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U.S. Department of Health and Human Services

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Enforcement Report for April 14, 2004

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.


April 14, 2004
04-15

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

_______________________________
PRODUCT
Deli Chef brand Sour Cream and Cheese Macaroni Salad, in 10
lb. tubs. **Keep Refrigerated** Net. Wt. 10 lb. (4.53 kg).
Recall # F-179-4.
CODE
Best If Used By: DEC 01 03; LINE NO. 1141.
RECALLING FIRM/MANUFACTURER
Kroger Co., Cincinnati, OH, by e-mail and fax on December 3, 2003. FDA initiated recall is complete.
REASON
The product is contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
274/10 lb. tubs.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Great Value Chocolate Chip Cookies, spoonable cookie dough, refrigerated, packaged I 18-oz. packages. Recall # F-180-4.
CODE
All use-before expiration dates through 04JAN04.
RECALLING FIRM/MANUFACTURER
Earthgrains Refrigerated Dough Products L.P., St. Louis, MO, by telephone on September 17, 2003. Firm initiated recall is complete.
REASON
The product contains undeclared milk fat.
VOLUME OF PRODUCT IN COMMERCE
67,657/12/18-oz. pkg. Cases.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Asian Boy (EBQ) brand Dried Ginger, 5.25 oz package and
7 oz. plastic tub. Recall # F-181-4.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
B.C.N. Trading, Inc., Brooklyn, NY, by letters on December 8, 2003. Florida State initiated recall is ongoing.
REASON
Product contains undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
15,650 - 5.25 oz; 11,328 7 oz.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Peregrina Cheese brand Queso Fresco Fresh Cheese, Wt. 14 oz. Recall # F-182-4.
CODE
Dairy sticker code 1635, barcode # 17424 00024, Plant ID # 36-8431.
RECALLING FIRM/MANUFACTURER
Peregrina Cheese Company, Brooklyn, NY, by press release on February 5, 2004 and letter and visit on February 6 and 7, 2004. FDA initiated recall is complete.
REASON
The product is contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
250 - 14 oz. units.
DISTRIBUTION
NY and NJ.

_______________________________
PRODUCT
Haitai brand Harmon's Cheese Cookies, net wt. 2.89 oz, cardboard box. Recall # F-183-4.
CODE
The product is not labeled with lot number or use by date.
RECALLING FIRM/MANUFACTURER
Rhee Brothers Inc., Columbia, MD, by press release on March 1, 2004 and by letter on March 13, 2004. New York State initiated recall is ongoing.
REASON
Imported cookies contain undeclared peanuts and almonds.
VOLUME OF PRODUCT IN COMMERCE
6,528 boxes.
DISTRIBUTION
The product was distributed directly to small Asian retail markets in states east of the Mississippi River.
 

 RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

_______________________________
PRODUCT
Perphenazine Tablets, USP, 2mg, 100 count bottles and 500
count bottles, Rx only. Recall # D-107-4.
CODE
Lot Numbers/Expiration Dates: 076092A (10/2004);
076092B (10/2004).
RECALLING FIRM/MANUFACTURER
Vintage Pharmaceuticals, Inc., Charlotte, NC, by letter on December 18, 2003. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products.
VOLUME OF PRODUCT IN COMMERCE
1.699 bottles/100 ct bottles & 144/500 ct bottles.
DISTRIBUTION
Nationwide.
 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
Platelets. Recall # B-0934-4.
CODE
Unit numbers: 4134780, 4134779.
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH, by letters, dated December 9, and 10, 2003. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
OH.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Removed. Recall # B-1017-4;
b) Recovered Plasma. Recall # B-1018-4.
CODE
a) and b) Unit number: 016LV92622.
RECALLING FIRM/MANUFACTURER
American Red Cross, Central Ohio Region, Columbus, OH, by letter or facsimile on July 1, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who engaged in multiple high-risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
OH, and Switzerland.

_______________________________
PRODUCT
a) Red Blood Cells, Leukoreduced. Recall # B-1020-4;
b) Red Blood Cells, Leukoreduced, Irradiated.
Recall # B-1021-4.
CODE
a) Units: 18FZ28725, 18FT62487, 18FT62488, 18FT62490,
18FT62491, 18FT62492, 18FT62493, 18FT62495, 18FT62496,
18FZ29590, 18FK68995, 18FK65999, 18FZ29819, 18FQ81594,
18FS66708, 18FK70692, 18FX45416, 18FW39480, 18FQ72701,
18FJ47664, 18FT54553, 18FW27872, 18FW27962, 18FJ48517,
18GK19660, 18FV37093, 18FQ75310, 18FQ75313, 18FQ75314,
18FQ75316, 18FQ75318, 18FQ75322, 18GK20411, 18FW31111,
18GH83541, 18GH83548, 18FT59186, 18FZ27447, 18FW33281;
b) Unit: 18GK20405.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Great Lakes Region, Lansing, MI, by letters dated February 5, 2003, and April 21, 2003. Firm initiated recall is complete.
REASON
Blood products, manufactured from units of whole blood more than eight hours after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
40 units.
DISTRIBUTION
KY, MA, and MI.
_____________________________
PRODUCT
Red Blood Cells, Leukoreduced. Recall # B-1022-4.
CODE
Unit 18233-6552.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Cheyenne, WY, by telephone and email on January 9, 2004 and January 13, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WY, and Switzerland.
_____________________________
PRODUCT
Red Blood Cells, Leukoreduced. Recall # B-1024-4.
CODE
Unit 18233-6347.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Cheyenne, WY, by letter and email on January 30, 2004 and February 20, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX, and Switzerland.

________________________________
PRODUCT
a) Red Blood Cells. Recall # B-1032-4;
b) Red Blood Cells, Leukoreduced. Recall # B-1033-4;
c) Platelets. Recall # B-1034-4;
d) Platelet pheresis. Recall # B-1035-4.
CODE
a) Units: 71J506154, 71J511312, 71J598241;
b) Unit: 71J630847;
c) Units: 71J549479, 71J863981;
d) Unit: 71W537185.
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc., Gainesville, FL, by telephone and letter dated November 11, 2003 and December 31, 2003. Firm initiated recall is complete.
REASON
Blood Products, incorrectly tested for Cytomegalovirus (CMV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units.
DISTRIBUTION
FL, and AL.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-1037-4.
CODE
Unit number 7515187.
RECALLING FIRM/MANUFACTURER
Manatee Community Blood Center, Bradenton, FL, by facsimile on May 10, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1038-4.
CODE
Unit number 7422790.
RECALLING FIRM/MANUFACTURER
Manatee Community Blood Center, Bradenton, FL, by facsimile on January 2, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to recent ingestion of an aspirin-like medication, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NY.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-1042-4.
CODE
Unit number 2051501.
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by telephone on October 31, 2003. Firm initiated recall is complete.
REASON
Blood product, in which the corresponding Platelets were contaminated with gram positive cocci, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.

_______________________________
PRODUCT
Source Plasma. Recall # B-1046-4.
CODE
Units 40224572, 42758600, 42570141, 42210269, 42202998, 42200666, 28695417, 41140154, 41137185, 41130520, 40744438, and 40741635.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Medford, OR, by facsimile on March 11, 2002. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had received a tongue piercing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1047-4.
CODE
Unit 71W469448.
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Center, Gainesville, FL, by facsimile on August 6, 2003. Firm initiated recall is complete.
REASON
Blood product, which yielded a platelet count that was below the acceptable limit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.

_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced. Recall # B-1048-4;
b) Platelets. Recall # B-1049-4.
CODE
a) Units 01Q63783, 01KM16426, and 01KF64192;
b) Units 01Q63783 and 01KF64192.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, West Henrietta, NY, by facsimile on March 18, 2003. 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
5 units
DISTRIBUTION
NY.

_______________________________
PRODUCT
a) Cryoprecipitate. Recall # B-1050-4;
b) Cryoprecipitate Poor Plasma. Recall # B-1051-4.
CODE
a) and b) Unit 2113269.
RECALLING FIRM/MANUFACTURER
Blood Bank of Delaware, Inc., Newark, DE, by telephone on October 17, 2003. Firm initiated recall is complete.
REASON
Blood products, in which the corresponding Red Blood Cells were contaminated with Staphylococcus warneri, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
DE.

_______________________________
PRODUCT
Platelets. Recall # B-1054-4.
CODE
Unit number 2043850.
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by letter on January 28, 2004. 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
KY.

_______________________________
PRODUCT
Platelets. Recall # B-1055-4.
CODE
Unit numbers 027FY09588, 027GM86068, 027GM86110, 027GX70520, 027GX70530, and 027LE58857.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Alleghenies Region, Johnston, PA, by telephone and letter on October 24, 2003. Firm initiated recall is complete.
REASON
Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
PA, VA, and MD.

_______________________________
PRODUCT
Platelets. Recall # B-1056-4.
CODE
Unit number 2021266.
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by letter on November 12, 2003. Firm initiated recall is complete.
REASON
Blood product, associated with a unit of Red Blood Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.

_______________________________
PRODUCT
Cryoprecipitated AHF. Recall # B-1057-4.
CODE
Unit number 6713531.
RECALLING FIRM/MANUFACTURER
LifeShare, Inc., Elyria, OH, by letter on December 29, 2003. Firm initiated recall is complete.
REASON
Blood product, associated with a unit of Red Blood Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH.

_______________________________
PRODUCT
a) Platelets. Recall # B-1058-4;
b) Fresh Frozen Plasma. Recall # B-1059-4.
CODE
a) and b) Unit number 6004190.
RECALLING FIRM/MANUFACTURER
LifeShare, Inc., Elyria, OH, by letter on January 5, 2004. Firm initiated recall is complete.
REASON
Blood product, associated with a unit of Red Blood Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
OH.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1060-4.
CODE
Units 113383935-split.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Dba United Blood Services, El Paso, TX, by telephone on August 26, 2003. Firm initiated recall is complete.
REASON
Blood products, which tested reactive for West Nile Virus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.

_______________________________
PRODUCT
Source Plasma. Recall # B-1062-4.
CODE
Unit numbers: 6270188720, 6270189490, 6270189982, 6270190563, 6270191344, 6270191916, 6270192819, 6270193746, 6270194787, 6270195004, 6270195674, 6270195833, 6270196213, 6270196564, 6270196755, 6270197152, 6270197869, 6270198059, and 6270197682.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., South Salt Lake City, UT, by facsimile on March 11, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor previously deferred due to history of IV drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
19 units.
DISTRIBUTION
NC.

_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-1063-4.
CODE
Unit 027LX15465.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Alleghenies Region, Johnstown, PA, by letter on October 26, 2003 and November 11, 2003. Firm initiated recall is complete.
REASON
Blood Product, corresponding to a unit of clotted Red Blood Cells, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 units.
DISTRIBUTION
WV.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1064-4.
CODE
Unit number 8105856.
RECALLING FIRM/MANUFACTURER
LifeShare, Inc., Elyria, OH, by letter on December 16, 2003. Firm initiated recall is complete.
REASON
Blood product, that was labeled leukoreduced but was not tested to determine the white blood cell count as required in the firm's standard operating procedures, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1066-4.
CODE
Unit numbers 16LL71985, 16LL72015, 16LL72053, and 16LL72098.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Central Ohio Region, Columbus, OH, by letter on December 22, 2003. Firm initiated recall is complete.
REASON
Blood products that failed to meet the minimum specification for product volume were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
OH.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1067-4;
b) Platelets, Leukocytes Reduced. Recall # B-1068-4;
c) Platelets, Leukocytes Reduced Pooled. Recall # B-1069-4; d) Fresh Frozen Plasma. Recall # B-1070-4;
e) Recovered Plasma. Recall # B-1071-4.
CODE
a) Unit numbers 0855626 and 0902160;
b) Unit number 0902160;
c) Pool number 0082103 (contained recalled unit 0855626);
d) Unit number 0855626;
e) Unit number 0902160;
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, OH, by letters on June 23, 2003, and January 8, 2004. Firm initiated recall is complete.
REASON
Blood products tested negative for viral markers but were collected from an ineligible donor due to a risk factor for increased incidence of infection with human immunodeficiency virus (HIV).
VOLUME OF PRODUCT IN COMMERCE
5 units; 1 pool.
DISTRIBUTION
OH, FL, and KY.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1072-4;
b) Red Blood Cells, Leukocytes Reduced, Irradiated.
Recall # B-1073-4.
CODE
a) Units 21GL83284, 21GL83290, 21GL83297, 21GL83383,
21GL83384, 21GL83386, 21GL83395, 21GL83405, 21GL83406,
21GL83412, 21GL83422, 21GL83429, 21GL83437, 21GL83314,
21GL83321, 21GL83371;
b) Unit 21GL83441.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Portland, OR, by telephone on December 6, 2002, and by letter dated December 17, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from donors with unacceptable hematocrit determinations, were distributed.
VOLUME OF PRODUCT IN COMMERCE
17 units.
DISTRIBUTION
OR, and WA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Removed, Irradiated.
Recall # B-1074-4.
CODE
Unit number 03GJ77150.
RECALLING FIRM/MANUFACTURER
American Red Cross, Southern Region, Atlanta, GA, by letter, dated April 15, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
GA.

_______________________________
PRODUCT
Platelets. Recall # B-1076-4.
CODE
Unit number: FC85274.
RECALLING FIRM/MANUFACTURER
Aurora Area Blood Bank, dba Heartland Blood Centers, Aurora, IL, by telephone on February 2, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1078-4.
CODE
Unit J62755.
RECALLING FIRM/MANUFACTURER
Regional Health Resource Center, Urbana, IL, by telephone on February 6, 2004, and by letter dated March 2, 2004. 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
IL.

_______________________________
PRODUCT
Cryoprecipitated AHF. Recall # B-1080-4.
CODE
Unit 9886242.
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on January 15, 2003. Firm initiated recall is complete.
REASON
Blood product, prepared from an overweight whole blood unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
LA.

_______________________________
PRODUCT
Source Plasma. Recall # B-1083-4.
CODE
Unit numbers: 6270207536, 6270207883, 6270208488, 6270210516, 6270211055, 6270211303, 6270211869, 6270212054, 6270212567, 6270212828, 6270213312, 6270213728, 6270214898, 6270215188, 6270216468, 6270216635, 6270217118, 6270217364, 6270217873, 6270218557, 6270218775, 6270229926, 6270231539, 6270233320, 6270238665, 6270239485, 6270239774, 6270240463, 6270241136, 6270270238, 6270273298, 6270275601, and 6270275940.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., South Salt Lake City, UT, by facsimile on October 8, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on previous deferral for IV drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
33 units.
DISTRIBUTION
NC.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1084-4;
b) Red Blood Cells, Leukocytes Reduced (Apheresis).
Recall # B-1085-4;
c) Cryoprecipitated AHF. Recall # B-1086-4.
CODE
a), and c), Unit 128001716;
b) Units 128017934 - split.
RECALLING FIRM/MANUFACTURER

Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter dated February 26, 2004.
Manufacturing Firm: Blood Systems, Inc., Albuquerque, NM. Firm initiated recall is complete.
REASON
Blood products, collected from donors who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
AZ, NM, and Switzerland.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1089-4;
b) Fresh Frozen Plasma. Recall # B-1090-4;
c) Recovered Plasma. Recall # B-1091-4.
CODE
a) Units FC40960, F40388, and C87387;
b) Unit F40388;
c) Units FC40960 and C87387.
RECALLING FIRM/MANUFACTURER
Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL, by telephone or facsimile on December 18, 2003 and by letters dated December 19-24, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was born or emigrated from an area with increased risk of human immunodeficiency virus (HIV) Group O, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
IL, and Switzerland.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-1102-4.
CODE
Unit numbers 7260190 and 7261377.
RECALLING FIRM/MANUFACTURER
Department of the Air Force, 375th Medical Group, Scott AFB, IL, by facsimile on October 28, 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
NJ and Bahrain.

_______________________________
PRODUCT
a) Fresh Frozen Plasma. Recall # B-1108-4;
b) Recovered Plasma. Recall # B-1109-4.
CODE
a) Unit number 02LC21122;
b) Unit number 02LC25121.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Central Plains Region, Wichita, KS, by telephone and facsimile on June 12 and 13, 2003. Firm initiated recall is complete.
REASON
Blood products collected from an unsuitable donor due to a history of travel to an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
KS and CA.
 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0653-4.
CODE
Unit number: 71H809942.
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Northeast Georgia Region, Gainesville, GA, by facsimile on May 28, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with a low body temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
GA.

_______________________________
PRODUCT
Plasma. Recall # B-0654-4.
CODE
Unit 03E38023.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern Region, Atlanta, GA, by telephone on April 24, 2003 and by letter dated April 29, 2003. Firm initiated recall is complete.
REASON
Blood product, manufactured from a whole blood unit with an extended collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
GA.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0657-4;
b) Cryoprecipitated AHF. Recall # B-0658-4.
CODE
a) Unit numbers: 3452513, 3452516, 3452518, 3452519,
3452520, 3452521, 3452522, 3452523, 3452524, 3452525,
3452526, 3452527, 3452528, 3452529, 3452530, 3452531,
and 3452532;
b) Unit numbers: 3452519, 3452521, 3452523, 3452526, and
3452528.
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSource, Glenview, IL, by telephone on September 19, 2003.
Manufacturing Firm: LifeSource Gurnee Donor Center, Gurnee, IL. Firm initiated recall is complete.
REASON
Blood products, manufactured from Whole Blood units that were stored at an incorrect temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE
22 units.
DISTRIBUTION
IL, IN, and WI.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-1016-4.
CODE
Units 12LJ37351, 12LJ37353, 12LJ37355, 12LJ37356, 12LJ37363.
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross, Carolinas Blood Services Region, Charlotte, NC, by telephone on July 5, 2000.
Manufacturing Firm: American Red Cross, Asheville Center, Asheville, NC. Firm initiated recall is complete.
REASON
Blood products, prepared from whole blood units that were stored at unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
NC.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-1023-4.
CODE
Unit 18233-6552.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Cheyenne, WY, by telephone and email on January 9, 2004 and January 13, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WY, and Switzerland.
_____________________________
PRODUCT
Recovered Plasma. Recall # B-1025-4.
CODE
Unit 18233-6347.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Cheyenne, WY, by letter and email on January 30, 2004 and February 20, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX, and Switzerland.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-1036-4.
CODE
Unit 20LF46601.
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Lewis and Clark Region, Boise, ID, by facsimile on November 2, 2001.
Responsible Firm: The American National Red Cross, Idaho Falls, ID. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Switzerland.

_______________________________
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced.
Recall # B-1039-4;
b) Platelets Irradiated. Recall # B-1040-4;
c) Fresh Frozen Plasma. Recall # B-1041-4.
CODE
a) Unit numbers 027GF14514, 027GF14516, 027GF14518,
027GF14674, 027GF14675, 027GF14677, 027GF14678,
027GF14772, 027GF14774, 027GF14928, 027GF14930,
027GF14932, 027GF15215, 027P62332, 027P62338, 027P62355,
027P62364, 027P62371, 027P62378, 027P62382, 027P62419,
027P62434, 027P62440, 027P62442, 027P62460, 027P62462,
027P62467, 027P62473, 027P62477, 027P62486, 027P62489,
027P62506, 027P62510, 027P62524, 027P62529, 027P62531,
027P62535, 027P62537, 027P62573, 027P62575, 027P62578,
027P62586, 027P62602, 027P62609, 027P62642, 027P62656,
027P62659, 027P62667, 027P62696, 027P62706, 027P62721,
027P62727, 027P62730, 027P62767, 027P62781, 027P62786,
027P62790, 027P62797, 027P62807, 027P62810, 027P62812,
027P62824, 027P62855, 027P62858, 027P62874, 027P62879,
027P62885, 027P62892, 027P62899, 027P62911, 027P62927,
027P62968, 027P62971, 027P62987, 027P62988, 027P62992,
027P62999, 027P63043, 027P63047, 027P63063, 027P63066,
027P63069, 027P63071, 027P63076, 027P63085, 027P63088,
027P63099, 027P63107, 027P63113, 027P63145, 027P63176,
027P63181, 027P63184, 027P63206, 027P63231, 027P63242,
027P63245, 027P63250, 027P63262, 027P63281, 027P63290,
027P63292, 027P63301, 027P63304, 027P63310, 027P63316,
027P63364, 027P63368, 027P63371, 027P63375, 027P63390,
027P63462, 027P63467, 027P63475, 027P63490, 027P63509,
027P63515, 027P63542, 027P63570, 027P63577, 027P63586,
027P63590, 027P63593, 027P63597, 027P63651, 027P63662,
027P63666, 027P63672, 027P63674, 027P63676, 027P63699,
027P63710, 027P63713, 027P63719, 027P63754, 027P63849,
027P63853, 027P63890, 027P63897, 027P63901, 027P63906,
027P63940, 027P63942, 027P63946, 027P63949, 027P63958,
027P63996, 027P64002, 027P64005, 027P64016, 027P64017,
027P64027, 027P64031, 027P64044, 027P64045, 027P64063,
027P64066, 027P64070, 027P64074, 027P64075, 027P64087,
027P64090, 027P64092, 027P64095, 027P64128, 027P64141,
027P64143, 027P64148, 027P64153, 027P64160, 027P64173,
027P64176, 027P64179, 027P64186, 027P64194, 027P64208,
027P64215, 027P64218, 027P64234, 027P64240, 027P64260,
027P64263, 027P64290, 027P64292, 027P64297, 027P64301,
027P64307, 027P64309, 027P64313, 027P64327, 027P64357,
027P64363, 027P64373, 027P64376, 027P64383, 027P64402,
027P64405, 027P64410, 027P64415, 027P64419, 027P64421,
027P64549, 027P64553, 027P64556, 027P64559, 027P64578,
027P64580, 027P64588, 027P64590, 027P64629, 027P64634,
027P64640, 027P64669, 027P64673, 027P64691, 027P64692,
027P64695, 027P64698, 027P64701, 027P64721, 027P64728,
027P64732, 027P64733, 027P64738, 027P64745, 027P64771,
027P64774, 027P64779, 027P64781, 027P64785, 027P64788,
027P64804, 027P64808, 027P64813, 027P64825, 027P64826,
027P64832, 027P64834, 027P64841, 027P64844, 027P64853,
027P64875, 027P65129, 027P65132, 027P65143, 027P65145,
027P65150, 027P65157, 027P65195, 027P65198, 027P65200,
027P65204, 027P65209, 027P65228, 027P65230, 027P65234,
027P65239, 027P65247, 027P65254, 027P65257, 027P65265,
027P65267, 027P65276, 027P65278, 027P65353, 027P65356,
027P65358, 027P65364, 027P65380, 027P65386, 027P65390,
027P65394, 027P65404, 027P65408, 027P65423, 027P65438,
027P65450, 027P65453, 027P65458, 027P65460, 027P65462,
027P65477, 027P65480, 027P65482, 027P65493, 027P65498,
027P65544, 027P65547, 027P65553, 027P65563, 027P65566,
027P65569, 027P65578, 027P65590, 027P65591, 027P65597,
027P65634, 027P65636, 027P65658, 027P65665, 027P65668,
027P65699, and 027P65704;
b) Unit numbers 027GF15213, 027GF15217, 027P62332,
027P62343, 027P62368, 027P62416, 027P62434, 027P62451,
027P62477, 027P62600, 027P62685, 027P62713, 027P62885,
027P62890, 027P62896, 027P62899, 027P62922, 027P62930,
027P62984, 027P63146, 027P63155, 027P63198, 027P63232,
027P63240, 027P63258, 027P63284, 027P63299, 027P63308,
027P63395, 027P63402, 027P63480, 027P63482, 027P63503,
027P63658, 027P63728, 027P63729, 027P63751, 027P63853,
027P63894, 027P63897, 027P63901, 027P63946, 027P63964,
027P64003, 027P64023, 027P64031, 027P64045, 027P64095,
027P64125, 027P64143, 027P64171, 027P64179, 027P64181,
027P64208, 027P64211, 027P64258, 027P64332, 027P64357,
027P64402, 027P64421, 027P64559, 027P64561, 027P64665,
027P64745, 027P64849, 027P65155, 027P65209, 027P65239,
027P65245, 027P65420, 027P65438, 027P65442, 027P65465,
027P65502, 027P65571, 027P65626, and 027P65708;
c) Unit numbers 027P62346, 027P62368, 027P62386, 027P62416,
027P62467, 027P62489, 027P62505, 027P62506, 027P62510,
027P62524, 027P62529, 027P62531, 027P62575, 027P62578,
027P62667, 027P62696, 027P62685, 027P62706, 027P62713,
027P62727, 027P62771, 027P62781, 027P62786, 027P62802,
027P62851, 027P62858, 027P62874, 027P62892, 027P62917,
027P62922, 027P62930, 027P62938, 027P62971, 027P62984,
027P62987, 027P62988, 027P63069, 027P63155, 027P63198,
027P63204, 027P63240, 027P63242, 027P63250, 027P63262,
027P63299, 027P63301, 027P63304, 027P63308, 027P63316,
027P63318, 027P63368, 027P63390, 027P63458, 027P63462,
027P63480, 027P63495, 027P63503, 027P63509, 027P63515,
027P63570, 027P63577, 027P63586, 027P63593, 027P63597,
027P63651, 027P63662, 027P63666, 027P63672, 027P63676,
027P63710, 027P63713, 027P63723, 027P63729, 027P64003,
027P64005, 027P64070, 027P64075, 027P64074, 027P64092,
027P64121, 027P64125, 027P64153, 027P64168, 027P64181,
027P64215, 027P64218, 027P64234, 027P64240, 027P64258,
027P64263, 027P64290, 027P64297, 027P64307, 027P64313,
027P64363, 027P64415, 027P64419, 027P64561, 027P64575,
027P64580, 027P64582, 027P64629, 027P64634, 027P64640,
027P64669, 027P64698, 027P64701, 027P64733, 027P64738,
027P64781, 027P64804, 027P64825, 027P64834, 027P64844,
027P64849, 027P65155, 027P65204, 027P65225, 027P65228,
027P65254, 027P65356, 027P65420, 027P65442, 027P65458,
027P65482, 027P65626, 027P65668, and 027P65704.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Alleghenies Region, Johnstown, PA, by letters on October 23 and 24, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose medical history screening may have been inadequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
508 units.
DISTRIBUTION
PA, WV, KY, OH, VA, and MD.

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1043-4;
Platelets. Recall #B-1044-4;
Recovered Plasma. Recall B-1045-4.
CODE
a), b), and c) Unit 027GX68385.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Johnstown, PA, by telephone on September 2, 2003, and by letter dated September 5, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
PA, and CA.

_______________________________
PRODUCT
Red Blood Cells, Irradiated. Recall # B-1053-4.
CODE
Unit number: FC45529.
RECALLING FIRM/MANUFACTURER
Aurora Area Blood Bank, dba Heartland Blood Centers, Aurora, IL, by telephone on January 14, 2004. Firm initiated recall is complete.
REASON
Blood product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.

_______________________________
PRODUCT
Red Blood Cells, Autologous. Recall # B-1061-4.
CODE
Unit G87260.
RECALLING FIRM/MANUFACTURER
Rock River Valley Blood Center, Rockford, IL, by telephone on January 26, 2004, and by facsimile dated February 3, 2004. Firm initiated recall is complete.
REASON
Autologous Red Cells, lacking a "Biohazard" label, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-1065-4.
CODE
Unit number 6805285.
RECALLING FIRM/MANUFACTURER
LifeShare, Inc., Elyria, OH, by letter on January 5, 2004. Firm initiated recall is complete.
REASON
Blood product, that did not have the additive solution included, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Removed. Recall # B-1077-4.
CODE
Unit numbers: 9382437, 9402866, 9365241, 9381985, 9407028, and 9394406.
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by facsimile on November 8, 2002 and by letter, dated November 19, 2002. Firm initiated recall is complete.
REASON
Blood products, that remained at room temperature for 35 minutes during leukodepletion, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
MS.

_______________________________
PRODUCT
Plasma, Frozen. Recall # B-1081-4.
CODE
Unit numbers: 20FM25160, 20GS20633, 20FM25129, 20FM25144, 20FM25149, 20FM25152, 20FM25161, 20FZ19619, 20FM25137, 20FM25142, 20FM25153, 20FC21529, 20FC21537, 20FC21549, 20FC21553, 20FC21554, 20FC21557, 20FC21559, 20FC21586, 20FM25154, 20GH18513, 20GH18518, 20GS20628, 20GS20640, 20GY12767, 20GY12771, 20GY12772, 20FC21593, 20FC21595, 20FC21598, 20FM21601, 20FC21605, 20FC21607, 20FC21610, 20FC21611, 20FC21618, 20FM25121, 20FM25126, 20FM25133, 20FM25143, and 20FM25148.
RECALLING FIRM/MANUFACTURER
American Red Cross, Lewis and Clark Region, Boise, ID, by telephone on November 8, 2002, and by letter, dated December 2, 2002. Firm initiated recall is complete.
REASON
Blood products, that lacked assurance of proper storage temperatures due to inaccurate documentation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
41 units.
DISTRIBUTION
MT.

_______________________________
PRODUCT
Source Plasma. Recall # B-1082-4.
CODE
Unit 80FRFXMFA.
RECALLING FIRM/MANUFACTURER
International BioResources, LLC, Rockford, IL, by facsimile on September 9, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which there was no documentation on the donor record of an arm inspection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-1087-4.
CODE
Unit 128001716.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter dated February 26, 2004.
Manufacturing Firm: Blood Systems, Inc., Albuquerque, NM. Firm initiated recall is complete.
REASON
Blood products, collected from donors who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AZ, NM, and Switzerland.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1103-4;
b) Fresh Frozen Plasma. Recall # B-1104-3.
CODE
a) and b) Unit number 23148-2926.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Billings, MT., by telephone on May 28, 2003, and by letter on June 23, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to a history of a human tissue transplant, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MT.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1105-4.
CODE
Unit numbers 21FS29585, 21KK71157, 21KK71159, 21KK71187, 21KS15675, 21KS15683, 21GL90100, 21GL90104, 21GL90105, 21GL90106, 21KC68631, 21KK71166, 21KK71170, and 21KL62517.
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Pacific Northwest Region, Portland, OR, by telephone on January 10, 2003, and by letter on January 31, 2003.
Manufacturer: American Red Cross Blood Services, Yakima, WA. Firm initiated recall is complete.
REASON
Blood products possibly exposed to unacceptable shipping temperatures were distributed.
VOLUME OF PRODUCT IN COMMERCE
14 units.
DISTRIBUTION
WA.
 

 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
a) BD Test Strips. The US market BD Test Strips are
identified by Catalog Numbers 322027 (50 count BD Test
Strips Durable medical Equipment consignees), 322053 (50
Count BD Test Strips Trade consignees), and 322060 (10
Count BD Test Strips packaged within BGM kits). The
Canadian market BD Test Strips are identified by Catalog
Numbers 322002 (50 count BD Test Strips), 322003 (100
count BD Test strips), and 322009 (10 count BD Test
strips). Health Hazard Evaluation: There is negligible
medical risk to patients with diabetes using the BD
blood glucose systems due to the increase of E-3 error
messages. Recall # Z-0763-04;
b) The BD Blood Glucose Monitoring Systems identified as
the BD Latitude, and BD Logic. Becton Dickinson also
distributes the Paradigm Link Blood glucose Monitor
which is sold exclusively for Medtronic Mini Med. US
Market BD Blood Glucose Monitoring System kit catalog
Numbers: 322025 (BD Logic Blood Glucose Monitor Durable
Medical Equipment consignees); 322050 (BD Latitude
Diabetes Management System); 322051 (BD Logic Blood
Glucose Monitor); 32205175 ( BD Logic Blood Glucose
Monitor); 322200 (Paradigm Link Blood Glucose Monitor -
clear); 322201 ( Paradigm Link Blood Glucose Monitor -
smoke); 322202 (Paradigm Link Blood Glucose Monitor -
blue); 322203 (Paradigm Link Blood Glucose Monitor -
purple). Canadian market BD Blood Glucose Monitoring
System kit catalog numbers: 322000 (BD Latitude Diabetes
Management System); 322001 (BD Logic Blood Glucose
Monitor). Recall # Z-0764-04.
CODE
a) US Market Lot Numbers: 2064322; 2064333; 2071311;
2078294; 2099353; 2120336; 3057009; 3064013; 3064016;
3064018; 3064030; 3064037; 3064069; 3064076; 3064079;
3064083; 3064090; 3064104; 3064107; 3064112; 3064118;
3064121; 3064125; 3064132; 3064156; 3064167; 3064170;
3064174; 3064182; 3064188; 3064237; 3064245; 3064279;
3071009; 3071153; 3078041; 3078128; 3092028; 3106007.
Canadian Market Lot Numbers: 3064125; 3071153; 3064279;
3071009; 3071153; 3064156; 3064182; 3064188.
b) US Market BD Logic Lot Numbers: 2057320; 2057325;
2507327; 2057361; 2064338; 2064339; 2064341; 2071322;
2071351; 2078324; 2078326; 2078351; 2085324; 2085339;
2085351; 2085360; 2092322; 2092341; 2099322; 2099360;
2106325; 2113325; 3057022; 3057136; 3057147; 3064143;
3064147; 3064148; 3071015; 3071122; 3071125; 3071127;
3071170; 3078023; 3078037; 3078126; 3078135; 3078136;
3078141; 3078142; 3078174; 3085127; 3085139; 3085142;
3085149; 3085161; 3085174; 3092021; 3092122; 3092147;
3092174; 3092176; 3092177; 3099020; 3099147; 3099153;
3099171; 3099174; 3099176; 3099178; 3106147; 3106162;
3113141; 3120176; 3127176.
US Market BD Latitude Lot Numbers: 2057360; 2064360;
2071352; 2078352; 2078353; 2085353; 2092354; 2092360;
2099354; 2099357; 2106357; 2113357; 3057020; 3057021;
3057052; 3064021; 3064055; 3064056; 3064064; 3071021;
3071064; 3085090; 3092106; 3106022.
US Market Paradigm Link Blood Glucose Monitors Lot
Numbers (co-Branded BD Logic): 3057049; 3057051;
3057055; 3057056; 3057058; 3057063; 3057064; 3057070;
3057071; 3057073; 3057098; 3057115; 3057120; 3064045;
3064058; 3064059; 3064077; 3064091; 3064097; 3071049;
3071056; 3071072; 3071076; 3071078; 3071080; 3071090;
3071104; 3071112; 3071120; 3078044; 3078045; 3078051;
3078064; 3078069; 3078077; 3078090; 3078101; 3078106;
3085055; 3085056; 3085079; 3085092; 3085093; 3085105;
3085106; 3085108; 3092044; 3092069; 3092085; 3092101;
3092104; 3099055; 3099083; 3099101; 3099108; 3099125;
3106072; 3106078; 3106097; 3106100; 3106118; 3113042;
3113069; 3113107; 3120104; 3127055; 3127056; 3127059;
3127076; 3134090; 3134107; 3141069; 3141112; 3155100.
US Market Paradigm Link (clear) Lot Numbers: 3057199;
3064189; 3064246; 3071178; 3085198; 3085281; 3085282;
3092188; 3120177.
US Market Paradigm Link (smoke) Lot Numbers: 3057183;
3057184; 3057197; 3057198; 3057227; 3057241; 3064204;
3064255; 3064267; 3071196; 3071199; 3071203; 3071245;
3071255; 3078202; 3085184; 3085287; 3092287.
US Market Paradigm Link (Blue) Lot Numbers: 3057189;
3057195; 3057233; 3064196; 3064197; 3064262; 3071232;
3071289; 3078196; 3078294; 3085181; 3085188; 3085261;
3085293; 3113178; 3113182.
US Market Paradigm Link (purple) Lot Numbers: 3057188;
3057196; 3057280; 3064192; 3064195; 3071205; 3071279;
3078184; 3078204; 3078232.
Canadian BD Latitude Lot Numbers: 3057041; 3057042;
3057043.
Canadian BD Logic Lot Numbers: 3057203; 3057205;
3057224; 3057234; 3064199; 3064203; 3064205; 3064224;
3071202; 3071204; 3071237; 3078198; 3078199; 3078205;
3085202; 3099204; 3120198.
RECALLING FIRM/MANUFACTURER
Becton Dickinson & Company, Franklin Lakes, NJ, by letters dated January 29, 2004. Firm initiated recall is ongoing.
REASON
39 lots of BD Test strip may produce an increased frequency of E-3 messages when used during blood glucose testing.
VOLUME OF PRODUCT IN COMMERCE
a) 15,011,221;
b) 207,092.
DISTRIBUTION
Nationwide and Canada.

_______________________________
PRODUCT
QPC1680 Quick Connect, for Pentax 30/40/K Series Two-Channel GI Endoscopes, in the Steris System 1 Sterile Processing System with the C1160 Universal Flexible Processing Tray, Cat. No. QPT1680. Recall # Z-0765-04.
CODE
Lots #2925196, #2911782, #2925238.
RECALLING FIRM/MANUFACTURER
Steris Corp., Mentor, OH, by letter and in person beginning on March 18, 2004. Firm initiated recall is ongoing.
REASON
A defective port adapter may affect the sterilization process of the attached endoscope.
VOLUME OF PRODUCT IN COMMERCE
40 units.
DISTRIBUTION
Nationwide, Canada, Italy, and Germany.

_______________________________
PRODUCT
a) Zimmer brand Coonrad/Morrey total elbow interchangeable
ulnar assembly, small, left, 3 in. length, tivanium
TI-6AL-4V alloy/UHMWPE, sterile, for use with bone
cement. Cat. No. 32-8105-53-01. Recall # Z-0767-04;
b) Zimmer brand Coonrad/Morrey total elbow interchangeable
Ulnar assembly, small, right, 3 in. length, tivanium
TI-6AL-4V alloy/UHMWPE, sterile, for use with bone
cement. Cat. No. 32-8105-53-02. Recall # Z-0768-04.
CODE
a) Lot 60039452;
b) Lots 60039453, 60039454, 60040852 and 60041552.
RECALLING FIRM/MANUFACTURER
Zimmer, Inc., Warsaw, IN, by e-mail on March 16, 2004. Firm initiated recall is ongoing.
REASON
Right ulna implants were etched and labeled as left ulna implants. Left ulna implants may have been etched and labeled as right ulna implants.
VOLUME OF PRODUCT IN COMMERCE
49 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Clinical Chemistry Uric Acid; LN 7D76-20. Recall # Z-0769-04.
CODE
Lot number: 95015HW00.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories Diagnostic, Div., South Pasadena, CA, by letters on March 18, 2004. Firm initiated recall is ongoing.
REASON
Unacceptable upward drift of results in control runs within 24 hour period.
VOLUME OF PRODUCT IN COMMERCE
796 kits.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Giardia/Cryptosporidium Rapid In-vitro diagnostic Test
Kits. These are sold under two names as follows: Meridian
ImmunoCard Stat Cryptosporidium/Giardia Rapid Assay; Becton
Dickenson (BD) ColorPac Giardia/Cryptosporidium Rapid
Assay. Recall # Z-0770-04.
CODE
Lots 081077, 081093, 081138, 071093, 071138.
RECALLING FIRM/MANUFACTURER
Genzyme Diagnostics, San Diego, CA, by letters on March 2004. Firm initiated recall is ongoing.
REASON
False Positive results.
VOLUME OF PRODUCT IN COMMERCE
2,671 kits.
DISTRIBUTION
OH, and MD.

_______________________________
PRODUCT
Codman Holter Salmon Rickham Reservoir with Ventricular Catheter, Catalog Number: 82-1671. Recall # Z-0772-04.
CODE
Lot Number: 1106525.
RECALLING FIRM/MANUFACTURER
Codman & Shurtleff, Inc., Raynham, MA, by telephone on March 11, 2004. Firm initiated recall is complete.
REASON
Drainage tips absent from catheter tip.
VOLUME OF PRODUCT IN COMMERCE
39 units.
DISTRIBUTION
CA, GA, MI, NC, SC, TN, TX, Italy and Germany.

_______________________________
PRODUCT
Cryo Valve, Aortic Valve & Conduit. Donor #69588, Model #AVOO. Recall # Z-0776-04.
CODE
Serial #8069423.
RECALLING FIRM/MANUFACTURER
Cryolife, Inc, Kennesaw, GA, by telephone on February 20, 2004 and by letter on April 2, 2004. Firm initiated recall is ongoing.
REASON
Microorganisms were detected in donor tissue associated with this allograft, specifically Aeormonas hydrophila.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Biomet brand Absolute Bi-Polar Shoulder Shell 48 mm w/locking ring; part 113156. Recall # Z-0777-04.
CODE
Lot 551440.
RECALLING FIRM/MANUFACTURER
Biomet, Inc., Warsaw, IN, by letter dated February 23, 2004. Firm initiated recall is complete.
REASON
The locking ring was not included and the shoulder implanted without the locking ring.
VOLUME OF PRODUCT IN COMMERCE
6.
DISTRIBUTION
CA, FL, WA, Germany and Venezuela.

_______________________________
PRODUCT
a) NOW RSV Test. Item Number 430-430, Kit Number 430-00R.
Recall # Z-0778-04;
b) NOW Filariasis Rapid test for W. bancrofti antigen.
(Export use only) Item Number 620-430, Kit Number 620-
000. Recall # Z-0779-04;
c) NOW Malaria (Export use only) Item Number 660-430, Kit
Number 66005, Kit Number 660-000. Recall # Z-0780-04.
CODE
a) Lot Numbers 015168 and 015172;
b) Lot Number 015187;
c) Lot Numbers 015001 and 015002.
RECALLING FIRM/MANUFACTURER
Binax, Inc, Portland, OR, by telephone, e-mail and letter on February 18, 2004. Firm initiated recall is complete.
REASON
Pouch integrity compromised.
VOLUME OF PRODUCT IN COMMERCE
1575 kits.
DISTRIBUTION
KS and Internationally.

_______________________________
PRODUCT
Architect Ca 19-9 Reagent Kit, list 6C04-20 (1 x 100 tests) and 6C04-25 (4 x 100 tests). Recall # Z-0781-04.
CODE
Lot numbers 07747M100 and 07747M101.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL, by e-mail on March 23, 2004. Firm initiated recall is ongoing.
REASON
The reagent lots may produce patient results that are lower than expected when compared to other lots of in-date reagents.
VOLUME OF PRODUCT IN COMMERCE
1,987 kits.
DISTRIBUTION
Canada, Australia, Germany and Japan.

_______________________________
PRODUCT
AxSYM Troponin-I Reagent Kit, list 3C29-20, 100 test kit. Recall # Z-0782-04.
CODE
Lot numbers 10264M300, 10264M301, 10265M300, and 10265M301.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL, by telephone on March 26, 2004 and by letter dated March 25, 2004. Firm initiated recall is ongoing.
REASON
An increase in complaints of higher than normal patient results, some from the healthy population range to above the diagnostic cutoff for an Acute Myocardial Infarction.
VOLUME OF PRODUCT IN COMMERCE
7,394 kits.
DISTRIBUTION
Nationwide and Internationally.
 

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

_______________________________
PRODUCT
MicroSTAAR Injector w/Foam Tip Plunger, Model MSI-PF.
Recall # Z-0766-04.
CODE
Lot 11853090. Sterility Date: 11/18/2003. Expiration Date: 10/31/2006.
RECALLING FIRM/MANUFACTURER
Staar Surgical Co, Inc., Monrovia, CA, by visit beginning on February 23, 2004. Firm initiated recall is ongoing.
REASON
Injector mold design/manufacture and wear caused material flash to develop preventing assembly of the device prior to use.
VOLUME OF PRODUCT IN COMMERCE
690 injectors.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Coag-A-Mate( MTX and MTX II Instrument Operator Manual. Recall # Z-0771-04.
CODE
All Codes.
RECALLING FIRM/MANUFACTURER
Biomerieux, Inc., Durham, NC, by letter on September 29, 2003. Firm initiated recall is ongoing.
REASON
Typographical error in the Operator Manual. In Chapter 11 of the MTX/MTX II Operator Manual, the numerical range for the Warning Flag is shown as 00-99. The correct numerical range is 0-99. The "list of error and warning" chart shows a numerical range representing the codes 00-9. The correct numerical range for the first ten error/warning codes are 0-9.
VOLUME OF PRODUCT IN COMMERCE
Unknown.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Pathromtin SL. Partial Thromboplastin Time Tests. The product is sold in kits containing 10 and 20 vials. Recall # Z-0773-04.
CODE
Lot numbers 523785, 523785A, 523785B, and 523787.
RECALLING FIRM/MANUFACTURER
Dade Behring, Inc., Newark, NJ, by letters dated March 4, 2004. Firm initiated recall is ongoing.
REASON
Cloudy appearance or precipitate.
VOLUME OF PRODUCT IN COMMERCE
77,886 vials.
DISTRIBUTION
PA, and Internationally.

_______________________________
PRODUCT
a) Cryo Valve, Pulmonary Valve & Conduit. Donor # 69091,
Model # PVOO. Recall # Z-0774-04;
b) Cryo Valve, Aortic Valve & Conduit. Donor # 69091,
Model # AVOO. Recall # Z-0775-04.
CODE
a) Serial # 8009917;
b) Serial # 8009937.
RECALLING FIRM/MANUFACTURER
Cryolife, Inc., Kennesaw, GA, by letter on March 24, 2004. Firm initiated recall is ongoing.
REASON
The donor of the tissue had a viral syndrome at the time of death.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CT, and PA.
 

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II

______________________________
PRODUCT
Custom dairy cattle feed made for two customers. Recall # V-123-4.
CODE
None.
RECALLING FIRM/MANUFACTURER
Maribel Grain Co., Maribel, WI, by visit on February 25, 2004. Firm initiated recall is complete.
REASON
Possible cross contamination of cattle feed by steamed bone meal which is prohibited material.
VOLUME OF PRODUCT IN COMMERCE
2,040 pounds.
DISTRIBUTION
WI.
______________________________
PRODUCT
Suppressor( brand Flunixin Meglumine Injection 50 mg/mL in 100mL & 250mL bottles for animal use only. Recall # V-125-4.
CODE
All codes (NADA # 200-124).
RECALLING FIRM/MANUFACTURER
Walco International, Inc., Ceres, CA, by letters on March 16, 2004 and March 17, 2004. FDA initiated recall is ongoing.
REASON
The animal drug product is mistakenly labeled with route of administration as "IM or IV," it is for IV use only and is likely to cause violative residues if used as IM.
VOLUME OF PRODUCT IN COMMERCE
Bottles are labeled at sale (upon filling client's order).
DISTRIBUTION
CA.

_______________________________
PRODUCT
B & G Seed Co., PIG GROWER, 50 lbs. Recall # V-126-4.
CODE
All.
RECALLING FIRM/MANUFACTURER
B & G Seed Company, Inc., Hull, GA, by telephone on March 30, 2004. Firm initiated recall is ongoing.
REASON
Feed contains meat & bone meal (prohibited material), without the mandatory ruminant warning on the label.
VOLUME OF PRODUCT IN COMMERCE
25/50 lb. bags.
DISTRIBUTION
GA.

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS III

______________________________
PRODUCT
Dexium (Dexamethasone) Tablets. Recall # V-124-4.
CODE
Lot 2206004.
RECALLING FIRM/MANUFACTURER
Bimeda, Inc., Le Sueur, MN, by letter on February 24, 2004. Firm initiated recall is ongoing.
REASON
Failure to meet USP dissolution requirements during product stability testing.
VOLUME OF PRODUCT IN COMMERCE
606 bottles, 1000 tablets/bottle.
DISTRIBUTION
Nationwide.

END OF ENFORCEMENT REPORT FOR APRIL 14, 2004

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