August 6, 2003
03-32
____________________________
PRODUCT
LIPITOR Tablets, (ATORVASTATIN CALCIUM), 20 MG, 90 and 1000 TABLETS bottles, Rx only. Recall # D-284-3.
CODE
Lot 0511022.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Local Repack, Inc., Richton Park, IL, by letters on June 16, 2003.
Manufacturer: Unknown. Firm initiated recall is ongoing.
REASON
Counterfeit product.
VOLUME OF PRODUCT IN COMMERCE
7,189 - 90 tab bottles, 15 - 1000 tab bottles
DISTRIBUTION
Nationwide.
______________________________
PRODUCT
Children's Kaopectate (Bismuth Subsalicylate), 87mg/5mL, 6 fl oz (177 mL), Anti-Diarrheal, New & Improved, Cherry. Recall # D-296-3.
CODE
Lots 86JHT and 01JKC.
RECALLING FIRM/MANUFACTURER
Pfizer, Inc., Morris Plains, NJ, by letters on June 23, 2003. Firm initiated recall is ongoing.
REASON
Mislabeled; the dosing cup does not contain the appropriate dosing units of measure for teaspoon or mL as listed on the product's label dosing chart.
VOLUME OF PRODUCT IN COMMERCE
385,241 bottles
DISTRIBUTION
Nationwide, Barbados, and Guyana.
______________________________
PRODUCT
CLOBETASOL PROPIONATE TOPICAL SOLUTION, USP, 0.05%, (0.5 mg/g), Rx Only, 25 mL (0.85 FL OZ) and 50 mL (1.7 FL OZ) plastic bottles. Recall # D-276-3.
CODE
Lot/Exp: RF1331 05/02 (25 mL and 50 mL),
RH1441 06/02 (50 mL), RJ1586 08/02 (50 mL),
RJ1588 08/02 (25 mL and 50 mL),
RN1918 09/02 (50 mL),
RP1996 10/02 (25 mL and 50 mL),
RS1125 12/02 (25 mL and 50 mL),
RA2011 02/03 (25 mL and 50 mL).
RECALLING FIRM/MANUFACTURER
Alpharma USPD, Baltimore, MD, by letters on September 3, 2002. Firm initiated recall is complete.
REASON
Largest Related Substance Failure; Benzophenone (from varnish coating on container label).
VOLUME OF PRODUCT IN COMMERCE
295,228 bottles.
DISTRIBUTION
Nationwide.
______________________________
PRODUCT
Ray Block Sunscreen Lotion, (Octyl Dimethyl PABA 5% and Benzophenone 3.3%) SPF 15, 1 FL OZ (29.6mL) and 4 FL OUNCES (118.3 mL). Recall # D-282-3.
CODE
Lot D32, expiration date 04/05.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Crown Laboratories, Inc., Johnson City, TN, by letters on June 5, 2003.
Manufacturer: DEL-RAY LABS, INC., Birmingham, AL. Firm initiated recall is ongoing.
REASON
Superpotent; octyl dimethyl PABA and oxybenzone.
VOLUME OF PRODUCT IN COMMERCE
319-4 oz and 324-1 oz bottles.
DISTRIBUTION
Nationwide.
______________________________
PRODUCT
LITHOBID Tablets (Lithium Carbonate, USP) Slow Release Tablets, 300 mg, 100 tablet bottles, Rx only. Recall # D-286-3.
CODE
Lot 92263.
RECALLING FIRM/MANUFACTURER
Solvay Pharmaceuticals, Inc., Marietta, GA, by letter on June 20, 2003. Firm initiated recall is ongoing.
REASON
Dissolution failure; 12 month stability.
VOLUME OF PRODUCT IN COMMERCE
14,029 bottles of 100 tablets.
DISTRIBUTION
Nationwide.
______________________________
PRODUCT
Premarin Tablets, (Conjugated Estrogens Tablets, USP), 0.625 mg, 100 tablet bottles, Rx Only. Recall # D-295-3.
CODE
03831 Exp 4/04.
RECALLING FIRM/MANUFACTURER
Recalling Firm: McKesson, Memphis, TN, by letters on May 20, 2003.
Manufacturer: Ayerst Laboratories, Inc., A Wyeth-Ayerst Company, Philadelphia, PA. Firm initiated recall is ongoing.
REASON
Dissolution Failure by the manufacturer (Wyeth).
VOLUME OF PRODUCT IN COMMERCE
39,793 bottles.
DISTRIBUTION
Nationwide.
______________________________
PRODUCT
Red Blood Cells Washed. Recall B-1180-3.
CODE
Units 6966406 and 6973760.
RECALLING FIRM/MANUFACTURER
Central Jersey Blood Center, Shrewsbury, NJ, by telephone and letter on January 23, 2003. Firm initiated recall is complete.
REASON
Blood products, which were prepared using 1.6% saline solution instead of the .9% saline solution, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NJ.
______________________________
PRODUCT
Red Blood Cells, Leukoreduced. Recall # B-0298-3.
CODE
Unit 01GY69999.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, New York-Penn Region, West Henrietta, NY, by letter dated August 27, 2002. 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
NY.
_____________________________
PRODUCT
Human Tissues for Transplantation. Recall # B-1230-3.
a) Temporal Bone Core;
b) Temporal Bone Blocks.
CODE
a) ID#EB1069;
b) ID#EB1069, EB1092, EB1139.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Providence Health Care, St. Paul's Hospital Site, Vancouver, BC, by letter dated February 18, 2003.
Manufacturer: BC Ear Bank, % St Paul's Hospital, Vancouver, BC.
Firm initiated recall is complete.
REASON
Tissues for transplantation, for which donor suitability and tissue processing documentation was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 2 units;
b) 16 units.
DISTRIBUTION
PA.
______________________________
PRODUCT
Red Blood Cells. Recall # B-1272-3.
CODE
Unit 5356669.
RECALLING FIRM/MANUFACTURER
Carter Blood Care, Bedford, TX, by letter on or about July 13, 2001. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had close contact with a person who had hepatitis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
______________________________
PRODUCT
Human tissue for transplantation, Corneas. Recall # B-1289-3.
CODE
ID number 03-0351OD, 03-0351OS.
RECALLING FIRM/MANUFACTURER
Northwest Lions Eye Bank, Seattle, WA, by telephone on May 20, 2003, and by letter dated May 30, 2003. Firm initiated recall is complete.
REASON
Corneas, collected from a donor who had intimate contact with an individual diagnosed with Hepatitis C, were distributed for tansplant.
VOLUME OF PRODUCT IN COMMERCE
2 tissues.
DISTRIBUTION
IN.
______________________________
PRODUCT
Human Tissues for transplantation.
Femoral Popliteal Artery SG. Recall # B-1301-3.
CODE
Serial # 8116577.
RECALLING FIRM/MANUFACTURER
CryoLife, Inc, Kennesaw, GA, by letter dated May 23, 2003. Firm initiated recall is ongoing.
REASON
Human tissues for transplantation, which were associated with a complaint of alleged microorganism infection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MA.
______________________________
PRODUCT
Genetic Systems HIV-1/HIV-2 Peptide EIA test kit. Recall # B-1316-3.
CODE
Lot 105VP1.
RECALLING FIRM/MANUFACTURER
Bio-Rad Laboratories, Inc., Redmond, WA, by telephone or fax, August 7-16, 2002. Firm initiated recall is complete.
REASON
Test kits that could produce low positive and elevated negative controls were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 lot.
DISTRIBUTION
Nationwide.
______________________________
PRODUCT
a) Fresh Frozen Plasma. Recall # B-1374-3;
b) Cryoprecipitate. Recall # B-1375-3;
c) Recovered Plasma. Recall # B-1376-3.
CODE
a) Unit LE14726;
b), and c) Unit FG67643.
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence, RI, by letter or fax dated March 13, 2003. 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
3 units.
DISTRIBUTION
ME, and Switzerland.
______________________________
PRODUCT
a) Red Blood Cells, Leukoreduced. Recall # B-1377-3;
b) Platelets. Recall # B-1378-3;
c) Fresh Froxen Plasma. Recall # B-1379-3.
CODE
a), b), and c) Unit LE06855.
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence, RI, by telephone on February 25, 2003. 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
3 units.
DISTRIBUTION
RI.
______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1380-3;
b) Platelets. Recall # B-1381-3.
CODE
a) and b) Unit 7825381.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated August 28, 2001. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose medical history screening was inadequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.
______________________________
PRODUCT
a) Platelets. Recall # B-1387-3;
b) Fresh Frozen Plasma. Recall # B-1388-3.
CODE
a) and b) Unit 5290340.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated August 19, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor with a history of Crohn's disease, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.
______________________________
PRODUCT
Recovered Plasma. Recall # B-1419-3.
CODE
Unit number 21KC43309.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pacific Northwest Region, Portland, OR, by electronic mail on June 11, 2002. Firm initiated recall is complete.
REASON
Blood product 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
1 unit.
DISTRIBUTION
CA.
______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1420-3.
CODE
Unit number 21KK63946.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pacific Northwest Region, Portland, OR, by letter on October 16, 2002. 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
OR.
______________________________
PRODUCT
Human Tissue for transplantation, Corneas. Recall # B-1421-3.
CODE
Tissue numbers 2003-05-4011 and 2003-05-4012.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Heartland Lions Eye Banks, Columbia, MO, by telephone or facsimile and letter on June 30, 2003.
Manufacturer: Heartland Lions Eye Banks, Hayes, KS. Firm initiated recall is complete.
REASON
Human tissue for transplantation, that tested negative for hepatitis prior to distribution, but was subsequently found to test repeatedly reactive for antibodies to hepatitis B core antigen (anti-HBc) by a different facility, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues.
DISTRIBUTION
KS, and Germany.
______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1424-3.
CODE
Unit number 30GH81556.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northeastern Pennsylvania Region, Ashley, PA, by letter on March 14, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to use of an antiviral medication, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MA.
______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1425-3;
b) Cryoprecipitated AHF. Recall # B-1426-3;
c) Recovered Plasma. Recall # B-1427-3.
CODE
a), b), and c) Unit number 30GL32538.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northeastern Pennsylvania Region, Ashley, PA, by telephone on February 17, 2003, by facsimile on February 18, 2003, and by letter on February 20, 2003. Firm initiated recall is complete.
REASON
Blood product 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
3 units.
DISTRIBUTION
MA, PA, and Switzerland.
______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1429-3;
b) Platelets, Irradiated. Recall # B-1430-3.
CODE
a) and b) Unit number 9745369.
RECALLING FIRM/MANUFACTURER
Our Lady of the Lake Hospital, Inc., Baton Rouge, LA, by facsimile on September 16, 2002. 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 unit.
DISTRIBUTION
LA.
______________________________
PRODUCT
Red Blood Cells. Recall # B-1431-3.
CODE
Unit number 9957364.
RECALLING FIRM/MANUFACTURER
Our Lady of the Lake Hospital, Inc., Baton Rouge, LA, by telephone on November 20, 2001. 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
LA.
______________________________
PRODUCT
Platelets. Recall # B-1432-3.
CODE
Unit number 9954288.
RECALLING FIRM/MANUFACTURER
Our Lady of the Lake Hospital, Inc., Baton Rouge, LA, by facsimile on October 3, 2001. 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
LA.
______________________________
PRODUCT
Red Blood Cells, Leukocytes. Recall # B-0296-3;
Red Blood Cells, Leukocytes, Irradiated. Recall # B-0297-3.
CODE
a) Unit numbers 01LW29287, 01LW29305;
b) Unit number 01LW29292.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, New York-Penn Region, West Henrietta, NY, by by telephone on August 30, 2002. Firm initiated recall is complete.
REASON
Blood products, collected in expired blood collection bags, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 2 units;
b) 1 unit.
DISTRIBUTION
NY.
______________________________
PRODUCT
Red Blood Cells, Leukoreduced. Recall # B-1273-3.
CODE
L40356, G18744, G18751, G18844.
RECALLING FIRM/MANUFACTURER
Central Illinois Community Blood Bank, Springfield, IL, by fax dated February 24, 2003. Firm initiated recall is complete.
REASON
Blood products, leukoreduced by filtration greater than five days past time of collection, but within the shelf life of the units, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
IL.
______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1382-3;
b) Recovered Plasma. Recall # B-1383-3.
CODE
a) and b) Unit 7827534.
RECALLING FIRM/MANUFACTURER
Carter Blood Care, Bedford, TX, by letter dated October 19, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor with a history of Crohn's disease, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX, and Switzerland.
______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1384-3;
b) Cryoprecipitate. Recall # B-1385-3;
c) Recovered Plasma. Recall # B-1386-3.
CODE
a), b), and c) Unit 7832759.
RECALLING FIRM/MANUFACTURER
Carter Blood Care, Bedford, TX, by letter dated August 28, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose arm inspection was not documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
TX, MO, and Switzerland.
______________________________
PRODUCT
Tissues for Transplantation: Recall # B-1401-3.
a) Achilles;
b) Cancellous;
c) 1/2 Patella;
d) Femur;
e) Cortical Shaft;
f) Cortical Segment;
g) Bone Plug;
h) Cortical Disc;
i) Iliac Crest Wedge.
CODE
a) PBA-62500001-02, PBA-62500002-02;
b) PBA-62500058-02, PBA-62500060-02, PBA-62500063-02, PBA-62500007-02,
PBA-62500053-02, PBA-62500061-02, PBA-62500054-02, PBA-62500056-02,
PBA-62500057-02, PBA-62500059-02;
c) PBA-62500003-02, PBA-62500005-02, PBA-62500006-02;
d) PBA-62500008-02;
e) PBA-62500010-02;
f) PBA-62500011-02;
g) PBA-62500018-02, PBA-62500023-02;
h) PBA-62500040-02, PBA-62500042-02, PBA-62500041-02, PBA-62500043-02,
PBA-62500044-02, PBA-62500045-02;
i) PBA-62500047-02, PBA-62500050-02, PBA-62500051-02.
RECALLING FIRM/MANUFACTURER
LifeLink Foundation Tissue Bank, Tampa, FL, by letter dated April 24, 2003. Firm initiated recall is complete.
REASON
Tissues for transplantation that were collected from donors who were found to test repeatedly reactive for Human Immunodeficiency Virus (HIV) 1/2 subsequent to distribution.
VOLUME OF PRODUCT IN COMMERCE
a) 2 units;
b) 10 units;
c) 3 units;
d) 1 unit;
e) 1 unit;
f) 1 unit;
g) 2 units;
h) 6 units;
i) 3 units.
DISTRIBUTION
FL, GA, and CA.
______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1422-3.
CODE
Unit number FM68985.
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence, RI, by telephone on March 10, 2003. Firm initiated recall is complete.
REASON
Blood product, that was labeled as leukoreduced but failed quality control testing due to an elevated white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
RI.
______________________________
PRODUCT
Red Blood Cells. Recall # B-1423-3.
CODE
Unit number T43539.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Saginaw Valley Blood Program, Saginaw, MI, by telephone on January 22, 2003. Firm initiated recall is complete.
REASON
An expired blood product was not properly quarantined and was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.
______________________________
PRODUCT
Recovered Plasma. Recall # B-1428-3.
CODE
Unit number 9035050.
RECALLING FIRM/MANUFACTURER
East Jefferson General Hospital Blood Bank, Metairie, LA, by letter on June 29, 2001. Firm initiated recall is complete.
REASON
Blood product collected from an unsuitable donor due to a history of residing in an area considered at risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.
______________________________
PRODUCT
Stryker Advanced Cement Mixing System Bowl and 180 Gram Cement Cartridge with Break-Away Femoral Nozzle for use with Stryker high vacuum cement injection system, 6 pack; part 0306-563-000. Recall # Z-0921-03.
CODE
Lot 03030232.
RECALLING FIRM/MANUFACTURER
Stryker Instruments, Instruments Div., Kalamazoo, MI, by letters dated June 12, 2003. Firm initiated recall is ongoing.
REASON
Non-sterilized product sold as sterile.
VOLUME OF PRODUCT IN COMMERCE
440.
DISTRIBUTION
Nationwide, Canada, Italy, Japan, and United Kingdom.
______________________________
PRODUCT
Custom Sterile Surgical Procedure Packs. The product packaging
consists of a vented polybag with a label insert inside the polybag.
a) Sterile Minor Extremity Pack, Catalog SOP11MEMMD, order 101449.
Recall # Z-1020-03;
b) Sterile Major Abdominal Pack, Catalog SBA21MAHVJ, order 101491.
Recall # Z-1021-03;
c) Sterile General Local Tray, Catalog SBA11GLMMD, order 101466.
Recall # Z-1022-03;
d) Sterile Laparotomy Pack, Catalog SBA61MJSFH, order 101438.
Recall # Z-1023-03;
e) Sterile General Surgery Pack, Catalog SBA35GSMOG, order 101467.
Recall # Z-1024-03.
CODE
a) Mfg date 5/20/03, Exp date 11/01/04;
b) Mfg date 5/22/03, Exp date 1/01/05;
c) Mfg date 5/20/03, Exp date 1/01/05;
d) Mfg date 5/21/03;
e) Mfg date 5/21/03.
RECALLING FIRM/MANUFACTURER
Cardinal Health, McGaw Park, IL, by letter dated June 27, 2003. Firm initiated recall is ongoing.
REASON
The kits labeled as sterile were stolen in transit to the sterilizer and have not been sterilized.
VOLUME OF PRODUCT IN COMMERCE
1,242 packs.
DISTRIBUTION
NJ, TN, MO, and MN.
______________________________
PRODUCT
Quest Myocardial Protection System (MPS) Arrest/Additive Cassettes.
Recall # Z-1037-03.
a) Catalog Number: 5001102;
b) Catalog Number: 5001104;
Lots manufactured but not distributed:
c) Catalog Number: 6001101;
d) Catalog Number: 7001102.
CODE
a) Lot numbers: 20823.R10, 20853.S01, and 20863.S04;
b) Lot Number: 20706.S09;
c) Lot Number: 20639.R10;
d) Lot Number: 20638.R10.
RECALLING FIRM/MANUFACTURER
Quest Medical, Inc., Allen, TX, by letters via fax on May 23, 2003, May 28, 2003, and May 29, 2003. Firm initiated recall is ongoing.
REASON
Cassettes leak causing a delay of administration of cardioplegia solutions to the heart during open heart surgery.
VOLUME OF PRODUCT IN COMMERCE
2,158 devices.
DISTRIBUTION
Nationwide, Japan, and Canada.
______________________________
PRODUCT
CryoValve, Synegraft Pulmonary Valve & Conduit. Recall # Z-1038-03.
CODE
Serial #7925364, Model #SGPV00.
RECALLING FIRM/MANUFACTURER
Cryolife, Inc. Kennesaw, GA, by letter on July 10, 2003. Firm initiated recall is ongoing.
REASON
Human tissue for transplantation, which was associated with a donor whose pre-processing culture detected microorganisms was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
______________________________
PRODUCT
a) ProVision Hytrel Elastomer Hood, product 5431-05-000.
Recall # Z-1040-03;
b) ProVision Hytrel Universal Hood/Gown, product 5431-31-000.
Recall # Z-1041-03;
c) ProVision Barrier Universal Hood/Gown, product 5431-33-000.
Recall # Z-1042-03;
d) ProVision Disposable Hood, product 5431-50-000. Recall # Z-1043-03;
CODE
All products manufactured between February 1, 2002 and June 17, 2003 that does not have a green square on the label above the CE mark. Product bearing the green square on the label has been 100% inspected and is not under recall.
RECALLING FIRM/MANUFACTURER
Depuy Orthopaedics, Inc. Warsaw, IN, by Urgent Recall Notice on June 27, 2003. Firm initiated recall is ongoing.
REASON
Lack of assurance of sterility, due to the possibility of an incomplete package seal.
VOLUME OF PRODUCT IN COMMERCE
168,528.
DISTRIBUTION
Nationwide, and Internationally.
______________________________
PRODUCT
MagNA Pure LC Instrument, Catalog number 2236931. Recall # Z-1044-03.
CODE
All systems using software version 3.0.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics, Corp., Indianapolis, IN, by letter dated June 26, 2003. Firm initiated recall is ongoing.
REASON
A software bug in version 3.0 may result in prolonged mixing time, evaporation of elution volume and biased sample results for various protocols.
VOLUME OF PRODUCT IN COMMERCE
17.
DISTRIBUTION
Nationwide, and Canada.
______________________________
PRODUCT
a) Positive Touch (TM) TEXTURED POWDER-FREE LATEX EXAM GLOVES, Large.
Reorder No. 8843. Single Use Only. Qty. 100 Per Box (50 pairs),
1000 Per Case. Recall # Z-1045-03;
b) Positive Touch (TM) SMOOTH POWDER-FREE LATEX EXAM GLOVES, Large.
Reorder No. 8878. Single Use Only. Qty. 100 Per Box (50 pairs),
1000 Per Case. Recall # Z-1046-03.
CODE
All lots distributed between May 28, 2003 and July 9, 2003, including Lot # 4E02A021.
RECALLING FIRM/MANUFACTURER
Henry Schein, Inc., Melville, NY, by telephone on June 27, 2003, and by letters on June 27, 2003 and July 10, 2003. FDA initiated recall is ongoing.
REASON
FDA's analysis revealed defects (holes) in the latex gloves.
VOLUME OF PRODUCT IN COMMERCE
96 cases.
DISTRIBUTION
Nationwide.
______________________________
PRODUCT
AxSYM AFP Reagent Pack, list 7A48-22 (100 test kit), 7A48-21 (French label), and AxSYM Cancer Assay Disk, list 3D50-02 (Version 2.0), 3D50-03 (Version 3.0), and 3D50-04 (Version 4.0). Recall # Z-1047-03.
CODE
All lots of AFP list 7A48-22 and 7A48-21 used with all lots of AxSYM Cancer Assay Disk list 3D50-02, 3D50-03 and 3D50-04 with AFP Assay File version 2.00.200, when used with AxSYM System Software Versions 3.00 and higher.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories HPD/ADD, Abbott Park, IL, by letter dated June 12, 2003. Firm initiated recall is ongoing.
REASON
AFP results obtained when using the 1:101 automated dilution protocol showed an overestimation of AFP of up to 30.5%.
VOLUME OF PRODUCT IN COMMERCE
23,000 kits.
DISTRIBUTION
Nationwide, and Internationally.
______________________________
PRODUCT
a) SurgASSIST System. Circular Stapler DLU 29 mm, product code CS29.
Recall # Z-1048-03;
b) SurgASSIST System. Circular Stapler DLU 33 mm, product code CS33.
Recall # Z-1049-03
CODE
a) Lot numbers DS-000036, DS-000043, DS-000047, DS-000049, DS-000052,
DS-000055, DS-000057, DS-000061, DS-000064, DS-000072, DS-000073,
DS-000077, DS-000078, DS-000082, DS-000084, DS-000085, DS-000086,
DS-000090, DS-000095, DS-000099, DS-000117, DS-000118, DS-000119,
DS-000126, DS-000132, DS-000133, DS-000135, DS-000138, DS-000140,
DS-000141, DS-000145, LC-000022, LC-000023, LC-000024, LC-000030,
LC-000044, LC-000052, LC-000053, LC-000055, LC-000056, LC-000061,
LC-000066, LC-000068, and LC-000074;
b) Lot numbers DS-000122, DS-000123, DS-000127, DS-000134, DS-000139,
DS-000142, DS-000146, and DS-000148.
RECALLING FIRM/MANUFACTURER
Power Medical Interventions, New Hope, PA, by letter dated June 30, 2003. FDA initiated recall is ongoing.
REASON
Latching mechanism failure.
VOLUME OF PRODUCT IN COMMERCE
4,978 units.
DISTRIBUTION
Nationwide, and Internationally.
______________________________
PRODUCT
a) Active Electrode Monitoring System. EM2 NC AEM Monitor (NON-COM).
Catalog Number EM2 NC. Recall # Z-1050-03;
b) Active Electrode Monitoring System. EM2+A NC AEM Monitor (NON-COM).
Catalog Number EM2+A NC. Recall # Z-1051-03.
CODE
All serial numbers.
RECALLING FIRM/MANUFACTURER
Encision, Inc., Boulder, CO, by visits beginning June 23, 2003. Firm initiated recall is ongoing.
REASON
Use of NC versions of AEM monitor presents burn hazard when used with single pad and capacitively coupled patient return electrodes.
VOLUME OF PRODUCT IN COMMERCE
27 units.
DISTRIBUTION
CA, IL, KS, OH, OK, PA, TN, Canada, and Italy.
______________________________
PRODUCT
LMA-Unique Laryngeal Mask Airway Size 4, Catalog No. 12140, and Catalog No. 12150. Recall # Z-1053-03.
CODE
Lots FH041202 and FJ021202.
RECALLING FIRM/MANUFACTURER
LMA North America Inc., San Diego, CA, by letters on June 18, 2003. Firm initiated recall is ongoing.
REASON
Sterility cannot be assured.
VOLUME OF PRODUCT IN COMMERCE
2,579.
DISTRIBUTION
Nationwide.
______________________________
PRODUCT
Medex 2000 Series Syringe Infusion Pumps.
The 2001 series is a general use pump,
2001E is for German use,
2001G is for use in the UK,
2001T is for use in Taiwan,
2010iK is for use in Korea, (the pumps with different languages have different syringes than those used in the U.S.),
001H has a different power cord connector,
"VX" in the suffix means it is an evaluation pump,
"NFHU" is not for human use; used in test labs for testing purposes,
2010 has an anesthesia mode built into the software,
"ZE" are returned because of outdated software. They are refurbished or up graded and re-distributed,
2010i has an anesthesia mode and library mode for programming.
Recall # Z-1060-03.
CODE
Series # 2001, 2201E, 2001G, 2001H, 2001VX, 2001HZE, 2001NFHU, 2001T,
2010, 2010E, 2010H, 2010HVX, 2010HZE, 2010i, 2010ik, 2010iVX, 2010iZE.
RECALLING FIRM/MANUFACTURER
Medex, Inc., Duluth, GA, by letter dated June, 2003. Firm initiated recall is ongoing.
REASON
Inadequate warning label as pertains to use of the pump in conjunction with Extracorporeal Membrane Oxygenation (ECMO) procedures.
VOLUME OF PRODUCT IN COMMERCE
59,938 units.
DISTRIBUTION
Nationwide, and Internationally.
______________________________
PRODUCT
a) ASAP Channel Cut Biopsy System, 14 gauge Reference Number: 1250.
Recall # Z-1061-03;
b) ASAP Channel Cut Biopsy System, 15 gauge Reference Number: 1390.
Recall # Z-1062-03;
c) ASAP Channel Cut Biopsy System, 18 gauge Reference Number: 1394.
Recall # Z-1063-03.
CODE
a) 4104836 4145036 4211323 4290090 4370503 4405122 4445839
4461241 4569317 4666229 4916051 5022356 5120746 5133248
5251508 5288530;
b) 4097154 4126946 4145035 4158456 4193792 4212753 4221510
4231545 4256164 4262043 4258584 4282986 4313907 4323261
4349628 4375687 4392520 4405118 4408527 4414677 4425997
4464404 4464403 4468969 4494611 4528589 4537936 4550692
4557360 4562655 4579693 4583642 4625634 4628069 4639625
4652811 4689625 4701139 4701138 4727026 4742360 4764119
4764122 4774555 4788365 4823397 4830419 4845754 4900789
4910488 4915451 4935096 4963935 4963936 4983393 4992627
5007857 5019451 5022419 5038639 5065152 5121437 5129514
5140440 5155296 5158742 5169243 5173373 5182914 5186852
5205601 5223778 5227258 5238638 5246424 5251510 5269078
5288531 5301576 5320588 5371233 5427428 5440613 5473223
5501877 5505775 5511863 5547602;
c) 4105648 4113988 4162641 4193798 4206664 4231542 4266299 4290089
4297846 4339339 4363204 4387477 4401411 4414613 4472494 4494612
4506626 4528577 4555320 4591333 4611363 4646473 4671080 4732694
4776718 4792615 4814439 4916050 4923749 4940371 4955250 5000456
5025458 5048339 5071211 5086862 5153158 5190439 5226638 5280768
5313310 5340135 5343856 5347420 5374497 5388620 5395693 5446265.
RECALLING FIRM/MANUFACTURER
Boston Scientific Corporation, Natick, MA, by letter on July 3, 2003. Firm initiated recall is ongoing.
REASON
Sterility of the device may be compromised due to a lack of package integrity.
VOLUME OF PRODUCT IN COMMERCE
12,990 units.
DISTRIBUTION
Nationwide.
______________________________
PRODUCT
a) Servo Controlled Oxygen System for Ohmeda's Medical Giraffe OmniBed;
b) Ohmeda's Medical Girraffe Incubators. Recall # Z-1064-03.
CODE
a) Giraffe OmniBeds (w/Servo O2 option): HEDF50041 - HEDF50076
HDGE50562 - HDGE50567, HDGF54039, HDGF54153 - HDGF54155
HDGF54165 - HDGF54167;
b) Giraffe Incubators (w/Servo O2 option): HDHE50160-HDHE50161,
HDHF50023-HDHF50024, HDHF50105, HDHF50109, HDHF50114, HDHF50227-
HDHF50245, HDHF50278, HDHF50302, HDHF50304, HDHF50306, HDHF50309,
HDHF50327-HDHF50328, HDHF50333-HDHF50343, HDHF53070, HDHF54046,
HDHF54122, HDHF54131-HDHF54133, HDHF54135, HDHF54143-HDHF54145,
HDHF54152-HDHF54155.
RECALLING FIRM/MANUFACTURER
Ohmedia Medical, A division of Datex-Ohmeda, Inc., Laurel, MD, by e-mail and telephone on June 13, 2003. Firm initiated recall is complete.
REASON
Medical device malfunction affecting instrument's calibration and alarm systems.
VOLUME OF PRODUCT IN COMMERCE
157 units.
DISTRIBUTION
Internationally.
______________________________
PRODUCT
Lo-Profile Fenestrated Tracheostomy Tube, Cuffed and Fenestrated Tube I.D.9.0mm Catalog Number: 593090. Recall # Z-1039-03.
CODE
Lot Number: 905486 EXP: 2004-05.
RECALLING FIRM/MANUFACTURER
Portex, Inc., Keene, NH, by telephone on June 18th and 19th, 2003. Firm initiated recall is ongoing.
REASON
Mislabeled: Tracheostomy tube was not fenestrated as specified on the label.
VOLUME OF PRODUCT IN COMMERCE
11 units.
DISTRIBUTION
CA, GA, KA, MO.
______________________________
PRODUCT
a) Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle
size 47-90 microns, 1 cc; order number PVA-50. Recall # Z-1054-03;
b) Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle
size 90-180 microns, 1 cc; order number PVA-100. Recall # Z-1055-03;
c) Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle
size 180-300 microns, 1 cc; order number PVA-200. Recall # Z-1056-03;
d) Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle
size 300-500 microns, 1 cc; order number PVA-300. Recall # Z-1057-03;
e) Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle
size 500-710 microns, 1 cc; order number PVA-500. Recall # Z-1058-03;
f) Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle
size 710-1000 microns, 1 cc; order number PVA-700. Recall # Z-1059-03.
CODE
All units distributed from February 24, 2003 through June 26, 2003.
RECALLING FIRM/MANUFACTURER
Cook, Inc., Bloomington, IN, by letter dated July 1, 2003. Firm initiated recall is ongoing.
REASON
Vial contains less product than is declared on the label.
VOLUME OF PRODUCT IN COMMERCE
4,179.
DISTRIBUTION
Nationwide and Internationally.
______________________________
PRODUCT
a) Kreycik Elk Supplement packaged in 50-lb. bags. Recall # V-210-3;
b) Kerber 3.0 Dynamite Starter "150", for 25-lb. -- 50-lb. pigs, packaged in
50-lb bags. Recall # V-211-3;
c) Nonmedicated cattle supplements or premixes packaged in bulk or 50-lb.
bags under the following product labels: Kerber Cow - Calf; Kerber Dry
Cow Premix, Cattle Supplement, EJM Farms Thiamine Carrier, Davis Dairy
Cow Premix, Floyd Jefson Lactation Premix, Floyd Jefson Niacin Carrier,
Hadacek Cow Supplement, Kutrous Grazing Mineral, Russ Salton Grower 1
1/4# and Twin Brook Finisher. Recall # V-212-3;
d) 15 bulk custom cattle supplements medicated with decoquinate at
levels ranging from 56-124.85 mg/lb. Recall # V-213-3;
e)9 bulk custom cattle supplements medicated with laidlomycin propionate at
levels ranging between 96-260 g/ton. Recall # V-214-3;
f) Bulk Neusch Beef Premix BOV 391 Medicated, containing 638 g/ton lasalocid
sodium. Recall # V-215-3;
g) MGA Carrier 2.0 Medicate, containing 0.00044% melengestrol acetate,
packaged in 50-lb. bags. Recall # V-216-3;
h) Bulk Schmidt Finisher MGA .28 Medicated, containing 0.00006% melengestrol
acetate. Recall # V-217-3;
i) 18 bulk custom cattle supplements medicated with monensin ranging in levels
between 200-800 g/ton. Recall # V-218-3;
j) Kutrous Calf Grower Mineral RUM 2000 Medicated, containing 4,000 g/ton monensin,
packaged in 50-lb. bags. Recall # V-219-3;
k)8 custom cattle supplements medicated with monensin and melengestrol acetate
at various levels. Recall # V-220-3;
l) Bulk custom cattle supplement RUM 160 TY 70 Medicated, containing 320 g/ton
monensin and 140 g/ton tylosin. Recall # V-221-3;
m) Bulk custom cattle supplement RUM 165 TY 60 Medicated, containing 330 g/ton
monensin and 120 g/ton tylosin. Recall # V-222-3;
n) Bulk custom cattle supplement RUM 250 TY 90 Medicated, containing 500 g/ton
monensin and 180 g/ton tylosin. Recall # V-223-3;
o) Phase 1 1/2, complete nonmedicated feed for pigs, packaged in 50-lb. bags
which list Manufactured for Lee's Feed & Farm Supply, Fairfax, MN, as the responsible
firm on the label. Recall # V-224-3;
p) T.N.T., complete nonmedicated feed for pigs, packaged in 50-lb. bags which
list Manufactured for Lee's Feed & Farm Supply, Fairfax, MN, as the responsible
firm on the label. Recall # V-225-3;
q) Nonmedicated swine starter feeds for 15-25-lb. pigs produced under the following
labels:
(1) Kerber Dynamite 2.0 "600", packaged in 50-lb. bags that list Manufactured
by Kerber Milling Co., Emmetsburg, IA, as the responsible firm on the label.
(2) Bulk Kerber Dyna 2 Supp. No Fat. The label lists Manufactured by Kerber
Milling Co., Emmetsburg, IA, as the responsible firm.
(3) 2.0 Dynamite Starter "600", packaged in 50-lb. bags under two different
labels that list Manufactured by Kerber Milling Co, Emmetsburg, IA, or Lee's
Feed & Farm Supply, Fairfax, MN, as the responsible firm.
(4) Dynamite 2.0 Complete, packaged in 50-lb. bags that list Manufactured by
Kerber Milling Co., Emmetsburg, IA, as the responsible firm on the label.
(5) Starter produced under the names Haugen Basemix 500, packaged in 50-lb.
bags, and bulk Rippe Basemix 500, both of which list Manufactured by Kerber
Milling Co., Emmetsburg, IA, as the responsible firm on the label; and bulk
Basemix 500 Starter, which lists Manufactured For Spillville Mill, Spillville,
IA, as the responsible firm on the label.
(6) Bulk Fransen 2.0 "1,000". The label lists Manufactured by Kerber Milling
Co., Emmetsburg, IA, as the responsible firm.
(7) Starter feed produced under the names Kleavland 2.0-367 Starter, K-Webb
2.0-367 Starter, and Toft 2.0-367 Starter, all packaged in 50-lb. bags. The
labels list Manufactured by Kerber Milling Co., Emmetsburg, IA, as the responsible
firm.
Nonmedicated swine starter feeds for 25-50-lb. pigs produced under the following
labels:
(1) Starter feed produced under the names Kleavland 3.0-65 Starter, K-Webb 3.0-65
Starter, and Toft 3.0-65 Starter, all packaged in 50-lb. bags, which list Manufactured
by Kerber Milling Co., Emmetsburg, IA, as the responsible firm on the label.
(2) 3.0 Dynamite Starter "150", packaged in 50-lb. bags, which lists Manufactured
for Lee's Feed & Farm Supply, Fairfax, MN, as the responsible firm on the label.
Recall # V-226-3;
r) Kerber Grower Micro Mix for Swine, packaged in 50-lb. bags. Recall # V-227-3;
s) Bulk 10# Phy Grower. Recall # V-228-3;
t) Kerber Finisher Micro Mix for Swine, packaged in 50-lb. bags. Recall # V-229-3;
u) Isonet Finisher 25 Premix, packaged in 50-lb. bags. Recall # V-230-3;
v) Bulk Warner Mineral Mix. Recall # V-231-3;
w) Kerber Phy L-Finisher 45# Swine Premix, packaged in 45-lb. bags. Recall #
V-232-3;
x) Bulk Spillville L-45 Premix. Recall # V-233-3;
y) Nonmedicated swine grower or finisher premixes produced under the
following labels:
(1) Kerber Big 50 Finisher Swine Premix and Neu Farms Big
50 Finisher Swine Premix, both packaged in 50-lb. bags that list
Manufactured by Kerber Milling Co., Emmetsburg, IA, as the responsible
firm on the label.
(2) Kerber Big L-50 Finisher Swine Premix, packaged in 50-lb. bags that list
Manufactured by Kerber Milling Co., Emmetsburg, IA, as the responsible firm
on the label.
(3) Kerber Phy L-Grower, packaged in 50-lb. bags that list Manufactured by Kerber
Milling Co., Emmetsburg,
IA, as the responsible firm on the label.
(4) L-50 Finisher Swine Premix, packaged in 50-lb. bags that list Manufactured
for Breda Feed & Grain,
Breda, IA, as the responsible firm on the label; and bulk Renze Finisher
L-50 Swine Premix that lists Manufactured by Kerber Milling Co.,
Emmetsburg, IA, as the responsible firm on the label.
(5) Toomsen L-50# Finisher Premix, Willems L-50# Finisher Premix, Alleven L-50#
Finisher
Premix, Crystal Valley L-50# Finisher Premix, Entinger L-50# Finisher
Premix, and Harvest States L-50# Finisher Premix, all packaged in 50-lb.
bags that list Manufactured by Kerber Milling Co., Emmetsburg, IA, as
the responsible firm on the label.
(6) Bulk Spillville L-50 Premix that lists Manufactured by Kerber Milling Co.,
Emmetsburg, IA, on the label.
(7) Swine Grower & Finisher Premix, packaged in 50-lb. bags that list
Manufactured for Lee's Feed & Farm Supply, Fairfax, MN, as the responsible
firm on the label. Recall # V-234-3;
z) Nonmedicated swine grower premixes packaged in 55-lb. bags under the
following labels:
(1) Alleven L-55# Grower Premix. The label lists Manufactured by Kerber Milling
Co., Emmetsburg, IA, as the responsible firm.
(2) Crystal Valley L-55 Grower Premix. The label lists Manufactured by Kerber
Milling Co., Emmetsburg, IA, as the responsible firm.
(3) Flygare L-55# Grower Premix. The label lists Manufactured by Kerber Milling
Co., Emmetsburg, IA, as the responsible firm.
(4) Toomsen L-55# Grower Premix. The label lists Manufactured by Kerber Milling
Co., Emmetsburg, IA, as the responsible firm.
(5) Willems L-55# Grower Premix. The label lists Manufactured by Kerber Milling
Co., Emmetsburg, IA, as the responsible firm.
(6) Trask GR/FIN 55 Premix. The label lists Manufactured by Kerber Milling Co.,
Emmetsburg, IA, as the responsible firm.
Recall # V-235-3;
aa) Nonmedicated swine premixes packaged in 60-lb. bags, with the exception
of product #1, Summit View Farms:
(1) Bulk Summit View Farms 60 Swine Premix. The label lists Manufactured by
Kerber Milling Co., Emmetsburg, IA,
as the responsible firm.
(2) Kerber Royal 60 Premix. The label lists Manufactured by Kerber Milling Co.,
Emmetsburg, IA, as the responsible firm.
(3) Kerber Royal L-60 Premix. The label lists Manufactured by Kerber Milling
Co., Emmetsburg, IA, as the responsible firm.
(4) Neu Farms 60 Premix. The label lists Manufactured by Kerber Milling Co.,
Emmetsburg, IA, as the responsible firm.
(5) Rippe Grain and Milling 60 Swine Premix. The label lists Manufactured by
Kerber Milling Co., Emmetsburg, IA, as the responsible firm.
(6) Ruzicka Swine Gro-Finish Premix 60. The label lists Manufactured by Kerber
Milling Co., Emmetsburg, IA, as the responsible firm.
(7) L-60 Swine Premix. The label lists Manufactured for Breda Feed & Grain,
Breda, IA, as the responsible firm. (8) L-60# Swine Premix. The label lists
Manufactured for Lee''s Feed & Farm Supply, Fairfax, MN, as the responsible
firm. Recall # V-236-3;
bb) Bulk Burke L-65 Swine Premix. Recall # V-237-3;
cc) Bulk Renze Grower L-65 Swine Premix. Recall # V-238-3;
dd) Bulk Renze L-Finisher Swine Premix. Recall # V-239-3;
ee) Bulk Hamilton L-75 Grower-Finisher Swine Premix. Recall # V-240-3;
ff) Bulk Kuecker 75 LY-3 Premix. Recall # V-241-3;
gg) Bulk Burke L-80. Recall # V-242-3;
hh) Bulk Breda Finisher Basemix. Recall # V-243-3;
ii) Stanton/Bayerl Hy-Tec L-100, packaged in 50-lb. bags. Recall # V-244-3;
jj) Bulk nonmedicated swine feed produced under the following labels which list
Manufactured by Kerber Milling Co., Emmetsburg, IA, as the responsible
firm: Hagers Swine L-100 Premix, Renze Grower L-100 Swine Premix, Swine
L-100 Grower-Finisher Premix, and Wahlert L-100 Premix. Recall # V-245-3;
kk) 6 bulk complete finisher feeds for swine labeled as Finisher #1 Swine
Complete Feed Plain through Finisher #6 Swine Complete Feed Plain. The
labels list Manufactured by Kerber Milling Co., Emmetsburg, IA, as the
responsible firm. Recall # V-246-3;
ll) Kerber Top Sow 100 and T & W Top Sow Premix, both packaged in 50-lb. bags.
Recall # V-247-3;
mm) 5 nonmedicated sow premixes produced under the following labels: (1) Haugen
Sow Micro Mix packaged in 50-lb. bags which list Manufactured by Kerber Milling
Co., Emmetsburg, IA, as the responsible firm on the label. (2) Hauser Top Sow
Premix packaged in 50-lb. bags which list Manufactured by Kerber Milling Co.,
Emmetsburg, IA, as the responsible firm on the label. (3) Kuecker Sow 110 packaged
in 55-lb. bags that list Manufactured by Kerber Milling Co., Emmetsburg, IA,
as the responsible firm on the label. (4) Sow Gilt Premix packaged in 60-lb.
bags that list Manufactured for Lee's Feed & Farm Supply, Fairfax, MN, as the
responsible firm on the label. (5) Trask Sow 100 Premix packaged in 50-lb. bags
that list Manufactured by Kerber Milling Co., Emmetsburg, IA, as the responsible
firm on the label. Recall # V-248-3;
nn) Krusemark L-50 Hog Premix Medicated, containing 1,200 g/ton bacitracin methylene
disalicylate, packaged in 50-lb. bags. Recall # V-249-3;
oo) 5 medicated swine feeds containing 0.0055% carbadox produced under the following
labels: (1) Kerber T.N.T. Pig Starter Crumbles, packaged in 50-lb. bags that
list Manufactured by Kerber Milling Co., Emmetsburg, IA, as the responsible
firm on the label. (2) T.N.T. Pig Starter Crumbles, packaged in 50-lb. bags
that list Manufactured for Lee''s Feed & Farm Supply, Fairfax, MN, as the responsible
firm on the label. (3) Kerber 1.5 Dynamite Pig Starter Medicated, packaged in
50-lb. bags which list Manufactured by Kerber Milling Co., Emmetsburg, IA, as
the responsible firm on the label. (4) 1.5 Dynamite Medicated, packaged in 50-lb.
bags which list Manufactured for Lee's Feed & Farm Supply, Fairfax, MN, as the
responsible firm on the label. (5) Dynamite 2.0 Complete Medicated, packaged
in 50-lb. bags. Recall # V-250-3;
pp) Lee's Phase 1 1/2 No-200 Medicated, containing 100 g/ton oxytetracycline
and 70 g/ton neomycin base, packaged in 50-lb. bags. Recall # V-251-3;
qq) Finish Lean 10 X Medicated, containing 0.19841% ractopamine hydrochloride,
packaged in 50-lb. bags. Recall # V-252-3;
rr) Bulk Lean Finisher #7 Swine Complete Feed Medicated, containing 0.19841%
ractopamine hydrochloride. Recall # V-253-3;
ss) Bulk Kerber Phase 1-1/2 Medicated, containing 363 g/ton tilmicosin. Recall
# V-254-3;
tt) Dynamite 2.0 Complete, containing 181 g/ton tilmicosin, packaged in 50-lb.
bags. Recall # V-255-3;
uu) Beef Feedlot Finisher packaged in 50-lb. bags. Recall # V-256-3;
vv) All Natural 34 packaged in 50-lb. bags. Recall # V-257-3;
ww) Feedlot Conditioner 2-32 Medicated, containing 68.1 mg/lb. decoquinate,
packaged in 50-lb. bags. Recall # V-258-3;
CODE
a) 254-2002 through 13-2003;
b)09-2002 through 17-2003;
c) 254-2002 through 13-2003;
d) 254-2002 through 13-2003;
e)254-2002 through 13-2003;
f)254-2002 through 13-2003;
g)254-2002 through 13-2003;
h)254-2002 through 13-2003;
i) 254-2002 through 13-2003;
j)254-2002 through 13-2003;
k)254-2002 through 13-2003;
l)254-2002 through 13-2003;
m)254-2002 through 13-2003;
n)254-2002 through 13-2003;
0)09-2002 through 17-2003;
p)09-2002 through 17-2003;
q)09-2002 through 17-2003;
r)09-2002 through 17-2003;
s)09-2002 through 17-2003;
t)09-2002 through 17-2003;
u)09-2002 through 17-2003;
v)09-2002 through 17-2003;
w)09-2002 through 17-2003;
x)09-2002 through 17-2003;
y)09-2002 through 17-2003;
z)09-2002 through 17-2003;
aa)09-2002 through 17-2003;
bb)09-2002 through 17-2003;
cc)09-2002 through 17-2003;
dd)09-2002 through 17-2003;
ee)09-2002 through 17-2003;
ff)09-2002 through 17-2003;
gg)09-2002 through 17-2003;
hh)09-2002 through 17-2003;
ii)09-2002 through 17-2003;
jj)09-2002 through 17-2003;
kk)09-2002 through 17-2003;
ll)09-2002 through 17-2003;
mm)09-2002 through 17-2003;
nn)09-2002 through 17-2003;
oo)09-2002 through 17-2003;
pp)09-2002 through 17-2003;
qq)09-2002 through 17-2003;
rr)09-2002 through 17-2003;
ss)09-2002 through 17-2003;
tt)254-2002 through 13-2003;
uu)254-2002 through 13-2003;
vv)254-2002 through 13-2003.
RECALLING FIRM/MANUFACTURER
Kerber Milling Co., Emmetsburg, IA, by visits on March 28, 2003, and by letters
dated April 7, 2003. FDA initiated recall is complete.
REASON
Firm used trace mineral products and raw material ingredient zinc oxide containing
elevated levels of dioxin in the manufacture of supplements, premixes, and feed.
VOLUME OF PRODUCT IN COMMERCE
Undetermined.
DISTRIBUTION
IA, and MN.
_________________________________
PRODUCT
Safe Guard (fenbendazole) (0.42%) Medicated Dewormer 35% Salt: Free Choice Mineral for Beef and Dairy Cattle. The product is a Type C Medicated Mineral Mix. The product is sold in 20 lb pails and shipped to distributors in cartons containing 2 pails. Recall # V-259-3.
CODE
Product code is SG-474-20, Lot number B2243002.
RECALLING FIRM/MANUFACTURER
Intervet, Inc., Millsboro, DE, by telephone on July 10, 2003. Firm initiated recall is ongoing.
REASON
Missing label.
VOLUME OF PRODUCT IN COMMERCE
553 containers.
DISTRIBUTION
Nationwide.
END OF ENFORCEMENT REPORT FOR AUGUST 6, 2003
###
Office of Public Affairs
Hypertext created by clb 2003-AUG-06.