September 17, 2003
03-38
_______________________________
PRODUCT
Smoked salmon in vacuum-packed package labeled “Pacific Seafood NORTHWEST STYLE Smoked Salmon Packed by: Pacific Smoking Co., Salem, Oregon. Recall # F-499-3.
CODE
052922 092903.
RECALLING FIRM/MANUFACTURER
Pacific Smoking Company, Clackamas, OR, by telephone on July 1, 2003 and July 3, 2003, and by press release on July 1, 2003. Firm initiated recall is complete.
REASON
Product was found to be contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
265 lbs.
DISTRIBUTION
WA, OR, CA, ID, MT and UT.
_______________________________
PRODUCT
a) Kushishang brand Dried Potato, Net Wt. 250 g. New–
Fashion Foodfactory. Product of China. The product is
packed in a heat-sealed plastic bag. Barcode # 6 920149
000348. Recall # F-500-3;
b) Hongfu Xiuxian Foods brand Dried Potato Slice. Net Wt.
250 g. Product of China. Product is packaged in a
plastic tray inside a sealed foil plastic bag.
Barcode # 6 924787 600922. Recall # F-501-3.
CODE
a) All products on the market at the time the recall was
initiated.
b) 2002.12.10.2.
RECALLING FIRM/MANUFACTURER
Star Mark Management, Inc., Brooklyn, NY, by press release and telephone on February 26, 2003 or letter on March 11, 2003. New York State initiated recall is complete.
REASON
The product contained undeclared sulfites based on NYSDAM sampling and analysis.
VOLUME OF PRODUCT IN COMMERCE
Undetermined.
DISTRIBUTION
NY.
_______________________________
PRODUCT
Ground Cumin Comino Molido, labeled under two brands, ORALE, 141-A, Net Wt. 1.50 OZ. and Lisy, L141 Net Wt. 1¼ oz. Recall # F-512-3.
CODE
All products with product numbers 141-A and L 141.
RECALLING FIRM/MANUFACTURER
Lisy Corporation, Miami, FL, by telephone and e-mail beginning on July 12, 2003, and by letter on July 21, 2003. Florida State initiated recall is ongoing.
REASON
State of Florida Dept. of Agriculture analysis found Salmonella in finished product.
VOLUME OF PRODUCT IN COMMERCE
5,818 dozen packets.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Galil brand Sun Dried Tomatoes in Oil, Drained Wt. 8.4 oz (240 g), Net Wt 14.4 oz (410 g). Product of Turkey. Imported by: Galil Importing Corp., Syosset, NY. Recall # F-515-3.
CODE
L33713/USE BY 12/3/2003 (printed on lid), and L21121/Use by 7/30/2001.
RECALLING FIRM/MANUFACTURER
Galil Importing Corp, Syosset, NY, by press release on March 5, 2003 and March 24, 2003. New York State initiated recall is complete.
REASON
Product contained undeclared sulfites (1094 ppm and 1581 ppm) based on NYSDAM samplings and analyses.
VOLUME OF PRODUCT IN COMMERCE
Undetermined.
DISTRIBUTION
Nationwide and Canada.
_______________________________
PRODUCT
a) Aloo Bokhara (Sour Prunes), 8 oz bag, 224 g.
Recall # F-516-3;
b) Apricot, 10 oz bag, 280 g. Recall # F-517-3;
c) Zaferani Pistachio, 8 oz. bag, 228 g. F-518-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Ala Import + Export, Inc., Reseda, CA, by deliverymen, beginning September 20, 2002. Florida State initiated recall is complete.
REASON
a) and b) Product contains undeclared sulfites.
c) Product contains undeclared color additive, sunset yellow FCF (certifiable as FD&C Yellow #6).
VOLUME OF PRODUCT IN COMMERCE
1,200 bags.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Land O’ Lakes Salted Butter, 1 pound net wt, 4 sticks of
butter per package. Recall # F-505-3.
CODE
Lots KE 107 P, KE
108 P, KE 109 P. Best when purchased by date of “10 01 03” precedes the lot
number on each retail package.
RECALLING FIRM/MANUFACTURER
Land
O’ Lakes, Inc., Arden Hills, MN, by telephone on July 25, and July 26, 2003.
Firm initiated recall is completed.
REASON
The product may contain
metal fragments.
VOLUME OF PRODUCT IN COMMERCE
3,515 cases/36
one lb. each.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
a) Davidson Farms Seafood Salad, Net Weight 5 Lbs.
Recall # F-506-3;
b) Davidson Farms Shrimp Salad, Net Weight 5 Lbs.
Recall # F-507-3.
CODE
May 4, 2003, May 5, 2003, and May 6, 2003 which are expiration dates stamped on the plastic containers.
RECALLING FIRM/MANUFACTURER
Davidson’s Farms, Punta Gorda, FL, by letters beginning on May 2, 2003. FDA initiated recall is complete.
REASON
The products listed mayonnaise and bread crumbs as ingredients but did not declare their subingredients including egg yolks and flour.
VOLUME OF PRODUCT IN COMMERCE
23-5 lb. tubs.
DISTRIBUTION
FL.
_______________________________
PRODUCT
a) Pimento Cheese Sandwich (cheddar cheese, red pepper,
mayonnaise) packaged in the rigid plastic triangle
shapes with a flexible plastic heat-sealed covering,
4 oz. Recall # F-508-3;
b) Reuben Sandwich (corned beef, swiss cheese, sauerkraut,
thousand island dressing, rye bread, butter) packaged in
the rigid plastic triangle shapes with a flexible
plastic heat-sealed, 7 oz covering. Recall # F-509-3;
c) Big Boy Sandwich (chopped beef, thousand island
dressing, grilled onions) packaged in heat-sealed
flexible plastic packaging, 9 oz. Recall # F-510-3;
d) Big Boy Sandwich with cheese (chopped beef, thousand
island dressing, grilled onions) packaged in heat-sealed
flexible plastic packaging, 9 oz. Recall # F-511-3.
CODE
Expiration dates: 7/11/03 – 7/18/03.
RECALLING FIRM/MANUFACTURER
Guaranteed Total Vending dba Creations Sandwich Co., Memphis, TN, by telephone, fax and visit on July 10, 2003. FDA initiated recall is complete.
REASON
The product listed mayonnaise as an ingredient without listing the subingredients of mayonnaise, including egg yolks.
VOLUME OF PRODUCT IN COMMERCE
561 sandwiches.
DISTRIBUTION
TN.
_______________________________
PRODUCT
Yoo-Hoo Chocolate Drink, 9 fl. Oz. (266mL). Product is a chocolate based drink packaged into a clear glass bottle with a metal crimp on cap and has a yellow and brown paper label. Recall # F-519-3.
CODE
Bottles coded “205273x xx:xx” and “205293x xx:xx” where x xx:xx represents the manufacturing line, time and day.
RECALLING FIRM/MANUFACTURER
Orangina Carbonted Beverage, White Plains, NY, by telephone and letter on June 27, 2003. Firm initiated recall is ongoing.
REASON
Product is spoiled.
VOLUME OF PRODUCT IN COMMERCE
9,798 cases of 24 bottles.
DISTRIBUTION
FL, SC, NC, and GA.
_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Removed. Recall # B-1527-3;
b) Recovered Plasma. Recall # B-1528-3.
CODE
a) and b) Unit 2324685.
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on August 28, 2002. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor at increased risk for nvCJD, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX and FL.
_______________________________
PRODUCT
Platelets Pheresis. Recall # B-1571-3.
CODE
Unit number 8721125 (distributed as two split products).
RECALLING FIRM/MANUFACTURER
Coffee Memorial Blood Center, Inc., Amarillo, TX, by letter on May 31, 2002. Firm initiated recall is complete.
REASON
Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.
_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1572-3.
CODE
Unit number 042KF09241.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northern Ohio Region, Cleveland, OH, by telephone on April 3, 2003, and by letter on April 10, 2003. Firm initiated recall is complete.
REASON
Platelets Pheresis with elevated platelet counts were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH.
_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced Irradiated. Recall # B-1573-3.
CODE
Unit number 20P15049.
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Lewis and Clark Region, Boise, ID, by telephone on March 18, 2003, and by letter on April 25, 2003.
Manufacturing Firm: The American National Red Cross, Salt Lake City, UT. Firm initiated recall is complete.
REASON
Blood product, corresponding to a blood product that was possibly contaminated with Staphylococcus sp. Bacteria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
UT.
_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1574-3.
CODE
Unit 5106338-P2, 4708527-P1.
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone on June 6, 2003. Firm initiated recall is complete.
REASON
Blood product, corresponding to a unit of Platelets, that was implicated in a transfusion reaction and found to be contaminated with Staphylococcus, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1620-3;
b) Platelets. Recall # B-1621-3;
c) Fresh Frozen Plasma. Recall # B-1622-3;
d) Red Blood Cells for Further Manufacture.
Recall # B-1623-3;
e) Recovered Plasma. Recall # B-1624-3.
CODE
a) Units 03FR22774, 03GQ02020, 03FL37606,
03W50954, 03LH02394, 03L76086, 03C25030;
b) Units 03FR22774, 03FL37606, 03L76086, 03C25030;
c) Units 03C25030, 03GM13736;
d) Unit 03GM13736;
e) Units 03FR22774, 03GQ02020, 03FL37606, 03W50954,
03LH02394, 03L76086.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Atlanta, GA, by letter dated November 16, 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 based on the subsequent disclosure of a previous positive test for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 7 units;
b) 4 units;
c) 2 units;
d) 1 unit;
e) 6 units.
DISTRIBUTION
CA, FL, GA, and MI.
_______________________________
PRODUCT
Source Plasma. Recall # B-1629-3.
CODE
0083696, 0083848, 0084203, 0084323, 0084593, 0084730, 0084973, 0085101, 0085318, 0085521, 0085674, 0085870, 0086008, 0086128, 0086350, 0086500, 0086683, 0086808, 0087046, 0087182, 0087436, 0087582, 0088000, 0088398, 0088742, 0089093, 0089295, 0089711, 0089795, 0090089, 0090320, 0090484, 0090763, 0090972, 0091485, 0091652, 0091840, 0092202, 0092312, 0092852, 0093201, 0093297, 0093553, 0093670, 0093776, 0093976, 0094033, 0094298, 0094420, 0095459, 0095647, 0096256, CD0102066, CD0102291, CD0102542, CD0102754, CD0102952, CD0103147, CD0103259, CD0103557, CD0103605, CD0103810, CD0103931, CD0104155, CD0104450, CD0104521, CD0104724, CD0104873, CD0105099, CD0105238, CD0105490, CD0105688, CD0105953, CD0106082, CD0106362, CD0106976, CD0107124, CD0107392, CD0107618, CD0107754, CD0107990, CD0108177, CD0108442, CD0108673, CD0108959, CD0109178, CD0109462, CD0109684, CD0109941, CD0110629, CD0110897, CD0111117, CD0111626, CD0112703, CD0113030, CD0113684, CD0113962, CD0114000, CD0114439, CD0114683, CD0115213, CD0115403, CD0115446, CD0115653, CD0115744, CD0116014, CD0116579, CD0117021, CD0117352, CD0119006, CD0119152, CD0119594, CD0119823, CD0120029, CD0120301, CD0120604, CD0120811, CD0121085, CD0122085, CD0122275.
RECALLING FIRM/MANUFACTURER
DCI Biologicals Carbondale, LLC, Carbondale, IL, by facsimile dated June 3, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had sexual contact with someone who lived in an HIV Group O risk area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
120 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Source Plasma Units. Recall #B-1630-3.
CODE
N-26327-030, G-08078-030, G-08214-030, G-08776-030,
G-09240-030, G-09416-030, G-09921-030, G-10184-030,
G-10641-030, G-10977-030, G-11374-030, G-12735-030,
G-13420-030, F-01317-030, F-04482-030, F-05147-030,
F-08389-030, F-09162-030, F-09835-030, F-10241-030,
F-10549-030, F-11107-030, F-11294-030, F-11849-030,
F-12035-030, F-12534-030, F-12697-030, F-13407-030,
F-19485-030.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Alpha Therapeutic Corporation, Los Angeles, CA, by facsimile on May 5, 2003.
Manufacturer: Alpha Therapeutic Corporation, Youngstown, OH. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had a tattoo applied within the previous twelve months, were distributed.
VOLUME OF PRODUCT IN COMMERCE
29 units.
DISTRIBUTION
NC and Spain.
_________________________________
PRODUCT
Source Plasma. Recall # B-1631-3.
CODE
46-DCDJMC-A, 46-DCHMWG-A, 46-DCHMZF-A, 46-DCHNBX-A,
46-DCHNGD-A, 46-DCHNJR-A, 46-DCHNMC-A, 46-DCHNQW-A,
46-DCHNTS-A, 46-DCHNXJ-A, 46-DCHPCH-A, 46-DCHPZK-A,
46-DCHQCL-A, 46-DCHQKF-A, 46-DCHQNM-A, 460DCHQQD-A,
46-DCHQVB-A, 46-DCHQZQ-A, 46-DCHRHF-A, 46-DCHRLK-A,
46-DCHSGH-A, 46-DCHSJM-A.
RECALLING FIRM/MANUFACTURER
Aventis Bio Services, Decatur, IL, by facsimile dated February 19 and March 7, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had his tongue pierced within the previous twelve months, were distributed.
VOLUME OF PRODUCT IN COMMERCE
22 units.
DISTRIBUTION
IL.
_______________________________
PRODUCT
Red Blood Cells Leukocytes Removed. Recall # B-1636-3.
CODE
Unit 2913844.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on July 17, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor whose hemoglobin was not documented on the donor’s record, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1637-3;
b) Liquid Plasma. Recall # B-1638-3.
CODE
a) Units 34018260, 32014628, and 34029922;
b) Units 34018260, 31022777, 32014628, and 34029922.
RECALLING FIRM/MANUFACTURER
W.E. and Lela Stewart Blood Center, Inc., Tyler, TX, by letter dated November 7, 2000. Firm initiated recall is complete.
REASON
Problem: Blood products, which were collected from a donor who was previously deferred for testing positive for the antibody to the human immunodeficiency virus (anti-HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units.
DISTRIBUTION
TX, FL, NJ, and Switzerland.
_______________________________
PRODUCT
Source Plasma. Recall # B-1656-3.
CODE
Unit number 02DTXB4954.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Denton, TX, by facsimile on August 22, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose medical history screening did not include questioning regarding risk factors for new variant Creutzfeldt-Jacob disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.
_______________________________
PRODUCT
Source Plasma. Recall # B-1657-3.
CODE
Unit numbers 02DTXA6835, 02DTXA7584, 02DTXA7808, 02DTXA8569, and 02DTXA8921.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Denton, TX, by facsimile on June 13, 2002. Firm initiated recall is complete.
REASON
Blood products tested negative for viral markers but were collected from an ineligible donor due to a sign or symptom of infection with human immunodeficiency virus (HIV).
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
MI.
_______________________________
PRODUCT
a) Platelets. Recall # B-1672-3;
b) Platelets, Leukocytes Reduced. Recall # B-1673-3;
c) Cryoprecipitated AHF. Recall # B-1674-3;
d) Fresh Frozen Plasma. Recall # B-1675-3;
e) Plasma. Recall # B-1676-3;
f) Plasma, Cryoprecipitate Reduced. Recall # B-1677-3;
CODE
a) Unit numbers 042FY95394, 042S63578, 042FW55290,
042FW55665, 042FG64632, 042T74613, 042Y97505,
042FY00188, 042FJ76799, 042K11492, 042FZ93471,
042T85923, 042FS58257, 042FR82077, 042FH92891,
042X24066, 042X25869, 042FT93444, 042T90219,
042FY14832, 042FX04567, 042FW75935, 042FH92877,
042FT88198, 042FE49600, 042T83167, 042Q64573,
042FX91758, 042FW78418, 042FG74880, 042K16815,
042Q64570, 042FH92672, 042FW55687, 042FW65610,
042FW93102, 042FG84467, and 042T80921;
b) Unit numbers 042K25967, 042S90951, 042FX13949,
042FY17347, and 042H35485;
c) Unit number 042R60850;
d) Unit numbers 042FZ93471, 042T85923, 042FR82077,
042FH92891, 042FH92877, 042FG64632, 042FG74880,
042FW75935, 042FW65610, 042K16815, 042K25967,
042FX04567, 042J33454, 042T86586, 042X24066, 042FH92672,
042FW55290, 042FW55665, 042S63578, and 042X25869;
e) Unit numbers 042K24502, 042GE04830, 042FY40741,
042S94511, and 042GE04006;
f) Unit number 042R60850.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northern Ohio Region, Cleveland, OH, by telephone on April 3, 2003, and by letter on April 25, 2003. Firm initiated recall is complete.
REASON
Blood products, associated with units of Red Blood Cells that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 38 units;
b) 5 units;
c) 1 unit;
d) 20 units;
e) 5 units;
f) 1 unit.
DISTRIBUTION
OH, CA, MI, and GA.
_______________________________
PRODUCT
Source Plasma. Recall # B-1698-3.
CODE
Unit number BFFVXZ.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Fort Worth, TX, by facsimile on February 19, 2002. Firm initiated recall is complete.
REASON
Blood product, that tested initially reactive for hepatitis B surface antigen (HBsAg), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.
_______________________________
PRODUCT
Source Plasma. Recall # B-1699-3.
CODE
Unit number 02OOKA7764.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Oklahoma City, OK, by facsimile on June 3, 2002. 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
MI.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1700-3;
b) Platelets. Recall # B-1701-3.
CODE
a) Unit numbers 30GN65242 and 30GJ51928;
b) Unit number 30GJ51928.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northeastern Pennsylvania Region, Ashley, PA, by telephone on May 7, 2003, and by letters on May 8, 2003, and June 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
3 units.
DISTRIBUTION
PA.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes, Reduced. Recall # B-1709-3;
b) Recovered Plasma. Recall # B-1710-3.
CODE
a) Unit 004KW11639;
b) Units 004KW11639, 004KW07567.
RECALLING FIRM/MANUFACTURER
American Red Cross, New England Region, Dedham, MA, by letter dated April 8, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of having jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
MA.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes, Reduced. Recall # B-1711-3;
b) Fresh Frozen Plasma. Recall # B-1712-3;
c) Cryoprecipitated AHF. Recall # B-1713-3;
d) Recovered Plasma. Recall # B-1714-3.
CODE
a) Unit 27GM40196, 27GM30126;
b) Unit 27GM30126;
c) and d) Unit 27GM40196.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Johnstown, PA, by letter dated March 21, 2003 and April 23, 2003. Firm initiated recall is complete.
REASON
Blood products, which tested negative for hepatitis but were collected from a donor who subsequently tested positive for an unknown type of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
PA, and WV.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes, Reduced. Recall # B-1719-3;
b) Platelets. Recall # B-1720-3;
c) Recovered Plasma. Recall # B-1721-3.
CODE
a), b), and c) Unit number 53GL11404.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by letters on April 2, and 12, 2003. 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 based on the subsequent determination of a previous positive test for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
MD, CA, and Washington D.C.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1722-3;
b) Recovered Plasma. Recall # B-1723-3.
CODE
a) and b) Unit number 53FL01948.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by letters on April 1, 2003, and by facsimile on April 2, 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
2 units.
DISTRIBUTION
MD and CA.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1728-3;
b) Recovered Plasma. Recall # B-1729-3.
CODE
a) and b) Unit number KT07658.
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Blood Donor Services, Annandale, VA, by letter and facsimile on March 4, 2002. Firm initiated recall is complete.
REASON
Blood products collected from an unsuitable donor due to a history of residing in an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
VA and NJ.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1730-3;
b) Fresh Frozen Plasma. Recall # B-1731-3.
CODE
a) and b) Unit number FW10483.
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Blood Donor Services, Annandale, VA, by letter on February 25, 2001. Firm initiated recall is complete.
REASON
Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a history of jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MD and VA.
_______________________________
PRODUCT
Red Blood Cells Leukocytes Removed. Recall # B-1654-3.
CODE
Unit 2944840.
RECALLING FIRM/MANUFACTURER
Carter Blood Care, Bedford, TX, telephone on July 17, 2002. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who presented for donation with an elevated body temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1655-3.
CODE
Unit number 20J70492.
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Lewis and Clark Region, Boise, ID, by letter on April 16, 2003.
Manufacturer: The American National Red Cross, Salt Lake City, UT. Firm initiated recall is complete.
REASON
Blood product, that was found to be out of specification for red blood cell recovery, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
UT.
_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Removed. Recall # B-1667-3;
b) Platelets Leukocytes Removed. Recall # B-1668-3;
c) Fresh Frozen Plasma. Recall # B-1669-3.
CODE
a) b) and c) unit 936633.
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, OH, by letter dated May 5, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had a medical history of Herpes Simplex, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
OH and KY.
_______________________________
PRODUCT
Platelets. Recall # B-1670-3.
CODE
Unit 2956604.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated July 26, 2002. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which the question concerning having taken any medications of drugs was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
_______________________________
PRODUCT
Red Blood Cells Leukocytes Removed. Recall # B-1671-3.
CODE
Unit 29913165.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on July 11, 2002. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which there was no documented response to the question concerning having had a major illness or surgery within the past twelve months, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1678-3;
b) Platelets. Recall # B-1679-3;
c) Cryoprecipitated AHF. Recall # B-1680-3.
CODE
a) Units 4129089, 5613515, 6413969, 6624662, 5744240.
b) Unit 7551255;
c) Unit 2194972.
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone on either March 31, April 7, or April 21, 2003. Firm initiated recall is complete.
REASON
Blood products, lacking assurance of proper temperature storage during shipment, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units.
DISTRIBUTION
IL and WI.
_______________________________
PRODUCT
Source Plasma. Recall # B-1688-3.
CODE
Unit F-01321-036.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Alpha Therapeutic Corporation, Los Angeles, CA, by facsimile dated April 25, 2003.
Manufacturer: Alpha Therapeutic Corporation, Cincinnati, OH. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Red Blood Cells for Further Manufacturer into Non-Injectables. Recall # B-1689-3.
CODE
Unit JT52669.
RECALLING FIRM/MANUFACTURER
Interstate Blood Bank, Inc., Memphis, TN, by letter dated October 22, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1697-3.
CODE
Unit number 26115-4757.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fort Smith, AR, by telephone on May 13, 2003. Firm initiated recall is complete.
REASON
Blood product, incorrectly tested for cytomegalovirus (CMV), but labeled CMV negative, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AR.
_______________________________
PRODUCT
Platelets. Recall # B-1705-3.
CODE
Unit number R49589.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter on March 21, 2003. Firm initiated recall is complete.
REASON
Blood product, manufactured from a unit of Whole Blood that had a discrepant collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1716-3;
b) Recovered Plasma. Recall # B-1717-3.
CODE
a) and b) Unit 182313956.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on May 12, 2003.
Manufacturer: Blood Systems, Inc., Cheyenne, WY. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had an elevated body temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
WY.
_______________________________
PRODUCT
Source Plasma. Recall # B-1718-3.
CODE
Unit number FJMVLS.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Roanoke, VA, by letter on March 26, 2003. Firm initialed recall is complete.
REASON
Blood product, collected from a donor that did not answer medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.
_______________________________
PRODUCT
Easy Access PACS System with software. Recall # Z-471-3.
CODE
Software Release 5, 6.2, or 7.2.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Bothell, WA, by letter on February 13, 2002. Firm initiated recall is complete.
REASON
Potential display of an incorrect body part description on patient images.
VOLUME OF PRODUCT IN COMMERCE
46 units.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Datex-Ohmeda S/5 Anesthesia Delivery Units. Recall # Z-937-3.
CODE
Serial numbers: 40022312, 40022313, 40027688, 40032184, 40032233, 4002321, 40032330, 40032546, 40036365, 40043483, 40043493 through 40043495, 40043497, 40054495, 40065046, 40065073, 40065818, 40067311, 40067345, 40080026, 40080031, 40080032, 40080035 through 40080037, 40080039, 40080041, 40080042, 40080056, 40080063, 40080064, 40080070, 40080073, 40082935, 40082937 through 40082941, 40082975, 40082979, 40082980, 40082981, 40082986 through 40082989, 40083005, 40083008 through 40083028, 40084505, 40084508, 40084509, 40084512, 40084523, 40084524, 40084535 through 40084538, 40085637, 40085638, 40085642 through 40085644, 40085656, 40085666, 40085681, 40085683 through 40085698, 40085700, 40085702 through 40085707, 40085710 through 40085712, 40085723, 40085734 through 40085736, 40086464, 40088538, 40088544 through 40088548, 40088550 through 40088553, 40088574, 40088585, 40088586, 40089324 through 40089328, 40089333 through 40089340, 40089342 through 40089350, 40089359 through 40089363, 40089398, 40089402, 40089420, 40089421, 40092286, 40092287, 40092290, 40092291, 40092368 through 40092372, 40094139, 40094140, 40094142 through 40094149, 40095400 through 40095433, 40097292 through 40097298, 40097314 through 40097319, 40097321, 40098708, 40098711, 40098714, 40098716 through 40098719, 40098725 through 40098738, 40098751 through 40098754, 40100505 through 40100510, 40102542, 40102543, 40103791, 40103792, 40103796, 40103809, 40103810, 40103817, 40103820, 40103821, 40104726, 40104728, 40104733 through 40104747, 40105932, 40105933, 40105944 through 40105946, 40105952 through 40105954, 40106542 through 40106547, 40106549, 40106551, 40106552, 40106568 through 40106585, 40107959, 40107963, 40107964, 40107976 through 40107985, 40107990 through 40107996, 40107998, 40108817, 40108821, 40108832 through 40108846, 40108848 through 40108850, 40108853, 40109523 through 40109525, 40109531, 40109532, 40109534 through 40109544, 40109546, 40109550, 40110654 through 40110673, 40110684 through 40110688, 40110700, 40110702, 40110703, 40111775 through 40111783, 40111791 through 40111795, 40111804, 40111807 through 40111809, 40112657, 40112659 through 40112661, 40113737, 40113747 through 40113749, 40113755, 40113761, 40113762, 40113767, 40113768, 40113770 through 40113774, 40114922 through 40114928, 40114931 through 40114933, 40115990 through 40116023, 40117237 through 40117244, 40118114 through 40118116, 40118125, 40119844, 40119864, 40119867 through 40119873, 40120169 through 40120178, 40120182, 40120183, 40120908 through 40120917, 40120920, 40120924, 40120929, 40120930, 40120932, 40122181, 40122187, 40122189, 40122627, and 40132124
RECALLING FIRM/MANUFACTURER
Datex-Ohmeda, Inc., Madison, WI, by letters dated July 15, 2003. Firm initiated recall is ongoing.
REASON
Possible disruption of mechanical ventilation or disruption of anesthetic agent delivery.
VOLUME OF PRODUCT IN COMMERCE
544 units.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
BiodivYsio? SV Over The Wire (OTW) Coronary Stent, 2.25 mm diameter; a) Catalog # B3225-10; b) Catalog # B3225-10;
c) Catalog # B3225-15; d) Catalog # B3225-18. Recall # Z-1141-03.
CODE
a) Lot # 010586G; b) Lot # 030176G; c) Lot # 010626G; d) Lot # 020246G.
RECALLING FIRM/MANUFACTURER
Abbott Vascular Devices, Redwood City, CA, by letters on July 21, 2003. Firm initiated recall is complete.
REASON
The medical device is misbranded in that the compliance chart of the Stent diameter may allow overexpansion that may result in vessel damage.
VOLUME OF PRODUCT IN COMMERCE
74 units.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
CryoValve Heart-valve, allograft. Recall # Z-1187-03.
CODE
Donor #60741, Model #SGAV10, Serial #783013.
RECALLING FIRM/MANUFACTURER
Cryolife, Inc., Kennesaw, GA, by telephone on February 4, 2002. Firm initiated recall is complete.
REASON
Donor of aortic valve had procurement cultures that were positive for E-coli.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_______________________________
PRODUCT
CryoValve Heart Valve. Recall # Z-1188-03.
CODE
Donors processed prior to 1/26/1998.
RECALLING FIRM/MANUFACTURER
Cryolife, Inc., Kennesaw, GA, by letter starting April, 2003. Firm initiated recall is ongoing.
REASON
CryoLife initiated a retrospective review per FDA request, to insure that current regulatory guidelines for donor blood testing have been met for certain donors.
VOLUME OF PRODUCT IN COMMERCE
325 units.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
Boston Scientific Medi-Tech Imager II 5F Selective Angiographic Catheter. Recall # Z-1189-03.
CODE
Lot 24495.
RECALLING FIRM/MANUFACTURER
Boston Scientific Scimed, Maple Grove, MN, by letter dated August 1, 2003. Firm initiated recall is ongoing.
REASON
Some of the recalled catheters may be in pouches with incomplete seals.
VOLUME OF PRODUCT IN COMMERCE
160 catheters (32 boxes of 5 each).
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
a) Sarns brand Retrograde Cardioplegia Cannula, 17 Fr,
steerable stylet, ribbed balloon, manual-inflate.
Catalog # 4428. Recall # Z-1190-03;
b) Sarns brand Retrograde Cardioplegia Cannula, 17 Fr,
malleable stylet, ribbed balloon, manual-inflate.
Catalog # 4430. Recall # Z-1191-03;
c) Sarns brand Retrograde Cardioplegia Cannula, 13 Fr,
steerable stylet, ribbed balloon, manual-inflate.
Catalog # 5578. Recall # Z-1192-03;
d) Sarns brand Retrograde Cardioplegia Cannula, 13 Fr,
malleable stylet, ribbed balloon, manual-inflate.
Catalog # 5579. Recall # Z-1193-03;
e) Sarns brand Retrograde Cardioplegia Cannula, 15 Fr,
guidewire stylet, smooth balloon, manual-inflate.
Catalog # 7270. Recall # Z-1194-03;
Sarns brand Retrograde Cardioplegia Cannula, 15 Fr,
guidewire stylet, ribbed balloon, manual-inflate.
Catalog # 7272. Recall # Z-1195-03.
CODE
a) Lots 1200590 and 1200600;
b) Lots 1200570, 1200580 and 1203920;
c) Lot 1197400;
d) Lots 1203930 and 1203940;
e) Lots 1200560, 1205410, 1205420 and 1209760;
f) Lot 1207930.
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems, Corp, Ann Arbor, MI, by letters on August 8, 2003. Firm initiated recall is ongoing.
REASON
Product is labeled as sterile, but inadequate package seal results in lack of assurance of sterility.
VOLUME OF PRODUCT IN COMMERCE
1,441.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
a) Angiotensin I (1251) Radioimmunoassay Kit, 250 Tube,
Catalog Number: NEA104 For in-vitro diagnostic use.
Recall # Z-1206-03;
b) Angiotensin I (1251) Radioimmunoassay Kit, 500 Tube,
Catalog Number: NEA105, For in-vitro diagnostic use.
Recall # Z-1207-03.
CODE
a) Lot 181269, Expiration 8/27/03;
b) Lot 181611, Expiration 8/27/03.
RECALLING FIRM/MANUFACTURER
Perkinelmer Life Sciences, Inc., Boston, MA, by telephone on July 23, 2003 and by letter dated July 25, 2003. Firm initiated recall is ongoing.
REASON
Incorrect calibration standard value may result in 25% higher assay values for controls and patient samples.
VOLUME OF PRODUCT IN COMMERCE
77 kits.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
Harvard 2, Dual Infusion Pump (P/N 2002-001). Recall # Z-1208-03.
CODE
Software versions V1.2R or earlier.
RECALLING FIRM/MANUFACTURER
Harvard Clinical Technology, South Natick, MA, by letter on August 11, 2003. Firm initiated recall is ongoing.
REASON
Under specific sequence conditions, the unit may appear to be infusing, but is not.
VOLUME OF PRODUCT IN COMMERCE
384 units.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Triton T-700 Traction Unit. Model/Catalogue Nos: 7950 (120 Volt) and 7952 (220 Volt). Recall # Z-1210-03.
CODE
Serial Numbers 6211-6230, 1907 and 1920.
RECALLING FIRM/MANUFACTURER
Chattanooga, Corp, Hixson, TN, by telephone on May 30, 2003. Firm initiated recall is ongoing.
REASON
Product contains an improper bracket for the transducer.
VOLUME OF PRODUCT IN COMMERCE
18 units.
DISTRIBUTION
IL, CA, TX, OH, FL, LA, WA, NC and DC.
_______________________________
PRODUCT
Misys Laboratory System. Recall # Z-1217-03.
CODE
Version 5.2 through 5.3.2 using LabAccess Results.
RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Tucson, AZ, by fax on July 22, 2003. Firm initiated recall is ongoing.
REASON
Software design deficiency. If the dilution factor is added to the same result twice, incorrect specimen values are reported.
VOLUME OF PRODUCT IN COMMERCE
171.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
AxSYM Homocysteine Reagent Pack, list 5F51-20. Recall # Z-1218-03.
CODE
Lots 01724M300, 03314HN00, 03533HN00.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL, by letters dated August 22,
2003. Firm initiated recall is ongoing.
REASON
There is a kit-to-kit difference within the lots, with the reagents generating different polarization values than those in others.
VOLUME OF PRODUCT IN COMMERCE
3,505 kits.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
Calculator/Data Processing Module for Clinical Use. Recall # Z-1220-03.
CODE
Version 3.x.
RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Tucson, AZ by facsimile on July 24, 2003. Firm initiated recall is ongoing.
REASON
Software Design Defect. Under certain conditions, results are removed.
VOLUME OF PRODUCT IN COMMERCE
47.
DISTRIBUTION
Nationwide.
END OF ENFORCEMENT REPORT FOR SEPTEMBER 17, 2003
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