November 13, 2002
_____________________________
PRODUCT
ABC brand Konjac Coconut Jelly Mini Fruit Bites Candy
Manufactured By/Tsang Lin Industries Ltd., Taiwan; Imported By: Five Continents, Ltd., Chicago, IL; the product is packaged in individual serving sized plastic cups with foil lids, with the product meant to be squeezed out of the cup directly into the mouth.
The 16.5-17 gram individual serving cups are packaged in 300 gram plastic bags/30 bags per case and 1500 gram plastic jars (round and bear-shaped)/6 jars per case.
Some packages are labeled in part "The product is insured for NT$10 million liability. Please use it without worry." and "It is to advise that 3 years old children and aged persons should not swallow it full mouth. Please do not expose the product to heat or sunshine." Other packages are labeled "CAUTION This product contains fruit chunks, must be chewed thoroughly before swallowing. Not recommended for children under 5 years old."
Different flavors are as follows:
a) Assorted Cocode Nut Jelly. Recall # F-050-3;
b) Grape-Nata Jelly. Recall # F-051-03;
c) Coconut-Jelly. Recall # F-052-3;
d) Strawberry Cocode Nut Jelly. Recall # F-053-3;
e) Green Tea Cocode Nut Jelly. Recall # F-054-3;
f) Lychee Mini Fruit Bites. Recall # F-055-3;
g) Assorted Mini Fruit Bites. Recall # F-056-3;
h) Taro Mini Fruit Bites. Recall # F-057-3;
i) Guava Konjac Coconut Jelly. Recall # F-058-3;
j) Peach Mini Fruit Bites. Recall # F-059-3;
k) Mango Pudding with Nata de Coco. Recall # F-060-3;
l) Mangosteen Cocode Nut Jelly. Recall # F-061-3;
m) Orange Cocode Nut Jelly. Recall # F-062-3;
n) Heart Fruit Gel - Assorted. Recall # F-063-3;
o) Heart Fruit Gel - Lychee. Recall # F-064-3;
p) Heart Fruit Gel - Peach. Recall # F-065-3;
q) Heart Fruit Gel - Mangosteen. Recall # F-066-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Five Continents Ltd., Chicago, IL, by telephone on December 14, 2001 and by letter dated January 8, 2002.
Manufacturer: Tsang Lin Industries Corporation, Taichung City, Taiwan. FDA initiated recall is complete.
REASON
This candy is in violation of section 402(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it is unfit for food due to the characteristics that result in a serious choking hazard.
VOLUME OF PRODUCT IN COMMERCE
7,615 cases.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
GOODY(TM) Nata Decoco Pudding MANGO FLAVOUR, packaged in rigid plastic cups, Net Wt. 80 grams and 118 grams. Made in Malaysia. Recall # F-047-3.
CODE
All codes including "Best Before: 09.09.2002".
80 gram barcode: 556437 004056;
180 gram barcode: 556437 004032.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ming River International Inc., Brooklyn, NY, by visit on/about June 20, 2001.
Manufacturer: Belly Marketing SDN, Malaysia.
State initiated recall is complete.
REASON
The product contained undeclared tartrazine (certifiable as FD&C Yellow #5) and allura red AC (certifiable as FD&C Red #40).
VOLUME OF PRODUCT IN COMMERCE
80g: 95 cases (3 cups x 32 packets per case); 118g: 20 cases (3 cups x 12 packets per case).
DISTRIBUTION
NY and NJ.
_____________________________
PRODUCT
Lemon Cake. Recall # F-067-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
La Mousse, Los Angeles, CA, by distributing an updated ingredient list to its customers beginning September 16, 2002. Firm initiated recall is complete.
REASON
The product contained the undeclared color FD&C Yellow No. 5.
VOLUME OF PRODUCT IN COMMERCE
Unknown.
DISTRIBUTION
CA.
_____________________________
PRODUCT
Lemon Coffee Cake in 14-oz. clear plastic containers, 12 containers per case. The coffee cake is packaged under two private labels: James Skinner Co., Omaha, NE, and H-E-B, San Antonio, TX. Recall # F-068-3.
CODE
Skinner brand - 2-205-1
H-E-B brand - 2-205-1, 2-192-1, and 2-177-1.
RECALLING FIRM/MANUFACTURER
The James Skinner Baking Company, Omaha, NE, by telephone and letter on August 23, 2002. FDA initiated recall is complete.
REASON
The product contained the undeclared colors FD&C Yellow No. 5 and No. 6.
VOLUME OF PRODUCT IN COMMERCE
126/12-pkg. cases Skinner brand;
483/12-pkg. cases H-E-B brand.
DISTRIBUTION
TX and KS.
_____________________________
PRODUCT
Liqui-Char (activated charcoal, USP), in an Aqueous Base, 15 grams, 2.5 fl. oz. unit dose bottles. Recall # D-037-3;
Liqui-Char (activated charcoal, USP), in an Aqueous Base, 25 grams, 4 fl. oz unit dose tubes and bottles. Recall # D-038-3;
Liqui-Char (activated charcoal, USP), in an Aqueous Base, 30 grams, 4 fl. oz. unit dose bottles. Recall # D-039-3;
Liqui-Char (activated charcoal, USP) in an Aqueous Base, 50 grams, 8 fl. oz. unit dose tubes and bottles. Recall # D-040-3;
Liqui-Char (activated charcoal) in a Sorbitol Base, 25 grams, 4 fl. oz. unit dose tubes and bottles. Recall # D-041-3;
Liqui-Char (activated charcoal, USP) in a Sorbitol Base, 50 grams, 8 fl. oz. unit dose tube. Recall # D-042-3;
Liqui-Char Oral Suspension (activated charcoal) 50 grams, 240 ml unit dose tube. Recall # D-044-3.
CODE
Liqui-Char in an Aqueous Base, 15gm, 2.5 ounce bottles (NDC 52604-8001-05):
J09503 (09/02), K03514 (03/03);
Liqui-Char in an Aqueous Base, 25gm, 4 ounce tubes (NDC 52604-8001-03):
K08506 (08/02), K12501 (12/02), M10501 (10/03), N02505 (02/04);
Liqui-Char in an Aqueous Base, 25gm, 4 ounce bottles (NDC 52604-8001-04):
J11504 (11/02), K01510 (01/03), K01511 (01/03), K03501 (03/03), K03502 (03/03), K03503 (03/03), K5510 (05/03), K05511 (05/03), M01508 (01/04), M06501 (06/04);
Liqui-Char in an Aqueous Base, 30gm, 4 ounce bottles (NDC 52604-8001304):
J08505 (08/02), M01510 (01/04);
Liqui-Char in an Aqueous Base, 50gm, 8 ounce tubes (NDC 52604-8001-06):
K12502 (12/02), M04501 (04/03), M11509 (11/03), M11511 (11/03);
Liqui-Char in an Aqueous Base, 50gm, 8 ounce tubes code:8001E-6:
K09501 (09/02), K09502 (09/02). This product is manufactured for Oxford Pharmaceuticals, Masters House 5 Sandridge Close, Harrow, England, HA11XD;
Liqui-Char in an Aqueous Base, 50gm, 8 ounce bottles (NDC52604-8001-08):
K01506 (01/03), K01509 (01/03), K02513 (02/03), K03519 (03/03), K03520 (03/03), K03521 (03/03), K03522 (03/03), K05512 (05/03), K05515 (05/03), K06501 (06/03), K06503 (06/03);
Liqui-Char in a Sorbitol base, 25gm/27gm (sorbitol), 4 ounce tubes (NDC 52604-8002-03):
K11502 (11/02), K12503 (12/02), M01509 (01/03), M06503 (06/03), M06507 (06/03), M10502 (10/03), M11502 (11/03), N03503 (03/04);
Liqui-Char in a Sorbitol base, 50gm/54gm (sorbitol), 8 ounce bottles (NDC 52604-8002-06):
K08502 (08/02), K09503 (09/02), K09504 (09/02), K09505 (09/02), K10503 (10/02), K11508 (11/02), M02501 (09/03), M04502 (04/03), M07502 (07/03), M11504 (11/03), M12501 (12/03) M12503 (12/03), M12504 (12/03).
RECALLING FIRM/MANUFACTURER
Recalling Firm: King Pharmaceuticals, Inc., Bristol, TN, by letter on August 12, 2002.
Manufacturer: Jones Pharma, Inc., St. Louis, MO.
Firm initiated recall is ongoing.
REASON
Stability; lack of assurance product potency will be maintained through labeled expiration date.
VOLUME OF PRODUCT IN COMMERCE
28,014 units.
DISTRIBUTION
Nationwide, England and Canada.
_____________________________
PRODUCT
Paradise Gold SUNSCREEN BROAD SPECTRUM PROTECTANT
(Octinoxate, Octisalate, Oxybenzone, Avobenzone), SPF 15, 8 FL OZ (237 mL), Exclusively at Walgreens, Deerfield, IL. Recall # D-046-3.
CODE
2096B.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tanning Research Laboratories, Inc., Ormond Beach, FL, by letter on July 11, 2002.
Manufacturer: Tanning Research Laboratories, Ormond Beach, FL. Firm initiated recall is complete.
REASON
Mislabeling; back label on bottle incorrectly declared as SPF 30 rather than the correct SPF 15.
VOLUME OF PRODUCT IN COMMERCE
5400.
DISTRIBUTION
IL, WI, FL, TX, CA, PA, AZ and IN.
_____________________________
PRODUCT
Member's Mark ACETAMINOPHEN Caplets, 500 mg, Non Aspirin, Extra Strength, 500 caplets per bottle. Recall # D-048-3.
CODE
Lot #'s 1CB0498, 1CB1311 and 1HA1970.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Leiner Health Products, Carson, CA, by letter on September 4, 2002.
Manufacturer: Leiner Health Products, Fort Mill, SC.
Firm initiated recall is ongoing.
REASON
Misbranding; product contains undeclared cherry flavoring.
VOLUME OF PRODUCT IN COMMERCE
14,570,437 caplets.
DISTRIBUTION
AR, OH, MD, GA, NH, NC, FL, PA, CA, IL and TX.
_____________________________
PRODUCT
Intralipid 20% I.V. Fat Emulsion, For Intravenous Use,
(Soybean Oil 20.0g, Phospholipids 1.2g, Glycerin, USP 2.25g) 500 mL bottles, Rx only. Recall # D-049-3.
CODE
NR66160, NR66161, NR66162, NR66163, NR66164, NR66166,
NR66169, NR66170, NR66171.
RECALLING FIRM/MANUFACTURER
Fresenius Kabi Clayton L.P., Clayton, NC, by letter on July 9, 2002. Firm initiated recall is ongoing.
REASON
Mislabeling: bottles incorrectly labeled as Intralipid 30% rather than correctly as Intralipid 20%.
VOLUME OF PRODUCT IN COMMERCE
30,115 units.
DISTRIBUTION
IL.
_____________________________
PRODUCT
Human Cornea Tissue, Recall # B-0112-3.
CODE
Tissue ID 2000-231C.
RECALLING FIRM/MANUFACTURER
Lions Eye Bank for Long Island, North Shore University Hospital, Manhasset, NY, by telephone on September 20, 2000. Firm initiated recall is complete.
REASON
Cornea, collected from a donor who tested repeatedly
reactive for the antibody to the Hepatitis B core antigen
(anti-HBc), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 tissue.
DISTRIBUTION
NY.
_____________________________
PRODUCT
a) Hamilton Brand Sunrise Software - for the Microlab AT series Instruments;
b) Hamilton Brand Sunplus Software - for the Microlab AT Plus and AT Plus 2 series Instruments; Recall # B-0115-3.
CODE
a) Versions 1.0, 2.0, 3.0, 4.0, 5.0, 5.1, 5.2, 5.3, 5.3.1, 5.3.3
b) Versions 1.0, 1.1, 2.0, 3.0, 3.1, 3.2, 3.3, 3.3.1, 3.3.2, 3.3.3.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hamilton Company, Reno, Nevada, by letter dated May 1, 2002.
Manufacturer: Hamilton Bonadux AG, Switzerland.
Firm initiated recall is complete.
REASON
Automated pipette software, which had a glitch or defect, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1,158 distributed.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
Source Plasma, Recall # B-0116-3.
CODE
Units 21075612, 21078422, 26831756, 26835259, 26836867, SH971377.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Harrisburg, PA, by letter dated April 10, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who tested positive for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
CA and France.
_____________________________
PRODUCT
Source Plasma, Recall # B-0117-3.
CODE
Units 28508885, 28509400, 31873093, 31874281, 31877916, 31878838, 31822343, 31823241, SH997753, 31825924, 31829410, 41750573, 41754030, 41756065, 41758786, SH978455, 41812846, 41815038, 41818305, 41820322, 28363972, SH979025, 28367918, 28800965, 28803140, 28806240, 28808626, 40272184, SH979990, 40274690, 40276441, 40279725, 40281957, 40284767, 41173251, 41175842, 41177846, 41471660, 41482926, SH982141, 41485767, 41489383, 42580584, 42583462, 42584445, 42587675, SH982141.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Harrisburg, PA, by letter dated March 12, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of having tested positive for Hepatitis B, were distributed.
VOLUME OF PRODUCT IN COMMERCE
47 units.
DISTRIBUTION
CA, NY and France.
_____________________________
PRODUCT
Source Plasma, Recall # B-0118-3.
CODE
Units 12905133, 12907311.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Harrisburg, PA, by letter dated October 17, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who tested positive for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.
_____________________________
PRODUCT
Red Blood Cells, Recall # B-0120-3.
CODE
Unit number 1845886.
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by letter dated August 16, 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
KY.
_____________________________
PRODUCT
Red Blood Cells, Leukoreduced, Recall # B-0124-3.
CODE
Units C75537.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter dated June 8, 2002. Firm initiated recall is complete.
REASON
Blood product, which was labeled as leukoreduced but did not meet the standard for a leukoreduced product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.
_____________________________
PRODUCT
a) Red Blood Cells, Leukoreduced, Recall # B-0125-3;
b) Platelets, Recall # B-0126-3;
c) Recovered Plasma, Recall # B-0127-3.
CODE
a); b) and c) Unit 27GM56028.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Greater Alleghenies Region, Johnstown, PA, by letter or fax dated February 13, 2002 or January 31, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had not completed the CJD/nvCJD increased risk questions, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
PA, WV and CA.
___________________________
PRODUCT
Source Plasma, Recall # B-0131-3.
CODE
Unit JM029331
RECALLING FIRM/MANUFACTURER
Sera-Tec Biologicals Limited partnership, Jackson, MS, by fax dated June 6, 2000. Firm initiated recall is complete.
REASON
Source Plasma, which tested negative for the hepatitis B surface antigen (HBsAg) but was collected from a donor who subsequently confirmed positive for HBsAg, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.
_____________________________
PRODUCT
Platelets Pheresis Leukocyte Removed, Recall # B-0149-3.
CODE
Unit FT000680A.
RECALLING FIRM/MANUFACTURER
HemaCare Corporation, Sherman Oaks, CA, by telephone on July 28, 2002. Firm initiated recall is complete.
REASON
Blood product, which may not have been labeled with the appropriate volume, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_____________________________
PRODUCT
a) Platelets Pheresis, Recall # B-0150-3;
b) Fresh Frozen Plasma, Recall # B-0151-3.
CODE
a) Unit number LE4790
b) Unit number LE4790 (distributed as two split units)
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence, RI, by telephone on September 30, 2002.
Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to use of the drug Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
RI and MA.
_____________________________
PRODUCT
a) Red Blood Cells, Recall # B-0152-3;
b) Platelets, Recall # B-0153-3.
CODE
a) Unit numbers 50H89201, 50FG02226, and 50LJ19440;
b) Unit numbers 50H89201 and 50FG02226.
RECALLING FIRM/MANUFACTURER
The American National Red Cross,Western Lake Erie Region, Toledo, OH, by letters on June 29, 2001 and July 18, 2001.
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
4 units.
DISTRIBUTION
OH and CA.
_____________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0156-3
CODE
Unit number 6007429.
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services, Inc., Jackson, MS, by letter on October 22, 1998
Firm initiated recall is complete.
REASON
Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MS.
_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0157-3;
CODE
Unit numbers 01LP45290, 01LM46259, 01LG43775, and 01LG41936;
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, New York-Penn Region, West Henrietta, NY, by letters dated February 1 and 4, 2002.
Manufacturer: American Red Cross Blood Services, New York-Penn Region, Buffalo, NY.
Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to use of the medication Arava, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
NY and CA.
_____________________________
PRODUCT
Source Plasma, Recall # B-0159-3.
CODE
Unit number MA011160.
RECALLING FIRM/MANUFACTURER
Sera-Tec Biologicals Limited Partnership (now BioLife Plasma Services, L.P.), Mobile, AL, by fax on January 18, 2000.
Firm initiated recall is complete.
REASON
Blood product, that tested repeatedly reactive for antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
England.
___________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-0160-3;
b) Red Blood Cells, Leukocytes Reduced, Recall # B-0161-3;
c) Red Blood Cells, Irradiated, Recall # B-0162-3;
d) Red Blood Cells, Recall # B-0163-3;
e) Platelets, Recall # B-0164-3;
f) Fresh Frozen Plasma, Recall # B-0165-3;
g )Recovered Plasma, Recall # B-0166-3.
CODE
a) Units 16-357-0033, 16-357-0080, 16-357-5634, 16-357-0299, 16-358-1922, 16-355-2728, 16-355-3081, 16-355-2717, 16-358-5605, 16-358-5602, 16-358-5571 , 16-358-5557, 16-358-5503, 16-358-5495, 16-358-5444, 16-358-5435, 16-358-1920, 16-358-1919, 16-358-1918, 16-358-1917, 16-358-1916, 16-358-1915, 16-358-1914, 16-358-5434, 16-358-5431, 16-358-5421, 16-358-5414, 16-358-5407, 16-358-2268, 16-358-2266, 16-358-2264, 16-358-2130, 16-358-2129, 16-358-2126, 16-358-2124, 16-358-1955, 16-358-1953, 16-358-1946 , 16-358-1940, 16-358-1937, 16-358-1934, 16-358-1931, 16-358-1930, 16-358-1929, 16-358-1924, 16-358-1734, 16-358-1733, 16-358-1731, 16-358-1728, 16-358-1727, 16-358-1726, 16-358-1725, 16-358-1724, 16-358-1723, 16-358-1722, 16-358-1720, 16-358-1719, 16-358-1716, 16-358-1716, 16-358-1758, 16-358-1757, 16-358-1756, 16-358-1755, 16-358-1754, 16-358-1751, 16-358-1749, 16-358-1748, 16-358-1747, 16-358-1746, 16-358-1745, 16-358-1744, 16-358-1743, 16-358-1911, 16-358-1910, 16-358-1907, 16-358-1906, 16-358-1905, 16-358-1904, 16-358-1903, 16-358-1901, 16-358-1898, 16-358-1775, 16-358-1774, 16-358-1771, 16-358-1765, 16-358-1761, 16-358-1760, 16-358-1759, 16-357-8060, 16-357-8061, 16-357-8066, 16-357-8067, 16-357-8079, 16-357-8080, 16-357-8082, 16-358-1699, 16-358-1706, 16-358-1707, 16-358-1715, 16-357-8017, 16-357-8019, 16-357-8021, 16-357-8026, 16-357-8027, 16-357-8028, 16-357-8030, 16-357-8031, 16-357-8039, 16-357-8042, 16-357-8043, 16-357-8045, 16-357-8055, 16-357-7843, 16-357-7844, 16-357-7851, 16-357-7861, 16-357-7867, 16-357-7870, 16-357-7875, 16-357-7877, 16-357-7878, 16-357-7882, 16-357-7885, 16-357-8014, 16-357-5794, 16-357-5795, 16-357-5797, 16-357-5798, 16-357-5800, 16-357-5906, 16-357-6140, 16-357-6145, 16-357-6147, 16-357-6151, 16-357-6152, 16-357-7090, 16-357-1029, 16-357-1025, 16-357-1023, 16-357-1020, 16-357-1017, 16-357-1015, 16-357-0995, 16-357-0981, 16-357-0976, 16-357-1202, 16-357-1194, 16-357-1189, 16-357-1188, 16-357-1187, 16-357-1186, 16-357-1185, 16-357-1184, 16-357-1123, 16-357-1112, 16-357-1075, 16-357-1070, 16-357-1068, 16-357-1049, 16-357-1035, 16-357-1033, 16-357-5629, 16-357-5628, 16-357-5616, 16-357-5451, 16-357-4422, 16-357-1279, 16-357-1272, 16-357-1251, 16-357-1247, 16-357-1243, 16-357-1238, 16-357-1233, 16-357-1208, 16-357-1207, 16-357-5793, 16-357-5792, 16-357-5791, 16-357-5790, 16-357-5789, 16-357-5787, 16-357-5786, 16-357-5785, 16-357-5784, 16-357-5705, 16-357-5637, 16-357-5633, 16-357-0732, 16-357-0735, 16-357-0736, 16-357-0738, 16-357-0739, 16-357-0745, 16-357-0747, 16-357-0748, 16-357-0439, 16-357-0335, 06-357-0333, 16-357-0329, 16-357-0328, 16-357-0326, 16-357-0705, 16-357-0706, 16-357-0710, 16-357-0712, 16-357-0717, 16-357-0723, 16-357-0728, 16-357-0790, 16-357-0651, 16-357-0629, 16-357-0622, 16-357-0619, 16-357-0617, 16-357-0616, 16-357-0614, 16-357-0613, 16-357-0467, 16-357-0463, 16-357-0462, 16-357-0440, 16-357-0967, 16-357-0947, 16-357-0943, 16-357-0940, 16-357-0917, 16-357-0913, 16-357-0906, 16-357-0904, 16-357-0902, 16-357-0886, 16-357-0880, 16-357-0798, 16-357-0793, 16-357-0023, 16-357-0039, 16-357-0038, 16-357-0037, 16-357-0036, 16-357-0035, 16-357-0034, 16-357-0030, 16-357-0029, 16-357-0027, 16-357-0025, 16-357-0024, 16-357-0085, 16-357-0084, 16-357-0083, 16-357-0081, 16-357-0076, 16-357-0072, 16-357-0068, 16-357-0067, 16-357-0066, 16-357-0063, 16-357-0062, 16-357-0056, 16-357-0041, 16-357-0190, 16-357-0180, 16-357-0175, 16-357-0166, 16-357-0163, 16-357-0161, 16-357-0158, 16-357-0156, 16-357-0155, 16-357-0152, 16-357-0095, 16-357-0325, 16-357-0304, 16-357-0301, 16-357-0300, 16-357-0298, 16-357-0297, 16-357-0198, 16-357-0195, 16-357-0192, 16-357-0191, 16-356-9586, 16-356-9585, 16-356-9583, 16-356-9582, 16-356-9580, 16-356-9560, 16-356-9546, 16-356-9545, 16-356-9543, 16-356-9542, 16-356-9946, 16-356-9945, 16-356-9943, 16-356-9942, 16-356-9940, 16-356-9939, 16-356-9938, 16-356-9935, 16-356-9933, 16-356-9881, 16-356-9875, 16-356-9589, 16-356-9588, 16-356-9587, 16-357-0008, 16-357-0007, 16-356-9963, 16-356-9960, 16-356-9959, 16-356-9958, 16-356-9957, 16-356-9955, 16-356-9952, 16-365-9951, 16-356-9950, 16-356-9948, 16-356-9947, 16-357-0022, 16-357-0021, 16-357-0020, 16-357-0019, 16-357-0018, 16-357-0017, 16-357-0016, 16-357-0015, 16-357-0014, 16-357-0013, 16-357-0012, 16-357-0010, 16-357-0009, 16-356-9514, 16-356-9511, 16-356-9485, 16-356-9482, 16-356-9481, 16-356-9479, 16-356-9478, 16-356-9476, 16-356-9470, 16-356-9467, 16-356-5711, 16-356-9540, 16-356-9537, 16-356-9536, 16-356-9534, 16-356-9533, 16-356-9532, 16-356-9530, 16-356-9527, 16-356-9523, 16-356-9521, 16-356-9519, 16-356-9516, 16-356-9515, 16-355-4824, 16-355-4823, 16-355-4822, 16-355-4818, 16-355-4847, 16-355-4846, 16-355-4843, 16-355-4840, 16-355-4839, 16-355-4834, 16-355-4833, 16-355-4832, 16-355-4831, 16-355-4827, 16-355-4826, 16-355-4825, 16-355-4862, 16-355-4861, 16-355-4860, 16-355-4858, 16-355-4857, 16-355-4854, 16-355-4853, 16-355-4851, 16-355-4850, 16-355-4849, 16-355-5000, 16-355-4958, 16-355-4957, 16-355-4943, 16-355-4942, 16-355-4871, 16-355-4870, 16-355-4868, 16-355-4867, 16-355-4866, 16-355-4863, 16-355-4688, 16-355-4686, 16-355-4686, 16-355-4685, 16-355-4711, 16-355-4709, 16-355-4707, 16-355-4704, 16-355-4702, 16-355-4700, 16-355-4699, 16-355-4695, 16-355-4694, 16-355-4691, 16-355-4690, 16-355-4689, 16-355-4762, 16-355-4761, 16-355-4759, 16-355-4758, 16-355-4729, 16-355-4728, 16-355-4726, 16-355-4725, 16-355-4721, 16-355-4719, 16-355-4716, 16-355-4776, 16-355-4775, 16-355-4774, 16-355-4773, 16-355-4772, 16-355-4771, 16-355-4770, 16-355-4769, 16-355-4768, 16-355-4766, 16-355-4765, 16-355-4763, 16-355-4816, 16-355-4814, 16-355-4808, 16-355-4807, 16-355-4806, 16-355-4803, 16-355-4802, 16-355-4801, 16-355-4780, 16-355-4777, 16-355-4191, 16-355-4190, 16-355-4189, 16-355-4188, 16-355-4186, 16-355-4185, 16-355-4183, 16-355-4182, 16-355-4354, 16-355-4331, 16-355-4330, 16-355-4200, 16-355-4198, 16-355-4197, 16-355-4195, 16-355-4194, 16-355-4193, 16-355-4192, 16-355-4384, 16-355-4383, 16-355-4380, 16-355-4379, 16-355-4378, 16-355-4374, 16-355-4369, 16-355-4367, 16-355-4355, 16-355-4661, 16-355-4658, 16-355-4656, 16-355-4398, 16-355-4396, 16-355-4394, 16-355-4392, 16-355-4388, 16-355-4387, 16-355-4386, 16-355-4385, 16-355-4684, 16-355-4683, 16-355-4682, 16-355-4681, 16-355-4680, 16-355-4679, 16-355-4677, 16-355-4675, 16-355-4673, 16-355-4670, 16-355-4668, 16-355-4665, 16-355-4664, 16-355-4662, 16-355-3721, 16-355-3719, 16-355-3718, 16-355-3713, 16-355-3708, 16-355-3707, 16-355-3739, 16-355-3738, 16-355-3737, 16-355-3736, 16-355-3735, 16-355-3733, 16-355-3731, 16-355-3730, 16-355-3728, 16-355-3725, 16-355-3724, 16-355-3722, 16-355-3791, 16-355-3787, 16-355-3764, 16-355-3755, 16-355-3753, 16-355-3749, 16-355-3748, 16-355-3747, 16-355-3746, 16-355-3743, 16-355-3742, 16-355-3741, 16-355-3740, 16-355-4087, 16-355-3809, 16-355-3808, 16-355-3807, 16-355-3799, 16-355-3796, 16-355-3795, 16-355-3794, 16-355-3793, 16-355-4120, 16-355-4118, 16-355-4108, 16-355-4106, 16-355-4105, 16-355-4103, 16-355-4102, 16-355-4101, 16-355-4099, 16-355-4097, 16-355-4094, 16-355-4090, 16-355-4088, 16-355-3367, 16-355-3366, 16-355-3364, 16-355-3362, 16-355-3359, 16-355-3354, 16-355-3353, 16-355-3346, 16-355-3344, 16-355-3339, 16-355-3411, 16-355-3409, 16-355-3408, 16-355-3407, 16-355-3406, 16-355-3395, 16-355-3382, 16-355-3381, 16-355-3378, 16-355-3376, 16-335-3370, 16-355-3484, 16-355-3482, 16-355-3481, 16-355-3480, 16-355-3475, 16-355-3444, 16-355-3441, 16-355-3440, 16-355-3438, 16-355-3434, 16-355-3421, 16-355-3419, 16-355-3418, 16-355-3706, 16-355-3590, 16-355-3588, 16-355-3586, 16-355-3540, 16-355-3539, 16-355-3538, 16-355-3537, 16-355-3488, 16-355-3487, 16-355-3180, 16-35-3179, 16-355-3178, 16-355-3177, 16-355-3176, 16-355-3175, 16-355-3098, 16-355-3097, 16-355-3095, 16-355-3094, 16-355-3092, 16-355-3089, 16-355-3088, 16-355-3087, 16-355-3086, 16-355-3085, 16-355-3084, 16-355-3083, 16-355-3198, 16-355-3195, 16-355-3194, 16-355-3191, 16-355-3190, 16-355-3189, 16-355-3188, 16-355-3187, 16-355-3186, 16-355-3185, 16-355-3183, 16-355-3182, 16-355-3181, 16-355-3308, 16-355-3306, 16-355-3305, 16-355-3303, 16-355-3302, 16-355-3301, 16-355-3300, 16-355-3297, 16-355-3296, 16-355-3199, 16-355-3333, 16-355-3332, 16-355-3331, 16-355-3330, 16-355-3325, 16-355-3323, 16-355-3321, 16-355-3318, 16-355-3317, 16-355-3316, 16-355-3315, 16-355-3313, 16-355-3311, 16-355-2942, 16-355-2941, 16-355-2727, 16-355-2974, 16-355-2973, 16-355-2972, 16-355-2969, 16-355-2967, 16-355-2965, 16-355-2960, 16-355-2959, 16-355-2958, 16-355-2955, 16-355-2953, 16-355-2950, 16-355-2947, 16-355-2946, 16-355-3009, 16-355-3008, 16-355-3007, 16-355-3006, 16-355-3005, 16-355-3004, 16-355-3003, 16-355-3001, 16-355-3000, 16-355-2999, 16-355-3082, 16-355-3080, 16-355-3038, 16-355-3033, 16-355-3028, 16-355-3022, 16-355-3021, 16-355-3020, 16-355-3016, 16-355-3015, 16-355-3011, 16-355-3010, 16-355-2724, 16-355-2400, 16-355-2398, 16-355-2335, 16-355-2329, 16-355-2319, 16-355-2318, 16-358-1740, 16-355-3309
b) Unit 16-358-1912
c) Units 16-355-3342, 16-355-3337, 16-355-3536, 16-355-3091, 16-355-3319, 16-356-9468, 16-355-3014
d) Units 16-358-5519, 16-358-5503, 16-358-5496, 16-358-5495, 16-358-5456, 16-358-5444, 16-358-5435, 16-358-5434, 16-358-5431, 16-358-5424, 16-358-1775, 16-358-1771, 16-358-1765, 16-357-8055, 16-357-7861, 16-357-7867, 16-357-7870, 16-357-5794, 16-357-5795, 16-357-5798, 16-357-6140, 16-357-6151, 13-357-6152, 16-357-0981, 16-357-1068, 16-357-5629, 16-357-5616, 16-357-1243, 16-357-1233, 16-357-5792, 16-357-5791, 16-357-5790, 16-357-5786, 16-357-5785, 16-357-5634, 16-357-5633, 16-357-0732, 16-357-0736, 16-357-0738, 16-357-0745, 16-357-0747, 16-357-0748, 16-357-0749, 16-357-0335, 16-357-0333, 16-357-0329, 16-357-0328, 16-357-0326, 16-357-0705, 16-357-0710, 16-357-0712, 16-357-0723, 16-357-0728, 16-357-0967, 16-357-0191, 16-357-0163, 16-357-0161, 16-357-0156, 16-357-0155, 16-357-0152, 16-357-0325, 16-357-0304, 16-357-0301, 16-357-0300, 16-357-0299, 16-357-0298, 16-357-0297, 16-357-0195, 16-357-0192, 16-355-4824, 16-355-4818, 16-355-4847, 16-355-4846, 16-355-4843, 16-355-4862, 16-355-4858, 16-355-4857, 16-355-4853, 16-355-4850, 16-355-4871, 16-355-4870, 16-355-4868, 16-355-4867, 16-355-4866, 16-355-4863, 16-355-4816, 16-355-4808, 16-355-4807, 16-355-4806, 16-355-4803, 16-355-4802, 16-355-4191, 16-355-4354, 16-355-4198, 16-355-4195, 16-355-4192, 16-355-4383, 16-355-4380, 16-355-4379, 16-355-4378, 16-355-4355, 16-355-4388, 16-355-4387, 16-355-4386, 16-355-4385, 16-355-3791, 16-355-3787, 16-355-4087, 16-355-3809, 16-355-3808, 16-355-3807, 16-355-3799, 16-355-3795, 16-355-3411, 16-355-3409, 16-355-3407, 16-355-3406, 16-355-3484, 16-355-3480, 16-355-3539, 16-355-3537, 16-355-3488, 16-355-3487, 16-355-3306, 16-355-3305, 16-355-3303, 16-355-3302, 16-355-3297, 16-355-3330, 16-355-3316, 16-355-3009, 16-355-3008, 16-355-3007, 16-355-3006, 16-355-3000, 16-355-3038, 16-355-3011, 16-355-3010, 16-355-2398
e) Units 16-357-5800, 16-357-4422, 16-357-5787, 16-357-0736, 16-357-0728, 16-357-1629, 16-357-0622, 16-357-0620, 16-357-0619, 16-357-0617, 16-357-0614, 16-357-0166, 16-357-0161, 16-357-0158, 16-357-0155, 16-357-0304, 16-357-0301, 16-357-0195, 16-355-3791, 16-355-3787, 16-355-3475, 16-355-3539, 16-355-3538, 16-355-3537, 16-355-3487, 16-355-3198, 16-355-3195, 16-355-3309, 16-355-3308, 16-355-3306, 16-355-3305, 16-355-3303, 16-355-3302, 16-355-3300, 16-355-3297, 16-355-3296, 16-355-3199, 16-355-3330, 16-355-3325, 16-355-3321, 16-355-3319, 16-355-3318, 16-355-3317, 16-355-3316, 16-355-3313, 16-355-3311
f) Units 16-358-1734, 16-358-1733, 16-358-1731, 16-358-1728, 16-358-1727, 16-358-1726, 16-358-1725, 16-358-1724, 16-358-1723, 16-358-1722, 16-358-1720, 16-358-1719, 16-358-1775, 16-358-1774, 16-358-1771, 16-357-8080, 16-358-1715, 16-357-8019, 16-357-8026, 16-357-8027, 16-357-8028, 16-357-8030, 16-357-8031, 16-357-8055, 16-357-7861, 16-357-7867, 16-357-7870, 16-357-7885, 16-357-6140, 16-357-6145, 16-357-6147, 16-357-6151, 13-357-6152, 16-357-0981, 16-357-1189, 16-357-1185, 16-357-1075, 16-357-1070, 16-357-1272, 16-357-1208, 16-357-1202, 16-357-5789, 16-357-0735, 16-357-0739, 16-357-0706, 16-357-0790, 16-357-0967, 16-357-0798, 16-357-0793, 16-357-0039, 16-357-0039, 16-357-0038, 16-357-0037, 16-357-0036, 16-357-0035, 16-357-0034, 16-357-0029, 16-357-0152, 16-357-0198, 16-356-9586, 16-356-9585, 16-356-9583, 16-356-9582, 16-356-9580, 16-356-9577, 16-356-9560, 16-356-9946, 16-356-9945, 16-356-9943, 16-356-9942, 16-356-9940, 16-356-9939, 16-356-9938, 16-356-9935, 16-356-9933, 16-356-9589, 16-356-9588, 16-356-9587, 16-356-9963, 16-356-9960, 16-356-9959, 16-356-9958, 16-356-9957, 16-356-9955, 16-356-9952, 16-356-9951, 16-356-9950, 16-356-9948, 16-356-9947, 16-356-9485, 16-356-9479, 16-356-9478, 16-356-9476, 16-356-9470, 16-356-9468, 16-356-9467, 16-355-4824, 16-355-4823, 16-355-4819, 16-355-4818, 16-355-4847, 16-355-4846, 16-355-4843, 16-355-4826, 16-355-4825, 16-355-4862, 16-355-4860, 16-355-4858, 16-355-4857, 16-355-4853, 16-355-4850, 16-355-4871, 16-355-4870, 16-355-4868, 16-355-4867, 16-355-4863, 16-355-4816, 16-355-4815, 16-355-4814, 16-355-4808, 16-355-4807, 16-355-4806, 16-355-4805, 16-355-4803, 16-355-4802, 16-355-4801, 16-355-4191, 16-355-4190, 16-355-4189, 16-355-4188, 16-355-4354, 16-355-4200, 16-355-4199, 16-355-4198, 16-355-4197, 16-355-4195, 16-355-4194, 16-355-4193, 16-355-4192, 16-355-4384, 16-355-4383, 16-355-4380, 16-355-4379, 16-355-4378, 16-355-4374, 16-355-4369, 16-355-4367, 16-355-4355, 16-355-4388, 16-355-4387, 16-355-4386, 16-355-4385, 16-355-4087, 16-355-3809, 16-355-3808, 16-355-3807, 16-355-3800, 16-355-3799, 16-355-3796, 16-355-3795, 16-355-3794, 16-355-3793, 16-355-4118, 16-355-4102, 16-355-4101, 16-355-4097, 16-355-3411, 16-355-3407, 16-355-3406, 16-355-3194, 16-355-3000, 16-355-2999, 16-355-2400, 16-355-2398, 16-355-2329, 16-358-1740, 16-358-1758, 16-358-1757, 16-358-1755, 16-358-1754, 16-358-1751, 16-358-1750, 16-358-1749, 16-358-1748, 16-358-1747, 16-358-1746, 16-358-1745, 16-358-1744, 16-358-1743, 16-358-1761, 16-358-1759, 16-357-8060, 16-357-8061, 16-357-8066, 16-357-8067, 16-357-8079, 16-357-8082, 16-358-1699, 16-358-1706, 16-358-1707, 16-357-8017, 16-357-8021, 16-357-8039, 16-357-8042, 16-357-8043, 16-357-8045, 16-357-7843, 16-357-7844, 16-357-7851, 16-357-7877, 16-357-7878, 16-357-7882, 16-357-8014, 16-357-1033, 16-357-1029, 16-357-1025, 16-357-1023, 16-357-1020, 16-357-1017, 16-357-1015, 16-357-1008, 16-357-0995, 16-357-0976, 16-357-1194, 16-357-1184, 16-357-1123, 16-357-1112, 16-357-1075, 16-357-1049, 16-357-1035, 16-357-1279, 16-357-1251, 16-357-1247, 16-357-1238, 16-357-5705, 16-357-0439, 16-357-0717, 16-357-0651, 16-357-0467, 16-357-0463, 16-357-0462, 16-357-0440, 16-357-0947, 16-357-0943, 16-357-0940, 16-357-0917, 16-357-0913, 16-357-0906, 16-357-0904, 16-357-0886, 16-357-0880, 16-357-0023, 16-357-0033, 16-357-0030, 16-357-0027, 16-357-0025, 16-357-0024, 16-357-0085, 16-357-0084, 16-357-0083, 16-357-0081, 16-357-0080, 16-375-0076, 16-357-0072, 16-357-0068, 16-357-0067, 16-357-0066, 16-357-0063, 16-357-0062, 16-357-0056, 16-357-0180, 16-357-0175, 16-357-0095, 16-357-0293, 16-356-9543, 16-356-9542, 16-356-9881, 16-356-9875, 16-357-0009, 16-357-0008, 16-357-0007, 16-357-0022, 16-357-0021, 16-357-0020, 16-357-0019, 16-357-0018, 16-357-0017, 16-357-0016, 16-357-0015, 16-357-0014, 16-357-0013, 16-357-0012, 16-357-0010, 16-356-9514, 16-356-9482, 16-356-5711, 16-356-9540, 16-356-9537, 16-356-9536, 16-356-9534, 16-356-9533, 16-356-9532, 16-356-9530, 16-356-9527, 16-356-9521, 16-356-9519, 16-356-9516, 16-356-9515, 16-355-4822, 16-355-4821, 16-355-4840, 16-355-4839, 16-355-4834, 16-355-4833, 16-355-4832, 16-355-4831, 16-355-4827, 16-355-4861, 16-355-4854, 16-355-4851, 16-355-4849, 16-355-5000, 16-355-4958, 16-355-4943, 16-355-4942, 16-355-4688, 16-355-4686, 16-355-4685, 16-355-4711, 16-355-4709, 16-355-4707, 16-355-4704, 16-355-4702, 16-355-4700, 16-355-4699, 16-355-4695, 16-355-4694, 16-355-4691, 16-355-4690, 16-355-4689, 16-355-4762, 16-355-4761, 16-355-4759, 16-355-4758, 16-355-4729, 16-355-4728, 16-355-4726, 16-355-4725, 16-355-4721, 16-355-4720, 16-355-4719, 16-355-4716, 16-355-4776, 16-355-4775, 16-355-4774, 16-355-4773, 16-355-4772, 16-355-4771, 16-355-4770, 16-355-4769, 16-355-4768, 16-355-4766, 16-355-4765, 16-355-4763, 16-355-4780, 16-355-4777, 16-355-4186, 16-355-4185, 16-355-4183, 16-355-4182, 16-355-4331, 16-355-4661, 16-355-4658, 16-355-4656, 16-355-4398, 16-355-4396, 16-355-4394, 16-355-4392, 16-355-4684, 16-355-4682, 16-355-4681, 16-355-4680, 16-355-4679, 16-355-4677, 16-355-4675, 16-355-4673, 16-355-4670, 16-355-4668, 16-355-4665, 16-355-4664, 16-355-4662, 16-355-3721, 16-355-3719, 16-355-3718, 16-355-3713, 16-355-3707, 16-355-3739, 16-355-3738, 16-355-3737, 16-355-3736, 16-355-3735, 16-355-3733, 16-355-3731, 16-355-3730, 16-355-3728, 16-355-3725, 16-355-3724, 16-355-3722, 16-355-3764, 16-355-3755, 16-355-3753, 16-355-3749, 16-355-3747, 16-355-3746, 16-355-3743, 16-355-3742, 16-355-3741, 16-355-3740, 16-355-4120, 16-355-4108, 16-355-4106, 16-355-4105, 16-355-4104, 16-355-4103, 16-355-4094, 16-355-4090, 16-355-4088, 16-355-3367, 16-355-3366, 16-355-3364, 16-355-3362, 16-355-3359, 16-355-3354, 16-355-3353, 16-355-3346, 16-355-3344, 16-355-3342, 16-355-3339, 16-355-3337, 16-355-3336, 16-355-3408, 16-355-3395, 16-355-3382, 16-355-3381, 16-355-3378, 16-355-3376, 16-355-3370, 16-355-3481, 16-355-3444, 16-355-3441, 16-355-3440, 16-355-3438, 16-355-3434, 16-355-3421, 16-355-3419, 16-355-3418, 16-355-3706, 16-355-3590, 16-355-3588, 16-355-3586, 16-355-3540, 16-355-3535, 16-355-3180, 16-355-3179, 16-355-3178, 16-355-3177, 16-355-3176, 16-355-3175, 16-355-3098, 16-355-3094, 16-355-3087, 16-355-3086, 16-355-3085, 16-355-3084, 16-355-3191, 16-355-3190, 16-355-3189, 16-355-3188, 16-355-3187, 16-355-3186, 16-355-3185, 16-355-3183, 16-355-3182, 16-355-3181, 16-355-3333, 16-355-3332, 16-355-3331, 16-355-2942, 16-355-2941, 16-355-2728, 16-355-2727, 16-355-2725, 16-355-2974, 16-355-2973, 16-355-2972, 16-355-2969, 16-355-2965, 16-355-2960, 16-355-2959, 16-355-2958, 16-355-2955, 16-355-2953, 16-355-2950, 16-355-2947, 16-355-2946, 16-355-3009, 16-355-3008, 16-355-3007, 16-355-3006, 16-355-3005, 16-355-3004, 16-355-3003, 16-355-3001, 16-355-3080, 16-355-3038, 16-355-3033, 16-355-3028, 16-355-3022, 16-355-3021, 16-355-3020, 16-355-3016, 16-355-3015, 16-355-3011, 16-355-3010, 16-355-2724, 16-355-2717, 16-355-2335, 16-355-2319, 16-355-4330, 16-355-3409, 16-358-1765, 16-357-7875, 16-355-4866.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone and letter beginning on February 17, 2001.
Manufacturer: United Blood Services, Meridian, MS.
Firm initiated recall is ongoing.
REASON
Blood products, collected in a manner that compromises the sterility of the collection system, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 2 units;
b) 693 units;
c) 1 unit;
d) 7 units;
e) 139 units;
f) 46 units;
g) 533 units;
DISTRIBUTION
AL, MS, MO, LA, NY, VA and Switzerland.
_____________________________
PRODUCT
Abbott HCV EIA 2.0 Diagnostic Kit, Hepatitis C Virus Encoded Antigen (Recombinant c100-3, HC-31, HC-34), Recall # B-0113-3.
CODE
Lot 91988M101.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc., Abbott Park, IL, by telephone beginning on September 5, 2002. Firm initiated recall is complete.
REASON
HCV test kits, containing a conjugate concentrate that has the potential to be overfilled, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1,339 test kits.
DISTRIBUTION
Nationwide.
____________________________
PRODUCT
Collagenase, Santyl Ointment, Recall # B-0114-3.
CODE
Lot number 0000075211, expiration date 2/05
RECALLING FIRM/MANUFACTURER
Advance Biofactures Corporation, a subsidiary of Biospecifics Technologies Corporation, Lynbrook, New York, by letter dated September 20, 2002. Firm initiated recall is complete.
REASON
Drug product, which exceed potency specifications (super-potent), was distributed.
VOLUME OF PRODUCT IN COMMERCE
13,692 units.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
Source Plasma, Recall # B-0134-3.
CODE
BRXGNW, BRXGNX, BRXGNY, BRXGNZ, BRXGPB, BRXGPC, BRXGPD, BRXGPF, BRXGPG, BRXGPH, BRXGPJ, BRXGPK, BRXGPL, BRXHBF, BRXGPM, BRXGPN, BRXGPP, BRXGPQ, BRXGPR, BRXHBB, BRXGPS, BRXGPT, BRXGPV, BRXGPW, BRXGPX, BRXGPY, BRXGPZ, BRXGQB, BRXGQC, BRXGQD, BRXGQF, BRXGQG, BRXGQH, BRXGQJ, BRXGQK, BRXHBL, BRXGQL, BRXGQM, BRXGRD, BRXHBC, BRXGRF, BRXGRG, BRXGRJ, BRXGRK, BRXGRL, BRXGRM, BRXGRN, BRXGRP, BRXGRQ, BRXGRR, BRXGRS, BRXGRT, BRXGRV, BRXGRW, BRXGRY, BRXGRZ, BRXGSB, BRXGSC, BRXGSD, BRXGSF, BRXGSG, BRXGSH, BRXGSJ, BRXGSK, BRXGSL, BRXGSM, BRXGSN, BRXGSP, BRXGSQ, BRXGSR, BRXGSS, BRXGST, BRXGSV, BRXGSW, BRXGSX, BRXGSY, BRXGSZ, BRXHBY, BRXGTB, BRXGTC, BRXGTD, BRXGTF, BRXGTG, BRXGTH, BRXGTJ, BRXGTK, BRXGTL, BRXGTM, BRXGTN, BRXGTP, BRXGTQ, BRXGTR, BRXGTS, BRXGTT, BRXHCJ, BRXGTV, BRXGTW, BRXGTX, BRXGTY, BRXGTZ, BRXHCH, BRXGVB, BRXGVC, BRXGVD, BRXGVF, BRXGVG, BRXGVH, BRXGVJ, BRXGVK, BRXGVL, BRXGVM, BRXGVN, BRXGVP, BRXGVQ, BRXGVR, BRXGVS, BRXGVT, BRXGVV, BRXGVW, BRXGVX, BRXGVY, BRXGVZ, BRXGWB, BRXGWC, BRXGWD, BRXGWF, BRXGWG, BRXGWH, BRXGWJ, BRXGWK, BRXGWL, BRXGWM, BRXGWN, BRXGWP, BRXGWQ, BRXGWS, BRXGWT, BRXGWV, BRXGWW, BRXGWX, BRXGWY, BRXGWZ, BRXGXB, BRXGXC, BRXGXD, BRXGXF, BRXGXG, BRXGXH, BRXGXJ, BRXGXK, BRXGXL, BRXGXM, BRXGXN, BRXGXP, BRXGXQ, BRXGXR, BRXGXS, BRXGXT, BRXGXV, BRXGXW, BRXGXX, BRXGYN, BRXGYP, BRXGYQ, BRXGYR, BRXGYS, BRXGYT, BRXGYV, BRXGYW, BRXGYX, BRXGYY, BRXGYZ, BRXGZB, BRXGZR, BRXGZS, BRXGZT, BRXGZV, BRXGZW, BRXGZX, BRXGZY, BRXGZZ, BRXHBD, BRXHBG, BRXHBH, BRXHBJ, BRXHBK, BRXHBM, BRXHBN, BRXHBP, BRXHBQ, BRXHBR, BRXHBS, BRXHBT, BRXHBV, BRXHBW, BRXHBX, BRXHBZ, BRXHCB, BRXHCC, BRXHCD, BRXHCF, BRXHCG, BRWRNV, BRWRNW, BRWRNX, BRWRNY, BRWRNZ, BRWRPB, BRWRPC, BRWRXJ, BRWRPD, BRWRPF, BRWRPG, BRWRPH, BRWRXM, BRWRPJ, BRWRQP, BRWRQQ, BRWRQR, BRWRQS, BRWRQT, BRWRQV, BRWRQW, BRWRQX, BRWRQY, BRWRQZ, BRWRRB, BRWRRC, BRWRRS, BRWRRT, BRWRRV, BRWRRW, BRWRRX, BRWRRY, BRWRRZ, BRWRSB, BRWRSC, BRWRSD, BRWRSF, BRWRSG, BRWRSH, BRWRSJ, BRWRSK, BRWRSL, BRWRSM, BRWRSN, BRWRSP, BRWRSQ, BRWRSR, BRWRSS, BRWRST, BRWRSV, BRWRSW, BRWRSX, BRWRSY, BRWRSZ, BRWRTB, BRWRTC, BRWRTD, BRWRTF, BRWRTG, BRWRTH, BRWRTJ, BRWRTK, BRWRTL, BRWRTM, BRWRTN, BRWRTP, BRWRTQ, BRWRTR, BRWRTS, BRWRTT, BRWRTV, BRWRTW, BRWRTX, BRWRTY, BRWRTZ, BRWRVB, BRWRVC, BRWRVD, BRWRVF, BRWRVG, BRWRVH, BRWRVJ, BRWRVK, BRWRVL, BRWRVM, BRWRVN, BRWRVP, BRWRVQ, BRWRVR, BRWRVS, BRWRVT, BRWRVV, BRWRVW, BRWRVX, BRWRVY, BRWRVZ, BRWRWB, BRWRWC, BRWRWD, BRWRWF, BRWRWG, BRWRWH, BRWRWJ, BRWRWK, BRWRWL, BRWRWM, BRWRWN, BRWRWP, BRWRWQ, BRWRWR, BRWRXH, BRWRXK, BRWRXL, BRWRXN, BRWRXP, BRWRXQ, BRWRXR, BRWRXS, BRWRXT, BRWRXV, BRWRXW, BRWRXX, BRWRXY, BRWRXZ, BRWRYB, BRWRYC, BRWRYD, BRWRYF, BRWRYG, BRWRYH, BRWRYJ, BRWRYK, BRTXLM, BRTXPH, BRTXLN, BRTXLP, BRTXLQ, BRTXLR, BRTXLS, BRTXLT, BRTXLV, BRTXLW, BRTXLX, BRTXLY, BRTXLZ, BRTXMB, BRTXMC, BRTXMD, BRTXMF, BRTXMG, BRTXMH, BRTXMJ, BRTXMK, BRTXML, BRTXMM, BRTXMN, BRTXMP, BRTXMQ, BRTXMR, BRTXMS, BRTXMT, BRTXMV, BRTXMW, BRTXMX, BRTXMY, BRTXMZ, BRTXNB, BRTXNC, BRTXND, BRTXNF, BRTXNG, BRTXNH, BRTXNJ, BRTXNK, BRTXNL, BRTXNM, BRTXNN, BRTXNP, BRTXNQ, BRTXNR, BRTXNS, BRTXNT, BRTXNV, BRTXNW, BRTXNX, BRTXNY, BRTXNZ, BRTXPB, BRTXPC, BRTXPD, BRTXPF, BRTXPG, BRTXPJ, BRTXPK, BRTXPL, BRTXPM, BRTXPN, BRTXPP, BRTXPQ, BRTXPR, BRTXPS, BRTXPT, BRTXPV, BRTXPW, BRTRFT, BRTRGQ, BRTRFV, BRTRGH, BRTRFW, BRTRFX, BRTRFY, BRTRGS, BRTRFZ, BRTRGB, BRTRGV, BRTRGC, BRTRGD, BRTRGF, BRTRGG, BRTRGJ, BRTRGK, BRTRGL, BRTRGM, BRTRGN, BRTRGP, BRTRGR, BRTRGT, BRTRGW, BRSMNK, BRSMNL, BRSMNM, BRSMNN, BRSMNP, BRSMNQ, BRSMNR, BRSMNS, BRSMNT, BRSMNV, BRSMNW, BRSMNX, BRSMNY, BRSMPB, BRSMPC, BRSMPD, BRSMPF, BRSMPG, BRSMPH, BRSMPJ, BRSMPK, BRSMPL, BRSMPM, BRRNSQ, BRRNSR, BRRNSS, BRRNST, BRRNSV, BRRNSW, BRRNSX, BRRNSY, BRRNSZ, BRRNTB, BRRNTC, BRRNTD, BRRNTT, BRRNTV, BRRNTW, BRRNTX, BRRNTY, BRRNTZ, BRRNVB, BRRNVC, BRRNVD, BRRNVF, BRRNVG, BRRNVH, BRPRZN, BRPRZP, BRPRZY, BRPRZQ, BRPRZR, BRPRZS, BRPRZT, BRPRZV, BRPRZW, BRPRZX, BRPRZZ, BRPSBB, BRXGXY, BRXGXZ, BRXGYB, BRXGYC, BRXGYD, BRXGYF, BRXGYG, BRXGYH, BRXGYJ, BRXGYK, BRXGYL, BRXGYM.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aventis Bio-Services, Inc., Knoxville, TN, by fax dated July 14 and 16, 2002.
Manufacturer: Aventis Bio-Services, Inc., Akron, OH.
Firm initiated recall is complete.
REASON
Source Plasma, that was exposed to unacceptable storage temperatures and was not properly relabeled as Source Plasma, Salvaged, was distributed.
VOLUME OF PRODUCT IN COMMERCE
501 units.
DISTRIBUTION
IN, Germany and Switzerland.
_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0154-3.
CODE
Unit numbers 42K51813 and 42K51767.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northern Ohio Region, Cleveland, OH, by telephone on August 7, 2002 and by letter on August 9, 2002. Firm initiated recall is complete.
REASON
Blood products, that tested out of specification for hematocrit, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
OH.
_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated, Recall # B-0155-3.
CODE
Unit number 1763108 (distributed as two split units).
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services, Inc., Jackson, MS, by letter on October 26, 1999. Firm initiated recall is complete.
REASON
Blood products, labeled with the incorrect expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MS.
_____________________________
PRODUCT
Recovered Plasma, Recall # B-0158-3.
CODE
Unit numbers 01LP45290, 01LM46259, 01LG43775, and 01LG41936.
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, New York-Penn Region, West Henrietta, NY, by letters dated February 1 and 4, 2002.
Manufacturer: American Red Cross Blood Services, New York-Penn Region, Buffalo, NY. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to use of the medication Arava, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
NY and CA.
_____________________________
PRODUCT
Summit Autonomous Inc. LADAR Vision Excimer Lasers Systems,
Ophthalmic Excimer Laser System. Recall # Z-0145-3.
CODE
LADARVision Excimer Laser Systems with the following serial numbers were subject to this field corrective action:
17, 21, 22, 23, 26, 28, 30, 31, 32, 33, 34, 38-49, 1018, 1019, 1025, 1027, 1035, 1037, 1051-1053, 1055-1064, 1066-1079, 1081, 1083, 1085-1096, 1098-1105, 1109-1110, 1113, 1116, 1118-1020 and 1122.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Alcon Laboratories (formerly Summit Autonomous), Orlando, FL, by fax on July 28, 2000.
Manufacturer: Alcon Laboratories, Inc., Orlando, FL.
Firm initiated recall is complete.
REASON
Patient had unsatisfactory vision correction due to error in ablation mask function during Lasix treatmen.
VOLUME OF PRODUCT IN COMMERCE
85.
DISTRIBUTION
Nationwide, Spain, Greece and Austrailia.
_____________________________
PRODUCT
2.8mm Drill Radiolucent Target. Recall # Z-0161-3;
3.2mm Drill Radiolucent Target. Recall # Z-0162-3;
3.7mm Drill Radiolucent Target. Recall # Z-0163-3;
4.0mm Drill Radiolucent Target. Recall # Z-0164-3'
4.3mm Drill Radiolucent Target. Recall # Z-0165-3;
5.0mm Drill Radiolucent Target. Recall # Z-0166-3;
5.5mm Drill Radiolucent Target. Recall # Z-0167-3.
CODE
Catalog No.
| 38152128 | 2.8mm Drill Radiolucent Target |
| 38152132 | 3.2 |
| 38152137 | 3.7 |
| 38152140 | 4.0 |
| 38152143 | 4.3 |
| 38152150 | 5.0 |
| 38152155 | 5.5 |
_____________________________
PRODUCT
Allograft Heart Valve. Recall # Z-0168-3.
CODE
Donor ID: 61611, Model Number: SGPV00, Allograft Serial Number: 7710510.
RECALLING FIRM/MANUFACTURER
Cryolife, Inc., Marietta, GA, by letter August 15, 2002.
Firm initiated recall is ongoing.
REASON
Donor post-mortem blood culture were positive for Clostridium septicum.
VOLUME OF PRODUCT IN COMMERCE
1 individual heart valve allograft.
DISTRIBUTION
IN.
_____________________________
PRODUCT
Multidiagnost 3 and Multidiagnost 4 X-Ray Systems: multi
functional/universal system used for general R/F. Fluorscopy, radiography and angiography can be performed with other specialized interventional applications. Units involved have joysticks. Recall # Z-0169-3/Z-0170-3.
CODE
Serial numbers as provided by the firm. The firm is verifying the accuracy of the serial numbers.
MD 3 part #s 9896 000 12231, 9896 000 12232, 9896 000 12211, 9896 000 12212 Serial Nos. 4502681, 4543400, 4626120, 4706721, 4543410, 476793, 4492410, 4492330, 4533250, 4532940, 4533180, 459527, 4543470, 4502601, 4564170, 4533200, 4594941, 4595110, 4532870, 4584330,
4502791, 4492320, 4502731, 4533170, 4533230, 4533240, 4502611, 4502701, 4706541, 4706411, 25, 4562000, 4706421, 4543580, 4532880, 481854, 4615310, 4532990, 4757741, 4594861, 4767960, 4533120, 42012G, 4543721, 4615330, 4533030, 4533140, 4543751, 4726860, 4532910, 4595200, 4502771, 4595190, 4492400, 4706711, 4564180, 4452270, 4502591, 4543550, 4563950, 4615450, 4543590, 4492370,
4706370, 4626290, 4584490, 4533070, 4615390, 4543460, 4564090, 4543310, 4615430, 4564280, 4757420, 4502761, 4564070, 4767831.
MD 4 part #s 9896 000 58511, 9896 000 58512, 9896 000 58521, 9896 000 58522 Serial Nos. 4594911, 4564280, 4767891, 4757620, 13172S, 4757640, 4594980, 4595070, 4615511, 4615671, 4706481, 4595090, 4594871, 459500, 4625880, 4706471, 4706360, 4706691, 4757630, 459516,
4595240, 4595290, 4615320, 4615681, 4615641, 4625940, 4706521, 4626090, 4706571, 4584570, 4757731, 4626040, 4615360, 4626110, 4706641, 4584721, 4615581, 1, 4615751, 4584610, 4626250, 4727230, 4767911, 4727160, 4726940, 4726830, 4594841, 4626270, 4615790, 0, 4706390, 4706380, 4727010, 0, 4706881, 4757490, 4757590, 4757711, 4757300, 4768150, 476807-0400, 4818471,4767921, 4584520, 4818640,
4818311, 4768260, 4818620, 4818451, 4818441, 4768220, 4818570, 4818560, 4818590, 4584320, 4595130, 4615661, 4615761, 4706581, 4706751, 481861-0301.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems North America, Inc., Bothell, WA, by letter dated September 20, 2002.
Manufacturer: Philips Medical Systems, Netherlands,
Firm initiated recall is complete.
Reason
Potential for x-ray stand or table to move.
VOLUME OF PRODUCT IN COMMERCE
MD3 - 77 units MD4 - 81 units.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
AXIS/IRIX Gamma Camera Systems. Recall # Z-0171-3/Z-0172-3.
CODE
Serial Numbers: 101 to 850.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Highland Heights, OH, by letter dated September 23,2002. Firm initiated recall is ongoing.
REASON
The collimator latches may not fully engage when performing collimator exchanges.
VOLUME OF PRODUCT IN COMMERCE
747.
DISTRIBUTION
Nationwide and Internationally.
_____________________________
PRODUCT
Depuy Ace brand Ace Trochanteric Nail, as follows:
Product 9032-11-225; 125 degree, 200mm X 11 mm.
Recall # Z-0240-3;
Product 9032-11-230; 130 degree, 200mm X 11 mm.
Recall # Z-0241-3;
Product 9032-11-240; 140 degree, 200mm X 11 mm.
Recall # Z-0242-3;
Product 9032-13-225; 125 degree, 200mm X 13 mm.
Recall # Z-0243-3;
Product 9032-13-230; 130 degree, 200mm X 13 mm.
Recall # Z-0244-3;
Product 9032-13-240; 140 degree, 200mm X 13 mm.
Recall # Z-0245-3.
CODE
Product Lot
9032-11-225 WN1AH7
9032-11-230 WN2AA7 and WN2AB7
9032-11-240 WN1AL7
9032-13-225 WN1AJ7
9032-13-230 WN1AK7
9032-13-240 WN1AG7.
RECALLING FIRM/MANUFACTURER
Depuy Orthopaedics, Inc., Warsaw, IN, by letter on August 26, 2002. Firm initiated recall is ongoing.
REASON
May be packaged/etched with an incorrect neck angle.
VOLUME OF PRODUCT IN COMMERCE
296 pieces.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
Steris Quick Connect Kits, catalog nos. #QCL1629 and #QLC1646.
#QCL1629 is for Olympus 40/140/240 Series Non-Therapeutic GI Endoscopes in the STERIS SYSTEM 1 Sterile Processing System with the C1160 Universal Flexible Processing Tray. Recall # Z-0246-3;
#QLC1646 is for Olympus 40/140/240 Series Duodenoscopes and
Therapeutic GI Endoscopes in the STERIS SYSTEM 1 Sterile
Processing System with the C1160 Universal Flexible Processing C1160 Tray. Recall # Z-0247-3.
CODE
Lot Numbers #3437936 and #343795, for Quick Connect Kit QLC1629;
Lot Number #3438074, for Quick Connect Kit QLC1646.
RECALLING FIRM/MANUFACTURER
Steris Corp., Mentor, OH, by telephone on October 3, 2002 and by fax on October 4, 2002. Firm initiated recall is complete.
REASON
Incorrect adapter component may affect the sterilization process of scopes.
VOLUME OF PRODUCT IN COMMERCE
90 units.
DISTRIBUTION
Nationwide and Australia.
_____________________________
PRODUCT
Portable Automated External Difibrillators [AED]
Model No. 9100-0100:
a) AccessAED
b) AccessALS
Recall # Z-0248-3.
CODE
Model Number: 9100-0100
S/N's:
5212
5886
5887
5888
5889
5943
5944
5945
5946
5421
5422
5426
5428
5431
5441
5469
5470
5617
5619
5633
5636
5638
5639
5401
5411
5414
5424
5502
5508
5658
5671
5673
5674
5675
5677
5691
5693
5710
5713
5715
5719
5721
5755
5773
5774
5780
5782
5786
5802
5811
5814
5819
5820
5823
5847
5853
5854
5855
5856
5857
5858
5860
5861
5863
5864
5867
5868
5869
5870
5871
5875
5879
5911
5915
5917
5918
5919
5922
5923
5924
5927
5522
5526
5530
5531
5471
5471
5635
5635
5641
5641
5644
5644
5645
5645
5646
5646
5609
5620
5631
5632
5634
5643
5650
5656
5665
5676
5678
5680
5682
5684
5685
5686
5687
5688
5689
5692
5694
5695
5696
5697
5699
5701
5702
5703
5704
5206
5397
5436
5605
5914
5928
5939
5954
5955
5957
5959
5960
5648
5651
5653
5466
5468
5458
5459
5463
5281
5323
5797
5798
5799
5800
5803
5805
5809
5812
5827
5828
5829
5831
5832
5833
5834
5835
5837
5838
5839
5840
5842
5845
5850
5851
5852
5474
5479
5245
5284
5662
5698
5722
5723
5726
5728
5729
5730
5731
5732
5733
5735
5736
5738
5739
5740
5741
5742
5743
5744
5745
5746
5747
5748
5756
5757
5758
5759
5762
5763
5764
5765
5769
5804
5822
5830
5883
5885
5894
5909
5920
5930
5938
5961
5982
5983
5984
5985
5265
5277.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Access Cardiosystems, Concord , MA, by e-mail on October 14, 2002.
Manufacturer: Access Cardiosystems Inc., concord, MA
Firm initiated recall is ongoing.
REASON
Portable External Defibrilator May Fail Self Test and Fail to Function.
VOLUME OF PRODUCT IN COMMERCE
227.
DISTRIBUTION
AZ, NY, MD, NV, OR, TX, WA, WI and Internationally.
_____________________________
PRODUCT
Viscous Fluid Injector Pak (aka the VFI Pak), 10cc, an accessory to the Accurus Ophthalmic Surgical System. Recall # Z-0249-3.
CODE
VFI Pack, Catalog Number 8065740254, Lot numbers:
60004852
60012226
60042438
60042790
60055946
60058700
60058701
60058923
60073586
60101513
60101515
60101517
60135334
60135335
60162614
60162618
60167797
60167800
60167801
60195239
970160.
RECALLING FIRM/MANUFACTURER
Alcon laboratories Houston, TX, by letter dated March 14, 2002. Firm initiated recall is ongoing.
REASONMalfunction may result in the operator's inability to stop the flow of fluid already present in the needle portion of the device
VOLUME OF PRODUCT IN COMMERCE
81,000.
DISTRIBUTION
Nationwide and Internationally.
_____________________________
PRODUCT
a) NAMIC High Pressure Contrast Injection Line - 10"
(25 cm). Recall # Z-0250-3;
b) NAMIC Low Pressure Contrast Injection Line - 10"
(25 cm). Recall # Z-0251-3.
Product description: The device is an extension between an
angiographic catheter and an injector.
CODE
789657, Exp. 2003-02
789951, Exp. 2003-02
RECALLING FIRM/MANUFACTURER
Boston Scientific Corp., Glens Falls, NY, by telephone on March 11, 2002 and by letter on/about March 12, 2002.
Firm initiated recall is complete.
REASON
Product mix up. Low pressure line labeled High Pressure.
VOLUME OF PRODUCT IN COMMERCE
1000 units (500 high pressure lines + 500 low pressure lines).
DISTRIBUTION
AZ, CO, GA, IN, MS, OK, VA and Canada.
_____________________________
PRODUCT
Blood Glucose Test Strips - two (2) brands are involved:
a) Genuine ONE TOUCH(TM), 50 Test Strips per unit carton. Unit carton labeled in part, "*** Genuine ONE TOUCH(TM) *** 50 TEST STRIPS *** For the quantitative measurement of glucose in whole blood *** For use with all ONE TOUCH(TM) Brand Glucose Meters ***
LIFESCAN a Johnson & Johnson company Milpitas, California 95035 ***
LOT *** 53885 10631 (UPC #)***. Recall # Z-0252-3;
b) Uni-Check (TM) BLOOD GLUCOSE TEST STRIPS, 50 strips per unit carton. Unit carton labeled in part,"*** Uni-Check(TM) *** BLOOD GLUCOSE TEST STRIPS *** 50 Test Strips for Use with ONE TOUCH METERS *** 53885 10631 (UPC #)*** For Quantitative Measurement of Glucose in Whole Blood *** Produced for Diagnostic Solutions, Inc. Irvine, CA U.S.A. One Touch is a registered trademark of LifeScan Inc. a Johnson & Johnson company *** LOT ***. Recall # Z-0253-3.
Outer carton containing 24 unit packages is labeled in part, ***
UNI-CHECK TEST STRIPS *** CATALOG NO. 1702720 *** QTY: 24 PACKAGES
of 50 STRIPS/PACKAGES *** LOT No.: *** EXPIRES: ***".
CODE
All lots. Example of lots include:
ONE TOUCH: UPC 53885-10631, Lot 158855A, EXP. 2003 - 11
Uni-Check: UPC 53885-10631, Lot No. 1208A5W, EXPIRES 18 JAN 2004; CATALOG NO. 1702720.
RECALLING FIRM/MANUFACTURER
Payless Wholesale Inc., Glendale, NY, by letters on August 15, 2002. FDA initiated recall is ongoing.
REASON
Products not approved for sale in USA & Canada, and may give inaccurate readings when used with readers from US & Canada.
VOLUME OF PRODUCT IN COMMERCE
Unknown.
DISTRIBUTION
OH, UT, MI and NY.
_____________________________
PRODUCT
Premier HSV, an EIA diagnostic test kit, packaged under the
Meridian Premier brand label. Recall # Z-1339-2.
CODE
--- Premier HSV kits ---
Lot Numbers and Exp. Dates:
#550010.079, Exp. 02 Aug 02
#550010.080, Exp. 02 Aug 02
#550010.082, Exp. 26 Jul 02
--- OPD Substrate Tablets (kit component) ---
Lot Number: 9677.043
The catalog number for the Premier HSV kit is #550010.
RECALLING FIRM/MANUFACTURER
Meridian Bioscience, Inc., Cincinnati, OH, by letter dated May 23, 2002. Firm initiated recall is ongoing.
REASON
The OPD Substrate Tablets have deteriorated due to moisture, and may result in inaccurate test results.
VOLUME OF PRODUCT IN COMMERCE
594 kits (lot .079=330; lot .080=162; lot .082=102).
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
Hoffmann II Hybrid Ring Clamp
Catalog No: 4936-2-010
Lot code: all manufacturing lot codes. Recall # Z-0144-3.
CODE
Product: Hoffmann II Hybrid Ring Clamp
Catalog No: 4936-2-010
Lot code: all manufacturing lot codes --J213338,J213339,
J213347,J213348,J213349,J226523,J226524,J226526,J226527,J226528,J226532,J250574,J250580,J250584,J250595,J250724,J250742,J250780,J250781,J250789,J277290,J277292,J277293,J277294,J277295,J277296,J277304,J277305,J277306,J277308,J279332,J279333,J280162,J282104,J282107,J282108,J282109,J284516,J289305,J289310,J289344,J289345,J289346,J289347,J289348,J289359,J289445,J293624,J293626,J293627,J302150,J304357,J304358,J304359,J304360,J304361,J304362,J305847,J305848,J305849,J306173,J306188,J306946,J307905.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Howmedica Osteonics Corp., Rutherford, NJ, by letter on May 2, 2001.
Manufacturer: Stryker Trauma SA Geneva, Switzerland,
Firm initiated recall is ongoing.
REASON
The ring clamps may not tighten around post.
VOLUME OF PRODUCT IN COMMERCE
6342 pieces.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
Medtronic Xomed "Cottle Mallet", a reuseable manual surgical instrument indicated for use in ENT (Nasal) surgical procedures.
Product is Catalog Number 37-14353 and some are contained in Kit Catalog Number 37-17008RF which is a nasal ENT surgical kit containing this mallet as a component and it is labeled as "Toriumi Set" Recall # Z-0151-3.
CODE
Mallet lot numbers 24178300, 24449600 and 24469500 sold
individually and also in the Toriumi Set kit lot numbers 16457 and 17529.
RECALLING FIRM/MANUFACTURER
Xomed, Inc., Jacksonville, FL, by letter on July 22, 2002.
Firm initiated recall is ongoing.
REASON
Nylon Mallet head may deform when sterilized at insert parameters.
VOLUME OF PRODUCT IN COMMERCE
69 mallets with 39 of these in kits.
DISTRIBUTION
Nationwide and Internationally.
_____________________________
PRODUCT
a) MetriCide 14 Day, cold sterilant solution, 1 gallon.
Recall # Z-254-3;
b) Gluteraldehyde NS, cold sterilant solution, 1 gallon.
Recall # Z-0255-3.
CODE
a) MetriCide 14 Day, Part number 10-1400, lot M630024;
b) Gluteraldehyde NS, Part number 97-95483 (Metrex internal
part number 10-6800), lot M639460.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sybron Dental Specialties, Inc., Orange, CA, by letters Manufacturer: Metrex Research Corp., Romulus, MI on/before May 28, 2002. Firm initiated recall is ongoing.
REASON
Cross-contamination with dissimilar steriliant.
VOLUME OF PRODUCT IN COMMERCE
2,107 cases 4-1 gallon bottles per case.
DISTRIBUTION
Nationwide.
END OF ENFORCEMENT REPORT FOR NOVEMBER 13, 2002
####
Enforcement Report Index | FDA News Page | FDA Home Page
Office of Public Affairs
Web page uploaded by clb 2002-NOV-14.