June 11, 2003
03-24
_______________________________
PRODUCT
Caribe brand Fresh Crab Claw Meat, Product of Venezuela, packed in a clear plastic container. Net Wt. 16 oz. Recall # F-391-3.
CODE
All products purchased between March 18, 2003, and April 10, 2003.
RECALLING FIRM/MANUFACTURER
Indumar Seafood Corp., Miami, FL, by letter on April 10, 2003. FDA initiated recall is ongoing.
REASON
Crabmeat was contaminated with Listeria moncytogenes.
VOLUME OF PRODUCT IN COMMERCE
1,180/16 oz. containers.
DISTRIBUTION
GA, TX, PA, MD, and NY.
_______________________________
PRODUCT
Elizabeth's Natural Golden Raisins packaged in rigid plastic tube, net wt. 10.5 oz. Recall # F-394-3.
CODE
"SELL BY SEPT 30, 2003"; Barcode # 48670 00046.
RECALLING FIRM/MANUFACTURER
Sagsveen & Sagsveen, Ltd., West Babylon, NY, by telephone on October 18, 2002, and by press release on October 21, 2002. State initiated recall is complete.
REASON
The product contained undeclared sulfites based on New York State Department of Agriculture and Markets analysis.
VOLUME OF PRODUCT IN COMMERCE
4,800 units.
DISTRIBUTION
NY.
_______________________________
PRODUCT
Golden Maple Leaf brand Dried Sweet Potato, Net Wt: 7 oz (200g). Product of the People's Republic of China. Barcode #54351 19474. Recall # F-395-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Recalling Firm: J. V. Trading (Glendale) Ltd., Hicksville, NY, by press release, and letters dated June 21, 2002.
Manufacturer: Taishan City Huafeng Food Co., Ltd, Taishan City, Guangdong. State initiated recall is complete.
REASON
The product contained undeclared sulfites based on New York State Department of Agriculture and Markets analysis.
VOLUME OF PRODUCT IN COMMERCE
Undetermined.
DISTRIBUTION
NY, PA, and MD.
_______________________________
PRODUCT
Vitaminka Prasoka Puding Bestacki Oboen I Aromatiziran Malina (Raspberry Flavored). Product is Raspberry pudding imported from Macedonia. Recall # F-393-3.
CODE
No identifiable codes. Expiration Date is April 2004.
RECALLING FIRM/MANUFACTURER
Fast-Pak Trading, Paterson, NJ, by telephone and faxes on April 23, 2003 and April 24, 2003. New York State initiated recall is ongoing.
REASON
Raspberry pudding contains unapproved color E122 (Carmosine).
VOLUME OF PRODUCT IN COMMERCE
59 cases.
DISTRIBUTION
Nationwide.
***CORRECTION***
The Enforcement Report of June 4, 2003 for Class II Drugs, Recall # D-263/264-3, Premarin, stated Robins Division of Wyeth, Richmond, VA, as the recalling firm. The recalling firm name should be Richmond Division of Wyeth, Richmond, VA. The manufacturer is: Wyeth Pharmaceuticals, Inc., Rouses Point, NY.
______________________________
PRODUCT
Human Tissues for transplantation:
a) Achilles Tendon. Recall # B-0941-3;
b) Tibialis Tendon. Recall # B-0942-3;
c) Hemi Patellar Tendon. Recall # B-0943-3;
d) Saphenous veins. Recall # B-0944-3;
e) Semi-quadriceps Tendon. Recall # B-0945-3.
CODE
a) Donor #60084, Serial #7785332;
b) Donor #60084, Serial #7785274;
c) Donor #60084, Serial #7785289;
d) Donor #57455, Serial #7442784;
Donor #57455, Serial #7315085;
Donor #57455, Serial #7442794;
Donor #55139, Serial #7238163;
e) Donor #42926, Serial #6643867.
RECALLING FIRM/MANUFACTURER
CryoLife, Inc., Kennesaw, GA, by telephone or letter on February 4, 6, 13, 24,
and 25, 2003. Firm initiated recall is ongoing.
REASON
Human tissues for transplantation, collected from donors whose companion sample,
from a different site, was positive for microorganisms, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units.
DISTRIBUTION
CO, MI, NH, NJ, TX, and Canada.
________________________________
PRODUCT
Human Tissues for transplantation:
a) Saphenous Vein. Recall # B-0946-3;
b) Femoral Artery. Recall # B-0947-3.
CODE
a) Donor # 49120, Serial # 6874115;
b) Donor # 49120, Serial # 6855223.
RECALLING FIRM/MANUFACTURER
CryoLife, Inc., Kennesaw, GA, by letter on or about February 18, 2003. Firm initiated recall is ongoing.
REASON
Human tissues for transplantation, collected from donors whose companion sample, from a different site, was positive for microorganisms, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
SC, and FL.
________________________________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced. Recall # B-1015-3.
CODE
Unit 7416085.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated December 7, 2001. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
______________________________
PRODUCT
Platelets. Recall # B-1016-3.
CODE
Unit 7548295.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated January 7, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1017-3;
b) Platelets. Recall # B-1018-3.
CODE
a) and b) Unit 7454109.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on December 5, 2001, and by letter dated December 8, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.
________________________________
PRODUCT
Platelets, Pheresis. Recall # B-1051-3.
CODE
Unit 0352423.
RECALLING FIRM/MANUFACTURER
Florida Blood Services, Inc., St. Petersburg, FL. By facsimile dated May 2, 2002. Firm initiated recall is complete.
REASON
Platelets, labeled with an incorrect expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.
______________________________
PRODUCT
a) Platelets, Leukocytes Reduced. Recall # B-1054-3;
b) Recovered Plasma. Recall # B-1055-3.
CODE
a) and b) Unit 19GN88726.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Tennessee Valley Region, Nashville, TN, by telephone on August 28, 2001, and by letter dated September 5, 2001. Firm initiated recall is complete.
REASON
Blood products, collected under conditions where the sterility of the products may have been compromised, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TN, and VA.
______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1056-3;
b) Recovered Plasma. Recall # B-1057-3.
CODE
a) and b) Unit 12Q58828.
RECALLING FIRM/MANUFACTURER
American Red Cross, Carolinas Blood Services Region, Charlotte, NC, by letter dated November 27, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NC, and CA.
______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1058-3;
b) Fresh Frozen Plasma. Recall # B-1059-3.
CODE
a) and b) Unit 20284-6039.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc, Scottsdale, AZ, by telephone on January 3, 2001.
Manufacturer: Blood Systems, Inc, Lafayette, LA. Firm initiated recall is complete.
REASON
Blood products, collected from a donor taking the drug Methotrexate, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NC, and LA.
______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-1070-3.
CODE
Unit 19GN94456.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Tennessee Valley Region, Nashville, TN, by telephone on December 6, 2001, and by letter dated January 3, 2002. Firm initiated recall is complete.
REASON
Blood product, corresponding to a unit of Red Blood Cells, that was implicated in a transfusion reaction and found to be contaminated with Staphylococcus, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.
______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1071-3;
b) Platelets. Recall # B-1072-3;
c) Recovered Plasma. Recall # B-1073-3.
CODE
a), b), and c) Unit 19KW12321.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Tennessee Valley Region, Nashville, TN, by letter dated February 28, 2001. 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
3 units.
DISTRIBUTION
TN.
______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Irradiated.
Recall # B-1074-3;
b) Fresh Frozen Plasma. Recall # B-1075-3;
c) Recovered Plasma. Recall # B-1076-3.
CODE
a) Units 0882793, 0847776;
b) Unit 084776;
c) Unit 0882793.
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, Cincinnati, OH, by letter dated December 19, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who took the drug Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
OH, and FL.
______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1086-3.
CODE
Unit 29FJ48235.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Mid-Atlantic Region, Norfolk, VA, by letter dated December 30, 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
NC.
______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1087-3.
CODE
Unit 29FN44316.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Mid-Atlantic Region, Norfolk, VA, by letter dated January 23, 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
VA.
______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1088-3.
CODE
Unit 035GC20849.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Appalachian Region, Roanoke, VA, by letter dated December 30, 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
WV.
________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1089-3.
CODE
Unit KT00769.
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Blood Donor Services, Annandale, VA, by letter on October 23, 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
VA.
______________________________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced. Recall # B-1091-3.
CODE
Unit KC09262.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on September 13, 2002.
Manufacturer: Tri-Counties Blood Bank, Inc, Santa Barbara, CA. Firm initiated recall is complete.
REASON
Platelets, Pheresis, which did not have a white blood cell determination, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
______________________________
PRODUCT
Corneas (two tissues). Recall # B-1092-3.
CODE
Tissue number 03-159 R and 03-159 L.
RECALLING FIRM/MANUFACTURER
Cincinnati Eye Bank for Sight Restoration, Inc, Cincinnati, OH, by facsimile and letter dated April 24, 2003. Firm initiated recall is complete.
REASON
Human corneas, collected from a donor who subsequently tested positive for antibody to the Hepatitis B core antigen (Anti-Hbcore) by another tissue procurement organization, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues.
DISTRIBUTION
Taiwan.
______________________________
PRODUCT
a) Platelets, Pheresis, Leukocytes Reduced. Recall # B-1093-3;
b) Platelets, Pheresis, Leukocytes Reduced, Irradiated.
Recall # B-1094-3.
CODE
a) 0893057(part 2); 0882561 (parts 1 & 2);
b) 0893057 (part 1).
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, Cincinnati, OH, by letter dated December 16, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
KY, and OH.
______________________________
PRODUCT
Platelets. Recall # B-1095-3.
CODE
9750024, 9750025, 9750035, 9750042, 9750052, 9750053, 9750058, 9750059, 9750060, 9750061, 9750062, 9750086, 9750093, 9750242, 9750245, 9750246, 9750247, 9750248, 9750249, 9750250, 9750251, 9750252, 9750253, 9750254, 9750255, 9750256, 9750257, 9750258, 9750260, 9750262, 9750263, 9750264, 9750269, 9750272, 9750274, 9750277, 9750278, 9750279, 9750280, 9750285, 9750287, 9750289, 9750290, 9750291, 9750292, 9750297, 9750300, 9750301, 9750303, 9750305, 9750308, 9750309, 9750310, 9750313, 9750314, 9750315, 9750316, 9750317, 9750318, 9750319, 9750320, 9750321, 9750322, 9750323, 9750326, 9750328, 9750329, 9750330, 9750332, 9750333, 9750334, 9750335, 9750338, 9750340, 9750341, 9750345, 9750347, 9750348, 9750349, 9750351, 9750354, 9750355, 9750356, 9750357, 9750358, 9750359, 9750360, 9750361, 9750363, 9750364, 9750367, 9750368, 9750369, 9750370, 9750373, 9750374, 9750375, 9750376, 9750377, 9750378, 9750380, 9750385, 9750387, 9750388, 9750391, 9750392, 9750393, 9750394, 9750395, 9750396, 9750398, 9750399, 9750400, 9750405, 9750406, 9750407, 9750408, 9750410, 9750411, 9750412, 9750413, 9750414, 9750415, 9750417, 9750418, 9750419, 9750421, 9750422, 9750425, 9750426, 9750427, 9750428, 9750430, 9750431, 9750432, 9750434, 9750436, 9750437, 9750438, 9750439, 9750440, 9750442, 9750445, 9750446, 9750450, 9750451, 9750452, 9750453, 9750454, 9750455, 9750456, 9750457, 9750459, 9750460, 9750462, 9750464, 9750467, 9750468, 9750469, 9750471, 9750472, 9750473, 9750474, 9750475, 9750476, 9750477, 9750478, 9750480, 9750481, 9750482, 9750483, 9750484, 9750485, 9750488, 9750489, 9750490, 9750492, 9750495, 9750496, 9750497, 9750500, 9750501, 9750502, 9750503, 9750609, 9750610, 9750615, 9750628, 9750630, 9750631, 9750632, 9750634, 9750635, 9750636, 9750637, 9750640
RECALLING FIRM/MANUFACTURER
HemaCare Corp., Coral Blood Services, Inc, Albany, NY, by letter dated March 19, 2003. Firm initiated recall is complete.
REASON
Platelets, with a decreased platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
196 units.
DISTRIBUTION
NY.
________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1101-3.
CODE
Unit number 04KF56285.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by letter dated December 11, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MA.
________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1102-3.
CODE
Unit numbers 04KL72175, 04KW18455, and 04KL66071.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by letter on November 13, 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
MA, and VT.
________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1103-3;
b) Recovered Plasma. Recall # B-1104-3.
CODE
a) and b) unit number 19GH34831.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Tennessee Valley Region, Nashville, TN, by facsimile on June 4, 2001, and by letter on June 6, 2001. Firm initiated recall is complete.
REASON
Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a subsequent disclosure of previous positive hepatitis testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TN, and CA.
________________________________
PRODUCT
Platelets, Leukocytes Reduced. Recall # B-1105-3.
CODE
Unit numbers 19LW23807, 19LW23765, 19LW23790, 19LW23776, 19LW23774, 19LW23772, 19LW23786, 19LW23777, and 19LW23799.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Tennessee Valley Region, Nashville, TN, by telephone on May 8, 2002, and by letter on May 21, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose health history screening were inadequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units.
DISTRIBUTION
TN.
_____________________________
PRODUCT
Red Blood Cells. Recall # B-1106-3.
CODE
Unit number FJ55294.
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence, RI, by letter on January 23, 2003. Firm initiated recall is complete.
REASON
Blood product, that tested negative for viral markers, but was collected from an ineligible donor due to intravenous drug use, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
RI.
_____________________________
PRODUCT
a) Red Blood Cells. Recall # B-1107-3;
b) Platelets. Recall # B-1108-3;
c) Cryoprecipitated AHF. Recall # B-1109-3;
d) Plasma, Cryoprecipitate Reduced. Recall # B-1110-3;
e) Fresh Frozen Plasma. Recall # B-1111-3.
CODE
a), b), and e) Unit number FG41412;
a), c), and d) Unit number FG54186.
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence, RI, by letter on January 24, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but was collected from an ineligible donor due to intravenous drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
RI, MA, and TX.
_____________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1112-3;
b) Platelets, Leukocytes Reduced. Recall # B-1113-3;
c) Fresh Frozen Plasma. Recall # B-1114-3.
CODE
a), and b) Unit numbers FG37970, FG22663, and FJ54319;
c) Unit numbers FG37970 and FJ54319.
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence, RI, by telephone on January 23, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but was collected from an ineligible donor due to intravenous drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units.
DISTRIBUTION
RI, and MA.
_____________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1115-3;
b) Platelets. Recall # B-1116-3;
c) Fresh Frozen Plasma. Recall # B-1117-3.
CODE
a), b) and c) Unit numbers FG35335 and FM34726.
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence, RI, by telephone on January 24, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to self-injected drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
RI, and MA
________________________________
PRODUCT
Red Blood Cells. Recall # B-1118-3.
CODE
Unit number 5301557.
RECALLING FIRM/MANUFACTURER
Department of the Navy, Naval Medical Center, Portsmouth, VA, by telephone and letter on January 10, 2003. Firm initiated recall is complete.
REASON
Blood product, collected using a phlebotomy method that may have compromised the sterility of the products, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.
________________________________
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced. Recall # B-1119-3;
b) Fresh Frozen Plasma. Recall # B-1120-3.
CODE
a) Unit number 035P39424 (distributed as two split products);
b) Unit number 035P39424.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Appalachian Region, Roanoke, VA, by telephone on December 6, 2002, and by letter dated December 17, 2002. Firm initiated recall is complete.
REASON
Blood products, untested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
NJ, and VA.
______________________________
PRODUCT
Menomune A/C/Y/W-135, Meningococcal Polysaccharide Vaccine,
Groups A, C, Y, W-135 Combined, single-dose vials (including single-dose in
five dose packaging). Recall # B-1043-3.
CODE
Lots UB040AA, UB040AB, UB070AA, UB096AA.
RECALLING FIRM/MANUFACTURER
Aventis Pasteur, Swiftwater, PA, by letter dated October 18, 2002, and January
6, 2003. Firm initiated recall is complete.
REASON
Product failed to meet potency specification during stability testing at twelve
months.
VOLUME OF PRODUCT IN COMMERCE
4 lots.
DISTRIBUTION
Nationwide, Argentina, Australia, Singapore, Thailand, Canada, and India.
_______________________________
PRODUCT
Red Blood Cells. Recall # B-1077-3.
CODE
Unit 5304584.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated January 16, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with an elevated body temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
________________________________
PRODUCT
Source Plasma. Recall # B-1080-3.
CODE
Unit number WSG009471.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston, TX, by facsimile on January 4, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.
________________________________
PRODUCT
Source Plasma. Recall # B-1081-3.
CODE
Unit number WSN001397.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston, TX, by facsimile on January 29, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that did not answer medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.
________________________________
PRODUCT
Source Plasma. Recall # B-1082-3.
CODE
Unit number WSG009639.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston, TX, by facsimile on January 27, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that did not answer medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.
________________________________
PRODUCT
Source Plasma. Recall # B-1083-3.
CODE
Unit number WSG009015.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston, TX, by facsimile on January 29, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that did not answer medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.
________________________________
PRODUCT
Source Plasma. Recall # B-1084-3.
CODE
Unit number XA0002596.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Port Arthur, TX, by facsimile on April 12, 2001. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that did not answer medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IN.
________________________________
PRODUCT
Source Plasma. Recall B-1085-3.
CODE
Unit number SS-9309.
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corp., Las Vegas, NV, by letter dated October 6, 2000. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that did not answer medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NJ.
________________________
PRODUCT
Platelets. Recall # B-1090-3.
CODE
Unit 5361361.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated June 21, 2001. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NY.
________________________________
PRODUCT
Corneas. Recall # B-1100-3.
CODE
ID numbers 01020738OS, 01020738OD.
RECALLING FIRM/MANUFACTURER
Old Dominion Eye Foundation, Inc., Richmond, VA, by letter dated April 23, 2003. Firm initiated recall is complete.
REASON
Corneas that were collected from a donor who was found to test repeatedly reactive for Human Immunodeficiency Virus (HIV) 1/2 subsequent to distribution.
VOLUME OF PRODUCT IN COMMERCE
2 tissues.
DISTRIBUTION
VA.
______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1126-3;
b) Recovered Plasma. Recall # B-1127-3.
CODE
a), and b) Unit number M74238.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter and facsimile on January 29 and 30, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due recent administration of the measles, mumps, and rubella (MMR) vaccine, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
VA, and Switzerland.
________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1145-3.
CODE
Unit 13FW01800.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southeastern Michigan Region, Detroit, MI, by telephone on January 15, 2003, and by letter dated January 16, 2003.
REASON
Red Blood Cells, possibly mislabeled for the Fyb antigen, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.
________________________________
PRODUCT
a) Pulsar Multiprogrammable Pacemaker, DDD Model 970.
Recall # Z-0875-03;
b) Pulsar Multiprogrammable Pacemaker, DDD Model 972.
Recall # Z-0876-03;
c) Pulsar Multiprogrammable Pacemaker, DDD Model 976.
Recall # Z-0877-03;
d) Pulsar Multiprogrammable Pacemaker, DDDR Model 1270.
Recall # Z-0878-03;
e) Pulsar Multiprogrammable Pacemaker, DDDDR Model 1272.
Recall # Z-0879-03;
f) Pulsar Max Multiprogrammable Pacemaker.
Recall # Z-0880-03;
g) Pulsar Max II Multiprogrammable Pacemaker, DDDR
Model 1284. Recall # Z-0881-03;
h) Pulsar Max II Multiprogrammable Pacemaker, DDDR
Model 1286. Recall # Z-0882-03;
i) Discovery Multiprogrammable Pacemaker, DDDR
Model 1273. Recall # Z-0883-03;
j) Discovery Multiprogrammable Pacemaker, DDDR Model
1274. Recall # Z-0884-03;
k) Discovery II Multiprogrammable Pacemaker, DDD Model
981. Recall # Z-0885-03;
l) Discovery II Multiprogrammable Pacemaker, DDDR Model
1280. Recall # Z-0886-03;
m) Discovery II Multiprogrammable Pacemaker, DDDR Model
1283. Recall # Z-0887-03;
n) Meridian Multiprogrammable Pacemaker, DDDR Model
1275. Recall # Z-0888-03;
o) Meridian Multiprogrammable Pacemaker, DDDR Model
1286. Recall # Z-0889-03;
p) Insignia Plus Multiprogrammable Pacemaker, DDD Model
985. Recall # Z-0890-03;
q) Insignia Plus Multiprogrammable Pacemaker, DDD Model
986. Recall # Z-0891-03;
r) Insignia Plus Multiprogrammable Pacemaker, DDDR Model
1294. Recall # Z-0892-03;
s) Insignia Plus Multiprogrammable Pacemaker, DDDR Model
1295. Recall # Z-0893-03;
t) Insignia Extra Multiprogrammable Pacemaker, DDDR
Model 1296. Recall # Z-0894-03;
u) Insignia Extra Multiprogrammable Pacemaker, DDDR
Model 1297. Recall # Z-0895-03;
v) Insignia Extra Multiprogrammable Pacemaker, DDDR
Model 1298. Recall # Z-0896-03;
w) Contak TR Multiprogrammable Pacemaker, DDDR Model
1241. Recall # Z-0897-03;
CODE
All Serial numbers.
RECALLING FIRM/MANUFACTURER
Guidant Corp-Cpi Division, St Paul, MN, by letter dated May 6, 2003. Firm initiated
field correction is ongoing. A May 6, 2003 letter to physicians gave recommendations
for avoiding the problem and indicated that software to prevent the problem
would be introduced.
REASON
In a rare circumstance (fallback mode when high-rate atrial activity is detected),
the battery gauge can over-estimate battery life.
VOLUME OF PRODUCT IN COMMERCE
298,000.
DISTRIBUTION
Nationwide, and Internationally.
________________________________
PRODUCT
Neonatal GALT Test Kit, 960 tests per box, packaged under the PerkinElmer Life Sciences Inc. label, catalog No. NG-1100.
Recall # Z-0898-03.
CODE
Lot #115496, Exp. 11/1/03.
RECALLING FIRM/MANUFACTURER
PerkinElmer Life Sciences Inc., Norton, OH, by letter on January 8, 2003. Firm initiated recall is ongoing.
REASON
The Control Cards are incorrectly labeled such that the normal 'N' and abnormal 'A' values are reversed.
VOLUME OF PRODUCT IN COMMERCE
75 kits.
DISTRIBUTION
WI, AR, and MI.
________________________________
PRODUCT
STA-Compact Hemostasis System with Cap piercing capability.
Recall # Z-0899-03.
CODE
All distributed units with cap piercing option.
RECALLING FIRM/MANUFACTURER
Diagnostica Stago, Inc., Parsippany, NY, by letters on March 5, 2003. Firm initiated recall is ongoing.
REASON
With maintenance of the STA line, the cap-piercing feature may involve potential risk of needle puncture injury.
VOLUME OF PRODUCT IN COMMERCE
137.
DISTRIBUTION
Nationwide.
________________________
PRODUCT
Misys Laboratory versions 5.2, 5.23 and 5.3 using Cache Database with linked CPUs. Recall # Z-0900-03.
CODE
Versions 5.2, 5.23 and 5.3.
RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Tucson, AZ, by fax on June 26, 2002. Firm initiated recall is complete.
REASON
Customer reports that the processor failed to make patient report updates with two processors running in the LABB area.
VOLUME OF PRODUCT IN COMMERCE
38.
DISTRIBUTION
Nationwide.
______________________________
PRODUCT
Trident Insert Impactor. Recall # Z-0901-03.
CODE
Catalog Number: 2111-0000.
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics, Mahwah, NJ, by letters and acknowledgement forms on April 29, 2003. Firm initiated recall is ongoing.
REASON
The ball retaining sleeve on the Trident Insert Impactor can possibly disassemble.
VOLUME OF PRODUCT IN COMMERCE
1,758.
DISTRIBUTION
Internationally.
______________________________
PRODUCT
a) Hill-Rom brand Affinity three birthing bed. Recall # Z-0902-03;
b) Hill-Rom brand Century+ series bed. Recall # Z-0903-03.
CODE
All units distributed between January 1, 1999 and July 1, 2002.
RECALLING FIRM/MANUFACTURER
Hill-Rom, Inc., Batesville, IN, by letters dated April 24, 2003. Firm initiated recall is ongoing.
REASON
Possible electrical shock hazard, as the power cord grounding pin may break off or become detached.
VOLUME OF PRODUCT IN COMMERCE
12,848.
DISTRIBUTION
Nationwide, and Internationally.
_____________________________
PRODUCT
Dermagraft, Human Fibroblast-Derived Dermal Substitute,
2 in. by 3 in. Recall # Z-0904-03.
CODE
Lot 116098.
RECALLING FIRM/MANUFACTURER
Smith and Nephew Wound Management (La Jolla), San Diego, CA, by telephone on or about May 2, 2003, and by letter on May 7, 2003. Firm initiated recall is ongoing.
REASON
Did not meet finished device specifications for DNA criteria.
VOLUME OF PRODUCT IN COMMERCE
22.
DISTRIBUTION
Nationwide.
______________________________
PRODUCT
a) Rascal Powered Scooters. Recall # Z-0909-03;
b) Chauffeur Powered Scooters. Recall # Z-0910-03.
CODE
a) Rascal Model Numbers 205, 215, 235, 245, 255, 305, 400.
There are 45,679 serial numbers.
b) Chauffeur Model Numbers are C205, C215, C235, C245, C255,
and C305. There are 45,679 serial numbers involved.
RECALLING FIRM/MANUFACTURER
Electric Mobility Corp., Sewell, NJ, by letter on February 7, 2003, and posted on the firms website on February 14, 2003. Firm initiated recall is ongoing.
REASON
The plastic tires may shatter if the tire is over-inflated and could cause serious injury.
VOLUME OF PRODUCT IN COMMERCE
45,679.
DISTRIBUTION
Nationwide, and Internationally.
______________________________
PRODUCT
a) Inject 10 Coronary Control Syringe (CCS), 10ml.
Recall # Z-0912-03;
b) Custom Kit. Recall # Z-0913-03.
CODE
a) REF/CAT No.: CCX010, Lot No's. A257336, A258248, A258893, A263340; b) REF/CAT No.: K09-03442C. Lot No. A259058.
RECALLING FIRM/MANUFACTURER
Merit Medical Systems, Inc., South Jordan, UT, by letter on May 16, 2003. Firm initiated recall is ongoing.
REASON
Cracks in the syringe barrels could allow for air aspiration into the syringe barrel.
VOLUME OF PRODUCT IN COMMERCE
7,277 units.
DISTRIBUTION
Nationwide, and France, Malaysia, Taiwan, and Dominican Republic.
______________________________
PRODUCT
10.5 Fr. Percor STAT-DL intra-Aortic Balloon Catheter Insertion
Kits which contain a Datascope 11.5 Fr. 11" introducer sheaths. These introducer sheaths include a hemostasis valve and a hub which work in conjunction with an introducer dilator. The introducer sheath, after it is dilated by the introducer dilator, is intended to assist the percutaneous insertion of the 10.5 Fr. Intra-Aortic Balloon catheter into the vasculature. Recall # Z-0916-03.
CODE
REF or Order #0684-00-0195-02; P/N #0684-00-0438; Lot #BRV; Exp. Date 03/03/05.
RECALLING FIRM/MANUFACTURER
Datascope Corp., Fairfield, NJ, by letters on March 28, 2003, and March 31, 2003. Firm initiated recall is ongoing.
REASON
10.5 Fr. Percor STAT-DL Intra-Aortic Balloon Insertion Kit, Introducer Sheath failed water leak test during final inspection.
VOLUME OF PRODUCT IN COMMERCE
60 units.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
COBAS TaqMan analyzer, Series 96; catalog number 8080216.
Recall # Z-0917-03.
CODE
All units with software versions TaqLink v 1.0 or TaqLink v 1.1.
RECALLING FIRM/MANUFACTURER
Roche Molecular Systems, Inc., Belleville, NJ, by telephone, and letter on March 6, 2003. Firm initiated recall is ongoing.
REASON
A false positive result may be reported.
VOLUME OF PRODUCT IN COMMERCE
16.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
2.75 mm Slit Knife, Angled, Bevel Up. Labeled "Stylus 2.75 mm Slit Knife Angled, Bevel, Up One Unit STERILE R Disposable Surgical Specialties Corporation Reading, PA 19606". Recall # Z-0918-03.
CODE
Model number: 52-2761 Lot/Serial # Exp. Date M262530 2/2008, M262540 3/2008, M262550 3/2008.
RECALLING FIRM/MANUFACTURER
Surgical Specialties Puerto Rico, Inc., Rincon, PR, by fax on May 7, 2003. Firm initiated recall is ongoing.
REASON
Incorrect handle was used in the manufacture of product 52-2761.
VOLUME OF PRODUCT IN COMMERCE
3,420 pieces.
DISTRIBUTION
Nationwide and worldwide.
_____________________________
PRODUCT
Misys Commercial Laboratory version 2.x thru 3.4.1.
Recall # Z-0920-03.
CODE
Versions 2.x through 3.4.1.
RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Tucson, AZ, by facsimile on April 1, 2003. Firm initiated recall is ongoing.
REASON
Urgent care STAT reports are not printing in a timely fashion.
VOLUME OF PRODUCT IN COMMERCE
109.
DISTRIBUTION
Nationwide and Canada.
______________________________
PRODUCT
a) LifeShield Latex-Free 150 mL Burette Set, Nonvented,
117 Inch with Prepierced Injection Site, Backcheck
Valve, 2 CLAVE Ports and Removable 4-Way High Flow
Stopcock Microdrip Soluset. Recall # Z-0914-3;
b) LifeShield Latex-Free Microdrip Soluset100 mL Burette
Plumset Convertible Pin, 121-1/2 Inch with CLAVE and
OPTION-LOK Dual Channel Secondary Port.
Recall # Z-0915-3.
CODE
a) Product number 19292-04-01, lots 961815H and 921675H;
b) Product number 19289-04-02, lot 960445H.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories HPD/ADD, Abbott Park, IL, by letter dated May 12, 2003.
Firm initiated recall is ongoing.
REASON
IV Burette administration sets are mislabeled as having pre-pierced injection
sites, when the injection sites are not pre-pierced.
VOLUME OF PRODUCT IN COMMERCE
12,840 units.
DISTRIBUTION
Nationwide.
________________________________
PRODUCT
Vitros TP Slides, for in vitro diagnostic use to quantitatively measure total protein concentration in serum and plasma. Packed 5 x 50 slides per box. Box identified with CAT 839 2292. Firm on label: Ortho-Clinical Diagnostics, a Johnson & Johnson Company.
Recall # Z-0919-03.
CODE
All slide lots with coatings "0292" and "0293". The coating lot numbers are seen as "xxxx-0292-xxxx" and "xxxx-0293-xxxx" in the lot number.
RECALLING FIRM/MANUFACTURER
Ortho-Clinical Diagnostics, Rochester, NY, via letter dated March 26, 2003. Firm initiated recall is ongoing.
REASON
Slides may exhibit random, elevated imprecision of results.
VOLUME OF PRODUCT IN COMMERCE
29,273 (domestic); 4,967 (international).
DISTRIBUTION
Nationwide, and Internationally.
________________________________
PRODUCT
a) 331 Co-op Supreme Mare & Foal Developer. Recall # V-164-3;
b) 328 Co-op 11% Supreme Performance, 50 pound bags and bulk;
Recall # V-165-3;
c) 333 Co-op 13% Supreme Performance. Recall # V-166-3;
d) 335 Army Horse Feed Coarse. Recall # V-167-3;
e) 93291 Co-op Equi-Mate 12. Recall # V-168-3.
CODE
a) 8028331 and 8030331;
b) 80293328, 8328 1/27/03;
c) 80283333, 80303333, 8333 1/27/03, 8333 1/29/03;
d) 8335 1/24/03;
e) 8028393921, 8030393291, 893291 1/27/03, 893291 1/29/03.
RECALLING FIRM/MANUFACTURER
Tennessee Farmers Cooperative, LaVergne, TN, via telephone on January 31, 2003. Firm initiated recall is complete.
REASON
Possible contamination of the drug Rumensin in feeds for a species (Equine) for which Rumensin is not intended.
VOLUME OF PRODUCT IN COMMERCE
40,368 pounds.
DISTRIBUTION
TN.
END OF ENFORCEMENT REPORT FOR JUNE 11, 2003
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