FDA

Enforcement Report

July 2, 2003
03-27

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

______________________________
PRODUCT
Mimi Conf. Brand Peanut Biscuits, Net Wt. 11.62 oz., packaged in a flexible plastic bag containing 15 individual biscuits. Product of Korea. Barcode # 803444 509824. Recall # F-403-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Han Sung SikPoom Trading Co., Inc., Ridgewood, NY, by a "Food Allergy Alert" on July 29, 2002, and letters on July 30, 2002.
Manufacturer: Mammos Confectionary Co., Ltd., Sungnam-City, Kyungki-do. State initiated recall is complete.
REASON
NYSDAM's analysis revealed the presence of undeclared egg in the product.
VOLUME OF PRODUCT IN COMMERCE
39 cases (15 packages per case).
DISTRIBUTION
NY, PA, NJ, MD, and VA.

______________________________
PRODUCT
Renaissance Bread Co. brand Hearth Baked Apple Harvest Bread, Net Wt. 24 oz. Barcode # 60219 30507.
Recall # F-404-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Renaissance Bakery, Inc., Corona, NY, by press release on May 22, 2002. FDA initiated recall is complete.
REASON
Product contains undeclared walnuts.
VOLUME OF PRODUCT IN COMMERCE
Approximately 15 packages.
DISTRIBUTION
NY.

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II

______________________________
PRODUCT
Kimbo Dried Noodle, Chinese Style, in cardboard cases, each containing 8 boxes of product. Each of the 8 boxes is wrapped in plastic. Labeled as distributed by: Dawa Marketing, Inc., Buena Park, CA. Recall # F-406-3.
CODE
All codes of item #s: 602522 and 602523.
RECALLING FIRM/MANUFACTURER
Diamond Team International, Inc., Hayward, CA, by letters on May 12, 2003. FDA initiated recall is ongoing.
REASON
Product contains undeclared colors - FD&C Yellow # 5, FD&C Yellow # 6, and FD&C Red # 40.
VOLUME OF PRODUCT IN COMMERCE
881 cases.
DISTRIBUTION
CA, WA, NV, and AZ.

______________________________
PRODUCT
a) Chunkie Face Paints 4-Pack packed in four plastic
squeezable tube applicator bottles with a cap
and a soft brush tip and four different colored tubes
(white, red, yellow and blue). Recall # F-407-3;
b) Chunkie Face Paints 4-Pack packed in four plastic
squeezable tube applicator bottles with a cap
and a soft brush tip and four different colored tubes
(white, red, black and green). Recall # F-408-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Publix Super Markets, Lakeland, FL,
by e-mail on February 19, 2003.
Manufacturer: Bluepath Industries, LTD, Edmonton, Alberta, Canada. FDA initiated recall is ongoing.
REASON
Both products contain D&C Red No. 7, a color that was not approved for use as a cosmetic in close proximity of the eye as shown in the vignette.
VOLUME OF PRODUCT IN COMMERCE
360 cases/6 per case.
DISTRIBUTION
FL.

______________________________
PRODUCT
a) Key Lime Creams, Net Weight 5 lbs. in bulk boxes.
Recall # F-410-3;
b) Lemon Creams, Net Weight 5 lbs. in bulk boxes.
Recall # F-411-3;
c) Irish Almonds, Net Weight 20 lbs. in bulk boxes.
Recall # F-412-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
South Bend Chocolate Co., South Bend, IN, by letters from March 3, 2003 through March 5, 2003. FDA initiated recall is ongoing.
REASON
a) Undeclared colors, FD&C Yellow #5 and FD&C Blue #1;
b) Undeclared colors, FD&C Yellow #5 and FD&C Yellow #6;
c) Undeclared colors, FD&C Yellow lake #5 and FD&C Blue
lake #1.
VOLUME OF PRODUCT IN COMMERCE
a) 225 lbs.;
b) 50 lbs.;
c) 80 boxes.
DISTRIBUTION
IL, IN, MI, and OH.

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III

______________________________
PRODUCT
Dark Raspberry Creams, Net Weight 5 lbs. In bulk boxes. Recall # F-409-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
South Bend Chocolate Co., South Bend, IN, by letters from March 3, 2003 through March 5, 2003. FDA initiated recall is ongoing.
REASON
The product contains undeclared colors, FD&C Red #40 and FD&C Blue #1.
VOLUME OF PRODUCT IN COMMERCE
300 lbs.
DISTRIBUTION
IL, IN, MI, and OH.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

______________________________
PRODUCT
a) Whole Blood. Recall # B-1096-3;
b) Red Blood Cells. Recall # B-1097-3;
c) Red Blood Cells, Leukocytes Reduced. Recall # B-1098-3;
d) Fresh Frozen Plasma. Recall # B-1099-3.
CODE
a) 12J034329, 12J03430;
b) 12J03431, 12J03429;
c) 12R29793, 12FF22814, 12FF22807, 12Z45886, 12V36196,
12V36187, 12K79908, 12K79899, 12K79851, 12H59516,
12H59507;
d) 12FF22811, 12FF22808, 12Z45888, 12FF22821, 12FF22845,
12FF22842, 12FF22830, 12FF22825, 12FF22824, 12FF22822,
12FF22819, 12FF22815, 12FF22809, 12FF22806, 12Z45905,
12Z45904, 12Z45903, 12Z45900, 12Z45899, 12Z45898,
12Z45897, 12Z45891, 12Z45890, 12Z45887, 12V36195,
12H59550, 12G5948, 12H59547, 12H59542, 12H54541,
12H59539, 12H59530, 12H59224, 12H59522, 12H59520,
12H59510, 12H59508, 12H59504.
RECALLING FIRM/MANUFACTURER
American Red Cross, Carolinas Blood Services Region, Charlotte, NC, by letter dated January 3, 2003. Firm initiated recall is ongoing.
REASON
Blood products, incorrectly tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 2 units;
b) 2 units;
c) 11 units;
d) 38 units.
DISTRIBUTION
NC, and SC.

______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1148-3;
b) Red Blood Cells, Leukocytes Reduced. Recall # B-1149-3.
CODE
a) Unit number 1329-8160;
b) Unit numbers 11328-8639, 11329-1497, 11329-9750,
11329-3011, 11332-2407, 11331-8358, 11330-4162.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., El Paso, IX, by letter dated July 31, 2002. Firm initiated recall is complete.
REASON
Blood products, with incomplete compatibility testing performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units.
DISTRIBUTION
TX.

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1178-3;
b) Platelets. Recall # B-1179-3.
CODE
a) and b) Unit number 4301146.
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by telephone, and by letter dated February 3, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor based on living in an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.

______________________________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced. Recall # B-1182-3.
CODE
Unit number LL76561.
RECALLING FIRM/MANUFACTURER
Blood Bank of the Redwoods, Santa Rosa, CA, by letter dated January 22, 2001. Firm initiated recall is complete.
REASON
Blood products, which were labeled as leukoreduced, but did not meet the requirements for a leukoreduced product, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
AZ.

______________________________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced. Recall # B-1183-3.
CODE
Unit number 4419947.
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by telephone on December 13, 2002. Firm initiated recall is complete.
REASON
Blood product, which tested negative for the antibody to the human T-lymphotropic virus type I/II, but was collected from a donor who on two occasions previously tested repeatedly reactive for anti-HTLV-I/II, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.

______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1184-3;
b) Recovered Plasma. Recall # B-1185-3.
CODE
a) and b) Unit number KC38318.
RECALLING FIRM/MANUFACTURER
Blood Bank of the Redwoods, Santa Rosa, CA, by letter dated June 1, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of IV drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.

______________________________
PRODUCT
Source Plasma. Recall # B-1186-3.
CODE
Unit numbers 59383727, 59218739, 59216537, 59211846, 59211006, 57864334, 57862231, 57747002, 57745404, 57630281, 57628400, 57623221, 56818826, 56816020, 56266993, 56263411, 56148855, 56143928, 56023237, 56021318.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Service, Richmond, VA, by facsimile dated August 29, 2001. Firm initiated recall is complete.
REASON
Blood products, which test reactive for syphilis, or were collected from a donor who previously tested reactive for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
20 units.
DISTRIBUTION
CA.

______________________________
PRODUCT
Source Plasma. Recall # B-1191-3.
CODE
59-FVCJRD-O, 59-FVCJVG-O, 59-FVCKCX-O, 59-FVCKJG-O,
59-FVCKMN-O, 59-FVCKTB-O, 59-FVCKYT-O, 59-FVCLBY-O,
59-FVCLHY-O, 59-FVCLKW-O, 59-FVCMYB-O, 59-FVCNCF-O,
59-FVCNGP-O, 59-FVCLPX-O, 59-FVCLSC-O, 59-FVCLWD-O.
RECALLING FIRM/MANUFACTURER
Aventis BioServices, Inc., dba Seramed BioServices, Champaign, IL, by facsimile dated November 14, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units.
DISTRIBUTION
IL.

______________________________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced. Recall # B-1198-3.
CODE
Unit number 4321553.
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by telephone, and by facsimile dated September 3, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose body temperature was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NY.

______________________________
PRODUCT
Source Plasma. Recall # B-1209-3.
CODE
HW043730, HW042443, HW042042, HW041484, HW041093, HW040557, HW040197, HW038667, HW037026, HW036468, HW036095, HW035413, HW035022.
RECALLING FIRM/MANUFACTURER
Bio Life Plasma Services, Huntington, WV, by facsimile dated January 28, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose eligibility to donate was not adequately verified, were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units.
DISTRIBUTION
NC.

______________________________
PRODUCT
Platelets. Recall # B-1210-3.
CODE
Unit number 4188244.
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by telephone on December 21, 2001, and by letter dated December 21, 2001. Firm initiated recall is complete.
REASON
Blood product, corresponding to a unit of clotted Red Blood Cells, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1211-3;
b) Fresh Frozen Plasma. Recall # B-1212-3.
CODE
a) 27LG53894, 27LG53896, 27LG53892, 27LG53950, 27LG53922,
27LG53890;
b) 27LG53894.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Johnstown, PA, by telephone on October 14, 2002. Firm initiated recall is complete.
REASON
Blood products, corresponding to Platelets that tested positive for Staphylococcus epidermidis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units.
DISTRIBUTION
MD, and PA.

______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1213-3;
b) Recovered Plasma. Recall # B-1214-3.
CODE
a) and b) Unit numbers 1922377, 2977052.
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Inc., Indianapolis, IN, by letter dated February 26, 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
4 units.
DISTRIBUTION
IN, and Switzerland.

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1215-3;
b) Platelets. Recall # B-1216-3;
c) Fresh Frozen Plasma. Recall # B-1217-3.
CODE
a), b) and c) Unit number 4024858.
RECALLING FIRM/MANUFACTURER
Gulf Cost Regional Blood Center, Houston, TX, by telephone, and by facsimile dated January 9, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of having tested positive for hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
TX, and NJ.

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1218-3.
CODE
Unit numbers 27GS57799, 27GS57796, 27GS57795, 27GS51187, 27LM15741.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Johnstown, PA, by telephone on August 6, 2002. Firm initiated recall is complete.
REASON
Blood products, in which the corresponding platelets were contaminated with Staphylococcus epidermidis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
MD, and PA.

______________________________
PRODUCT
Red Blood Cells, Leukoreduced. Recall # B-1233-3.
CODE
Unit number 163563648.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Meridian, MS, by telephone on June 14, 2002, and by letter dated June 19, 2002. Firm initiated recall is complete.
REASON
Blood product, which was stored at unacceptable temperatures, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MS.

______________________________
PRODUCT
Platelet, Pheresis, Leukoreduced (Split).
Recall # B-1235-3.
CODE
Unit number 163562619.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Meridian, MS, by telephone on April 19, 2002. Firm initiated recall is complete.
REASON
Blood product, which had a high platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MS.

______________________________
PRODUCT
Platelet, Pheresis, Leukoreduced, Irradiated.
Recall # B-1236-3.
CODE
Unit number 163650773.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Meridian, MS, by letter dated May 8, 2002. Firm initiated recall is complete.
REASON
Blood product, which were labeled as leukoreduced, but that failed the quality control specification for white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MS.

______________________________
PRODUCT
Platelets. Recall # B-1237-3.
CODE
Unit number 163631724.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Meridian, MS, by telephone on March 28, 2002, and by letter dated April 23, 2002. Firm initiated recall is complete.
REASON
Blood product, corresponding to a unit that was observed to have clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MS.

______________________________
PRODUCT
Platelet, Pheresis, Leukoreduced. Recall # B-1238-3.
CODE
Unit number 163643817.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Meridian, MS, by telephone on February 7, 2002, and by letter dated March 5, 2002. Firm initiated recall is complete.
REASON
Blood product, which had a high platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MS.

______________________________
PRODUCT
Recovered Plasma. Recall # B-1239-3.
CODE
Unit number 163643156.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Meridian, MS, by facsimile on February 27, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose health history screening was not adequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Switzerland.

______________________________
PRODUCT
Red Blood Cells, Leukoreduced. Recall # B-1240-3.
CODE
Unit number 182306224.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Cheyenne, WY, by letter dated March 26, 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
TX.

______________________________
PRODUCT
Red Blood Cells, Leukoreduced. Recall # B-1242-3.
CODE
Unit number 127939517.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Albuquerque, NM, by letter dated March 19, 2003. Firm initiated recall is ongoing.
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
New Mexico.

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1255-3;
b) Platelets, Pheresis. Recall # B-1256-3;
c) Fresh Frozen Plasma. Recall # B-1257-3;
d) Plasma. Recall # B-1258-3.
CODE
a) Unit numbers 035J70375, 035J70378, 035J70383, 035L37117,
035L37118, 035S10888, 035S10892, 035S10893, 035S10932,
035S10939, 035S10953, 035S10961;
b) Unit numbers 035P39423, 035P39425, and the following
split units: 035P39419, 035P39424, 035P39431;
c) Unit number 035P39424;
d) Unit number 035J70377.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Roanoke, VA, by telephone on December 2, and 6, 2002, and by letter dated December 17, 2002. Firm initiated recall is complete.
REASON
Blood products, incorrectly tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
22 units.
DISTRIBUTION
NJ, PA, MD, VA, and WV.

______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1259-3;
b) Red Blood Cells, Leukocytes Reduced. Recall # B-1260-3;
c) Platelets. Recall # B-1261-3;
d) Fresh Frozen Plasma. Recall # B-1262-3;
e) Plasma. Recall # B-1263-3;
f) Recovered Plasma. Recall # B-1264-3.
CODE
a) Unit numbers 04KS06250, 04KS03106, 04KS50502, 04KS33175;
b) Unit numbers 04KS66640, 04KS63318, 04KK28274;
c) Unit number 04KS33175;
d) Unit number 04KS33175;
e) Unit number 34KS03106;
f) Unit numbers 04KS06250, 04KS50502, 04KS63318, 04KK28274.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Dedham, MA, by letters dated December 2, and December 20, 2002. Firm initiated recall is complete.
REASON
Blood products, that tested negative for antibodies to human immunodeficiency virus (anti-HIV-1/2), but were collected from a donor that was subsequently determined to have a previous reactive test for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
14 units.
DISTRIBUTION
CA, NH, MA, ME, NY, and VT.

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1267-3.
CODE
Unit numbers 16362-9702 (distributed as two split products), 16362-9712, and 16362-9721.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on July 2, 2002, and by letter on July 11, 2002.
Manufacturer: Blood Systems, Inc., Meridian, MS. Firm initiated recall is complete.
REASON
Blood products, that were collected during a period of apheresis machine validation but were not properly quality control tested, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
MS.

______________________________
PRODUCT
Source Plasma. Recall # B-1268-3.
CODE
Unit numbers G-94520-070, G-94235-070, G-93908-070,
G-93531-070, G-93254-070, G-92882-070, G-92625-070,
G-92252-070, G-86580-070, G-86157-070, G-86011-070,
G-85597-070, G-85416-070, G-84772-070, G-84343-070,
G-84175-070, G-83751-070, G-83598-070, G-83228-070,
G-83058-070, G-82398-070, G-81953-070, G-81776-070,
G-80592-070, G-80151-070, G-79833-070, G-79475-070,
G-79114-070, G-78812-070, G-78112-070, G-72032-070,
G-71719-070, G-71374-070, G-70999-070, N-92780-070, and
N-92738-070.
RECALLING FIRM/MANUFACTURER
By facsimile on February 20 and 21, 2002. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to previous reactive viral marker testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
36 units.
DISTRIBUTION
CA, Spain, and Switzerland.

______________________________
PRODUCT
Source Plasma. Recall # B-1274-3.
CODE
Unit numbers 70488791, 70485578, and 70484274.
RECALLING FIRM/MANUFACTURER
Nabi, Scranton, PA, by letter on August 12, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for new variant Creutzfeldt-Jacob disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
CA.

______________________________
PRODUCT
Source Plasma. Recall # B-1275-3.
CODE
Unit numbers 0090631358 and 0090631136.
RECALLING FIRM/MANUFACTURER
Nabi, Scranton, PA, by letter on August 12, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for new variant Creutzfeldt-Jacob disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
Korea.

______________________________
PRODUCT
Source Plasma. Recall # B-1276-3.
CODE
Unit numbers 0090629821, 0090630179, 0090630321, 0090630570, and 0090631118.
RECALLING FIRM/MANUFACTURER
Nabi, Scranton, PA, by letter on August 12, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for new variant Creutzfeldt-Jacob disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
Korea.

______________________________
PRODUCT
Source Plasma. Recall # B-1277-3.
CODE
Unit numbers 0090631490, 0090631155, 0090631049, 0090630721, 0090630276, 0090630156, and 0090629787.
RECALLING FIRM/MANUFACTURER
Nabi, Scranton, PA, by letter on August 12, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for new variant Creutzfeldt-Jacob disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units.
DISTRIBUTION
Korea.

______________________________
PRODUCT
Source Plasma. Recall # B-1278-3.
CODE
Unit numbers 0090631384 and 0090631224.
RECALLING FIRM/MANUFACTURER
Nabi, Scranton, PA, by letter on August 12, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for new variant Creutzfeldt-Jacob disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
Korea.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

______________________________
PRODUCT
Source Plasma. Recall # B-1199-3.
CODE
Unit number 26-BLQNMR-A.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Rock Island, IL, by facsimile dated January 1, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with an elevated temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.

______________________________
PRODUCT
Red Blood Cells, Leukoreduced. Recall # B-1234-3.
CODE
Unit number 163591629.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Meridian, MS, by telephone on June 14, 2002, and by letter dated June 19, 2002. Firm initiated recall is complete.
REASON
Blood product, which was determined to have a high hematocrit value, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MS.

______________________________
PRODUCT
Red Blood Cells, Leukoreduced (Split). Recall # B-1241-3.
CODE
Unit number 182307460.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Cheyenne, WY, by telephone on March 4, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking the drug Cephalexin, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
WY.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

______________________________
PRODUCT
OmniDiagnost x-ray systems. Recall # Z-0874-03.
CODE
All OmniDiagnost x-ray systems.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Bothell, WA, by letter beginning June 12, 2003. Corrections are expected to be completed by the end of October 2003. Firm initiated recall is ongoing.
REASON
The units do not provide the source to image receptor distance (SID) on the beam limiting device.
VOLUME OF PRODUCT IN COMMERCE
Approximately 42 units.
DISTRIBUTION
Nationwide.

______________________________
PRODUCT
Rational Imaging TM Software, model Ultra 10 PACS System. Recall # Z-0905-03.
CODE
RIUpdate 7.1.OK.
RECALLING FIRM/MANUFACTURER
Canon USA, Inc., Irvine, CA, by letters on March 11, and March 26, 2003. Firm initiated recall is ongoing.
REASON
Imaging archive system software mismatches images and patient names.
VOLUME OF PRODUCT IN COMMERCE
34.
DISTRIBUTION
IA, CA, AR, WA, and OR.

______________________________
PRODUCT
ATF 40 Fast Start Kit - contains one each AT1 Autotransfusion Set, ATS Suction Line, and the ATR 40 Autotransfusion Reservoir. The component that is the subject of the recall is the AT1 Autotransfusion Set. Recall # Z-0906-03.
CODE
ATF 40 Fast Start Kit - Catalog no. 9108491, batch no. NKT257 AT1: Catalog no. 9005101, lot no. NHT272.
RECALLING FIRM/MANUFACTURER
Fresenius Hemocare, Inc., Redmond, WA, by telephone on January 21, and January 23, 2003, and by letter on January 21, 2003. Firm initiated recall is complete.
REASON
Sterility may be compromised.
VOLUME OF PRODUCT IN COMMERCE
1,264.
DISTRIBUTION
Nationwide.

______________________________
PRODUCT
TransFx Pin, External Fixation Pin. 3.0/4.0mm x 80mm, 20mm thread. Recall # Z-0907-03.
CODE
Catalog No./Part No./Ref. No. 00-4453-34-08.
Lot Number: 70209800.
RECALLING FIRM/MANUFACTURER
Immedica, Inc., Chatham, NJ, by letter on February 10, 2003. Firm initiated recall is ongoing.
REASON
Mislabeled, wrong identification number on pin.
VOLUME OF PRODUCT IN COMMERCE
127.
DISTRIBUTION
OH.

______________________________
PRODUCT
Model 8666 Washer/Disinfector with holding tank heater option. Recall # Z-0908-03.
CODE
Serial numbers 81972 through 82063; and SEV0141098 through SEV0304112.
RECALLING FIRM/MANUFACTURER
Getinge/Castle, Inc., Rochester, NY, by letter dated March 25, 2003. Firm initiated recall is ongoing.
REASON
Hot water may splash from the washer chamber creating a burn hazard.
VOLUME OF PRODUCT IN COMMERCE
75 units.
DISTRIBUTION
Nationwide.

______________________________
PRODUCT
Clinitek 50 Urine Chemistry Analyzer; Product codes 6509C, 6513K, 6514C, 6516C, 6516F, and 6518C. (The different product codes are for the various countries where the product is distributed). Recall # Z-0911-03.
CODE
Serial numbers 168252 through 169574.
RECALLING FIRM/MANUFACTURER
Bayer HealthCare LLC, Diagnostics Div., Elkhart, IN., by letter on May 13, 2003, and on or about June 20, 2003. Firm initiated recall is ongoing.
REASON
Analyzer will produce erroneous results due to missing grounding strap.
VOLUME OF PRODUCT IN COMMERCE
1,324.
DISTRIBUTION
Nationwide, and Internationally.

______________________________
PRODUCT
Supergrade Earloop Masks, surgical mask; 50 masks per box. Recall # Z-0944-03.
CODE
All lots of product code 372-8114 (blue) and 372-8125 (pink).
RECALLING FIRM/MANUFACTURER
Safco Dental Supply Co., Inc., Northbrook, IL, by letter dated May 30, 2003. Firm initiated recall is ongoing.
REASON
The product labeling incorrectly lists the particle filtration efficiency as exceeding 99% at 0.1 micron when it should state 95% filtration.
VOLUME OF PRODUCT IN COMMERCE
60,000 boxes.
DISTRIBUTION
Nationwide.

______________________________
PRODUCT
a) Uroview 2000 X-ray System. Recall # Z-0945-03;
b) Uroview 2500 X-ray System. Recall # Z-0946-03;
c) Uroview 2600 Uroview System. Recall # Z-0947-03.
CODE
a) Serial numbers beginning with T2 and T9;
b) Serial numbers beginning with M2 and M9;
c) Serial numbers beginning with W2 and W9.
RECALLING FIRM/MANUFACTURER
GE OEC Medical Systems, Inc., Salt Lake City, UT, by letter on May 12, 2003. Firm initiated recall is ongoing.
REASON
Uncommanded motion of the urological table is possible should the hand control assembly be exposed to liquids.
VOLUME OF PRODUCT IN COMMERCE
1,109 units.
DISTRIBUTION
Nationwide, and Internationally.

______________________________
PRODUCT
StayFuse PROX 03.3 MM sterile intramedullary bone screw distributed by Zimmer. Recall # Z-0948-03.
CODE
Lot 77091367.
RECALLING FIRM/MANUFACTURER
Pioneer Surgical Technology, Marquette, MI, by letter dated May 29, 2003. Firm initiated recall is ongoing.
REASON
Label may bear an incorrect part number (2227-02-02) and size (03.8MM).
VOLUME OF PRODUCT IN COMMERCE
159.
DISTRIBUTION
IN.

______________________________
PRODUCT
Alpha Mirage Top Tightening Spinal System 5.5 mm x 45 mm Length Bone Screws. Recall # Z-0949-03.
CODE
Lot 251219G.
RECALLING FIRM/MANUFACTURER
Alphatec Mfg., Inc., Carlsbad, CA, by letter dated May 19, 2003. Firm initiated recall is ongoing.
REASON
Laser marking is wrong on bone screws, says 40 and is 45 mm long.
VOLUME OF PRODUCT IN COMMERCE
31.
DISTRIBUTION
FL, MD, CA, TX, Greece and Japan.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

______________________________
PRODUCT
Fixion PF ("Proximal Femur") Hip Peg. Fixion PF Hip Pegs are manufactured in the following various lengths; 80mm, 81mm, 90mm, 91mm, 100mm, 101mm, 105mm, 110mm, 111mm, 120mm, and 121mm. The Fixion PF Hip Peg is intended for use in the fixation of proximal fractures in the femur.
Recall # Z-0943-03.
CODE
Catalog # Lot #

4418080 -- PF02385; PF02437; PF02477; PF02696; PF02697;
           PF02695; PF02378; PF02333;
4408080 -- FP-1161; FP-1094; FP01176; FP-1089;
4408081 -- PF02333;
4418090 -- PF02701; PF02700; PF02478; PF02438; PF02640; 4408101 -- PF02335;
4418105 -- PF02336;
4408111 -- PF02193; 
4418110 -- PF02713; PF02712; PF02709; PF02641; PF02495; 
           PF02480; PF02440; PF02387; PF02380;
4408110 -- FP01175; FP-1147; FP-1097; FP-1092; 
4408090 -- FP01179; FP-1163; FP-1095; FP-1090; 271201; 4408091 -- PF02192; 
4418095 -- PF02334; 
4408100 -- FP-1096; FP-1091; FP01178; FP-1160; 
4418100 -- PF02335; PF02707; PF02371; PF02379; PF02386; 
           PF02439; PF02479; PF02703; PF02705; PF02706; 
4418120 -- PF02715; PF02714; PF02539; PF02441; PF02388; 
           PF02381; PF02372; PF02337;
4408120 -- FP01177; FP-1162; FP-1098; FP-1093; 
4408121 -- PF02337.

______________________________
PRODUCT
Bindazyme, Human AntiCardiolipin IgM Enzyme Immunoassay Kits, MK029. Recall # Z-0950-03.
CODE
Lot 074461.
RECALLING FIRM/MANUFACTURER
The Binding Site, Inc, San Diego, CA, by fax on March 27, 2003. Firm initiated recall is complete.
REASON
Risk of false positives.
VOLUME OF PRODUCT IN COMMERCE
239.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II

______________________________
PRODUCT
Purina Impact Starter Complete WC CTSM 77 Medicated 32W6, bulk and 50-lb. bags, containing 77.0 g/ton chlortetracycline and .0084% sulfamethazine, complete weaning ration for beef cattle only. Recall # V-173-3.
CODE
Bags coded 019NOV06021; bulk date code 11/06/02.
RECALLING FIRM/MANUFACTURER
Purina Mills, Inc., St. Louis, MO, by telephone on November 15, 2002. Firm initiated recall is complete.
REASON
Superpotent complete feed.
VOLUME OF PRODUCT IN COMMERCE
13,215 lbs. Bulk and 160/50-lb. bags.
DISTRIBUTION
Mo.

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS III

______________________________
PRODUCT
Broiler Premix: 313 PMB Pak 78Y packaged in 50 lb paper bags, Code 151313, Drug included: Monensin, Lincomycin, and Roxarsone. Recall # V-172-3.
CODE
Lot no. 091822-1 Exp. Date Jul - 2003.
RECALLING FIRM/MANUFACTURER
Precision Microblenders, Inc., Ciales, PR, by letter on November 28, 2002. Firm initiated recall is complete.
REASON
High level of Lincomycin.
VOLUME OF PRODUCT IN COMMERCE
200 lbs.
DISTRIBUTION
Puerto Rico.

______________________________
PRODUCT
Show Pig 40-200 BN96MX50, Item #503F, Medicated Growing Swine Feed. Contains: 50g/ton Carbadox and 96g/ton Pyrantel Tartrate. Recall #V-174-3.
CODE
75/04/04/17/03; 75/04/21/03; and 75/04/29/03.
RECALLING FIRM/MANUFACTURER
Hubbard Feeds, Inc., Mankato, MN, by telephone on May 15, 2003. Firm initiated recall is ongoing.
REASON
The product is incorrectly labeled as a grower/finisher feed for swine weighing 40-200 lb., instead of a grower feed for swine weighing 40-75 lb.
VOLUME OF PRODUCT IN COMMERCE
490 / 50 lb bags.
DISTRIBUTION
OH, and IN.

END OF ENFORCEMENT REPORT FOR JULY 2, 2003

###

FDA News Page   |   FDA Home Page

Office of Public Affairs
Hypertext created by clb 2003-JUL-02.