October 22, 2003
03-43
_______________________________
PRODUCT
Dried Guava Slice; product of Thailand. Recall # F-002-4.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Roxy Trading Inc., Azusa, CA, by press release and recall notifications on August 28, 2003. New York State initiated recall is ongoing.
REASON
New York State Department of Agriculture & Markets found undeclared sulfites in the product.
VOLUME OF PRODUCT IN COMMERCE
20 cases.
DISTRIBUTION
CA, NY and TX.
_______________________________
PRODUCT
Merenguitos brand cookies, packed in 1.1/16 oz. hard plastic containers. Recall # F-003-4.
CODE
Nov 20 2003 on the label.
RECALLING FIRM/MANUFACTURER
Hermanos Bakery Corp., Passaic, NJ, by press release and telephone on July 3, 2003. New York State initiated recall is ongoing.
REASON
The product contains undeclared egg whites.
VOLUME OF PRODUCT IN COMMERCE
110/1.1/16 oz packages.
DISTRIBUTION
NY.
_______________________________
PRODUCT
Mitica brand Apricot Bar, Net Wt. 2 oz. Product is packed in a clear plastic package. Barcode # 8 25325 00056 2. Recall # F-004-4.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Forever Cheese Inc., Whitestone, NY, by press release and letters dated April 29, 2003. New York State initiated recall is complete.
REASON
Labeling failed to declare sulfites based on New York State Department of Agriculture and Markets sampling and analysis.
VOLUME OF PRODUCT IN COMMERCE
1,380 bars (69 cases).
DISTRIBUTION
NY and NJ.
_______________________________
PRODUCT
Wu Hsing brand Red Pepper Powder in 1.4 oz. glass bottles; product of Taiwan. Recall # F-005-4.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Golden Luck, Inc., Commerce, CA, by telephone and fax on August 8, 2003. FDA initiated recall is complete.
REASON
The product is contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1,200 units.
DISTRIBUTION
CA, WA and HI.
_______________________________
PRODUCT
REAL GUACAMOLE HOT, Net Wt. 13 oz.(368g). Recall # F-006-4.
CODE
JUN 25 2003.
RECALLING FIRM/MANUFACTURER
Productions Real, Anthony, TX, by press release on June 13, 2003. FDA initiated recall is complete.
REASON
Product coded JUNE 25 2003 was found by FDA to be contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
3,050 units.
DISTRIBUTION
TX and AZ.
_______________________________
PRODUCT
a) Long Sliced Cold Smoked Fresh Salmon in 4, 8, and 16 oz
vacuum packages under MacKnight Traditional Oak Smoked
Premium Scottish Salmon, Rice Epicurean Markets Premium
Quality Smoked Salmon, and Cromarty's Oak Smoked
Scottish-Salmon labels. Recall # F-007-4;
b) Long Sliced Smoked Trout in 4 oz vacuum packages under
the Cromarty's label. The product is labeled as
Atlantic Foods' Smoked Atlantic Trout. Recall # F-008-4.
CODE
a) Batch codes: 1248, 1249, 1258, 1259, 1263, 1265, 1266,
1269, 1270, and 1271;
b) Batch codes: 1263 and 1265.
RECALLING FIRM/MANUFACTURER
MacKnight Smoked Foods, Inc., New Britain, PA, by press release dated April 1, 2003. Firm initiated recall is complete.
REASON
Products are contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
a) 845 pounds;
b) 144 pounds.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Capricious Cheese Company brand Capricious Washed Curd Cheese in 7-8 wheels and in random weight slices. Recall # F-009-4.
CODE
Green stamp of 01/28/03 on the side and bottom of the cheese.
RECALLING FIRM/MANUFACTURER
Capricious Cheese, Eureka, CA, by telephone on July 25, 2003, by letter on July 28, 2003 and by press release on July 30, 2003. FDA initiated recall is complete.
REASON
The product is contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
16 wheels.
DISTRIBUTION
CA, OR and NY.
_______________________________
PRODUCT
Mason Natural Chewable Calcium 600 with Vitamin D**Coffee Mocha Flavor tablet. A calcium/vitamin D supplement in a tablet dosage form, packed in plastic bottles with a white, blue, red, black and brown paper label. Recall # F-010-4.
CODE
Lot 0656N Exp. 10/2005, Lot 0793N Exp. 12/2005.
RECALLING FIRM/MANUFACTURER
Mason Distributors, Inc, Hialeah, FL, by letter on February 21, 2003. FDA initiated recall is complete.
REASON
Dietary Supplement is misbranded in that it claims to be dairy free when it contains sodium caseinate, a milk-derived ingredient.
VOLUME OF PRODUCT IN COMMERCE
2,866-100 tablet bottles.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Golden Buffalo brand Coconut Powder, Net Wt. 8 oz., packed in clear plastic bags. Product of Taiwan. Recall # F-520-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Prosperity Resources International, Irvington, NJ, by telephone on August 18, 2003. New York State initiated recall is complete.
REASON
Product contains undeclared sulfites (76.8 ppm).
VOLUME OF PRODUCT IN COMMERCE
7 cases x 50 bags.
DISTRIBUTION
NY and GA.
_______________________________
PRODUCT
Novartis Isosource 1.5 Cal, High Calorie - High Nitrogen, Ready to Use Medical Food, Vanilla Artificial Flavor, Net 8.45 Fl. Oz. (250 mL). Recall # F-001-4.
CODE
Lot code 1533B in cases numbered 01955 to 02231.
RECALLING FIRM/MANUFACTURER
Novartis Nutrition Corp., St. Louis Park, MN., by telephone and letter dated August 18, 2003. Firm initiated recall is ongoing.
REASON
The cans labeled as Isosource 1.5Cal actually contained a different product, Peptinex DT.
VOLUME OF PRODUCT IN COMMERCE
279 cases (24 cans per case).
DISTRIBUTION
IL, MI and OH.
_______________________________
PRODUCT
Red Blood Cells. Recall # B-0003-4.
CODE
Unit 7501077.
RECALLING FIRM/MANUFACTURER
Lane Memorial Blood Bank, Eugene, OR, by letter dated July 23, 2002. Firm initiated recall is complete.
REASON
Autologous Red Cells, which tested repeatedly reactive for antibody to hepatitis B core antigen (anti-Hbcore) and antibody to the hepatitis C virus (anti-HCV), were distributed without the "Biohazard" label on the bag.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OR.
_______________________________
PRODUCT
Source Plasma. Recall # B-0004-4.
CODE
GPBLTX, GPBHXV, GPBHMV, GPBGTG, GPBGHP, 857158, 856975, 856281, 856092, 837212, 836859, 836317, 836076, 834805, 834644, 834392, 834233, 833922, 833776, 837051, 833543, 833352, 833183, 833060, 832770, 832234, 832092, 831823, 831708, 831427, 831121, 143555, 143538, 004015.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc, Flint, MI, by facsimile dated March 14 and March 17, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
34 units.
DISTRIBUTION
IL, and NC.
_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0006-4.
CODE
Unit 3894467.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on October 22, 2002. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
_______________________________
PRODUCT
a) Platelets. Recall # B-0007-4;
b) Fresh Frozen Plasma. Recall # B-0008-4.
CODE
a) and b) Unit 2909395.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on October 30, 2002. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.
_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced. Recall # B-0009-4;
b) Platelets. Recall # B-0010-4.
CODE
a) and b) Unit 2990078.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on September 3, 2002, and by letter dated September 4, 2002. Firm initiated recall is complete.
REASON
Blood product, which were collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX, and NY.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0011-4;
b) Platelets, Leukocytes Reduced. Recall # B-0012-4.
CODE
a) and b) Unit 0943356.
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, OH, by letter on April 30, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
OH.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0013-4.
CODE
Unit 24219-9962.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Rapid City, SD, by telephone on May 12, 2003. Firm initiated recall is complete.
REASON
Blood product was collected in a manner that may compromise the sterility of the product.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
SD.
_______________________________
PRODUCT
Red Blood Cells. Recall # B-0014-4.
CODE
Unit number 17J09879.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, North Central Region, St. Paul, MN, by letter on May 20, 1997. Firm initiated recall is complete.
REASON
Blood product, that tested negative for antibodies to human immunodeficiency virus (anti-HIV), but was collected from a donor that previously tested repeatedly reactive for anti-HIV, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WI.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0017-4;
b) Platelets. Recall # B-0018-4.
CODE
a) and b) Unit W1632959.
RECALLING FIRM/MANUFACTURER
Community Blood Council of New Jersey, Trenton, NJ, by facsimile on February 13, 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
2 units.
DISTRIBUTION
NJ.
_______________________________
PRODUCT
Platelets. Recall # B-0019-4.
CODE
Unit FC20-05616.
RECALLING FIRM/MANUFACTURER
Community Blood Council of New Jersey, Trenton, NJ, by facsimile on March 21, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to recent ingestion of aspirin, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NJ.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0021-4.
CODE
Unit 2984544.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated September 17, 2002. Firm initiated recall is complete.
REASON
Red Cells, collected from a donor whose hemoglobin was not documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0033-4;
b) Recovered Plasma. Recall # B-0034-4.
CODE
a) and b) Unit 0391645.
RECALLING FIRM/MANUFACTURER
Community Blood Bank of Erie County, Erie, PA, by letter dated May 21, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was taking the medication finasteride, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
PA and Austria.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0035-4.
CODE
Unit 0149740 (double RBC product).
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter on September 25, 2002. 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
2 units.
DISTRIBUTION
TX.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0036-4.
CODE
Unit 2862679.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter on September 17,
2002. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor whose hemoglobin was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0037-4.
CODE
Unit 5465597.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter on September 22, 2002. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor whose hemoglobin was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0038-4.
CODE
Unit 08W41430.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Oakland, CA, by letter dated September 23, 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
CA.
_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced. Recall # B-0039-4;
b) Platelets. Recall # B-0040-4.
CODE
a) and b) Unit 2075467.
RECALLING FIRM/MANUFACTURER
Blood Bank of Delaware, Inc., Newark, DE, by telephone on November 20, 2002, and letters dated December 20, 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
2 units.
DISTRIBUTION
MD.
_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0041-4.
CODE
Unit 301808737.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc, Bismarck, ND, by letter dated October 8, 2002. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
ND.
_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0043-4.
CODE
Unit 38L75818 and 38H99976.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN, by telephone and letter on July 18, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on living in an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IN.
_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0048-4.
CODE
Unit 13Y87356.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southeastern Michigan Region, Detroit, MI, by telephone on March 10, 2003. Firm initiated recall is complete.
REASON
Blood product, manufactured from a unit of Whole Blood more than 8 hours after collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.
_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0049-4.
CODE
Unit 13FE24696 and 13GX63448.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southeastern Michigan Region, Detroit, MI, by telephone on February 24, 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
2 units.
DISTRIBUTION
MI.
_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0050-4.
CODE
Unit 13FY85188, 13FC5367, 13FC35366, 13GR41672, 13FV17756, and 13GX61930.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southeastern Michigan Region, Detroit, MI, by telephone on February 13, 2003, and by letter on February 20, 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
6 units.
DISTRIBUTION
MI.
_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-0053-4.
CODE
Unit 41LR78893.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Birmingham, AL, by telephone on March 12, 2002. Firm initiated recall is complete.
REASON
Blood product, in which the corresponding blood component was contaminated with Pseudomonas fluorescens and implicated in a transfusion reaction, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AL.
_______________________________
PRODUCT
Source Plasma. Recall # B-0054-4.
CODE
Unit 0125152, 0125507, 0126677, 0127193, 0129546, 0129693, 0130280, 0130435, 0131219, 0131623, 0132498.
RECALLING FIRM/MANUFACTURER
Westgate Biologicals, Inc., College Station, TX, by letter dated June 28, 2002 and July 1, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units.
DISTRIBUTION
NY.
_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0055-4.
CODE
Unit 41FV56720.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Birmingham, AL, by letter dated July 15, 2002. Firm initiated recall is complete.
REASON
Blood product, in which the corresponding blood component was contaminated with Ralstonia (Burkholderia) pickettii and implicated in a transfusion reaction, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AL.
_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0057-4.
CODE
Unit 12797-0484.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on August 13, 2003.
Manufacturer: Blood Systems, Inc., Albuquerque, NM. 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
FL.
_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced. Recall # B-0058-4;
b) Platelets. Recall # B-0059-4.
CODE
a) and b) Unit 53FE75842.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by letters dated December 30, 2002, and February 10, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on living in an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
DC.
_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced. Recall # B-0060-4;
b) Red Blood Cells, Washed. Recall # B-0061-4.
c) Recovered Plasma. Recall # B-0062-4.
CODE
a) and c) Unit 042FS74579;
b) and c) Unit 042FE76125.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northern Ohio Region, Cleveland, OH, by telephone, letters, and facsimile on May 15, 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
4 units.
DISTRIBUTION
OH, CA, and Switzerland.
_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0064-4.
CODE
Unit 8422668.
RECALLING FIRM/MANUFACTURER
South Florida Blood Banks, Inc., West Palm Beach, FL, by letter on May 15, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose record of responses to the medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV) could not be located, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.
_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced. Recall # B-0065-4;
b) Recovered Plasma. Recall # B-0066-4.
CODE
a) and b) Unit 8482923 and 8440712.
RECALLING FIRM/MANUFACTURER
South Florida Banks, Inc., West Palm Beach, FL, by letters on November 7, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to use of the medication Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
FL, and Switzerland.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0067-4;
b) Red Blood Cells, Leukocytes Reduced. Recall # B-0068-4.
CODE
a) Unit 29FJ40892 and 29KL13527;
b) Unit 29FW46400, 29FK39618, and 29FJ39147.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Mid-Atlantic Region, Norfolk, VA, by facsimile on January 17, 2003, and February 18, 2003, and by letters on February 5, 2003 and March 5, 2003. 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
5 units.
DISTRIBUTION
NC, VA, MD, DC, CA and Switzerland.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0072-4;
b) Platelets, Leukocytes Reduced. Recall # B-0073-4.
CODE
a) and b) Unit 33GS40402.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Connecticut Region, Farmington, CT, by letter on July 8, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CT.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0074-4;
b) Platelets. Recall # B-0075-4.
CODE
a) and b) Unit 53FE77209.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by letter on June 18, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MD.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0076-4.
CODE
a) and b) Unit 53FE77209.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by letter on March 19, 2003. Firm initiated recall is complete.
REASON
Blood products, 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
D.C.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0077-4.
CODE
Unit 53FH01292.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by letter on March 14, 2003. 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
1 unit.
DISTRIBUTION
MD.
_______________________________
PRODUCT
Source Plasma. Recall # B-0078-4.
CODE
Unit numbers NF203616, NF203793, NF204050, and NF204193.
RECALLING FIRM/MANUFACTURER
Biolife Plasma Services L.P., Nutterfort, WV, by facsimile on May 29, 2002. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from an unsuitable donor due to body piercing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Source Plasma. Recall # B-0080-4.
CODE
Unit numbers 77137104, 77131546, 77086143, 77083258, 76397547, 76394805, 76162589, 63177435, 63173499, 72236918, 72232811, 74400881, 72837382, 72831076, 72807668, 72801369, 72717677, 71829685, 71820590, 71706955, 71620046, 71615370, 71489704, 61439610, 61435933, 61431454, 61388703, 61382312, and 60780140.
RECALLING FIRM/MANUFACTURER
Biolife Plasma Services L.P., Richmond, VA, by facsimile on June 12, 2002. Firm initiated recall is complete.
REASON
Blood products, that tested negative for the antibody to hepatitis C virus (anti-HCV), but were collected from an ineligible donor due to previous reactive testing for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
29 units.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0106-4.
CODE
Unit 2941342.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on August 19, 2002. Firm initiated recall is complete.
REASON
Blood product, manufactured in a manner that may have compromised the sterility of the unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0001-4.
CODE
Units 13GE11173, 13Ge11201.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southeastern Michigan Region, Detroit, MI, by telephone on February 27, 2003, and by letter dated March 17, 2003. Firm initiated recall is complete.
REASON
Red Cells, incorrectly tested and labeled for the S antigen, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MI.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0002-4.
CODE
Unit 13FM86350.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southeastern Michigan Region, Detroit, MI, by letter dated February 18, 2003. Firm initiated recall is complete.
REASON
Red Cells, incorrectly tested and labeled for the Fy(b) antigen, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.
_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-0005-4.
CODE
Unit 2897248.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter on December 10, 2002. Firm initiated recall is complete.
REASON
Blood product, which was prepared from Whole Blood with an extended collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated. Recall # B-0015-4.
CODE
Unit numbers 1039197, 1051074, 1051084, and 1051100.
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Minneapolis, MN, by letter on July 16, 2003. Firm initiated recall is complete.
REASON
Blood products that were out of controlled storage for more than 30 minutes were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
MN.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0016-4.
CODE
Unit 24KG56780.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, River Valley Region, Louisville, KY, by telephone on May 31, 2003. Firm initiated recall is complete.
REASON
Blood product, manufactured from a unit of Whole Blood more than 8 hours after collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.
_______________________________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced. Recall # B-0020-4.
CODE
Units 2965076.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated October 22, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.
_______________________________
PRODUCT
Platelets. Recall # B-0022-4.
CODE
Unit 2922404.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated September 12, 2002. Firm initiated recall is complete.
REASON
Blood product, manufactured with an incorrect ratio of anticoagulant, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0028-4.
CODE
Units 13LG96994, 13LG96999, 13LG97005, 13FM13422, 13GW17122, 13GW17104, 13GW18543, 13GL09473, 13GV33727, 13FQ09747, 13FV07085, 13GR34313, 13GW15791, 13GW15787, 13GL08044, 13FV08086.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southeastern Michigan Region, Detroit, MI, by telephone on March 27, 2003, and by letter dated April 8, 2003. Firm initiated recall is complete.
REASON
Blood products, that may not have been leukoreduced within a 24 hour time frame, were distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units.
DISTRIBUTION
MI.
_______________________________
PRODUCT
Source Plasma. Recall # B-0032-4.
CODE
FJMIS0127N FJMIS0127RA, FJMIS0128N, FJMIS0128RA, FJMIS0129RA,FJMIS0129N, FJMIS0130N, FJMIS0130RA, FJMIS0131N, FJMIS0131RA, FJMIS0131, FJMIS0132, FJMIS0132CX,FJMIS0133CX, FJMIS0133, FJMIS0134CX,
FJMIS0134, FJMIS0135CX, FJMIS0135, FJMIS0136CX, FJMIS0136, FJMIS0137CX, FJMIS0137, FJMIS0138CX, FJMIS0138, FJMIS0139, FJMIS0139CX, 0335S0141CX, 0335S0141NX, 0335S0142CX, 0335S0142NX.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Flint, MI, by facsimile dated February 21, 2002. 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
31 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0044-4;
b) Platelets. Recall # B-0045-4;
c) Recovered Plasma. Recall # B-0046-4.
CODE
a), b) and c) Unit T03886.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Traverse City, MI, by facsimile on February 4, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with an elevated body temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
MI, and Switzerland.
_______________________________
PRODUCT
Source Plasma. Recall # B-0047-4.
CODE
Unit 08634958.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Flint, MI, by facsimile on September 13, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with an elevated body temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Human Corneas For Transplantation. Recall # B-0051-4.
CODE
Units 00490301 and 00490302.
RECALLING FIRM/MANUFACTURER
Lions Eye Bank of Lexington, Lexington, KY, by telephone on July 16, 2003 and by letter dated July 31, 2003. Firm initiated recall is complete.
REASON
Corneas, which tested negative for the antibody to the human immunodeficiency virus types 1 and 2 (anti-HIV-1/2), but subsequently tested repeatedly reactive for HIV-1 p24 antigen and indeterminate by confirmatory testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
KY.
_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0056-4.
CODE
Unit 7423741.
RECALLING FIRM/MANUFACTURER
Manatee Community Blood Center, Bradenton, FL, by facsimile on April 10, 2003. Firm initiated recall is complete.
REASON
Unlicensed blood product was distributed interstate.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
GA.
_______________________________
PRODUCT
Source Plasma. Recall # B-0063-4.
CODE
Unit numbers FXPWMQ, FXPVHV, FXPTXN, FXPRWC, and FXPRQD.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aventis Bio-Services, Inc., by facsimile on June 16, 2003.
Manufacturer: Aventis Bio-Services, Inc., Akron, OH. Firm initiated recall is complete.
REASON
Blood products, collected from a donor that did not answer medical history questions concerning signs and symptoms and behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
IL.
_______________________________
PRODUCT
Recovered Plasma. Recall # B-0069-4.
CODE
Unit 29FJ40892, 29KL13527, 29FW46400, 29FK39618, and 29FJ39147.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Mid-Atlantic Region, Norfolk, VA, by facsimile on January 17, 2003, and February 18, 2003, and by letters on February 5, 2003 and March 5, 2003. 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
5 units.
DISTRIBUTION
NC, VA, MD, DC, CA and Switzerland.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0070-4.
CODE
Unit numbers 35FH81344, 35FH81347, and 35FH81348.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Appalachian Region, Roanoke, VA, by telephone on May 12, 2003. Firm initiated recall is complete.
REASON
Blood products, that were not leukoreduced within the appropriate time period after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
VA.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0071-4.
CODE
Unit T23683.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter on June 17, 2003. Firm initiated recall is complete.
REASON
Blood product, manufactured from a unit of Whole Blood more than 8 hours after collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.
_______________________________
PRODUCT
Red Blood Cells. Recall # B-0079-4.
CODE
Unit 12470-5518 and 12791-8207.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter on June 9, 2003.
Manufacturer: Blood Systems, Inc., Albuquerque, NM. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to a history of ulcerative colitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NM.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0081-4.
CODE
Unit 21KL59113.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Portland, OR, by telephone on November 1, 2002 and by letter dated November 8, 2002. Firm initiated recall is complete.
REASON
Red Cells, that did not have the complete amount of additive solution included, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Opti-Plast Balloon Dilatation Catheters. Recall # Z-0002-04.
CODE
Models: XT75410, XT100410, XT120410.
RECALLING FIRM/MANUFACTURER
Bard Peripheral Vascular, Tempe, AZ, by telephone on August 20, 2003. Firm initiated recall is complete.
REASON
Product intended for distribution outside USA was distributed without pre-market notification requirements being met.
VOLUME OF PRODUCT IN COMMERCE
14.
DISTRIBUTION
OH, AL, MS, LA, and VA.
_______________________________
PRODUCT
Rultract Surgical Retractor, 4100 Series, all system configurations, reusable. Recall # Z-0008-04.
CODE
S/Ns: 0001 to 2005, and S/Ns: 2172 to 2885.
RECALLING FIRM/MANUFACTURER
Rultract Inc., Independence, OH, by letter on September 18, 2003. Firm initiated recall is ongoing.
REASON
Component spring or nut may loosen, detach, and fall into chest of patient during surgical procedure.
VOLUME OF PRODUCT IN COMMERCE
2,718.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Urology X-Ray System, Hardware for Motor Drive. Recall # Z-0009-04.
CODE
Uroskop D1/D2/D3.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Malvern, PA, by Service Engineer visit, beginning on August 8, 2003. Firm initiated recall is ongoing.
REASON
Possible movement of table tilt and table longitudinal.
VOLUME OF PRODUCT IN COMMERCE
34 units.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Conquest Ballon Dilation Catheters Model/Catalog Number CQ 75124. Recall # Z-0010-04.
CODE
Lot 93DN0081.
RECALLING FIRM/MANUFACTURER
Bard Peripheral Vascular, Tempe, AZ, by letter dated September 17, 2003. Firm initiated recall is ongoing.
REASON
Mislabeled. 7mm balloon labeled 12mm.
VOLUME OF PRODUCT IN COMMERCE
124.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Power cord manufactured by ElectriCord Manufacturing Company, P/N 316579, used with DINAMAP Patient Monitors as Follows: DINAMAP PRO Series, DINAMAP PRO 1000 Monitor under both the Critikon and GE Medical Systems. The company name EliectriCord is on the power cord plug. Recall # Z-0011-04.
CODE
Lot numbers 01-08 through 02-16 which are embossed into the power cord metal blades and also those with no lot numbers.
RECALLING FIRM/MANUFACTURER
GE Medical Systems Information Technologies, Tampa, FL, by letter beginning on April 30, 2003 until August 14, 2003. Firm initiated recall is ongoing.
REASON
Reports of broken plug ground pins on AC power cords for patient monitors.
VOLUME OF PRODUCT IN COMMERCE
17,006.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
Roche/Hitachi Modular Analytics P clinical chemistry analyzer; Modular P. Catalog number 766-8156. Recall # Z-0012-04.
CODE
All units with current software versions (v 06-06 and 07-01).
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corp., Indianapolis, IN, by letter on or about May 12, 2003. Firm initiated recall is complete.
REASON
Incorrect results, without a data flag, reported if one of the other reagent containers becomes depleted before the RI reagent is depleted.
VOLUME OF PRODUCT IN COMMERCE
478.
DISTRIBUTION
Nationwide.
____________________________
PRODUCT
a) Critikon brand Omni-Stat Finger Sensor - P/N 009084.
Recall # Z-0013-04;
b) Critikon brand Omni-Sat Neonatal, Semi-Disposable
Sensor, P/N 009130. Recall # Z-0014-04;
c) Critikon brand Omni-Sat Adult, Semi-Disposable Sensor -
P/N 009136. Recall # Z-0015-04.
CODE
a) Lot 006;
b) Lot numbers 008 and 005;
c) Lot 3910.
RECALLING FIRM/MANUFACTURER
GE Medical Systems Information Technologies, Tampa, Fl, by letter on November 16, 2000. Firm initiated recall is complete.
REASON
Instructions for use contained incorrect sensor reference.
VOLUME OF PRODUCT IN COMMERCE
481.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
TC-PLUS Solution Tibial Component-Symmetric. Recall # Z-0017-04.
CODE
Lot 0211.13.4553.
RECALLING FIRM/MANUFACTURER
Plus Endoprothetik AG, Rotkreuz, China, by letter and telephone on May 16, 2003, June 2, 2003 and August 26, 2003. FDA initiated recall is complete.
REASON
Labeling/packaging mix-up.
VOLUME OF PRODUCT IN COMMERCE
15.
DISTRIBUTION
TX, CA, VA, ID, NY, UT, and FL.
_______________________________
PRODUCT
CryoValve, Pulmonary Valve & Conduit SG. Recall # Z-0019-04.
CODE
Donor #61354, Device #7693941, Model #SGPV00.
RECALLING FIRM/MANUFACTURER
Cryolife, Inc., Kennesaw, GA, by letter on August 18, 2002. Firm initiated recall is ongoing.
REASON
The heart valve procurement exceeded the warm ischemic time criteria.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_______________________________
PRODUCT
a) Huntington Instruments brand Irrigation Aspiration
System with Single Spike Tubing and 33 cm Probe,
Disposable (single use only), sterile, latex free.
Catalog # 55040. Recall # Z-0020-04;
b) Irrigation Aspiration System with Double Spike Tubing
and 33 cm Probe, Disposable (single use only), sterile,
latex free. Catalog # 55060. HYDRO-PRO brand labeled as
sold by Vital Concepts, Inc., Grand Rapids, Michigan.
Huntington Instruments brand labeled as Manufactured for
Huntington Instruments, Ogden Utah. Quanta Technologies
L.L.C. brand Manufactured for Quanta Technologies,
L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada
and labeled as Manufactured for Jac-Cell Medic, Dorval,
Quebec. Recall # Z-0021-04;
c) HYDRO-PRO brand Irrigation Aspiration System with double
Spike Tubing, no Probe, Disposable (single use only),
sterile, latex free. Catalog # 55160. Recall # Z0022-04;
d) HYDRO-PRO brand Suction-Irrigation System without Probe,
Disposable (single use only), sterile, latex free. R-Med
Re-Order # 55170R. Recall # Z-0023-04;
e) Quanta Technologies L.L.C. brand REORDER # LAPKIT 3.
Contents 1 -55060 Suction/Irrigation Valve 2- 30012
Insufflation Tubing set 3- 5010 Anti Fog Solution with
Sponge. Recall # Z-0024-04;
f) Irrigation Aspiration System for Nezhat Dorsey Type
Pumps with 33 cm Probe, and Tubing, Disposable (single
use only), sterile, latex free. Catalog # 55050.
Recall # Z-0025-04.
CODE
a) Lots 50905127 and 50905036;
b) Lots 50904840, 50904918, 50904919, 50904935, 50904958,
50904959, 50904988, 50904994, 50905033, 50905050A,
50905093, 50905121 and 50905148;
c) Lots 50904972 and 50905039;
d) Lots 50904954, 50905019 and 50905099;
e) Lots 994985, 994986 and 995044;
f) Lots 50904971 and 50905123.
RECALLING FIRM/MANUFACTURER
Vital Concepts, Inc., Grand Rapids, MI, by letter beginning on July 11, 2003. Firm initiated recall is ongoing.
REASON
The suction valve may become stuck in the 'suction on' position under vacuum.
VOLUME OF PRODUCT IN COMMERCE
3,355.
DISTRIBUTION
Nationwide, Canada, Israel and Japan.
_______________________________
PRODUCT
Lactate Disposable Membrane Caps Product Number: 0018108400. Recall # Z-0027-04.
CODE
US Distribution Lot Numbers: N307, Exp. 1/30/04 N30601, Exp. 12/30/03; International Distribution: N30301 Exp. 9/30/03 N30501 Exp. 11/30/03 N306 Exp 12/30/03 N30604 Exp. 12/30/03 N308 Exp. 2/28/04.
RECALLING FIRM/MANUFACTURER
Instrumentation Laboratory Co., Lexington, MA, by telephone on August 28, 2003. Firm initiated recall is ongoing.
REASON
Lactate Disposable Membrane Caps linearity was determined to be significantly biased and could potentially cause erroneous patient results above 6.0 mmol/L.
VOLUME OF PRODUCT IN COMMERCE
287 boxes.
DISTRIBUTION
IL, NY, Italy and Mexico.
_______________________________
PRODUCT
Roche/Hitachi brand lactate reagent for the quantitative determination of L-lactate in plasma, cerebrospinal fluid or whole blood. Catalog # 1822837. Recall # Z-0028-04.
CODE
All lots of reagent when used manually or on the Roche/Hitachi 902, 911, 912, 917 or Modular Analytics P module analyzers.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corp, Indianapolis, IN, by letters on September 2, 2003 and September 18, 2003. Firm initiated recall is ongoing.
REASON
Patient samples with very high lactate values may falsely be reported as within the normal range without the instrument giving a warning flag to the technician.
VOLUME OF PRODUCT IN COMMERCE
42,887.
DISTRIBUTION
Nationwide, Canada and Germany.
_______________________________
PRODUCT
a) Ace Percutaneous Transluminal Coronary Angioplasty
(PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon,
Catalog Number H74902071011. Recall # Z-0030-04;
b) Ace Percutaneous Transluminal Coronary Angioplasty
(PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon,
Catalog Number H74902071051. Recall # Z-0031-04;
c) Ace Percutaneous Transluminal Coronary Angioplasty
(PTCA) Dilatation Catheter with 1cm Tip 20 mm Balloon,
Catalog Number H74903628151. Recall # Z-0032-04.
CODE
a) Lot 5689062;
b) Lots 5685024 and 5685027;
c) Lot 5707453.
RECALLING FIRM/MANUFACTURER
Boston Scientific Scimed, Maple Grove, MN, by letter dated August 20, 2003. Firm initiated recall is ongoing.
REASON
Some of the recalled catheters have a component that has levels of pyrogens above specification.
VOLUME OF PRODUCT IN COMMERCE
16 catheters.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
a) Neonatal/Infant Hyperinflation Circuit, consisting of a
0.5 L breathing bag, pressure monitoring tube with Bird
adapter, oxygen supply tubing, sideport connector with
adjustable bleed valve, and 40 cm H2O Popoff elbow; 20
units per case; reorder #BLD-83124-2. Recall # Z-0033-4;
b) Neonatal/Infant Hyperinflation Circuit, consisting of a
0.5 L breathing bag, pressure monitoring tube, oxygen
supply tubing, sideport connector with adjustable bleed
valve, ported elbow and infant mask; 20 units per case;
reorder #BLD-83100-24. Recall # Z-0034-04;
c) Neonatal/Infant Hyperinflation Circuit, consisting of a
0.5 L breathing bag, pressure monitoring tube, oxygen
supply tubing, sideport connector with adjustable bleed
valve, 40 cm H2O Popoff elbow and infant mask; 20 units
per case; reorder #BLD-83144-24. Recall # Z-0035-04;
d) Hyperinflation Circuit, consisting of a 2.0 L breathing
bag, pressure monitoring tube, oxygen supply tubing,
sideport connector with adjustable bleed valve and
ported elbow; 20 units per case; reorder #BLD-83120.
Recall # Z-0036-04;
e) Sideport Kit, consisting of an adjustable sideport valve
and an O2 port elbow; 20 units per case; reorder #BLD-
83166. Recall # Z-0037-04;
f) Sideport Kit w/Oxygen Line, consisting of an adjustable
sideport valve, an O2 port elbow and O2 supply tubing;
20 units per case; reorder #BLD-83167. Recall # Z-0038-
04.
CODE
a) Lot 11409;
b) Lots 11394 and 11680;
c) Lot 11679;
d) Lot 11593;
e) Lot 11384;
f) Lots 11385 and 11541.
RECALLING FIRM/MANUFACTURER
VIASYS Med Systems, Wheeling, IL, by telephone and fax on September 10 and 11, 2003. Firm initiated recall is ongoing.
REASON
The exhalation hole in the side-port relief valve may be blocked, allowing excess pressure build-up.
VOLUME OF PRODUCT IN COMMERCE
5,540 units.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Cyto-Stat Tetra Chrome CD45-FITC/CD56-RD-1/CD-19-ECD/CD3-PC5 Monoclonal Antibody Reagent. Recall # Z-0046-04.
CODE
Lot 758031F1, Part number 6607073.
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA., by letter on August 26, 2003. Firm initiated recall is ongoing.
REASON
Package insert contains inaccurate information.
VOLUME OF PRODUCT IN COMMERCE
233.
DISTRIBUTION
Nationwide
_______________________________
PRODUCT
Olympus ImageManager Software, Common name: Medical image storage device {NOTE: any ImageManager Software sold as a stand-alone system is not impacted by this software malfunction since no opportunity exists for any image cross-linking.) Recall # Z-0047-04.
CODE
Versons 6.0 through 6.4.1 (excluding version 6.3.8).
RECALLING FIRM/MANUFACTURER
Olympus America Inc., Melville, NY, by letters dated August 19, 2003. Firm initiated recall is ongoing.
REASON
Software malfunction; potential for simultaneous cross-linking of exam images to another patient's file.
VOLUME OF PRODUCT IN COMMERCE
1,014.
DISTRIBUTION
Nationwide, Puerto Rico, Canada, Mexico, Ecuador and Chile.
_______________________________
PRODUCT
T2 Tibia Nail, Standard 9 x 300 mm, T2 Tibia System, Catalog No. 1822-0930S. Recall # Z-1295-03.
CODE
Lot K884459.
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics, Mahwah, NJ, by letters on August 4, 2003. Firm initiated recall is complete.
REASON
The device does not have an oblong hole for dynamic locking as required.
VOLUME OF PRODUCT IN COMMERCE
6.
DISTRIBUTION
PA, VA, GA, KS, and CA.
_______________________________
PRODUCT
a) Liberty brand Insulin Syringes for use with U-100
insulin, ‡ cc X 30G X 5/16" syringes.
Recall # Z-0003-04;
b) Liberty brand Insulin Syringes for use with U-100
insulin, 1 cc X 29G X ‡" insulin syringes. Recall # Z-
0004-04;
c) Liberty brand Insulin Syringes for use with U-100
insulin, ‡ cc X 29G X ‡" insulin syringes. Recall # Z-
0005-04
CODE
a) Lot # 2IE03;
b) Lot # 2HC02;
c) Lot # 21A03.
RECALLING FIRM/MANUFACTURER
Liberty Medical Supplies, Port Saint Lucie, FL, by letter on February 25, 2003. Firm initiated recall is ongoing.
REASON
The correct individual insulin syringe labeling size and guage may be different than what is on the incorrectly labeled shelf box.
VOLUME OF PRODUCT IN COMMERCE
1,880 cases (100 syringes).
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
McGhan Style 40, Round Breast Implant, Standard Projection, Silicone-filled Smooth INTRASHIEL Barrier Catalog Numbers: 25-40401, 25-40461, 25-40501, 25-40561. Recall # Z-0006-04
CODE
Serial numbers are too numerous to include.
RECALLING FIRM/MANUFACTURER
Inamed Corp, Goleta, CA, by letter on September 12, 2003. Firm initiated recall is ongoing.
REASON
The 400cc, 460cc, 500cc 560cc sizes of the McGhan Style 40 Silicone-filled Breast Implants were manufactured using one size smaller shells that required.
VOLUME OF PRODUCT IN COMMERCE
694.
DISTRIBUTION
Nationwide and Canada.
_______________________________
PRODUCT
Acticoat* Moisture Control Dressing, Product Code 20211. Recall # Z-0016-04.
CODE
021022A, 021023A, 021118A, 030106A, 030107A.
RECALLING FIRM/MANUFACTURER
Smith and Nephew, Inc., Wound Management Division, Largo, FL, by letter on April 15, 2003. Firm initiated recall is complete.
REASON
Product may not meet the established stability specification before the end of labeled expiry date.
VOLUME OF PRODUCT IN COMMERCE
3,355.
DISTRIBUTION
Nationwide.
END OF ENFORCEMENT REPORT FOR OCTOBER 22, 2003
###
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Hypertext created by clb 2003-OCT-23.