY53559, 01GY53560, 01GY53696, 01GY54335, 01GY54336, 01GY54337, 01GY55136, 01GY55138, 01GY55588, 01GY55589, 01GY55590, 01GY55591, 01GY55592, 01GY55593, 01GY55594, 01GY55595, 01GY55596, 01GY56024, 01GY56025, 01GY56631, 01GY56632, 01GY57144, 01GY58238, 01GY58237, 01GY58382, 01GY58383, 01GY59125, 01GY59126, 01GY59127, 01GY59129, 01GY59130, 01LC33380, 01LC33385, 01LC34714, 01LC34715, 01LC35807, 01LC35808, 01LC35809, 01LE22616, 01LE22617, 01LE22618, 01LE22687, 01LE22692, 01LE22697, 01LE23471, 01LE23473, 01LE23474, 01LE23475, 01LE23477, 01LE23478, 01LE23810, 01LE23811, 01LE24176, 01LE24177, 01LE24179, 01LE24180, 01LE24181, 01LE24408, 01LE24409, 01LE24471, 01LE24472, 01LE25087, 01LE25088, 01LF07023, 01LF07028, 01LF07301, 01LF07302, 01LH36320, 01LH36767, 01LN20930, 01LN21252, 01LN21253, 01LN21976, 01LN21977, 01LN22430, 01LN22431, 01LN22426, 01LN24735, 01LN24736, 01LP40052, 01LP40053, 01LS24347, 01LS27007, 01LS27040, 01LS27759, 01LS27761, 01LS28059, 01LS28060, 01LS28061, 01LS28352, 01LS28353, 01LS28355, 01LS30230, 01LS30231, 01LS30382, 01LS30383, 01LS30384, 01LS30385, 01LS30386, 01LT29415, 01LT29416, 01LT31048, 01LT31049, 01LT31451, 01LT31452, 01LV36450, 01LV37608, 01LV41382, 01LV42207, 01LV42389, 01LV42386, 01LV42491, 01LV43664, 01LV43665, 01LV43666, 01LV43667, 01LW20365, 01LW20366, 01LW20363, 01LW20361, 01LW20431, 01LW22573, 01LW22572, 01LW22568, 01LW22567, 01LW23627, 01LW24124, 01LY13193, 01LY14689, 01LY14690, 01LY14691, 01LY14692, and 01Y26249;
b) Unit numbers 01GN49355, 01GN49354, 01GN59157,
01GN59155, 01GY68152, 01GY68153, 01GY68154,
01GY68155, 01LC41079, 01LE28742, and 01LE28739;
c) Unit number 01LW24123;
d) Unit numbers 01LV42490 and 01LY13192.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New York-Penn Region, West Henrietta, NY, by letters dated May 29, and 30, 2002. Firm initiated recall is complete.
REASON
Blood products, manufactured by a method that may have resulted in the products being out of specification for hematocrit, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 201 units;
b) 11 units;
c) 1 unit;
d) 2units.
DISTRIBUTION
NY, PA, and MD.
_________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced Irradiated.
Recall # B-0737-3;
b) Platelets Pheresis, Leukocytes Reduced Irradiated.
Recall # B-0738-3;
CODE
a) Unit number 035FC45849;
b) Unit number 035P37754.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Appalachian Region, Roanoke, VA, by letters on July 23, 2002, and August 28, 2002. Firm initiated recall is complete.
REASON
Blood products that were possibly exposed to unacceptable temperatures when removed from controlled storage for irradiation were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
VA.
_________________________________
PRODUCT
Red Blood Cells. Recall # B-0741-3.
CODE
Unit 8231911.
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Inc., Indianapolis, IN, by telephone on January 10, 2003. Firm initiated recall is complete.
REASON
Unlicensed blood product was distributed interstate.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.
_________________________________
PRODUCT
a) Platelets. Recall # B-0744-3;
b) Platelet, Pheresis. Recall # B-0745-3.
CODE
a) Units 18FS65072, 18FS65077, 18FV42377,
18FZ30105, 18GN17108, 18N82282;
b) Units 18P50566, 18P50563, 18P50562, 18P50557,
18P50556, 18P50558, 18P50560.
RECALLING FIRM/MANUFACTURER
American Red Cross, Great Lakes Region, Lansing, Michigan, by telephone on July 13, 2002. Firm initiated recall is complete.
REASON
Blood products, which were exposed to room temperature for an unacceptable resting time, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 6 units;
b) 7 units.
DISTRIBUTION
MI.
_________________________________
PRODUCT
Recovered Plasma. Recall # B-0822-3.
CODE
Unit number 9288868.
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone and facsimile on October 9, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from a donor that did not answer 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
1 units.
DISTRIBUTION
LA, and Switzerland.
_________________________________
PRODUCT
Disetronic D-TRON Insulin Infusion Pump, Models 8100001 D-TRON (blue) and 8100005 D-TRON (anthracite). Recall # Z-1350-02. This correction was previously classified as a Class II. The health risk was reevaluated after receipt of new information.
CODE
All Serial numbers.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Disetronic Medical Systems, Inc. St. Paul, MN, by letter dated June 17, 2002.
Manufacturer: Disetronic Medical Systems AG Burgdorf, Switzerland. Firm initiated recall is ongoing.
REASON
Some pumps started programming a bolus that was not initiated by the pump user, and the delivery of an unintended bolus was made unless interrupted by the device user.
VOLUME OF PRODUCT IN COMMERCE
3357 insulin infusion pumps.
DISTRIBUTION
Nationwide.
_________________________________
PRODUCT
Homepump Eclipse Infusion Pump, Disposable Elastomeric Infusion System (100 ml x 50 ml/hr) Model E100500,
Part No. 5001065. Recall # Z-0687-03.
CODE
Lot 262074.
RECALLING FIRM/MANUFACTURER
I-Flow Corporation, Lake Forest, CA., by fax on March 4, 2003, and telephone on March 5, 2003. Firm initiated recall is ongoing.
REASON
Product infuses too fast at rate of 30 minutes instead of 2 hours. Component mix-up.
VOLUME OF PRODUCT IN COMMERCE
2,832 units.
DISTRIBUTION
CA, OH, WA,TX,UT, SC, MI, IL.
_________________________________
PRODUCT
HeartMate Stroke Volume Limiter (SVL) Catalog # 1295. Recall # Z-0688-03.
CODE
All Codes.
RECALLING FIRM/MANUFACTURER
Thoratec Corp., Pleasanton, CA., by Safety Bulletin and Safety Instructions on February 7, 2003. Firm initiated recall is ongoing.
REASON
Driveline tubing connections on the SVL if under STRESS condition may snap off, VAD support is compromised, a serious injury or death can occur.
VOLUME OF PRODUCT IN COMMERCE
203.
DISTRIBUTION
Nationwide and Internationally.
_________________________________
PRODUCT
a) AxSYM Tricyclic Antidepressants Reagent.
Recall # Z-0689-03;
b) Adx Tricyclic Antidepressants Reagent.
Recall # Z-0690-03;
c) TDx/TDxFlx Tricyclic Antidepressant Reagent.
Recall # Z-0691-03.
CODE
a) List No. 3B34-20;
b) List No. 9681-55;
c) List No. 9681-60.
RECALLING FIRM/MANUFACTURER
Abbott Health Products, Inc., Barceloneta, PR, by letter on December 11, 2002. Firm initiated recall is ongoing.
REASON
Unexpected false positive TCA results.
VOLUME OF PRODUCT IN COMMERCE
7,049 units.
DISTRIBUTION
Nationwide, and Internationally.
_________________________________
PRODUCT
a) Tachos DR-Implantable Cardioverter Defibrillator.
Recall # Z-0700-03;
b) Deikos A+ Implantable Cardioverter Defibrillator.
Recall # Z-0701-03;
c) Tachos DR - Atrial TX Implantable Cardioverter
Defibrillator. Recall # Z-0702-03.
CODE
a) Model No. 355 572 Serial Nos. 78011361, 78011362,
78011364, 78011365, 78011376, 78011378-78011385,
78011389-78011414, 78011416-78011424, 78011426-78011430,
78011432-78011464, 78011466-78011491, 78011493-78011499,
78011600-78011617, 78011619, 78011621-78011639,
78011641, 78011643, 78011647-78011654,
78011656-78011660, 78011684-78011686, 78011689,
78011691, 78011692, 78011699-78011701,
78011704-78011708, 78011713, 78011720-78011723,
78011730-78011743, 78011745-78011758, 78011764-78011768,
78011779;
b) Model No. 334 341 Serial Nos. 78062821, 78062822,
78062831, 78062838, 78062839, 78062901, 78062957;
c) Model No. 122 499 Serial Nos. 78010961, 78012035,
78012076, 78012077, 78012083, 78012090-78012092,
78012103-78012105, 78012109-78012111, 78012117-78012120,
78012122-78012125, 78012127, 78012132, 78012163,
78012197, 78012236, 78012292, 78012296,
78012298-78012302, 78012352, 78012354, 78012355,
78012366, 78012369, 78012374, 78012386, 78012413,
78012415, 78012564, 78012652.
RECALLING FIRM/MANUFACTURER
Biotronik, Inc., Lake Oswego, OR, by letter dated February 21, 2003. Firm initiated recall is ongoing.
REASON
Potential for battery to delivery less than full amount of energy.
VOLUME OF PRODUCT IN COMMERCE
a) 240 devices;
b) 7 devices;
c) 49 devices.
DISTRIBUTION
Nationwide.
________________________________
PRODUCT
Glitter Eyes (tefilcon), daily wear soft (hydrophilic) contact lenses packed as single units or kits in multiple glass vials. Recall # Z-0703-03.
CODE
Green, PID Lot#NA, Button Lot#22940-32,
Blue, PID Lot#40523337, Button Lot#22940-32,
Bronze, PID Lot#40538359, Button Lot#22940-32,
Violet, PID Lot#40522198, Button Lot #22940-32,
Green, PID Lot#40581596, Button Lot#22985-95,
Blue PID Lot 40550786, Button Lot#22620-19,
Blue PID Lot#40505677, Button Lot#22620-20,
Bronze PID Lot#40540880, Button Lot#22620-19,
Violet, PID Lot#40543810, Button Lot#22620-19.
RECALLING FIRM/MANUFACTURER
Ciba Vision Corporation, Duluth, GA, via traceable mail on/about March 17, 2003. Firm initiated recall is ongoing.
REASON
The lens may partially 'delaminate' in the area of one of the encapsulated cosmetic prints.
VOLUME OF PRODUCT IN COMMERCE
29,821 units.
DISTRIBUTION
Nationwide, Canada, and Puerto Rico.
_________________________________
PRODUCT
ICON DS hCG, an in-vitro diagnostic. Part number 44025. Recall # Z-0706-03.
CODE
Lot numbers hCG010401, hCG010704, hCG010902.
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Brea, CA, by letter dated February 20, 2003. Firm initiated recall is ongoing.
REASON
Failure to meet sensitivity claims at end of shelf life. Potential for false negative reports.
VOLUME OF PRODUCT IN COMMERCE
12,804.
DISTRIBUTION
Nationwide and Canada.
_________________________________
PRODUCT
a) Westmin Zinc Oxide 72%, Feed Grade, 50 lb. multilayer
paper bags and 1000 Kg. (2205 Lb.) supersacks.
Recall # V-014-3;
b) Fishbelt Feeds Trace Mineral Premix; 50 lb. multilayer
paper bags. Recall # V-015-3;
c) Illini Feeds Trace Mineral Premix #2; 50 lb. multilayer
paper bags. Recall # V-016-3;
d) Western Specialties WSRTM #8 Premix; 50 lb. Multiplayer
paper bags. Recall # V-017-3;
e) Ragland Mills Trace Mineral Premix #1; 50 lb. multilayer
paper bags. Recall # V-018-3;
f) Agco Manufacturing Trace Mineral Premix; 50 lb.
multilayer paper bags. Recall # V-019-3;
g) Nufeeds Sulfate Trace Mineral Base; 50 lb. multilayer
paper bags. Recall # V-020-3;
h) Nufeeds Minor Element Trace Mineral Base; 50 lb.
multilayer paper bags. Recall # V021-3.
i) Kerber MIlling Company Swine Trace Mineral Premix #1676;
50 lb. multilayer paper bags. Recall # V-022-3.
j) Kerber Milling Company Cattle Trace Mineral Premix
#1700; 50 lb. miultilayer paper bags. Recall # V-023-3.
CODE
a) 1-7-02, 1-25-02, 2-29-02, 5-28-02, 6-27-02, 7-22-02,
8-13-02, 9-09-02, 9-18-02, 10-25-02;
b) 7-24-02, 8-07-02, 9-17-02;
c) 1-02-02, 10-29-02;
d) 8-27-02;
e) 1-11-02, 8-05-02;
f) 1-22-02;
g) 7-30-02;
h) 8-01-02, 9-13-02, 10-31-02, 12-06-02;
i) 1-08-02, 1-23-02, 11-12-02, 11-27-02;
j) 9-06-02, 11-11-02.
RECALLING FIRM/MANUFACTURER
Westmin, Corp., Quincy, IL, by telephone on January 13, 2003 and January 16, 2003. FDA initiated recall is ongoing.
REASON
The zinc oxide is contaminated with dioxin.
VOLUME OF PRODUCT IN COMMERCE
a) 272,770 lbs;
b) 132,000 lbs;
c) 16,000 lbs;
d) 16,000 lbs;
e) 44,000 lbs;
f) 18,000 lbs;
g) 4,000 lbs;
h) 110,000 lbs;
i) 110,000 lbs;
j) 8,000 lbs.
DISTRIBUTION
Nationwide and Canada.
_________________________________
PRODUCT
ZINC OXIDE baghouse dust (Mixture of zinc oxide and carbon). Shipped in white goretex bags ranging in weight from 1,200 to 2,000 pounds. The bags are not labeled. The baghouse dust is a by-product of brass productions.
Recall # V-024-3.
CODE
Uncoded.
RECALLING FIRM/MANUFACTURER
Outokumpu American Brass, Inc., Buffalo, NY, by letters dated January 16, 2003, and March 11, 2003. FDA initiated recall is ongoing.
REASON
Contaminated with dioxin.
VOLUME OF PRODUCT IN COMMERCE
155,150.
DISTRIBUTION
IL.
_________________________________
PRODUCT
a) FISHBELT FEEDS, INC. brand feed: 25% Extruded Catfish
Food (bulk). Recall # V-025-3.
b) FISHBELT FEEDS, INC. brand feed: 35% Fry/Fingerling
Catfish Food Medicated (Romet-30) (bulk).
Recall # V-026-3.
c) FISHBELT FEEDS, INC. brand feed: 36% Hybrid Striped Bass
Food (bulk). Recall # V-027-3.
d) FISHBELT FEEDS, INC. brand feed: 28% Floating Catfish
Food (bulk), 28% Floating Catfish Food EXP (bulk).
Recall # V-028-3;
e) FISHBELT FEEDS, INC. brand feed: 32% APP Floating
Catfish Food (bulk), 32% Floating Catfish Food (bulk and
50 lb-bagged feed), 32% Floating Catfish Food EXP
(bulk). Recall # V-029-3;
f) FISHBELT FEEDS, INC. brand feed: 35% Fry/Fingerling
Catfish Food (bulk and 50 lb-bagged feed).
Recall # V-030-3.
CODE
Product is not coded.
RECALLING FIRM/MANUFACTURER
Fishbelt Feeds, Inc., Moorhead, MS, by telephone on February 26, 2003. FDA initiated recall is ongoing.
REASON
Samples collected from the manufacturer contained dioxin.
VOLUME OF PRODUCT IN COMMERCE
14,615 tons of bulk feed and 52 tons of bagged feed
(2,080/50 pound bags);
DISTRIBUTION
AL, AR, GA, IN, KY, LA, MS, and WV.
_________________________________
PRODUCT
a) Garasol Injection, (Gentamicin Sulfate), 100mg/mL,
80 mL Vial. An 80ml vial is the unit of sale, packed
in individual printed folded cartons. Product is a
sterile solution for subcutaneous use only.
Recall # V-031-3;
b) Azium Injection Solution, 2mg/mL Dexamethasone. A 100mL
vial is the unit of sale, packed in individual printed
folded cartons. Product is a sterile solution intended
for bovine and equine intravenous or intramuscular
injection. Recall # V-032-3;
c) Pro-Labs Flu-Nix Injectable Solution, Flunixin meglumine
equivalent to 50mg/mL flunixin. 50 mL and 100mL vials
are the units of sale, packed in individual printed
folded cartons. Product is a sterile solution intended
for intravenous or intramuscular use in horses and for
intravenous use in beef and nonlactating dairy cattle
only. Recall # V-033-3;
d) Banamine Injectable Solution, Flunixin meglumine
equivalent to 50mg/mL flunixin. 50mL, 100mL and 250mL
vials are the units of sale, packed in individual
printed folding cartons. Product is a sterile solution
intended for intravenous or intramuscular use in horses
and for intravenous use in beef and nonlactating dairy
cattle only. Recall # V-034-3.
e) Betasone Aqueous Suspension. 5mg/mL Betamethasone as
diporpionate and 2mg/mL Betamethasone as sodium
phosphate. A 5mL vial is the unit of sale, packed in
individual printed folded cartons. Product should be
administered aseptically by intramuscular injection in
dogs only. Recall # V-035-3;
f) Durvet Garacin Piglet Injection, 5mg/mL Gentamicin base.
A 250mL vial is the unit of sale, packed in individual
printed folded cartons. Recall # V-036-3;
g) Garacin Piglet Injection, 5mg/mL Gentamicin base.
An 250mL vial is the unit of sale, packed in individual
Printed folded cartons. Recall # V-037-3;
h) Gentocin Solution, 100mg/mL Gentamicin Base. An 100mL
vial is the unit of sale, packed in individual printed
folded cartons. Product is a sterile solution for
intra-uterine use in horses only. Recall # V-038-3;
i) Gentocin Ophthalmic Ointment, 3mg/mL Gentamicin base.
12 (1/8oz) tubes, packed in a printed folded carton,
make up a unit of sale. Recall # V-039-3;
j) Nuflor Injectable Solution, 300 mg/mL Florfenicol.
100mL, 250mL, and 500mL vials are the units of sale.
Product is a sterile solution intended for intramuscular
and subcutaneous use in cattle only. Recall # V-040-3.
CODE
a) Batch Number 0-EJR-9 Exp. Oct 02; 0-EJR-11 Exp Nov 02;
b) Batch Number: 1-AGJ-1 Exp. Feb-03;
c) Batch Number: 1-CNX-102 Exp Feb-03; 1-CNX-1 Exp. Feb-03.
d) Banamine Solution 50MG/100ML 0-CNX-115 Oct-02 Banamine
Solution 50MG/100ML 0-CNX-115 Nov. 02 Banamine Solution
50MG/100ML 1-CNX-101 Feb. 03 Banamine Solution
50MG/100ML 1-CNX-102 Feb. 03 Banamine Solution
50MG/100ML 1-CNX-103 Mar. 03 Banamine Solution
50MG/100ML 1-CNX-104 Apr. 03 Banamine Solution
50MG/250ML 0-CNX-235 Oct-02 Banamine Solution
50MG/250ML 0-CNX-237 Oct-02 Banamine Solution
50MG/250ML 0-CNX-240 Oct-02 Banamine Solution
50MG/250ML 0-CNX-241 Oct-02 Banamine Solution
50MG/250ML 0-CNX-238 Oct-02 Banamine Solution
50MG/250ML 0-CNX-242 Oct-02 Banamine Solution
50MG/250ML 0-CNX-236 Oct-02 Banamine Solution
50MG/250ML 0-CNX-239 Oct-02 Banamine Solution
50MG/250ML 0-CNX-243 Nov. 02 Banamine Solution
50MG/250ML 0-CNX-244 Nov. 02 Banamine Solution
50MG/250ML 0-CNX-245 Nov. 02 Banamine Solution
50MG/250ML 0-CNX-246 Nov. 02 Banamine Solution
50MG/250ML 0-CNX-247 Dec. 02 Banamine Solution
50MG/250ML 0-CNX-248 Dec. 02 Banamine Solution
50MG/250ML 1-CNX-201 Feb. 03 Banamine Solution
50MG/250ML 1-CNX-203 Mar. 03 Banamine Solution
50MG/250ML 1-CNX-204 Apr. 03 Banamine Solution
50MG/250ML 1-CNX-207 May 03 Banamine Solution
50MG/250ML 1-CNX-208 May 03 Banamine Solution
50MG/250ML 1-CNX-202 Mar. 03 Banamine Solution
50MG/250ML 1-CNX-206 May 03 Banamine Solution
50MG/250ML 1-CNX-209 May 03 Banamine Solution
50MG/50ML 1-CNX-1 Feb. 03 Banamine Solution
50MG/50ML 1-CNX-2 Apr. 03;
e) Batch Number: 0-BBK--4 Exp. Oct-03;
f) Batch Number: 9-DFX-9 Exp. Oct-02;
g) Batch Number: 9-DFX-10 Exp Oct-02;
h) Batch Number: 0-BNP-11 Nov. 02 0-BNP-10 Oct 02;
i) Batch Numbers: 1-HJ-101 Feb. 03 1-HJ-102 Feb. 03
1-HJ-103 Feb. 03;
j) Nuflor Injectable Solution 100ML 0-RKP-8 Nov. 02
Nuflor Injectable Solution 100ML 0-RKP-9 Nov. 02
Nuflor Injectable Solution 100ML 0-RKP-10 Nov. 02
Nuflor Injectable Solution 100ML 1-RKP-1 June 03
Nuflor Injectable Solution 250ML 0-RKP-116 Nov. 02
Nuflor Injectable Solution 250ML 0-RKP-118 Dec. 02
Nuflor Injectable Solution 250ML 1-RKP-102 Apr. 03
Nuflor Injectable Solution 250ML 1-RKP-101 Apr. 03
Nuflor Injectable Solution 250ML 1-RKP-103 Apr. 03
Nuflor Injectable Solution 250ML 1-RKP-104 June 03
Nuflor Injectable Solution 500ML 0-RKP-211 Dec. 02
Nuflor Injectable Solution 500ML 0-RKP-214 Dec. 02
Nuflor Injectable Solution 500ML 0-RKP-207 Nov. 02
Nuflor Injectable Solution 500ML 0-RKP-208 Nov. 02
Nuflor Injectable Solution 500ML 0-RKP-209 Dec. 02
Nuflor Injectable Solution 500ML 0-RKP-210 Dec. 02
Nuflor Injectable Solution 500ML 0-RKP-213 Dec. 02
Nuflor Injectable Solution 500ML 0-RKP-212 Dec. 02
Nuflor Injectable Solution 500ML 1-RKP-201 Mar. 03
Nuflor Injectable Solution 500ML 1-RKP-202 Mar. 03
Nuflor Injectable Solution 500ML 1-RKP-204 Mar. 03
Nuflor Injectable Solution 500ML 1-RKP-203 Mar. 03
Nuflor Injectable Solution 500ML 1-RKP-205 Mar. 03
Nuflor Injectable Solution 500ML 1-RKP-207 Apr. 03
Nuflor Injectable Solution 500ML 1-RKP-209 Apr. 03
Nuflor Injectable Solution 500ML 1-RKP-210 Apr. 03
Nuflor Injectable Solution 500ML 1-RKP-211 Apr. 03
Nuflor Injectable Solution 500ML 1-RKP-212 May 03
Nuflor Injectable Solution 500ML 1-RKP-215 May 03
Nuflor Injectable Solution 500ML 1-RKP-206 Apr. 03
Nuflor Injectable Solution 500ML 1-RKP-208 Apr. 03
Nuflor Injectable Solution 500ML 1-RKP-214 May 03
Nuflor Injectable Solution 500ML 1-RKP-216 May 03
Nuflor Injectable Solution 500ML 1-RKP-217 May 03
Nuflor Injectable Solution 500ML 1-RKP-222 June 03
Nuflor Injectable Solution 500ML 1-RKP-221 June 03
Nuflor Injectable Solution 500ML 1-RKP-219 June 03
Nuflor Injectable Solution 500ML 1-RKP-220 June 03
Nuflor Injectable Solution 500ML 1-RKP-224 Aug. 03
Nuflor Injectable Solution 500ML 1-RKP-225 Sep. 03
Nuflor Injectable Solution 500ML 1-RKP-226 Sep. 03
Nuflor Injectable Solution 500ML 1-RKP-227 Sep. 03
Nuflor Injectable Solution 500ML 1-RKP-228 Sep. 03
Nuflor Injectable Solution 500ML 1-RKP-229 Sep. 03
Nuflor Injectable Solution 500ML 1-RKP-230 Sep. 03
Nuflor Injectable Solution 500ML 1-RKP-223 June 03
Nuflor Injectable Solution 500ML 1-RKP-231 Oct. 03
Nuflor Injectable Solution 500ML 1-RKP-233 Oct. 03
Nuflor Injectable Solution 500ML 1-RKP-232 Oct. 03
Nuflor Injectable Solution 500ML 1-RKP-237 Oct. 03
Nuflor Injectable Solution 500ML 1-RKP-239 Oct. 03
Nuflor Injectable Solution 500ML 1-RKP-234 Oct. 03
Nuflor Injectable Solution 500ML 1-RKP-238 Oct. 03
Nuflor Injectable Solution 500ML 1-RKP-240 Oct. 03
Nuflor Injectable Solution 500ML 1-RKP-241 Oct. 03
Nuflor Injectable Solution 500ML 1-RKP-236 Oct. 03
Nuflor Injectable Solution 500ML 1-RKP-243 Oct. 03
Nuflor Injectable Solution 500ML 1-RKP-244 Oct. 03
Nuflor Injectable Solution 500ML 1-RKP-245 Oct. 03
Nuflor Injectable Solution 500ML 1-RKP-246 Oct. 03
Nuflor Injectable Solution 500ML 1-RKP-247 Oct. 03
Nuflor Injectable Solution 500ML 1-RKP-250 Oct. 03
Nuflor Injectable Solution 500ML 1-RKP-256 Nov. 03
Nuflor Injectable Solution 500ML 1-RKP-258 Nov. 03
Nuflor Injectable Solution 500ML 1-RKP-260 Nov. 03
Nuflor Injectable Solution 500ML 1-RKP-252 Nov. 03
Nuflor Injectable Solution 500ML 1-RKP-254 Nov. 03
Nuflor Injectable Solution 500ML 1-RKP-257 Nov. 03
Nuflor Injectable Solution 500ML 1-RKP-259 Nov. 03
Nuflor Injectable Solution 500ML 1-RKP-235 Oct. 03
Nuflor Injectable Solution 500ML 1-RKP-248 Oct. 03
Nuflor Injectable Solution 500ML 1-RKP-255 Nov. 03
Nuflor Injectable Solution 500ML 1-RKP-261 Dec. 03
Nuflor Injectable Solution 500ML 1-RKP-262 Dec. 03
Nuflor Injectable Solution 500ML 1-RKP-263 Dec. 03
Nuflor Injectable Solution 500ML 1-RKP-264 Dec. 03
Nuflor Injectable Solution 500ML 2-RKP-203 Jan. 04
Nuflor Injectable Solution 500ML 2-RKP-204 Jan. 04
Nuflor Injectable Solution 500ML 2-RKP-201 Jan. 04
Nuflor Injectable Solution 500ML 2-RKP-202 Jan. 04
Nuflor Injectable Solution 500ML 2-RKP-206 Jan. 04
Nuflor Injectable Solution 500ML 2-RKP-207 Jan. 04
Nuflor Injectable Solution 500ML 2-RKP-208 Jan. 04
Nuflor Injectable Solution 500ML 2-RKP-209 Jan. 04
Nuflor Injectable Solution 500ML 2-RKP-210 Jan. 04
Nuflor Injectable Solution 500ML 2-RKP-211 Jan. 04
Nuflor Injectable Solution 500ML 2-RKP-214 Feb. 04
Nuflor Injectable Solution 500ML 2-RKP-215 Feb. 04
Nuflor Injectable Solution 500ML 2-RKP-216 Feb. 04
Nuflor Injectable Solution 500ML 2-RKP-217 Feb. 04.
RECALLING FIRM/MANUFACTURER
Schering, Corp., Kenilworth, NJ, by letters between November 15, November 18,
2002. Firm initiated recall is ongoing.
REASON
Problems with sterility assurance.
VOLUME OF PRODUCT IN COMMERCE
628,673.
DISTRIBUTION
Nationwide and Internationally.
END OF ENFORCEMENT REPORT FOR APRIL 16, 2003
###
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