August 27, 2003
03-35
_______________________________
PRODUCT
K. McGill New York USA brand Pickled Lotus Rootlets, Ngu Sen Chua Ngot, Net Wt. 15 oz (430 grs). Product of Vietnam. Product is packaged in glass jars. Serving Size 100 g; Servings Per Container 4.3. Recall # F-467-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Kien Import Corp., Brooklyn, NY, by letters dated May 28, 2003, and by press release on May 30, 2003. New York State initiated recall is complete.
REASON
Product contained undeclared sulfites based on NYSDAM sampling & analysis.
VOLUME OF PRODUCT IN COMMERCE
48 cases (24 - 15 oz. Jars per case).
DISTRIBUTION
NY, MA, FL, NC, and PA.
_______________________________
PRODUCT
Aztec Hot Chocolate in 10 oz. and 20 oz. square tins. Recall # F-468-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Maribel Sweets, Inc., New York, NY, by press release and letters on March 27, 2003. FDA initiated recall is complete.
REASON
Product contained undeclared milk and cornstarch based on FDA consumer complaint #17787 (LOS-DO).
VOLUME OF PRODUCT IN COMMERCE
10,000 - 10 oz. tins and 10,000 - 20 oz tins.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Dragon Bac San Vietnam - Quality Foods of Vietnam brand Sweetened Coconut (Mut Dua), Net Wt. 200g (7 ox). Product of Vietnam. Serving size 85 g (3 oz), Serving Per Container about 3. Product is packed in a sealed foil package. Barcode # 8 935129 708204. Recall # F-469-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Sincere Trading Co., Inc., Brooklyn, NY, by press release and letters on April 8, 2003. New York State initiated recall is complete.
REASON
Product contained undeclared sulfites (806 ppm) and undeclared color additives certifiable as FD&C Yellow #5, FD&C Red #3, and FD&C Blue #1 based on NYSDAM sampling and analysis.
VOLUME OF PRODUCT IN COMMERCE
1,440 - 7 oz. packages.
DISTRIBUTION
Ny, PA, CT, OH, and VA.
_______________________________
PRODUCT
Sweetened Winter Melon Candy, 12 oz. (340 g +/-5 g). Product is packed in a flexible plastic bag. Barcode #6 64460 107176. Recall # F-470-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Ho's Trading, Inc., Brooklyn, NY, by press release on March 12, 2003, and by letters, dated March 15, 2003. New York State initiated recall is complete.
REASON
Product contained undeclared sulfites (800 ppm) and sugar based on NYSDAM sampling & analysis.
VOLUME OF PRODUCT IN COMMERCE
800 - 12 oz. packages.
DISTRIBUTION
NY, NJ, VA, FL, PA, and TX.
_______________________________
PRODUCT
Master Chao brand Candy, 10 oz (283 g +/-5 g). Product of China. Barcode #64460 10719. Recall # F-472-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Ho's Trading Inc., Brooklyn, NY, by press release on November 20, 2002, and January 29, 2003 and by letters, dated December 20, 2002. New York State initiated recall is complete.
REASON
The product contained undeclared peanuts based on NYSDAM visual observation and analysis.
VOLUME OF PRODUCT IN COMMERCE
66 cases (50 - 10 oz. packages per case).
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
a) Crab Cakes, Frozen. Product labeled as Wick's Gourmet
Homestyle Crab Cakes, Wick's Unfried Crab Cakes, Wick's
Maryland Style, Wicks Deluxe Maryland Style and Henry's
Oven Ready Maryland Style Crab Cakes. The Henry's
labeled product sold in 2.81 lb. cartons. The Wick's
labaeled products are sold in 42 ox, 3.37 lbs, 2.25 lbs,
2.81 lbs, 12.5 lbs (bulk), 9 lbs (bulk) and 25 lbs
(bulk) cartons. Recall # F-474-3;
b) Breaded Stuffed Shrimp with Crabmeat, Frozen. The
product is labeled as Wick's Breaded Stuffed Shrimp w/
Crabmeat and sold in 2.25 lb cartons. Recall # F-475-3;
c) Breaded Stuffed Flounder with Crab Stuffing, Frozen.
Sold in 9 lb cartons. Recall # F-476-3;
d) Crab Bites, Frozen. The product is labeled as Wick's
Kitchens Crab Bits and sold in 6 lb. cartons. Recall #
F-477-3;
e) Crabmeat Stuffing, Frozen. The product is labeled as
Wick's Crabmeat Stuffing and sold in 20 lb. containers.
Recall # F-478-3;
f) Lobster Cakes, Frozen. The product is labeled as
Henry's and sold in 12.5 lb. cartons. Recall # F-479-3;
CODE
All lots prior to 4/22/03.
RECALLING FIRM/MANUFACTURER
H & G Diners, Corp., Trainer, PA, by letters on April 23, 2003. FDA initiated recall is complete.
REASON
The label did not declare the presence of nonfat dry milk, a sub ingredient of the scrambled egg mix used in these products.
VOLUME OF PRODUCT IN COMMERCE
Approximately 40,000 pounds.
DISTRIBUTION
PA, NJ, NY, MA, and OH.
_______________________________
PRODUCT
Asian Boy (E.B.Q.) brand Lotus Rootlet (NGO SEN CHUA NGOT), Net Wt. 29.8 oz(850g). Product of Vietnam. Product is packed in a glass jar, 12 jars per carton. Commercial Invoice # 04/XK MN - B.C.N., dated 3/14/02; B/L # SGN-NYC-1062126 dated 3/15/02. Barcode # 6 27404 02055. Recall # F-480-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
B. C. N. Trading, Inc., Brooklyn, NY, by press release and letters on June 6, 2003. New York State initiated recall is complete.
REASON
Product contained undeclared sulfites (192 ppm) and benzoic acid based on NYSDAM sampling & analysis.
VOLUME OF PRODUCT IN COMMERCE
480 - 29.8 oz.
DISTRIBUTION
NY, NJ, CT, MA, PA, and FL.
_______________________________
PRODUCT
Tops Vitality Fat Free Chocolate Milk, Grade A Pasteurized Homogenized Milk, packed in 1/2 gallon cartons. Recall # F-482-3.
CODE
MAR 27.
RECALLING FIRM/MANUFACTURER
Reiter Dairy, Inc., Barberton, OH, by telephone and email on March 19, 20, and 21, 2003. Firm initiated recall is complete.
REASON
Product contains excessive levels of Vitamins A and D.
VOLUME OF PRODUCT IN COMMERCE
490 1/2 gallon containers.
DISTRIBUTION
OH, Pa, and NY.
_______________________________
PRODUCT
a) Homerun Ball brand Korean Cracker, Net Wt., 1.62 ox.
(46 g). Product of Korea. Product is packed in a sealed
foil package. Recall # F-489-3;
b) Lotty Lorry brand Korean Cracker, Net Wt. 1.83 oz. (52g)
and 7.4 oz. Product of Korea. Packaged in sealed foil
bags within cardboard boxes. Recall # F-490-3.
CODE
a) Item # 02549. Code # 2003 09 17. Barcode # 8 801019
402166.
b) 1.83 oz: Item #05928;
7.4 oz.: Item # 08739.
RECALLING FIRM/MANUFACTURER
Hanmi, Inc., Brooklyn, NY, by letters dated March 27, 2003, and by press release on March 28, 2003. New York State initiated recall is complete.
REASON
Product contained undeclared eggs based on NYSDAM sampling and analysis, and confirmation by manufacturer.
VOLUME OF PRODUCT IN COMMERCE
1,00 - 1.62 oz. packages, 1,200 - 1.83 oz. packages,
and 1,200 - 7.4 oz. packages.
DISTRIBUTION
NY, NJ, MA, CT, NH, and ME.
_______________________________
PRODUCT
Master Chao brand Glace Coconut, 12 oz. (340 g). Product is packed in a sealed plastic bag. Recall # F-494-3.
CODE
UPC # 6 64460 10734 3.
RECALLING FIRM/MANUFACTURER
Ho's Trading, Inc., Brooklyn, NY, by press release and letters dated March 24, 2003. New York State initiated recall is complete.
REASON
Product contained undeclared sulfites and sugar based on New York State sampling and analysis.
VOLUME OF PRODUCT IN COMMERCE
1,300 - 12 oz. packages.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Wiser's Deluxe Canadian Whisky 750-ml. Gift Pack containing one 750-ml. Bottle of Wiser's DeLuxe Canadian Whisky and one of two styles of a leather-bound stainless steel flask. One of the flasks bears a stainless steel nameplate on the front with the name "Wiser's" engraved on it. The other flask is labeled "Wiser's Canadian Whisky Canadien" embossed in gold across the front on the leather. Recall # F-487-3.
CODE
There are no codes on the gift packs. The gift packs were distributed between 11/15/00 - 3/7/03.
RECALLING FIRM/MANUFACTURER
McCormick Distilling Co., Weston, MO., by letter, fax, and e-mail beginning March 21, 2003. Firm initiated recall is complete.
REASON
Whiskey gift pack contained flask with lead soldered seams that could come in contact with food stored in the flask.
VOLUME OF PRODUCT IN COMMERCE
4,908 flasks.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Lee Iacocca's brand Olivio Premium Spread with olive oil, packed in 1 lb. plastic tubs, 18 tubes per case. Recall # F-493-3.
CODE
Mar0604F Mar1304F Mar1404F Mar1904F.
RECALLING FIRM/MANUFACTURER
Unilever, Inc., Baltimore, MD, by letter dated July 29, 2003. Firm initiated the recall is ongoing.
REASON
1 lb. tubs of Olivio Premium Spread were distributed without an ingredient statement. The product, vegetable spread contains whey, a known allergen, which is not declared on the label.
VOLUME OF PRODUCT IN COMMERCE
35,745 tubs.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
New Diet Sunkist Orange. Recall # F-466-3.
CODE
985067006 (Bottled October 14, 2002);
985070140 (Bottled October 21, 2002).
RECALLING FIRM/MANUFACTURER
Dr Pepper Seven Up, Inc., Plano, TX, by visit beginning November 1, 2002. Firm initiated recall is complete.
REASON
The product contained undeclared sweetening agent - acesulfame potassium.
VOLUME OF PRODUCT IN COMMERCE
1,200 cases.
DISTRIBUTION
TX.
_______________________________
PRODUCT
Schweppes Ginger Ale 8 pack cases of 2 liter bottles. Recall # F-471-3.
CODE
FEB 1003 XXXXZG110622 where XXXX indicates the military time that the product was produced from 1500-1630.
RECALLING FIRM/MANUFACTURER
Dr Pepper Seven Up, Inc., Plano, TX, via memo on November 20, 2002. Firm initiated recall is complete.
REASON
The product contained undeclared quinine.
VOLUME OF PRODUCT IN COMMERCE
1,374 cases of 8 bottles each.
DISTRIBUTION
MO and IL.
_______________________________
PRODUCT
Heart Loc Egg Shade Food Color, net wt. 16 fl. Ox. (1 pint) and 32 fl. Oz. bottles. Recall # F-495-3.
CODE
16 fl. Oz. - 2L16SGBA and @L16SGBB;
32 fl. Oz. - 3A17SGAA and 3A17SGAB.
RECALLING FIRM/MANUFACTURER
Tone Brothers, Inc., Ankeny, IA, by telephone and letter on June 2, 2003. Firm initiated recall is ongoing.
REASON
Product contained undeclared FD&C Red #40 and incorrectly listed FD&C Yellow #6 as an ingredient.
VOLUME OF PRODUCT IN COMMERCE
1,441/16 fl. Oz. bottles, and 2,370/32 oz bottles.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
a) Accutane Capsules, (Isotrentinoin) 10 mg, prescription
pak of 10 capsules, Rx only, Roche Laboratories, Inc.,
Nutley, NJ. Recall # D-314-3;
b) Accutane Capsules, (Isotretinoin) 20 mg, prescription
pak of 10 capsules, Rx only, Roche Laboratories, Inc.,
Nutley, NJ. Recall # D-315-3;
c) Accutane Capsules, (Isotretinoin) 40 mg, prescription
pak of 10 capsules, Rx only, Roche Laboratories, Inc.,
Nutley, NJ. Recall # D-316-3.
CODE
Any code missing labeling.
RECALLING FIRM/MANUFACTURER
Hoffmann La Roche, Inc., Nutley, NJ, by letters, and telephone on July 28/31, 2003. Firm initiated recall is ongoing.
REASON
Mislabeled; the yellow qualification sticker does not contain the words "No refills allowed".
VOLUME OF PRODUCT IN COMMERCE
Unknown.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Tecan Genesis RSP and NPS Instruments:
a) Genesis RSP Instruments: Genesis RSP 100,
Genesis RSP 150, Genesis RSP 200;
b) Genesis NPS Instruments: Genesis NPS 100,
Genesis NPS 150.
Recall # B-1203-3.
CODE
Barcode scanner type PosID 2 option and firmware version 2.45 or lower.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tecan US, Inc., Durham, NC, by letter and e-mail dated March 13, 2003.
Manufacturer: Tecan Schweiz Ag, Hombrechtikon, Switzerland. Firm initiated recall is complete.
REASON
Pipetting instruments, in which the barcode readers fail to correctly read sample bar code labels, were distributed.
VOLUME OF PRODUCT IN COMMERCE
327 instruments.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
Red Blood Cells, Autologous. Recall # B-1449-3.
CODE
Units 10026916, 13002907.
RECALLING FIRM/MANUFACTURER
W. E. & Lela I Stewart Blood Center, Tyler, TX, by letter dated March 14, 2000. Firm initiated recall is complete.
REASON
Autologous blood products, which tested repeatedly reactive for infectious disease tests, were distributed without the "Biohazard" label on the bag.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.
_______________________________
PRODUCT
Source Plasma. Recall # B-1464-3.
CODE
Units GP64824 and GP64220.
RECALLING FIRM/MANUFACTURER
Bio-Blood Components, Inc., Gary, IN, by fax dated November 5, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had body piercing within twelve months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
Austria.
_______________________________
PRODUCT
Cornea Tissue. Recall # B-1471-3.
CODE
C-1024234-OS.
RECALLING FIRM/MANUFACTURER
Michigan Eye Bank, Ann Arbor, MI, by telephone, and by follow-up letter dated May 9, 2003. Firm initiated recall is complete.
REASON
Human corneas, collected from a donor who subsequently tested positive for HBsAg, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 tissue.
DISTRIBUTION
OH.
_______________________________
PRODUCT
Corneas Tissues. Recall # B-1472-3.
CODE
2003-0569 and 2003-0570.
RECALLING FIRM/MANUFACTURER
Transplant Services Center, University of Texas, Southwestern Medical Center, Dallas, TX, by telephone and by follow-up letter dated May 22, 2003. Firm initiated recall is complete.
REASON
Human corneas, collected from a donor who subsequently tested positive for HIV (PCR) by another tissue procurement organization, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues.
DISTRIBUTION
TX.
________________________________
PRODUCT
Recovered Plasma. Recall # B-1501-3.
CODE
Unit number FG65837.
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence, RI, by facsimile on April 29, 2003. Firm initiated recall is complete.
REASON
Blood product collected from an unsuitable donor due to a history of residing in an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Switzerland.
________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1502-3;
b) Platelets. Recall # B-1503-3.
CODE
a) Unit number 2310572;
b) Unit number 2310579.
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on March 22 and 25, 2002. Firm initiated recall is complete.
REASON
Blood products were collected in a manner that may compromise the sterility of the products.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.
_______________________________
PRODUCT
Platelets. Recall # B-1504-3.
CODE
Unit numbers 2398798, 2398790, 2398807, 2397002, 2397001, 2392931, 2395083, 2395085, 2397005, 2396901, 2396900, 2397006, 2396899, 2397008, 2398797, and 2398796.
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on November 27, 2002, and December 4, 2002. Firm initiated recall is complete.
REASON
Blood products, manufactured from units of Whole Blood exposed to incorrect temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units.
DISTRIBUTION
TX, and WI.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1505-3.
CODE
Unit number 20J63252.
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Lewis and Clark Region, Boise, ID, by letter on September 9, 2002.
Manufacturer: The American National Red Cross, Salt Lake City, UT. 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
CA.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1506-3;
b) Platelets Pheresis, Leukocytes Reduced. Recall # B-1507-3.
CODE
a) Unit number 7060698;
b) Unit number 7060698(distributed as two split products).
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on February 25, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor due to a history of residing in an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
TX.
_______________________________
PRODUCT
Platelets Leukocytes Removed. Recall # B-1508-3.
CODE
Unit number 04K60209.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Cleveland, OH, by telephone on March 27, 2003. Firm initiated recall is complete.
REASON
Blood product, which was prepared in a manner that may compromise the sterility of the product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1509-3;
b) Platelets. Recall # B-1510-3.
CODE
a) and b) Unit number 1190649.
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH, by letter dated February 11, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had received the Hepatitis A Immune Globulin, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
OH.
_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1517-3.
CODE
Unit number 7057350.
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on June 17, 2002. Firm initiated recall is complete.
REASON
Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1518-3;
b) Platelets Irradiated. Recall # B-1519-3;
c) Fresh Frozen Plasma. Recall # B-1520-3.
CODE
a), b), and c) Unit number 1816504.
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on July 2, 2001. Firm initiated recall is complete.
REASON
Blood products collected from an unsuitable donor due to a history of residing in an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
TX.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1521-3;
b) Platelets. Recall # B-1522-3;
c) Fresh Frozen Plasma. Recall # B-1523-3.
CODE
a), b), and c) Unit number 1842054.
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on November 26, 2001. Firm initiated recall is complete.
REASON
Blood products collected from an unsuitable donor due to a history of residing in an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
TX.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1524-3;
b) Recovered Plasma. Recall # B-1525-3.
CODE
a), b) Unit number 1890553.
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on February 13, 2002. Firm initiated recall is complete.
REASON
Blood products collected from an unsuitable donor due to a history of residing in an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX and FL.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Removed. Recall # B-1526-3.
CODE
Unit number 0920524.
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, Cincinnati, OH, by letter dated March 17, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH.
_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1530-3.
CODE
Units 9536933 and 9536931.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by facsimile on December 2, 2002. Firm initiated recall is complete.
REASON
Blood product, which were collected from a donor who had lived in a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TN.
_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1531-3.
CODE
Unit 2008279.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by facsimile on August 9, 2002. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.
_______________________________
PRODUCT
Platelets. Recall # B-1533-3.
CODE
Unit 2011555.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by telephone on August 9, 2002. Firm initiated recall is complete.
REASON
Blood product, which were collected from a donor who was taking the medication Plavix, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.
_______________________________
PRODUCT
Red Blood Cells. Recall # B-1535-3.
CODE
Units 9032853, 9032852, and 9036306.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter dated April 10, 2002. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
TN.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1538-3.
CODE
Units 24KL61869, 24KL61871, 24KL61873, 24KL61875.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, River Valley Region, Louisville, KY, by telephone on February 6, 2003, and by letter dated February 24, 2003. Firm initiated recall is complete.
REASON
Red Cells, prepared more than eight hours after collection of the corresponding Whole Blood units, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
IN and KY.
_______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1541-3.
CODE
Unit 7058820.
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on August 19, 2002. Firm initiated recall is complete.
REASON
Blood product, in which the corresponding blood component was contaminated with Staphlyococcus aureus, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
_______________________________
PRODUCT
ALYX Component Collection System. Recall # B-1543-3.
CODE
Product code 4R5707, all serial numbers.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corporation, Aka BioLife Plasma Services L.P., Round Lake, IL, by facsimile and telephone on May 23, 2003.
Manufacturer: Baxter Healthcare Corporation, Largo, FL. Firm initiated recall is complete.
REASON
The main power switch on an apheresis instrument could become dislodged and could result in an electric shock to the user.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NJ, NY, TX, MN, OK, FL, and LA.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1544-3;
b) Red Blood Cells for Further Manufacturer.
Recall # B- 1545-3;
c) Recovered Plasma. Recall # B-1546-3.
CODE
a) Unit number 04G25114;
b) Unit number 04S43376;
c) Unit numbers 04GF25114 and 04S43376.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by letter and facsimile on March 13, 2003. 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
4 units.
DISTRIBUTION
CA, NH, MA, and Switzerland.
_______________________________
PRODUCT
Source Plasma. Recall # B-1553-3.
CODE
Unit numbers 43Q004, 43Q014, 43Q026, 43Q038, 43Q046, 43Q059, 43Q070, 43Q083, 43Q089, 43Q100, 43Q106, 43Q114, 43Q120, 43Q131, 43Q135, 43Q148, 43Q150, 43Q161, 43Q170, 43Q181, 43Q184, 43Q196, 43Q200, 43Q211, 43Q217, 43Q228, 43Q232, 43Q239, 43Q247, 43Q256, 43Q264, 43Q268, 43Q273, 43Q279, 43Q284, 43Q874, 43Q880, 43Q886, 43Q899, 43Q907, 43Q920, 43Q925, 43Q937, 43Q946, 43Q958, 43Q967, 43Q977, 43Q992, 43Q289, 43Q294, 43Q299, 43Q305, 43Q317, 43Q320, 43Q329, 43Q340, 43Q346, 43Q357, 43Q365, 43Q372, 43Q379, 43Q386, 43Q390, 43Q394, 43Q404, 43Q417, 43Q430, 43Q436, 43Q446, 43Q457, 43Q464, 43Q467, 43Q479, 43Q483, 43Q494, 8TA653, 8TJ001, 8TJ008, 8TJ012, 8TJ020, 8TJ024, 8TJ039, 8TJ042, 8TJ050, 8TJ057, 8TJ071, 8TJ080, 8TJ084, 8TJ090, 8TJ096, 8TJ103, and 8TJ113.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Fort Worth, TX, by letter dated May 29, 2000. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from a donor that was subsequently determined to have multiple risk factors for increased incidence of infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
92 units.
DISTRIBUTION
IL.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1554-3.
CODE
Unit numbers 24KG49198, 24KL55687, 24KE43287, 24KW37086, 24KJ63212, 24KJ63213, 24KJ63215, 24KJ63216, 24KJ63217, 24KJ63218, 24KJ63219, 24KJ63220, 24KJ63285, 24KJ63286, 24KJ63291, 24KJ63292, 24KJ63294, 24KJ63295, 24KJ63296, 24KJ63297, 24KJ63298, 24KJ63299, 24KJ63301, 24KJ63302, 24KJ63303, 24KJ63304, 24KJ63305, 24KJ63306, 24KJ63307, 24KJ63308, 24FC10903, 24KS47844, 24KH82494, 24KY53639, 24KY53641, 24KH84228, 24KH84229, 24KH84230, 24KH84232, 24KH84294, 24KC29854, 24KY55230, 24KL58889, 24KQ51380, 24KQ51381, 24KQ51382, 24KQ51384, 24KC30359, 24KH86379, 24KH86380, 24KH86381, 24KE45500, 24KL59603, 24KH86707, 24KG52580, 24KS51211, 24GQ64729, 24KW37260, 24KS47806, 24GQ63978, 24KM79669, 24KG54165, 24KL61584, 24KC31398, 24KC31377, 24KH89351, 24KH90316, 24KH90315, 24KH90317, and 24KS51899.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, River Valley Region, Louisville, KY, by letter on February 3, 2003. Firm initiated recall is complete.
REASON
Blood products, manufactured from units of Whole Blood more than 8 hours after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
70 units.
DISTRIBUTION
KY, IN, IL, SC, and AL.
_______________________________
PRODUCT
Platelets, Leukoreduced. Recall # B-1555-3.
CODE
Unit 042FT32162.
RECALLING FIRM/MANUFACTURER
The American Red Cross, Northern Ohio Region, Cleveland, OH, by telephone on March 4, 2003 and by letter dated March 7, 2003. Firm initiated recall is complete.
REASON
Blood product, collected in a manner that may have compromised sterility, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH.
_______________________________
PRODUCT
Source Plasma. Recall # B-1556-3.
CODE
Units 91075154, 91072924.
RECALLING FIRM/MANUFACTURER
Bio-Blood Components, Inc., Columbus, OH, by facsimile on March 12, 2003. Firm initiated recall is complete.
REASON
Blood Products, that tested negative for antibody to hepatitis C virus (anti-HCV), but were collected from a donor who previously tested repeatedly reactive for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Source Plasma. Recall # B-1557-3.
CODE
Units BMFGSJ, BMFHFY, BMFHNV.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., West Lafayette, IN, by facsimile dated November 29, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor previously deferred for evidence of possible IV drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
IL.
_______________________________
PRODUCT
a) Red Blood Cells, Leukoreduced. Recall # B-1558-3;
b) Platelets, Leukoreduced. Recall # B-1559-3;
c) Fresh Frozen Plasma. Recall # B-1560-3;
d) Recovered Plasma. Recall # B-1561-3.
CODE
a) Units 042R62178, 042Q73850, 042H32889, 042Q75667,
042S93524, 042S94359;
b) Units 042R62178, 042Q73850;
c) Unit 042R62178;
d) Units 042Q73850, 042H32889, 042Q75667, 042S93524,
042S94359.
RECALLING FIRM/MANUFACTURER
The American Red Cross, Northern Ohio Region, Cleveland, OH, by letter dated January 22, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who resided in an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
14 units.
DISTRIBUTION
OH.
_______________________________
PRODUCT
Platelets Leukocytes Reduced. Recall # B-1181-3.
CODE
Unit 27LC28068.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Johnstown, PA, by letter dated November 18, 2002. Firm initiated recall is complete.
REASON
Blood product, which was identified as having a discrepant collection time and was not appropriately quarantined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.
_______________________________
PRODUCT
Saphenous Vein. Recall # B-1487-3.
CODE
Unit 7041472.
RECALLING FIRM/MANUFACTURER
Cryolife, Inc., Kennesaw, GA, by telephone on February 7, 2003, and by letter dated February 21, 2003. Firm initiated recall is complete.
REASON
Human tissue intended for transplantation, which was associated with tissue that may have been contaminated with gram-negative Staphylococcus microorganism, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Canada.
_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated.
Recall # B-1529-3.
CODE
Units 2016301 and 2016291.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by telephone on November 25, 2002. Firm initiated recall is complete.
REASON
Blood products, which were labeled with an incorrect expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TN.
_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1532-3.
CODE
Unit 2502870.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by telephone on July 19, 2002. Firm initiated recall is complete.
REASON
Blood product, which was prepared in a manner that may compromise the sterility of the product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.
_______________________________
PRODUCT
Platelets Pheresis Leukocytes Removed. Recall # B-1534-3.
CODE
Unit 2006852.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by telephone on April 17, 2002. Firm initiated recall is complete.
REASON
Blood product, which was received at a temperature above acceptable limits, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1539-3.
CODE
Units 24KL61877, 24KS52150.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, River Valley Region, Louisville, KY, by telephone on February 6, 2003, and by letter dated February 24, 2003. Firm initiated recall is complete.
REASON
Red Cells, prepared more than eight hours after collection of the corresponding Whole Blood units, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IN and KY.
_______________________________
PRODUCT
Foundation Knee System, non-porous Femur Size 8, Right. Recall # Z-1069-03.
CODE
Lot numbers 811761, 815241, 815251, 817891, 834781, 835291, 838201, 850611.
RECALLING FIRM/MANUFACTURER
Encore Medical, LP, Austin, TX, by telephone on April 23, 2003. Firm initiated recall is complete.
REASON
Product container was labeled incorrectly indicating left femur instead of right.
VOLUME OF PRODUCT IN COMMERCE
14 units.
DISTRIBUTION
PA, TX, MA, FL, NV, AZ, France, and Saudi Arabia.
____________________________
PRODUCT
a) Ultra-soft SV Monorail Balloon Dilatation Catheters,
4.0 mm / 1.5 cm /90 cm (balloon width/balloon
length/catheter length), Reference Catalog Number
37915-4015. Recall # Z-1096-03;
b) Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0
mm/2.0 cm/90 cm, Reference Catalog Number 37915-4020.
Recall # Z-1097-03;
c) Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.5
mm/ 1.5 cm/90 cm, Reference Catalog Number 37915-4515.
Recall # Z-1098-03;
d) Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.0
mm/ 2.0 cm/90 cm, Reference Catalog Number 37915-5020.
Recall # Z-1099-03;
e) Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.0
mm/ 1.5 cm/90 cm, Reference Catalog Number 37915-6015.
Recall # Z-1100-03;
f) Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.5
mm/ 2.0 cm/90 cm, Reference Catalog Number 37915-6520.
Recall # Z-1101-03;
g) Ultra-soft SV Monorail Balloon Dilatation Catheters, 7.0
mm/ 1.5 cm/90 cm, Reference Catalog Number 37915-7015.
Recall # Z-1102-03;
h) Ultra-soft SV Monorail Balloon Dilatation Catheters,
7.0 mm/ 2.0 cm/90 cm, Reference Catalog Number 37915-
7020. Recall # Z-1103-03;
i) Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0
mm/ 1.5 cm/150 cm, Reference Catalog Number 37916-4015.
Recall # Z-1104-03;
j) Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0
mm/ 2.0 cm/150 cm, Reference Catalog Number 37916-4020.
Recall # Z-1105-03;
k) Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.5
mm/ 1.5 cm/150 cm, Reference Catalog Number 37916-4515.
Recall # Z-1106-03;
l) Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.5
mm/ 1.5 cm/150 cm, Reference Catalog Number 37916-4515.
Recall # Z-1107-03;
m) Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.0
mm/ 1.5 cm/150 cm, Reference Catalog Number 37916-5015.
Recall # Z-1108-03;
n) Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.5
mm/ 2.0 cm/150 cm, Reference Catalog Number 37916-5520.
Recall # Z-1109-03;
o) Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.0
mm/ 1.5 cm/150 cm, Reference Catalog Number 37916-6015.
Recall # Z-1110-03;
p) Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.5
mm/ 1.5 cm/150 cm, Reference Catalog Number 37916-6515.
Recall # Z-1111-03;
q) Ultra-soft SV Monorail Balloon Dilatation Catheters, 7.0
mm/ 2.0 cm/150 cm, Reference Catalog Number 37916-7020.
Recall # Z-1112-03;
r) Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.0
mm/2.0 cm/150 cm, Reference Catalog Number 38950-5020.
Recall # Z-1113-03;
s) Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.0
mm/2.0 cm/150 cm, Reference Catalog Number 38950-6020.
Recall # Z-1114-03;
t) Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0
mm/1.5 cm/90 cm, Reference Catalog Number 38990-4015,
Product Number H7493791540150. Recall # Z-1115-03;
u) Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0
mm/2.0 cm/90 cm, Reference Catalog Number 38990-4020.
Recall # Z-1116-03;
v) Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.0
mm/1.5 cm/90 cm, Reference Catalog Number 38990-5015.
Recall # Z-1117-03;
w) Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.0
mm/2.0 cm/90 cm, Reference Catalog Number 38990-5020.
Recall # Z-1118-03;
x) Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.0
mm/2.0 cm/90 cm, Reference Catalog Number 38990-6020.
Recall # Z-1119-03;
y) Ultra-soft SV Monorail Balloon Dilatation Catheters, 7.0
mm/2.0 cm/90 cm, Reference Catalog Number 38990-7020.
Recall # Z-1120-03.
CODE
a) Lot numbers 5490976, 5530109, and 5564475;
b) Lot numbers 5462665, 5486700, 5509423, 5570097, 5580887,
5591636, and 5592100;
c) Lot number 5491423;
d) Lot numbers 5458926, 5459705, 5462880, 5464053, 5523106,
5570556, 5576584, and 5581120;
e) Lot numbers 5486922 and 5625627;
f) Lot number 5138299;
g) Lot numbers 5491707 and 5563990;
h) Lot numbers 5487644, 5514945, 5524567, 5531394, 5560048,
5571045, and 5581781;
i) Lot number 5493302;
j) Lot numbers 5463361, 5463825, 5467755, 5591116, and
5592367;
k) Lot number 5523632;
l) Lot numbers 5470240 and 5493444;
m) Lot number 5464221;
n) Lot number 5463435;
o) Lot number 5515405;
p) Lot number 5493691;
q) Lot numbers 5463705 and 5464511;
r) Lot number 5554279;
s) Lot numbers 5470562, 5536519, 5543449, and 5554623.
t) Lot number 5562834;
u) Lot numbers 5531084 and 5543317;
v) Lot number 5455553;
w) Lot numbers 5519448, 5519891, 5537795, and 5551411;
x) Lot numbers 5455345, 5536214, 5551137, 5563785, and
5620006;
y) Lot numbers 5490680, 5540265, and 5584469.
RECALLING FIRM/MANUFACTURER
Boston Scientific Scimed, Maple Grove, MN, by letter dated July 1, 2003. Firm initiated recall is ongoing.
REASON
Some of the product pouches have holes in the seals.
VOLUME OF PRODUCT IN COMMERCE
751 catheters.
DISTRIBUTION
Nationwide.
________________________________
PRODUCT
a) Radionics Disposable Grounding Plate.
Recall # Z-1121-03;
b) Radionics Cool-tip RF Electrode Kit, containing DGP-HP
single-use grounding pads. Recall # Z-1122-03.
CODE
a) Catalog Number DGP-HP;
b) Catalog Numbers: CT-1020, CT-1030, CT-1510, CT-1520,
CT-1530, CT-2020, CT-2030, CT-2530, CTC-1025, CTC-1525,
CTC-2025.
RECALLING FIRM/MANUFACTURER
Valleylab, Inc., Boulder, CO, by letter on July 16, 2003. Firm initiated recall is ongoing.
REASON
Pads may have a thin plastic film covering the conductive gel surface underneath the normal printed cover, causing non-adherence and possible burn.
VOLUME OF PRODUCT IN COMMERCE
25,000 pads.
DISTRIBUTION
Nationwide, and Internationally.
________________________________
PRODUCT
Boston Scientific Scimed Monorail Express 2 Coronary Stent System, 3.5 mm x 32 mm, Catalog number 35050-3235. Recall # Z-1123-03.
CODE
Lot 5570485.
RECALLING FIRM/MANUFACTURER
Boston Scientific Scimed, Maple Grove, MN, by letter dated July 16, 2003. FDA initiated recall is ongoing.
REASON
There is an increased potential for broken struts of the stents.
VOLUME OF PRODUCT IN COMMERCE
17 stent systems.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Intralase FS Laser System. Laser Keratome. Recall # Z-1124-03.
CODE
All codes.
RECALLING FIRM/MANUFACTURER
Intralase Corp., Irvine, CA, by letters on July 15, 2003. Firm initiated recall is ongoing.
REASON
Gantry moves toward patient when 'Home' button is used after procedure.
VOLUME OF PRODUCT IN COMMERCE
70.
DISTRIBUTION
Nationwide and Japan.
_______________________________
PRODUCT
Premier CMV IgG Elisa Kits, EIA diagnostic test kits, 96 tests per kit, Catalog Numbers: 620096 and 9Z9501G. Recall # Z-1127-03.
CODE
Lot Numbers: #03022371 and #03022472.
All lots Exp. Date: 2004-07.
RECALLING FIRM/MANUFACTURER
Meridian Bioscience, Inc., Cincinnati, OH, by telephone and fax on June 18, 2003. Firm initiated recall is ongoing.
REASON
The low Positive Standard kit component is losing potency that may result in false positive test results.
VOLUME OF PRODUCT IN COMMERCE
43 kits.
DISTRIBUTION
CA, UT, NY, MD, KY and Belgium.
_______________________________
PRODUCT
Easy Web. Recall # Z-1128-03.
CODE
Site number: Z1776, 86233, 86264, 83198, 86944, 85075, 85077, 85083, 85071, 85067, 10377, 85048, 86026, X1676, 83675, 86025, 87131, 87158, 82683, 84027, 84087, 84359, 86007, 84405, 85453, 83917, 85189, 83961.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Bothell, WA, by letter dated February 13, 2002. Firm initiated recall is ongoing.
REASON
Potential for incorrect body part information.
VOLUME OF PRODUCT IN COMMERCE
28.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Architect Processing Module, List number 8C89-01. Recall # Z-1133-03.
CODE
All units.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc, Irving, CA, by Technical Service Bulletin on December 10, 2001. Firm initiated recall is complete.
REASON
Under specific conditions, the system can allow an incorrect sample ID to be assigned to another sample in a different carrier.
VOLUME OF PRODUCT IN COMMERCE
787 units.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
Barrier Hip Sheet with Side Pockets. Recall # Z-1137-03.
CODE
Product Code 0202 Lot numbers 03149759 and 03165584. Product Code 0204 Lot numbers 030305, 030321, and 03165583. Product Code 9202 Lot numbers 250203, 03205562, and 03255432.
RECALLING FIRM/MANUFACTURER
Molnlycke Health Care, Inc., Newton, PA, by letters dated July 9, 2003. Firm initiated recall is ongoing.
REASON
Pouch may tear which could result in contamination of sterile field.
VOLUME OF PRODUCT IN COMMERCE
2,714 units.
DISTRIBUTION
Nationwide and Internationally.
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III
_______________________________
PRODUCT
IRMA SL Blood Analysis System CC pH, pCO2, p)O2, Hct, Na+, K+, iCa Cartridge, Part Number 039903(M3586A). There are 25 disposable cartridges in a box. Recall # Z-1072-03.
CODE
The lot on the boxes of the product is ALHCB (this is the correct lot) and is incorrectly printed as ALOHC on the packages of the recalled disposable cartridges.
RECALLING FIRM/MANUFACTURER
Diametrics Medical, Inc. Roseville, MN, by telephone on July 14, 2003. Firm initiated recall is ongoing.
REASON
An incorrect lot designation, when entered into the blood analysis device, causes the device to give an error message and not operate.
VOLUME OF PRODUCT IN COMMERCE
103 boxes of 25 cartridges per box.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Blood Agar Plates, 5%. Recall # Z-1076-03.
CODE
Lot number A-10-3155A.
RECALLING FIRM/MANUFACTURER
Hardy Media, Inc. Dba Hardy Diag., Santa Maria, CA, by telephone on June 25, 2003, and by letter. Firm initiated recall is ongoing.
REASON
Customers complained of bacterial contamination.
VOLUME OF PRODUCT IN COMMERCE
11,250 plates.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Synchron LX Systems Primary Tube Sample Template ( a piece of "labeling" for use with the Synchron LX 20 and LX 20 Pro systems), Part Number: 967178. Recall # Z-1077-03.
CODE
No range of serial numbers apply.
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc. Brea, CA, by letter on June 19, 2003. Firm initiated recall is ongoing.
REASON
Dead volume on sight gauge for the Synchron LX 20 Pro Systems not stated, which may result in instrument error.
VOLUME OF PRODUCT IN COMMERCE
502.
DISTRIBUTION
Nationwide and Canada.
_______________________________
PRODUCT
Prosorba Protein A Immunoadsorption Column. Recall # Z-1086-03.
CODE
Lot #PNC001A.
RECALLING FIRM/MANUFACTURER
Fresenius Hemocare, Inc., Redmond, WA, by letter dated July 10, 2003. Firm initiated recall is ongoing.
REASON
No package insert.
VOLUME OF PRODUCT IN COMMERCE
19 cases/6 columns each.
DISTRIBUTION
AZ, CA, MI, MN, MO, PA, TN, TX, and VA.
_______________________________
PRODUCT
a) MR Systems. Recall # Z-1087-03;
b) Leonardo Workstations with software version 2022A/B,
2003A. Recall # Z-1088-03;
c) Leonardo Workstations with software versions prior to
2022A. Recall # Z-1089-03.
CODE
a) Upgrade Harmony Syngo MR, model 7106714 K2200, Serial
# 10501 through 10587.
Harmony Syngo MR, model 7104693 K2200, Serial # 11001
through 11172.
Upgrade Symphony Syngo MR, model 7106557 K2210, Serial
# 14001 through 14321.
IMPACT - Upgrade Syngo MR (MU3S), model 5751438 K2220,
Serial # 15001 through 15030.
IMPACT - Upgrade Syngo MR (MU3L), model 7106466 K2220,
Serial # 15501 through 15519.
VISION - Upgrade Quantum, model 4772971 K2230 Serial #
16001 through 16017.
VISION - Upgrade Sonata, model 7388148 K2230 Serial #
16501 through 16513.
Concerto Upgrade, model 7106995 K2221 Serial # 17201
through 17211.
Concerto, model 4772906 K2221 Serial # 17301 through
17473.
Syngo Allegra, model 7106433 K2183 Serial #20101 through
20110.
Upgrade Allegra syngo MR, model 7387736 K2183 Serial
# 20401 through 20421.
Trio (Bruker), model 7106441 K2180 Serial #20500 through
20507.
Trio, model 7387074 K2180 Serial #20510 through
20524 and 20550 through 20552.
Sonata Syngo MR, model 7104719 K2240 Serial #21101
through 21248.
Syngo MR SYM-Sonata-Upgrade, model 7104735 K2240 Serial
#21604 through 21612.
Syngo MR Upgrade Sonata, model 7106425 K2240 Serial
#21901 through 21942.
Symphony syngo MR, model 7104594 K2210 Serial 22001
through 22996.
Rhapsody, model 7384568 K2190 Serial # 24001 through
24004.
b) Model 7129534, Serial # 01001 through 01380, 05001
through 05600, and 10001 through 10320;
c) Model 7129534, Serial #01001 through 01380, 05001
through 05600, and 10001 through 103320.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA, by letters dated February 28, 2003, March 01, 2003, and April 14, 2003. Firm initiated recall is ongoing.
REASON
Software problem. This error may cause the loss of peripheral image information when there is a difference between the dimensions of the image matrix and the display segment.
VOLUME OF PRODUCT IN COMMERCE
1,374 units.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Frequency 55 Toric (methafilcon B), flexible wear contact lenses (tinted). Recall # Z-1091-03.
CODE
1468-212, Exp. 10/2008.
RECALLING FIRM/MANUFACTURER
Coopervision, Inc., Scottsville, NY, by telephone on July 22, 2003. FDA initiated recall is complete.
REASON
Mislabeled with incorrect sphere power.
VOLUME OF PRODUCT IN COMMERCE
152 lenses.
DISTRIBUTION
Nationwide, United Kingdom, and Canada.
_______________________________
PRODUCT
Misys Laboratory System versions 5.3 up to 5.3.2 with Lab Access Results Workstation. Recall # Z-1093-03.
CODE
Versions 5.3 up to 5.3.2.
RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Tucson, AZ, by fax on June 23, 2003. Firm initiated recall is ongoing.
REASON
Software defect. When Quality Assurance failure warnings are missing from a patient's report abnormal results could be used for diagnosis or treatment.
VOLUME OF PRODUCT IN COMMERCE
157.
DISTRIBUTION
Nationwide, United Kingdom, Ireland, Canada, Denmark, Saudi Arabia.
_______________________________
PRODUCT
Olympus Image Manager Software. Recall # Z-1126-03.
CODE
Versions 6.0 through 6.4.
RECALLING FIRM/MANUFACTURER
Olympus America, Inc., Melville, NY, by letters, dated March 5, 2003. Firm initiated recall is ongoing.
REASON
Software defect; potential under certain circumstances to incorrectly identify endoscopy images that have been uploaded & saved to the network system.
VOLUME OF PRODUCT IN COMMERCE
856.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
Imx Rubella IgM Reagent Kit, 100 tests. Recall # Z-1129-03.
CODE
List 7A24-20, lot 01687M300.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL, by letters dated July 21, 2003. Firm initiated recall is ongoing.
REASON
The package insert contains incomplete information for the English text. Pages 4 and 5 are missing and pages 14 and 15 are duplicated.
VOLUME OF PRODUCT IN COMMERCE
423 kits.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
a) Free T4 Control Pack, list 9C03-10; the kit consists of
3 bottles of controls, L-0.7,M - 1.2 and H - 3.0.
Recall # Z-1130-03;
b) Imx Free T4 Reagent Kit, list 2222-20, 100 test kit.
Recall # Z-1131-03;
c) Architect Free T4 Calibrator Kit, list 7G96-01; the kit
consists of 2 bottles of calibrators, CAL 1 - 0.5 and
CAL 2 - 6.0. Recall # Z-1132-03.
CODE
a) List 9C03-10, lot numbers 95881Q100 and 95881Q101;
b) List2222-20, lot number 01550Q100;
c) List7G96-01, lot number 94493M300.
RECALLING FIRM/MANUFACTURER
Abbott Park Laboratories, Abbott Park, IL, by letter dated May 30, 2003, and June 4, 2003. Firm initiated recall is ongoing.
REASON
The Free T4 Controls, may yield control values that are high and outside of the package insert ranges.
VOLUME OF PRODUCT IN COMMERCE
5,103 kits.
DISTRIBUTION
Nationwide and Internationally.
______________________________
PRODUCT
a) Custom formula TW 2, containing 100 g/ton
chlortetracycline, 0.011% sulfathiazole, and 50 g/ton
penicillin, packaged in 50-lb. bags. Recall # V-260-3;
b) Custom mix Sander Transition, containing 100 g/ton
chlortetracycline, 0.011% sulfathiazole, and 50 g/ton
penicillin, packaged in 50-lb. bags. Recall # V-261-3;
c) Custom beef cattle supplement for Z Bar, packaged in
50-lb. bags. Recall # V-262-3.
CODE
Unknown.
RECALLING FIRM/MANUFACTURER
Swiss Valley Ag Service, Hopkinton, IA, by telephone on June 4, 2003 and June
23, 2003. FDA initiated recall is complete.
REASON
Firm used raw material zinc oxide containing elevated levels of dioxin in feed.
VOLUME OF PRODUCT IN COMMERCE
286/50-lb. bags.
DISTRIBUTION
IA.
______________________________
PRODUCT
a) FCS 10-15 CBD Medicated, Starter for Pigs Weaned at
14-28 Days, containing 50 g/ton carbadox, packaged in
50-lb. bags, product #22972. Recall # V-263-3;
b) FCS 10-15/CTC-DEN P (bag tag not available), containing
400 g/ton chlortetracycline and 35 g/ton tiamulin
hydrogen fumerate, packaged in 50-lb. bags, product
#22973. Recall # V-264-3;
c) FCS 15-22 Mixer (bag tag not available), packaged in
50-lb. bags, product #22979. Recall # V-265-3;
d) FCS 15-22 (bag tag not available), packaged in
50-lb. bags, product #22981. Recall # V-266-3;
e) FCS 15-22 CBD Medicated, For Pigs 15 to 22 Pounds in
Weight, containing 50 g/ton carbadox, packaged in
50-lb. bags, product #22982. Recall # V-267-3;
f) FCS 15-22 CTC-Den Medicated, For Pigs 15 to 22 Pounds in
Weight, containing 35 g/ton tiamulin hydrogen fumarate
and 400 g/ton chlortetracycline, product #22983. Recall
# V-268-3;
g) Lean Gain Nursery Base (bag tag not available), packaged
in 50-lb. bags, product #24190. Recall # V-269-3;
h) FCS 1.4L Starter CBD Medicated, Starter Feed for Pigs
Weighting 22 to 40 Pounds, containing 50 g/ton carbadox,
packaged in 50-lb. bags, product #24206.
Recall # V-270-3;
i) FCS 1.4L Starter NT Medicated, Starter Feed for Pigs
Weighing 22 to 40 Pounds, containing 150 g/ton
oxytetracycline and 105 g/ton neomycin base, packaged in
50-lb. bags, product #24208. Recall # V-271-3;
j) FCS 1.3L Starter NT Medicated, Starter Feed for Pigs
Weighing 30 to 50 Pounds, containing 150 g/ton
oxytetracycline and 105 g/ton neomycin base, packaged in
50-lb. bags, product #24210. Recall # V-272-3;
k) FCS 1.3L Starter CBD Medicated, Starter Feed for Pigs
Weighing 30 to 50 Pounds, containing 50 g/ton carbadox,
packaged in 50-lb. bags, product #24211.
Recall # V-273-3;
l) Land O'Lakes Farmland Feed Lean Gain 95 T40 Meal
Medicated, Swine Grow/Finish Complete Feed, containing
40 g/ton tylosin phosphate, packaged in 50-lb. bags.
Recall # V-274-3;
m) Phase III Mixer (bag tag not available), packaged in 50
lb. bags, product #72023. Recall # V-275-3.
CODE
MAR 01 2002 through NOV 15 200.
RECALLING FIRM/MANUFACTURER
Farmers Coop Society, Sioux Center, IA, by letters dated April 22, 2003. Firm
initiated recall is complete.
REASON
Firm received raw material ingredient zinc oxide from a supplier and it contained
elevated levels of dioxin.
VOLUME OF PRODUCT IN COMMERCE
5, 700.18 CWT.
DISTRIBUTION
IA, MN, MO, NE, and SE.
END OF ENFORCEMENT REPORT FOR AUGUST 27, 2003
###
Office of Public Affairs
Hypertext created by clb 2003-AUG-27.