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U.S. Department of Health and Human Services

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Enforcement Report for July 26, 2006

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.

 

July 26, 2006
06-30

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS -- CLASS I

______________________________
PRODUCT
a) Nestlé brand Country Creamery Toll House® Chocolate Chip Ice Cream in 1.75-quart
size.Recall # F-265-6;
b) Nestlé brand Country Creamery French Vanilla Ice Cram in 1.75-quart size.
Recall # F-266-6
CODE
a) "Best If Purchased By 11/10/06". Additional code information on carton "48-18-42
ML 4X" and specific time codes on each package of "22:00" through "13:00";
b) ''Best If Purchased By 11/10/06''.Additional code information on carton ''48-18-42
ML 4X'' and specific time codes on each package of ''22:00'' through ''13:00'';
RECALLING FIRM/MANUFACTURER
Dreyers Grand Ice Cream Inc., Oakland, CA, by press release on March 28, 2006.Firm initiated recall is ongoing.
REASON
Products may contain undeclared eggs.
VOLUME OF PRODUCT IN COMMERCE
3,638 packages/4 pack per bundle
DISTRIBUTION
Nationwide

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PRODUCT
a) Chef Alain's smoked gravlax, 4 oz. (Smoked Salmon), Ingredients: Farm Raised
Salmon, Salt, Sugar, Dill. Keep Refrigerated, UPC 6541311030, Recall # F-267-6;
b) Chief Alain's smoked Norwegian salmon. Keep Refrigerated. Ingredients: Farm
Raised Salmon, Salt, Sugar, and Hickory Wood Smoke. UPC 6541311014,
Recall # F-268-6;
c) Chief Alain's smoked Scottish Salmon, 4 oz and 8 oz packages. Ingredients: Salmon,
Salt, Sugar, and Hickory Wood Smoke.Keep Refrigerated. UPC 6541311004,
Recall # F-269-6;
d) Chef Alain's whole sides Norwegian salmon. Ingredients: Farm Raised Salmon, Salt,
Sugar, and Hickory Wood Smoke. Keep Refrigerated, UPC 6541311014,
Recall # F-270-6;
e) Chef Alain's pre-sliced sides Scottish salmon. Ingredients: Salmon, Salt, Sugar, and
Hickory Wood Smoke. Keep Refrigerated. UPC 6541311015, Recall # F-271-6;
f) Chef Alain's Smoked salmon bits, 5 lb bucket. Ingredients: Salmon, Salt, Sugar and
Hickory Wood Smoke. Keep Refrigerated. UPC #6541311014, Recall # Z-272-6;
g) Chef Alain's Pastrami Salmon. 4 oz. Ingredients: Salmon, salt, sugar and Pastrami
Spices. Keep Refrigerated. UPC # 65413110144, Recall F-273-6;
h) Chef Alain's Sliced pastrami side. Ingredients: Farm Raised Salmon, salt, sugar and
pastrami spices. UPC #65413110182, Recall # Z-274-6
CODE
a) Sell date 5/4 /2006;
b) Sell by date 5/4/2006;
c) Sell by date 5/4/2006;
d) Pack date 4/13/2006 sell by 5/4/2006;
e) Pack date 4/19/2006, sell by date 5/11/2006;
f) Sell by Date 5/4/2006;
g) Sell by Date: 5/4/2006;
h) Packed date 4/49/2006
RECALLING FIRM/MANUFACTURER
Moveable Feast Inc., Moonachie, NJ, by telephone on April 24, 2006, by fax on April 25, 2006 and by letter on April 26, 2006.Firm initiated recall is complete.
REASON
Smoked Salmon products were contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
894 packages/8 buckets
DISTRIBUTION
NY, NJ and CT

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS -- CLASS II

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PRODUCT
Rookie's Snax Trail Mix in 8oz clear, flexible plastic bags. Recall # F-275-6
CODE
The retail units of the packages are not coded with information. Only the case packaging bears a lot number. The firm is recalling all its products manufactured therefore there are no specific lot codes associated.
RECALLING FIRM/MANUFACTURER
Recalling Firm: World Variety Produce Inc., Vernon, CA, by letter on June 7, 2006.
Manufacturer: Universal Foods, Inc./DBA/Consolidated Foods, Co., Gardena, CA.Firm initiated recall is ongoing.
REASON
Product contains undeclared colors - FD&C Yellow # 5 and # 6.
VOLUME OF PRODUCT IN COMMERCE
334 (12/8 oz bags per case)
DISTRIBUTION
Nationwide

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PRODUCT
Caribbean Dreams Cerasee Tea, herbal Tea all natural caffeine free. NET WT. 31.2g (1.09 oz) ''Caribbean Dreams''-brand Cerasee Tea, packed in cases containing 24 boxes of 24 tea bags per box, with a total of 576 tea bags per case. The tea is packed in individual tea bags, of 24 tea bags per cellophane-sealed paper box, net weight 31.2 g (1.09.oz). Twenty-four boxes are packed per cardboard case. Recall # F-277-6
CODE
FEB 24 2006, FEB 23 2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ocho Rios Miami, Inc., by press release and telephone on June 5, 2006.
Manufacturer: Risk Management Ltd., Kingston, Jamaica.State initiated recall is ongoing.
REASON
The product was tested by the State of Georgia and found to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
149 cases, 24 boxes per case
DISTRIBUTION
GA and FL

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PRODUCT
Germack Pistachio Company Trail Mix - raisins, pineapple, papaya, banana chips, walnuts, cashews, almonds, brazils, pecans, apricots; net wt 14 oz, Recall # F-278-6
CODE
Best before 06/07/07
RECALLING FIRM/MANUFACTURER
Nutco, Inc., Detroit, MI, by telephone and/or letter on or about June 8, 2006.FDA initiated recall is ongoing.
REASON
The product contains the undeclared color Yellow #5
VOLUME OF PRODUCT IN COMMERCE
108 packages
DISTRIBUTION
MI and NY

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS -- CLASS III

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PRODUCT
Shrimp Shumai Dumplings - label reads in part ** L-SIZE GOURMET SHRIMP SHUMAI DUMPLINGS L-SIZE** NET WT. 3.36 KG (4 x 840 G) 7.40 LB, Recall # F-276-6
CODE
181471 and 181472
RECALLING FIRM/MANUFACTURER
Ajinomoto Frozen Foods U.S.A., Inc., Portland, OR, by telephone on June 2, 2006 and by e-mail on June 6, 2006.Firm initiated recall is complete.
REASON
FS-L-Shumai Shrimp and Shumai-Pork dumplings may be contaminated with metal fragments. Pork dumplings are a USDA product.
VOLUME OF PRODUCT IN COMMERCE
365 cases
DISTRIBUTION
CA, CO, HI, IL, NY and TX

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I

______________________________
PRODUCT
Tacrolimus Bulk Powder, Spectrum Catalog #T3192. Recall # D-299-6
CODE
Lots TA1210 pack letters A-F (Batch #031002);
Lots UD1060 pack letter A (Batch #20050323), UF0298 pack letter A-B (Batch#20050323), UL0964 pack letter A (Batch #20051129), & VB0031 pack letter A-B (Batch# 20051129)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Spectrum Laboratory Products Inc., Gardena, CA, by telephone on May 12, 2006, by press release on May 17, 2006 and by letter on the week of May 15, 2006.
Manufacturer: Changzhou Huaren Chemical Co Ltd, Jiangsu, China (Mainland). Firm initiated recall is ongoing.
REASON
Subpotent
VOLUME OF PRODUCT IN COMMERCE
465 Containers
DISTRIBUTION
Nationwide and South Africa

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

______________________________
PRODUCT
a) Zosyn for Injection, (Piperacillin and Tazobactam for Injection), 2.25gram,
Each vial contains piperacillin and tazobactam cryodesiccated powders
for injection equivalent to 2 grams of piperacillin, 0.025 gram tazobactam
and 5.58 mEq (128 mg) of sodium, 10x2.25gram ADD-Vantage Vial,
For IV Use, Rx only, NDC 0206-8452-17 and NDC 0206-8452-18,
Recall # D-292-6;
b) Zosyn for Injection, (Piperacillin and Tazobactam for Injection), 3.375 gram,
Each vial contains piperacillin and tazobactam cryodesiccated powders for
injection equivalent to 3 grams of piperacillin, 0.375 gram tazobactam,
packaged as 10x3.375 gram ADD-Vantage Vial, For IV Use, Rx only,
NDC 0206-8454-17 and NDC 0206-8854-18, Recall # D-293-6;
c) Zosyn for Injection, (Piperacillin and Tazobactam for Injection), 4.5 gram,
Each vial contains piperacillin and tazobactam cryodesiccated powders for
injection equivalent to 4 grams of piperacillin, 0.5 gram tazobactam, packaged
as 10x4.5 gram ADD-Vantage Vial, For IV Use, Rx only, Recall # D-294-6
CODE
a) NDC 0206-8452-17 ---A70871 (EXP. 3/07), A70872 (EXP. 3/07),
A91364 (EXP. 3/07), A91368 (EXP. 3/07), A91369 (EXP. 3/07),
A91370 (EXP. 4/07), A91379 (EXP. 4/07), A91384 (EXP. 4/07),
A91399 (EXP. 5/07), A91402 (EXP. 5/07), B00210 (EXP. 5/07),
B00214 (EXP. 6/07), B00767 (EXP. 7/07), B00768 (EXP. 6/07),
B06087 (EXP. 6/07), B06088 (EXP. 7/07), B06089 (EXP. 7/07),
B06090 (EXP. 7/07) NDC 0206-8452-18---B42509 (EXP. 3/08),
B42533 (EXP. 3/08);
b) NDC 0206-8454-17 ---- A56107 (EXP. 2/07), A56108 (EXP. 2/07),
A56109 (EXP. 2/07), A70875 (EXP. 3/07), A70876 (EXP. 3/07),
A70877 (EXP. 3/07), A70878 (EXP. 3/07), A70879 (EXP. 3/07),
A70880 (EXP. 3/07), A70881 (EXP. 3/07), A91452 (EXP. 3/07),
A91458 (EXP. 4/07), A91473 (EXP. 4/07), A91572 (EXP. 4/07),
A91573 (EXP. 4/07), A91575 (EXP. 4/07), A91576 (EXP. 4/07),
A91585 (EXP. 4/07), A91586 (EXP. 4/07), A91587 (EXP. 4/07),
A91590 (EXP. 4/07), A91591 (EXP. 4/07), A91592 (EXP. 4/07),
A91593 (EXP. 4/07), A91594 (EXP. 5/07), A91596 (EXP. 5/07),
B00357 (EXP. 5/07), B00358 (EXP. 5/07), B00359 (EXP. 5/07),
B00360 (EXP. 5/07), B00361 (EXP. 5/07), B00362 (EXP. 5/07),
B00363 (EXP. 5/07), B00364 (EXP. 5/07), B00365 (EXP. 5/07),
B00366 (EXP. 5/07), B00367 (EXP. 6/07), B00368 (EXP. 6/07),
B00369 (EXP. 6/07), B00370 (EXP. 6/07), B00371 (EXP. 6/07),
B00372 (EXP. 6/07), B00373 (EXP. 6/07), B00374 (EXP. 6/07),
B00375 (EXP. 7/07), B00376 (EXP. 7/07), B00378 (EXP. 7/07),
(EXP. 7/07), B06176 (EXP. 7/07), B06179 (EXP. 7/07),
B06180 (EXP. 7/07), B06181 (EXP. 7/07), B51100 (EXP. 2/08),
B51101 (EXP. 2/08), B51102 (EXP. 2/08), B51711 (EXP. 1/08),
B51712 (EXP. 1/08), B51713 (EXP. 1/08)
NDC 0206-8854-18 ---- B42530 (EXP. 2/08), B42531 (EXP. 2/08),
B42532 (EXP. 2/08), B42931 (EXP. 2/08), B42932 (EXP. 3/08),
B42934 (EXP. 3/08), B42935 (EXP. 3/08), B42937 (EXP. 3/08),
B42938 (EXP. 3/08), B42940 (EXP. 3/08), B42941 (EXP. 3/08),
B42942 (EXP. 3/08), B45248 (EXP. 3/08);
c) A56143 (EXP. 3/07), A70903 (EXP. 3/07), A70906 (EXP. 4/07),
A92203 (EXP. 5/07), A92205 (EXP. 5/07), A92211 (EXP. 6/07),
B04363 (EXP. 6/07), B04364 (EXP. 6/07), B04365 (EXP. 7/07),
B06357 (EXP. 7/07)
NDC 0206-8855-18 ---- B42510 (EXP. 2/08), B42511 (EXP. 1/08)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wyeth Ayerst Laboratories, Philadelphia, PA, by letter dated May 26, 2006.
Manufacturer: Wyeth Pharmaceuticals, Guayama, Puerto Rico. Firm initiated recall is ongoing.
REASON
Lack of Assurance of Sterility; possible damage to the breakaway cap.
VOLUME OF PRODUCT IN COMMERCE
427,081 vials
DISTRIBUTION
Nationwide

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PRODUCT
Triphasil - 28 Tablets, levonorgestrel and ethinyl estradiol tablets-triphasic regimen), Packages of 3 Dial Packs, Rx only.Recall # D-295-6
CODE
Lots: A36954, A36955, A63687, A67660, A67664, A67671, A67680, A86544, A88644, A92651, A93846, A97336, A97337, B15552, B22428, B24181, B31843, B32893, B40792, and B47404
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wyeth Ayerst Laboratories, Philadelphia, PA, by letter on May 26, 2006.
Manufacturer: Wyeth Pharmaceuticals, Guayama, Puerto Rico. FDA initiated recall is ongoing.
REASON
Presence of Foreign Substance; phenol
VOLUME OF PRODUCT IN COMMERCE
459,970
DISTRIBUTION
Nationwide

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PRODUCT
a) Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 100 count bottles,
Rx only, Recall # D-301-6;
b) Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 100 count bottles,
Rx only, Recall # D -302-6;
c) Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), 100 count bottles,
Rx only, Recall # D-303-6;
d) Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), 100 count bottles,
Rx only, Recall # D-304-6
CODE
a) Pkg. Combo Lot # C04T1921A / 04T14200 / 04T14210;
b) Pkg. Combo Lot # C05T0441A / 05T1130 / 05T1140,
Pkg. Combo Lot # C05T0111A2 (05T7060),
Pkg. Combo Lot # C05T0471A / 05T2250 / 05T2260;
c) Pkg. Combo Lot # C05T0221A4 / 05T7140,
Pkg. Combo Lot # C05T0701A3 / 05T2960,
Pkg. Combo Lot # C05T0711A / 05T3010;
d) Pkg. Combo Lot # C05T0131A2 (05T7330),
Pkg. Combo Lot # C05T0801A2 (05T11190),
Pkg. Combo Lot # C05T0721A / 05T3070 / 05T3080 / 05T3090,
Lot # 05T3051A, Lot # 05T3061A, Lot # 05T3101A, Lot # 05T3111A,
Lot # 05T3201A
RECALLING FIRM/MANUFACTURER
Recalling Firm: ALARA Pharmaceutical Corporation, Caguas, PR, by telephone on July 7, 2006.
Manufacturer: Mova Pharmaceutical Corp., Caguas, Puerto Rico.Firm initiated recall is ongoing.
REASON
Subpotent
VOLUME OF PRODUCT IN COMMERCE
266,236 Bottles (All Lots and Strenghts)
DISTRIBUTION
Nationwide

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PRODUCT
a) Synthroid Tablets (levothyroxine sodium tablets, USP, 25 mcg (0.025 mg), 100 tablet
bottles, Rx only. Recall # D-305-6;
b )Synthroid Tablets (levothyroxine sodium tablets, USP, 200 mcg (0.2 mg), 100 tablet
bottles, Rx only. Recall # D-306-6
CODE
a) Lot # 0000354304 Exp. September 1, 2006;
b) Lot # 0000354314 Exp. September 1, 2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories MPG, Abbott Park, IL, by letter dated June 28, 2006.
Manufacturer: Abbott Laboratories, Jayuya, PR.Firm initiated recall is ongoing.
REASON
Failed Impurity Specification
VOLUME OF PRODUCT IN COMMERCE
4,633 bottles/100 count
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

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PRODUCT
a) PROCAINAMIDE HCl Capsules USP, 250 mg, 100 count bottles (Yellow),
Rx only. --- NDC 0172-2345-60 Recall # D-296-6;
b) PROCAINAMIDE HCl Capsules USP, 500 mg, 100 count bottles (Orange/Yellow),
Rx only. ---- NDC 0172-2347-60 Recall # D-297-6
CODE
a) Lot 2345-119603A Expiration Date July 2006 &
Lot 2345-136349A Expiration Date February 2008;
b) Lot 2347-137085A Expiration date December 2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: IVAX Pharmaceuticals, Miami, FL, by letter on May 30, 2006.
Manufacturer: Ivax Pharmaceuticals, Inc., Cidra, PR.Firm initiated recall is ongoing.
REASON
Discoloration
VOLUME OF PRODUCT IN COMMERCE
24,968 bottles
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Nature's Cure brand 3-Day Yeast Infection Treatment, (Miconazole Nitrate Vaginal Cream (4%) and Miconazole Nitrate Cream (2%)] Vaginal Antifungal (Miconazole Nitrate 200 mg per Applicator plus 2% External Vulvar Cream) Combination Pack; 3 prefilled applicators plus external vulvar cream. Recall # D-298-6
CODE
Lot 6CE0201, Exp. 12/08.
RECALLING FIRM/MANUFACTURER
Perrigo Company, Allegan, MI, by telephone on or about May 3, 2006 and by letter on May 31, 2006.Firm initiated recall is complete.
REASON
Exceeds Impurity Specification
VOLUME OF PRODUCT IN COMMERCE
2,160 packages
DISTRIBUTION
CA

______________________________
PRODUCT
Dr. Hauschka Skin Care Sunscreen Spray for Children and Sensitive Skin, Titanium Dioxide and Zinc Oxide, SPF 20, 5.1 Fl. Oz. Spray Bottle, Dr. Hauschka Skin Care,Recall # D-300-6
CODE
All lots codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Doctor Hauschka Cosmetics USA In, Hatfield, MA, by letter on June 2, 2006.
Manufacturer: WALA Heilmittel GmbH, Eckwalden/Bad Boll, Germany, Firm initiated recall is ongoing.
REASON
Suspension problems; inadequate emulsification
VOLUME OF PRODUCT IN COMMERCE
9,788 bottles
DISTRIBUTION
Nationwide and Caribbean

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1278-6
CODE
Unit FQ72304
RECALLING FIRM/MANUFACTURER
The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI, by facsimile transmission dated June 12, 2004.Firm initiated recall is complete.
REASON
Platelets, possibly contaminated with Micrococcus species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI

______________________________
PRODUCT
a) Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1491-6;
b) Platelets Pheresis Leukocytes Reduced, Recall # B-1492-6
CODE
a) and b) Unit E49218
RECALLING FIRM/MANUFACTURER
Northern Illinois Blood Bank, Inc., Rockford, IL, by telephone on April 18, 2006, and by letter dated April 18, 2006.Firm initiated recall is complete.
REASON
Fresh Frozen Plasma, possibly contaminated with Corynebacterium, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IL

______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1503-6
CODE
Unit KW51452
RECALLING FIRM/MANUFACTURER
Rex Hospital, Inc., Raleigh, NC, by telephone on August 25, 1998. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had received oral typhoid vaccine, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC

______________________________
PRODUCT
Red Blood Cells (Pheresis) Leukocytes Reduced, Recall # B-1506-6
CODE
Units:10746-9765 (split product)
RECALLING FIRM/MANUFACTURER
Blood Systems Inc., Scottsdale, AZ, by telephone on February 24, 2003. Firm initiated recall is complete.
REASON
Blood products, collected by apheresis without documentation of the "prime time" for the collection kit, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AZ

______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1511-6;
b) Platelets leukocytes Reduced, Recall # B-1512-6
CODE
a) and b) Unit:11GW53680
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Missouri-Illinois Region, St. Louis, MO, by telephone on August 4, 2004 and follow-up letter dated August 17, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PR

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1523-6;
b) Cryoprecipitated, AHF, Recall # B-1524-6;
c) Fresh Frozen Plasma, Recall #B-1525-6;
d) Recovered Plasma, Recall #B-1526-6
CODE
a) Unit numbers:2303195, 2385527, 2339912, 2421332 and 1905196;
b) Unit numbers 2421332;
c) Unit numbers: 1905196 and 2385527;
d) Unit numbers: 2303195 and 2339912
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile June 25, 2003.Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to a history of Rheumatoid Arthritis and use of the medications Methotrexate and Prednisone, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
TX, Switzerland, and Austria

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1527-6
CODE
Unit numbers:7070641 (parts 1&2) and 7069204 (parts 1&2)
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile dated November 19, 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
4 units
DISTRIBUTION
TX

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1528-6
CODE
Unit numbers:2488292 and 2508827
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile dated December 12, 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
2 units
DISTRIBUTION
TX

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1529-6;
b) Platelets Pheresis, Leukocytes Reduced, Recall # B-1530-6
CODE
a) Unit number:7066273;
b) Unit numbers:7066273 and 7067398
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile dated December 5, 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
3 units
DISTRIBUTION
TX

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1531-6;
b) Fresh Frozen Plasma, Recall # B-1532-6
CODE
a) and b) Unit number:2427753
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile dated October 16, 2003.Firm initiated recall is complete.
REASON
Blood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1533-6;
b) Platelets, Recall # B-1534-6;
c) Fresh Frozen Plasma, Recall # B-1535-6
CODE
a) b) and c) Unit number:2374360
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile dated December17, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TX

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1536-6;
b) Recovered Plasma, Recall # B-1537-6
CODE
a) and b) Unit number:2461485
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile dated October 13, 2003.Firm initiated recall is complete.
REASON
Blood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX and Austria

______________________________
PRODUCT
Cryoprecipitated, AHF, Recall # B-1538-6
CODE
Unit number: J26336
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Saginaw, MI, by facsimile dated May 19, 2006.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
CA

______________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-1539-6
CODE
Unit numbers:M84514 and M83895
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Saginaw, MI, by facsimile dated May 12, 2006.Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for variant Creutzfeldt-Jakob Disease (VcJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL and MI

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1541-6
CODE
Unit number:2455746
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile dated October 1, 2003.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
TX

______________________________
PRODUCT
Red Blood Cells, Irradiated, Recall # B-1542-6
CODE
Unit number:V90891
RECALLING FIRM/MANUFACTURER
Stanford Medical School Blood Center, Palo Alto, CA, by letter dated April 15, 2005.Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

______________________________
PRODUCT
Cryoprecipitated AHF, Recall # B-1574-6
CODE
Unit numbers:LH87373, GH90024, LS94839, LS94837, LJ85576, KP35249, LJ87040, LV12799, GH90944, LQ83736, LQ83741, LE82406, LW63375, LK63239, LE85026, LE83871, LJ73235, LN78441, LE85500, LH88596, LV02757, LX73100, LS79669, LS79676, LS79670, LJ87950, LQ91025, LN93658, LV13242, LV04177, LG85451, LC79867, LG88543, LJ74003, LE87108, LE87101, LE87106, LN77575, LG94634, LQ75831, LE90744, LE90741, LE90743, LE90747, LS79687, LC82247, LS79625, LS79627, LS79686, V08693, FM98379, FM98393, GM30108, GM30121, GM30140, FM98384, GM30386, GM30388, N92549, N92551, N92555, S60488, S60492, S60496, S60501, V06548, X30100, X30105, X33537, KM14386, LY11722, S57731, S57733, S57740, X27243, X27255, X27423, FM95938, FM95246, X27221, X27411, J10405, KM13773, S56961, S56966, S56969, S56979, S56981, S57003, S57000, S57089, S56995, X26272, S57064, S57095, S57099, X26368, X26391, X26394, X26397, V05835, GM28513, V05836, S58539, J10406, S58896, FM96473, FM95895, LY11727, N89255, FM95727, FM95729, LC79580, LE86864, LK64529, LG92352, LJ76788, LJ76786, LG88759, LK63843, LK63838, LG88761, LN76312, LG95017, LG92635, LQ77428, LR69257, LJ76534, LH94821, LH94819, LH96078, LJ78804, LH94082, LH93969, LG92648, LS80256, LH93954, LG91352, LG91347, LQ75671, LH92446, LQ75661, LG91345, LG91344, LG90803, LQ75664, LS78658, LS78662, LS78664, LS78665, LG91493, LG91504, LC81582, GM30146, GM30154, FM98391, GM30150, FM98380, GM30002, GM29963, GM29967, GM29968, GM29970, GM29978, GM29984, GM29989, GM29990, J11844, R03177, N89272, LV13242, LN93658, LQ91025, LJ87950, GM29426, GM29432, GM29434, S49726, S49695, FM87194, FM87189, FM87185, FM87184, LH62429, LH62328, LG72702, LG72706, LS66427, LS66437, LG72696, LW61396, LH74506, KH11543, KH11527, N91025, FM97894, FM97892, FM97886, S50624, FM87391, LH80784, LH80791, LQ70489, LH80796, LH80793, LH80757, LQ71177, LN73529, LV00527, LQ71173, LE77416, LQ70837, LQ71172, LH81387, LE77413, LR64611, LQ71176, GM35321, GM35346, GM35312, W41486, N96388, S65501, S65500, S65494, S65503, S65492, V09168, V09175, V09171, S65631, S65624, GM36761, V09070, V09065, Y02496, KM20017, KM20014, KM19991, KM20022, KM20016, V09676, V09675, GM36856, V09673, V11318, V11306, V11276, Y02853, Y02855, J15193, V11312, KM20739, V11311, V11291, Y02860, Y02852, LH77706, LE74422, LH78161, LH77704, LK62026, LL62751, LG76316, LQ69011, LQ69016, LC72188, LG60475, LE60473, LH60124, LH62615, LH62600, LH62597, LH62598, LH62595, LX60921, LH62593, LX60914, LX60924, LH62609, LH79266, LH79224, LH79211, LH79254, LH79220, LH79209, LH79223, LH79190, GM29436, S59933, S59944, GN18141, LH81932, LH81933, LH81947, LH81940, LH81945, LX66949, LX66938, LX66950, LX66952, LX66945, LH81960, GH91214, GH91216, GH91209, GH91201, LW64906, LJ75695, LH92286, KH11532, LN93806, KH11525, LN91648, GH90007, LQ87903, LN91635, LN91647, LQ87776, KP33333, LQ87782, LS94274, LQ87794, KH07719, LQ87794, GH90012, KH07702, LS94278, LC75378, LQ72217, LV01753, LN76499, LG82932, LJ70554, LH86492, LX71999, LX68384, LS73269, LJ71879, LE79791, LN76882, LJ70906, LN76806, LS72762, LX70628, LN76883, LN76803, LN76880, LS72757, LL64138, LW62777, LC75875, LW62779, LS83486, LG81522, LW62728, LW62729, LJ70764, LX70691, LG95985, LS82744, LV08492, LG97637, LS86285, LJ79527, LN86117, G27199, G27195, G27291, G27293, G27308, FM77145, FM77157, FM77161, N75014, GM14992, G27307, GM15000, G27298, G27306, FM77042, FM77038, FM77028, FM77027, FM77007, FM77006, GM13095, FM77163, FM77168, FM77171, GM13124, GM13125, GM13126, KM01172, GM15015, FM80733, FM80754, FM80755, FM80757, FM80759, FM80760, FM80763, FM80766, FM82093, GM16871, GM16853, X13945, X13951, KM04861, GM16873, GM16867, GM16862, GM16837, GM16848, GM16841, GM16818, GM16812, GM16836, GM16827, GM16825, FM81790, FM82690, FM82691, FM82693, FM82697, FM82698, FM82705, FM82706, FM82709, FM82710, FM82711, GM21265, GM21317, FM86859, FM87285, FM87298, FM87299, S49731, LQ87860, LQ87790, LQ87793, LG95984, LE95421, LS82729, LV07796, LS86282, LS86302, V09182, GH90022, LR72460, FM98382, FM98392, GM30131, GM30138, GM30142, FM98385, GM30387, N92552, S60491, S60503, V06546, V06554, S59274, S58876, S58895, S59291, S58880, N89258, LH93419, LQ76087, LJ76692, LH93799, LH93806, LN84107, LE92235, LH94077, LQ76678, LE92225, LE92223, FM98390, GM30158, GM30151, GM30157, V06158, GM29964, GM29965, GM29977, GM29982, GM29983, GM29987, V06102, V06109, V06113, S57034, N89307, N89285, N89252, G38101, X27558, X27208, FM95835, FM95841, LN76931, LS73268, LS73266, LV01932, LE81564, LK63043, LC76827, LG83382, LC76785, LH85211, LN87016, LC84861, LS86287, LJ79537, LW66113, FM77154, LN93814, GM15042, LQ83750, LC62494, LY12249, J11681, LH79491, LH79524, LH79526, GM36860, GM36874, GM36859, V11146, Y02950, V11250, LE60431, LE60449, LE60447, LE60434, LH79233, LE84102, LR66392, LR66394, GM30136, LE90517, LE90521, LV05555, LQ76542, FM98386, GM30155, GM30159, FM98383, GM30147, GM30149, GM30156, GM30144, GM30152, GM30148, GM30125, S60358, LE90026, LQ87933, LV01746, LJ70575, LN76508, FM77033, FM77166, FM87306, LH62538, LH62532, LH62548, LQ61472, LQ61489, LV10073, LX80290, LX80292, LX80294, LX80296, LV10088, LQ83748, LQ83746, LR70616, LJ82647, LX80288, LG99715, LX80293, LV10078, LH79151, LH79161, LH79162, LH79154, LS69180, G39413, LE60461, LG60469, LC72004, LQ68988, LC72005, LC72016, LG75728, LE91409, LS79688, LS97639, LS79685, LJ76983, LS79632, LE81062, LE81054, LN79631, LX76135, LK63753, LJ76540, LE91169, LV05978, LE91831, LJ76538, KP33786, LN91765, KH07995, GN18139, LR71312, KP32301, KP35743, LS97088, LS97094, LQ90359, GH91218, GN21632, KP35745, LV08491, LH98436, LV08499, LE96947, LH98448, LQ81541, LE96982, LS86286, LS85984, LQ87959, GM30114, FM98381, S60487, X27262, N89303, G38124, G38431, S57745, N89260, GM27979, KM13775, LV05556, LG92495, LG91596, LG88044, FM98387, GM30128, S60363, S60377, V06139, GM29980, X27312, GH91210, LQ90377, LQ90371, LQ90388, LQ90362, LN93808, LN93809, LW75295, GN22320, LN93811, GN22319, LN76500, GM14134, FM87289, FM87300, N95090, N95079, X34533, GM35314, GM35328, S65527, V11195, GM37461, V11266, V11263, V11254, Y02862, Y02859, Y02848, LH75072, LJ71878, LH87378, LH87377, LG84586, LG84946, LE83225, LS94456, KH07915, GH90015, KH07920, KH07724, GN19355, KP33479, KP33487, LS94851, LS94834, KH10316, LN93075, KP35250, LN93074, LJ87038, KH10307, LN93076, KH10313, LG84479, KH05130, LQ83757, LQ83747, LQ83740, LH86352, LE83870, LX73103, LS79658, LS79649, LS79662, LE84097, LE84103, LE84105, LN78607, LN78612, LX73405, LN78612, LX73405, LX73411, LX73412, LX73415, LV13233, LG88533, LG88541, LG84742, LE90746, LS77950, LS77959, LS77951, LN83175, LN83166, LE90749, S57743, N89904, S56988, S57001, W39832, X26271, KM14741, GM28508, KM14742, GM28511, GM27893, FM95739, FM95868, G38120, N89318, X27269, N89310, LY11693, LY11720, LY11723, FM95877, FM95881, FM95862, FM95875, FM95879, FM95887, FM95908, N89257, N89274, N89280, FM95718, FM95732, FM95734, FM95738, FM95863, FM95871, GM27890, LY11730, N89423, X27273, LS75862, LN80551, LE86865, LK63754, LS75843, LS75857, LK64527, LN83628, LV05861, LE91412, LK64526, LL66491, LL66488, LE91416, LV03798, LG88039, LS79927, LJ5985, LS79912, LG91432, LE90736, LE90734, LS79916, LG92493, LE90750, LE90739, LG92503, LS80198, LH94080, LE92239, LE95483, LJ79540, LJ80611, LS86301, LS86229, LS86279, LS86305, LJ79541, S60355, S60362, S60375, V06153, V06159, GM29975, FM95905, G38059, G38110, N89256, FM95876, FM95902, FM95906, KM14286, N89263, N89265, X27204, LE81128, LX72001, LH86491, LN77888, LH86490, LV01889, LN77890, LX71998, LX72002, LX72011, LJ70807, LJ70806, LW62986, LH85213, LR65667, LS83481, LQ80243, LJ79737, LE95750, LJ79573, LQ80241, LQ80240, GN22323, LV13349, GN22324, LW75293, LV13350, LV13233, GM29427, GM29430, GM29431, GM29435, KP32330, GN18142, LN90872, GN18139, LR71311, GN18143, LR71313, LX66926, LH81956, LH81939, LG91100, LQ75183, LE89923, LV05350, LW64904, LV05350, LW64902, LW64905, LW64907, LQ75196, LQ75193, KH11540, LN93816, LH74524, LR62986, LG72709, LS66452, LH74550, LQ61650, LS65770, LS73476, LE70834, LL61989, LK61387, LH73470, LH73467, LS65774, LS65772, LS65769, LH79515, LH79532, LH79479, LH79501, LH79531, LS69183, LQ69667, , S65506, S64596, S65619, S65617, V09191, V09194, X37178, LX60036, LG60468, LE60444, LE60460, LC72003, LE74486, LC72008, LH75056, LS66721, LH75060, LH79218, LH79193, G27290, N73410, KM01899, FM78939, FM78932, FM78924, FM78917, KM02513, KM01885, S45743, S45735, KM03150, X11766, N75012, GM15006, GM15014, FM80764, FM80762, FM80758, FM85726, FM85725, FM85723, FM85719, FM85564, V04047, V04016, FM87183, FM87187, S49724, S49725, S49734, LE87374, LE87375, KH07913, LS94453, LS94462, KH07938, KH07985, LQ83742, LQ83745, LQ83735, LS89410, LX71831, LN77660, LE82689, LJ71596, LX71813, LX71829, LH86355, LH86358, LH86353, LG84470, LN78443, LS79663, LR69162, LJ78731, LG92558, LH93858, LH94351, LH94420, LE94046, LE91628, LQ77126, LQ76940, LS80235, LQ84141, LQ84148, LS89420, LQ84144, LQ84163, LQ84160, S60500, LE81446, LG84774, LG84777, LC75877, LN75421, LG81136, LJ70802, LH84858, LH97091, LW66156, LQ80043, LQ80049, LV07723, LJ79528, LS83474, LH97026, LS82747, LE95430, LH97023, LH97020, LH97029, LH98628, LS86306, LH97231, LV07800, LH97211, LW66110, LJ79523, LG95999, LS83802, V06553, N89393, FM95880, GM28085, GM28088, GM28094, S57738, S57732, S57729, S57726, GM28074, GM28074, GM28086, KM14384, S57728, S57736, S57744, FM95950, N89396, S57741, FM95262, G37493, G37497, J10407, J10408, KM13776, KM13777, X26367, X26373, X26378, FM97387, N90809, N90811, S59612, LX76136, LK63758, LS75863, LG88529, LN83627, LH93429, LH93420, LH93427, LH93425, LQ76081, LQ76253, LQ76249, LQ76252, LQ76255, LH94395, LV06193, LX68667, LN76092, LV01707, LC76549, LE81550, LW62892, LC76334, LG82754, LS69968, LN76323, LV01612, LJ76836, LN85485, LN84106, LG92552, LH91611, LH91625, LS78655, LS78661, LN83114, LV05521, GM30113, GM30145, S60380, GM29971, GM29969, S59936, LN90873, LH81946, LX66951, LH81953, LX66942, LL63496, LC74661, LH81934, LX66930, LX66925, LX66955, GH91213, GH91212, GH91198, GH91204, GH91202, GH91200, LJ75719, LG91098, LV05358, LJ75694, LJ75696, LJ75717, LH92273, LC75305, LE78920, LC75376, LC75307, LS69925, LR64837, LE78895, LH83117, LE78974, LN74564, LR64966, LX71621, LX71626, LG84166, LC77229, LN77437, LG84165, LG84158, LE82359, LE82361, LN77432, LW63229, LN76505, G27185, G27196, LQ80045, G27296, FM77030, FM77026, FM77019, FM79732, GM15047, GM15777, FM82095, FM82091, FM82089, GM16868, X13955, KM04864, FM82701, FM82704, GM20235, FM85720, FM85550, FM86907, FM86845, FM86755, LH62340, LH62539, LN61726, LQ61480, LH62549, LH74551, LX60987, LQ61612, LQ61658, LQ61640, LQ61649, LH62928, LE62719, KM15575, JI1683, GM27898, G39401, FM97900, FM87115, FM87061, S50644, J07592, S50625, FM87109, LQ70490, LQ70492, LH80794, LH80792, LH80844, LH79477, LH79483, LN72185, LH78880, LR64113, LH78995, LH78876, N95060, N95101, KM18669, S65509, KM19620, V09195, G45576, GM36849, V09679, V09681, KM19826, KM19825, LC72190, LX60061, LX60025, LX60032, LX60029, LX60051, LX60048, Y05272, LX60049, LX60044, LX60043, LX60053, LH62592, LH62601, LG75732, LG75730, LC72006, LJ66975, LX65319, LQ67591, and LQ67595
RECALLING FIRM/MANUFACTURER
Mid-South Regional Blood Center, Memphis, TN, by letter dated October 12, 2004.Firm initiated recall is ongoing.
REASON
Blood products, which were not manufactured in accordance to current Good Manufacturing Practices, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1,258 units
DISTRIBUTION
TN, MS, and AR

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1575-6
CODE
Unit number:311379375
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Tupelo, MS, by telephone on August 3, 2004. Firm initiated recall is complete.
REASON
Blood product, which was not manufactured in accordance with current Good Manufacturing Practices, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MS

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1576-6;
b) Recovered Plasma, Recall # B-1577-6
CODE
a) and b) Unit number:311370408
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Tupelo, MS, by telephone and facsimile on October 18, 2004.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
2 units
DISTRIBUTION
MS and Switzerland

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-1287-6
CODE
Unit KY00294
RECALLING FIRM/MANUFACTURER
Rex Hospital, Inc., Raleigh, NC, by telephone on November 26, 2002. Firm initiated recall is complete.
REASON
Red Cells, labeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1443-6;
b) Red Blood Cells Pheresis, Leukocytes Reduced, Recall # B-1444-6
CODE
a) Units 32KV45829, 32LX77949;
b) Unit 32KX23414
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone on January 4, 2006 and by letter dated January 6, 2006. Firm initiated recall is complete.
REASON
Blood products, which may have been exposed to unacceptable shipping temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
PA

______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1505-6
CODE
Unit numbers: 9013675 (split product), 9013689 (split product), 9013705 (split product)
RECALLING FIRM/MANUFACTURER
The Blood Connection, Inc., Greenville, SC, by telephone on February 8, 2001. Firm initiated recall is complete.
REASON
Blood products, collected using automated equipment that was not subjected to performance qualification, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
SC

______________________________
PRODUCT
Platelets Pheresis, Recall # B-1510-6
CODE
Unit numbers:R84094, R84097
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Community Blood Center of Carolinas, Charlotte, NC, by telephone on January 14, 2005.Firm initiated recall is complete.
REASON
Blood products, possible contaminated with Enterobacter cloacae, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC

______________________________
PRODUCT
a) Red Blood Cells Leukoreduced, Recall # B-1521-6;
b) Fresh Frozen Plasma,Recall # B-1522-6
CODE
a) and b) Unit number:2557314
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on June 7, 2004.Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking the drug Sulfasalazine, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX

______________________________
PRODUCT
Red Blood Cells Leukoreduced, Reduced, Recall # B-1543-6
CODE
Unit number:10743-5020
RECALLING FIRM/MANUFACTURER
Blood Systems Inc., Scottsdale, AZ, by letter dated March 4, 2003. Firm initiated recall is complete.
REASON
Blood product, lacking assurance of acceptable temperatures during shipping, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AZ

______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1544-6;
b) Red Blood Cells Leukoreduced, Reduced, Recall # B-1545-6
CODE
a) Unit number:03E61466;
b) Unit number:03L83941
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern Region, Atlanta, GA, by telephone on January 11, 2006.Firm initiated recall is complete.
REASON
Blood products, which were not quarantined after receiving information regarding a post-donation illness, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

______________________________
PRODUCT
Green Spec Fiberoptic Laryngoscope Handle -- Stubby/Short; a battery operated fiberoptic laryngoscope handle for use with green coded fiberoptic systems and single use laryngoscope blades; catalog number 004413300, Recall # Z-1225-06
CODE
Any lot number greater than and including 050901
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teleflex Medical, Bannockburn, IL, by letters dated June 15, 2006.
Manufacturer: Truphatek, Ltd., Netanya, Israel.Firm initiated recall is ongoing.
REASON
Teleflex Medical has identified that the product may malfunction, causing the handle to heat up.There is a potential for the heated handle to burn the user.
VOLUME OF PRODUCT IN COMMERCE
1,408 units
DISTRIBUTION
Nationwide, Canada, Columbia, Costa Rica and Chile

______________________________
PRODUCT
a) TriVex 100SV Resector Kit, 4.5 Part Number:7205876,
Recall # Z-1226-06;
b) TriVex 200LV Resector Kit, 5.5 Part Number:7209271,
Recall # Z-1227-06;
c) 4.5 mm TriVex System Resector Kit (blade and tubing),
3 per box, Part Number: 7209514, Recall # Z-1228-06;
d) 5.5 mm TriVex System Resector Kit (blade and tubing),
3 per box, Part Number: 7209514, Recall # Z-1229-06
CODE
a) All lot numbers lower than 50156094;
b)All lot numbers lower than 50156900;
c)All lot numbers lower than 50165371;
d) All lot numbers lower than 50165180
RECALLING FIRM/MANUFACTURER
Smith & Nephew, Inc., Andover, MA, by letter on June 19, 2006. Firm initiated recall is ongoing.
REASON
The sterility seal of the package trays may have incomplete seals compromising the sterility of the device.
VOLUME OF PRODUCT IN COMMERCE
9,405 boxes (28,215 units)
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
a) Dyonics Electroblade, 4.5 Full Radius, Valleylab Generator-Compatible
Part Number: 7205961, Recall # Z-1230-06;
b) Dyonics Electroblade 4.5 ELITE, Full Radius, Valleylab
Generator- Compatible Part Number: 7209700, Recall # Z-1231-06;
c) Dyonics Electroblade 4.5 Full Radius, VULCAN Generator-Compatible
Product number: 7209855, Recall # Z-1232-06;
d) Dyonics Electroblade 4.5 ELITE, Full Radius, VULCAN
Generator-Compatible Part Number: 7209983, Recall # Z-1233-06
CODE
a) Lot Numbers:Equal to or lower 50151697;
b) Lot Numbers:Equal to or lower 50164304;
c) Lot Numbers:Equal to or lower 50169658 (or within lot S595485S);
d) Lot Numbers:Equal to or lower 50170383
RECALLING FIRM/MANUFACTURER
Smith & Nephew, Inc., Andover, MA, by letter dated June 19, 2006. Firm initiated recall is ongoing.
REASON
Sterility seal of the package tray may have gaps/voids compromising the sterility of the device.
VOLUME OF PRODUCT IN COMMERCE
3,989 boxes (11,967 units)
DISTRIBUTION
Nationwide, Canada, Germany, France and Istanbul

______________________________
PRODUCT
3M Nexcare First Aid High Performance Gauze Pad. Individually wrapped and sterile. Catalog # 434-10. Made in USA, UPC 05113166774, Recall # Z-1234-06
CODE
Lots 6018, 6019
RECALLING FIRM/MANUFACTURER
Recalling Firm: 3M Company/Medical Division, South St Paul, MN, by telephone between February 7 and February 8, 2006 and by letters dated February 9, 2006.
Manufacturer: 3M Healthcare Markets, Brookings, SD.Firm initiated recall is ongoing.
REASON
After reviewing manufacturing records it has been determined that these lots inadvertently were not sterilized after packaging in individual boxes labeled as sterile product.
VOLUME OF PRODUCT IN COMMERCE
432 boxes
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) GORE TAG THORACIC ENDOPROSTHESIS System,
Endovascular Graft, Aortic Aneurysm Treatment, Catalogue
Number TG3410, 34mm x 10cm, Recall # Z-1236-06;
b) GORE TAG THORACIC ENDOPROSTHESIS System,
Endovascular Graft, Aortic Aneurysm Treatment, Catalogue
Number TG3415, 34mm x 15cm, Recall # Z-1237-06
CODE
a) Lot numbers: 04150282, 04150283, 04150284, 04150285,
04150286, 04150287, 04150288, 04150289, 04150290,
& 04150291;
b) Lot numbers: 04150272, 04150273, 04150274, 04150275,
04150276, 04150277, 04150278, 04150279, 04150280, & 04150281
RECALLING FIRM/MANUFACTURER
W. L. Gore and Assoc., Inc., Flagstaff, AZ, by letters to be hand delivered on May 18, or May 19, 2006.Firm initiated recall is ongoing.
REASON
Two lots of uniquely different product were switched and mislabeled. 34mm x10 cm were labeled as 34mm x 15cm and vice versa.
VOLUME OF PRODUCT IN COMMERCE
20 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Aksys PHD Personal Hemodialysis System for daily home hemodialysis; an automated high permeability hemodialysis system, water purification system for hemodialysis; Model 1M101, Recall # Z-1239-06
CODE
Serial numbers A000089, A000093, A000095, A100002, A100003, A100005, A100009, A100016, A100024, A100031, A100042, A100043, A100049, A100066, A100067, A100076, A100077, A100081, A100083, A100084, A100094, C100104, C100107, C100109, C100114, C100116, C100117, C100123, C100124, C100125, C100126, C100127, C100128, C100131, C100132, C100133, C100136, C100139, C100140, C100142, C100143, C100146, C100149, C100151, C100152, C100157, C100161, C100162, C100163, C100164, C100166, C100173, C100174, C100175, C100176, C100178, C100179, C100180, C100181, C100185, C100187, C100188, C100190, C100191, C100192, C100194, C100195, C100198, C100199, C100200, C100201, C100202, C100204, C100206, C100207, C100209, C100211, C100212, C100214, C100217, C100218, C100219, C100222, C100226, C100227, C100228, C100229, C100230, C100232, C100233, C100234, C100236, C100238, C100239, C100240, C100241, C100243, C100244, C100245, C100246, C100247, C100248, C100249, C100251, C100252, C100253, C100254, C100255, C100256, C100257, C100259, C100260, C100263, C100264, C100265, C100266, C100302, C100305, C100306, C100307, C100308, C100310, C100311, C100312, C100314, C100315, C100317, C100318, C100320, C100321, C100326, C100328, C100329
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aksys, Ltd., Lincolnshire, IL, by Field Correction Recall on June 26, 2006.
Manufacturer: Delphi Medical Systems Colorado Corporation, Longmont, CO.Firm initiated recall is ongoing.
REASON
The hemodialysis device was being marketed with a modified treatment length that exceeds the treatment length for which the device was originally designed.
VOLUME OF PRODUCT IN COMMERCE
133 units
DISTRIBUTION
Nationwide and the United Kingdom

______________________________
PRODUCT
Cordis INFINITI 6 French Diagnostic Catheter.Used to deliver radiopaque contrast medium to selected sites in the vascular system.Catalog 534-6xxT. That is: 534614T, 534615T, 534617T, 534618T, 534619T, 534620T, 534621T, 534622T, 534623T, 534624T, 534625T, 534627T, 534628T, 534629T, 534635T, 534637T, 534641T, 534642T, 534643T, 534644T, 534645T, 534646T, 534647T, 534648T, 534649T, 534660T, 534670T, 534672T, 534674T, Recall # Z-1240-06
CODE
Lot numbers: 40705193 40805619 41005306 50306108 50705083 A0905134 A1005280 X0705708 X1005724 Y0605076 40106153 A0206717 A1005281 X0705155 X0705314 X1005730 40106375 40206347 40805902 40905856 41005501 41105323 41105582 41105939 50106663 50206119 50705092 50805731 50905554 51005668 51105747 A0106975 A0206598 A0306835 A0705922 A0805247 A0905091 A0905954 A1005698 A1105266 A1205756 X0106487 X0206177 X0805958 X0905701 X1005374 40106168 40106369 40106567 40206172 40206341 40705732 40805500 40805732 40905782 40905857 41005239 41005502 41105064 41105324 41105594 41105875 50106661 50106665 50206120 50206265 50705084 50705093 50805580 50805732 50905454 50905555 51005540 51005657 51105254 51105748 51205387 51205397 51205696 A0106041 A0106970 A0206591 A0206599 A0306913 A0306914 A0705846 A0705918 A0805038 A0805048 A0905043 A0905760 A0905955 A1005384 A1005551 A1105258 A1105267 A1205747 A1205754 A1205755 X0106252 X0106369 X0206148 X0206155 X0705250 X0805535 X0805537 X0905689 X0905702 X1005188 X1005204 X1105534 X1105676 X1105787 X1205300 Y0605077 Y0805725 40106559 40106568 40206379 40805632 40805733 40905134 40905849 41005240 41005503 41105065 41105876 41105940 50106666 50206114 50206121 50705085 50705094 50805052 50805581 50805723 50905455 51005541 51105739 51205693 51205697 51205698 A0106042 A0106230 A0206600 A0705847 A0705961 A0805039 A0805049 A0905104 A0905105 A0905956 A1005450 A1105224 A1105268 A1205158 A1205605 A1205748 X0106370 X0106377 X0206164 X0705258 X0705336 X0805804 X0905690 X1005735 X1105535 X1105677 X1105788 X1205301 Y0605078 40106167 40106169 40106198 40106199 40106203 40106204 40106205 40106208 40106370 40106371 40106424 40206173 40206174 40206175 40206185 40206187 40206189 40206210 40206380 40705053 40705058 40705110 40705841 40705847 40705917 40805484 40805635 40805642 40805729 40805757 40805901 40905458 40905459 40905785 40905787 40905791 40905903 40905904 40905906 41005162 41005166 41005167 41005290 41005513 41005534 41005535 41005536 41005537 41105066 41105067 41105199 41105219 41105220 41105221 41105540 41105541 41105542 41105543 41105741 41105742 41105784 41105786 41105791 50106577 50106578 50106579 50106580 50106673 50106674 50106790 50106791 50106792 50106793 50206270 50206272 50206273 50206274 50306309 50306310 50306311 50306312 50306313 50306317 50705086 50705095 50705169 50705176 50705188 50705316 50705327 50705430 50705431 50705432 50805586 50805590 50805724 50805819 50805861 50805862 50805863 50905388 50905456 50905457 50905462 50905546 50905585 50905638 50905639 50905640 50905697 50905958 50905960 51005289 51005441 51005442 51005443 51005562 51005563 51005564 51005565 51005572 51005573 51005628 51005643 51005644 51005648 51105265 51105266 51105400 51105401 51105402 51105403 51105741 51105742 51105749 51205025 51205294 51205295 51205296 51205694 51205872 51205873 51205874 51205875 51205876 A0106043 A0106044 A0106045 A0106064 A0106589 A0106598 A0106599 A0106600 A0106601 A0106818 A0106819 A0106820 A0106903 A0106906 A0206276 A0206287 A0206288 A0206289 A0206453 A0206454 A0206455 A0206592 A0206593 A0306341 A0306342 A0306447 A0306448 A0306450 A0306836 A0306837 A0306838 A0306915 A0306916 A0705086 A0705281 A0705282 A0705283 A0705284 A0705286 A0705287 A0705288 A0705289 A0705563 A0705848 A0705954 A0705956 A0705964 A0805040 A0805231 A0805234 A0805753 A0805802 A0805885 A0805887 A0805888 A0805949 A0905044 A0905045 A0905085 A0905087 A0905137 A0905138 A0905215 A0905216 A0905273 A0905722 A0905723 A0905916 A0905946 A0905947 A0905953 A0905958 A1005386 A1005393 A1005460 A1005461 A1005552 A1005553 A1005554 A1005555 A1105119 A1105120 A1105121 A1105259 A1105260 A1105261 A1105951 A1205179 A1205180 A1205181 A1205651 A1205653 A1205705 A1205987 A1205988 X0106206 X0106208 X0106248 X0106371 X0106378 X0106482 X0106483 X0106497 X0206149 X0206166 X0206167 X0206168 X0206169 X0206170 X0206325 X0206326 X0206327 X0206858 X0206859 X0206943 X0206997 X0705252 X0705256 X0705259 X0705264 X0705266 X0705330 X0705337 X0705338 X0805721 X0805727 X0805797 X0805801 X0805805 X0805857 X0905247 X0905347 X0905629 X0905630 X0905633 X0905657 X0905658 X0905818 X1005130 X1005131 X1005132 X1005133 X1005191 X1005237 X1005244 X1005245 X1005246 X1005350 X1005382 X1005383 X1005384 X1005385 X1105393 X1105394 X1105395 X1105536 X1105537 X1105538 X1105685 X1105784 X1205378 X1205379 X1205380 X1205443 X1205444 X1205446 X1205566 Y0605079 Y0605080 Y0605081 Y0605097 Y0605098 Y0605099 50206016 40106376 40106377 40106378 40106379 40106421 40106422 40106560 40206381 40206382 40206383 40206384 40206385 40206388 40206389 40206390 40206652 40705055 40705061 40705106 40705107 40705108 40705109 40705843 40705845 40705913 40805486 40805639 40805644 40805730 40805752 40905001 40905002 40905019 40905021 40905026 40905029 40905460 40905670 40905671 40905672 40905673 40905674 40905913 41005171 41005172 41005241 41005253 41005254 41005504 41005505 41005506 41005507 41105031 41105032 41105197 41105198 41105667 41105743 41105744 41105788 41105789 41105790 41105805 41105806 41105807 41105821 41105822 41105823 41105919 41105942 50106475 50106476 50106477 50106478 50106609 50106610 50106611 50106612 50106794 50206005 50206006 50206007 50206017 50705087 50705096 50705172 50705179 50705317 50705318 50805589 50805591 50805725 50805865 50805866 50805867 50905390 50905461 50905463 50905584 50905698 50905699 50905700 50905701 50905957 50905959 51005408 51005444 51005555 51005556 51005557 51005645 51005646 51005647 51005649 51005733 51005734 51005735 51005736 51105155 51105156 51105157 51105609 51105799 51105821 51105822 51105823 51205026 51205027 51205028 51205262 51205297 51205298 51205299 51205300 51205699 51205700 51205701 51205702 51205703 A0106046 A0106191 A0106192 A0106193 A0106194 A0106590 A0106747 A0106748 A0106749 A0106750 A0106821 A0106822 A0106823 A0106904 A0106907 A0206452 A0206578 A0206579 A0206580 A0206594 A0306273 A0306343 A0306344 A0306622 A0306623 A0306624 A0306625 A0306626 A0306627 A0306839 A0306840 A0306841 A0306842 A0306917 A0306918 A0705295 A0705296 A0705297 A0705298 A0705299 A0705300 A0705301 A0705302 A0705360 A0705564 A0705849 A0805043 A0805052 A0805238 A0805241 A0805462 A0805751 A0805803 A0805804 A0805805 A0805806 A0805886 A0805889 A0805890 A0905094 A0905096 A0905098 A0905102 A0905142 A0905761 A0905762 A0905918 A1005471 A1005543 A1005544 A1005625 A1005626 A1005627 A1005628 A1005629 A1005630 A1005631 A1105316 A1105577 A1105578 A1105579 A1205477 A1205602 A1205603 A1205606 A1205607 A1205608 A1205609 A1205610 X0106207 X0106209 X0106249 X0106253 X0106484 X0106485 X0106494 X0106496 X0206150 X0206151 X0206152 X0206328 X0206329 X0206330 X0206331 X0206944 X0705257 X0705262 X0705263 X0705265 X0705331 X0705332 X0705339 X0805724 X0805728 X0805798 X0805802 X0805945 X0805951 X0905348 X0905631 X0905632 X0905659 X0905819 X0905820 X1005539 X1005540 X1005570 X1005571 X1005572 X1005573 X1005574 X1005575 X1005731 X1005732 X1005733 X1105533 X1105610 X1105611 X1105612 X1105686 X1105785 X1105786 X1205117 X1205118 X1205119 X1205309 X1205310 X1205311 X1205560 X1205565 Y0605082 Y0605083 Y0605084 Y0605100 Y0605101 Y0605102 Y0605103 Y0605104 Y0805658 Y0805659 Y0805660 Y0805661 Y0805662 40106372 40106569 40206386 40206391 40705059 40705849 40705915 40805640 40805903 40905025 40905783 40905909 41005242 41005508 41105185 41105238 41105544 50106671 50206040 50605078 50705088 50705097 50805726 50805864 50905885 50905886 50905962 51005542 51005658 51105255 51205388 51205398 A0106195 A0106971 A0106976 A0206581 A0206595 A0306274 A0306628 A0306843 A0705850 A0805045 A0805046 A0905095 A0905957 A1005451 A1105225 A1105269 A1205757 X0106093 X0106372 X0106379 X0206153 X0206178 X0805950 X0805959 X0905691 X0905703 X1005576 X1005577 X1105678 X1105687 X1205302 X1205306 X1205561 Y0605085 Y0805726 40106561 40206392 40705054 40705914 40805485 40805904 40905027 40905784 40905851 41005243 41005509 41105186 41105239 41105922 41105943 50705173 50705180 50805727 50805820 50905641 50905644 51105256 51205389 51205399 A0106231 A0106977 A0206445 A0306275 A0306451 A0306629 A0705851 A0805041 A0805050 A0905097 A0905950 A1005452 A1005556 A1105226 A1105233 A1205156 A1205758 X0106506 X0106561 X0206154 X0206156 X0805723 X0805799 X0905692 X0905704 X1005135 X1005375 X1105034 X1105679 X1105688 Y0605086 Y0805727 40106383 40206393 40705057 40705848 40805905 40905858 41005510 41105944 50106795 50705184 50805728 50905645 51005551 51205263 51205869 A0206446 A0306276 A0306452 A0805051 A0905099 A0905949 A1005557 A1105234 A1205157 X0106380 X0206157 X0805725 X0905705 X1005376 X1105606 X1105924 X1205307 40106570 41005511 41105240 50206036 50705177 50905556 51105817 A0106978 A0705955 A0805239 A0905948 X0106503 X0905706 40106571 40705846 40805906 40905859 41005512 41105941 50106004 50206037 50705185 50805729 50905557 51005552 51105818 51205029 51205870 A0206447 A0705957 A0805240 A0905101 X0805726 X0905707 X1005377 X1105607 X1105925 Y0605105 40106562 40705916 40905031 40905786 41005244 41105187 41105926 50705171 50805821 50905042 50905548 50905558 51005543 51105257 51205390 A0106972 A0206451 A0306630 A0705852 A0805042 A0905959 A1005453 A1105227 X0106086 X0106486 X0106488 X0206171 X0805722 X0905821 X1005197 X1205303 Y0605087 Y0805728 40106572 41105241 50106796 50206038 51205030 A0106235 A0206448 A0805242 A0905960 A1005558 A1205425 X0106504 X0805803 X1105608 X1105926 X1205308 40805907 50106797 50705328 A0106979 A1005559 50106798 50905559 A0106980 40106207 40705842 40705844 40805487 40805908 40905024 40905788 41005245 41005514 41105188 41105189 41105242 50206039 50206041 50705174 50705186 50805584 50805730 50905549 50905560 51005544 51005553 A0106981 A0206583 A0306453 A0705853 A0705958 A0805044 A0805243 A0905961 A1005454 A1005560 A1105228 A1105235 A1205759 X0106381 X0206332 X0805856 X0805946 X0905693 X0905708 X1005200 X1005378 X1105680 Y0605088 Y0805729 40106563 40206342 40705919 40805637 40905850 41005246 41105929 50206042 50705089 50805585 50905642 51005545 51105258 51205391 51205695 A0106973 A0206596 A0306832 A0705854 A0805047 A0905926 A1005387 A1105262 A1205764 X0106373 X0206172 X0805952 X0905694 X1005372 X1105681 X1205304 Y0605089 Y0805730 40106564 40106573 40206343 40206394 40705840 40805726 40905030 41005515 41105190 41105932 50206043 50206266 50705170 50705178 50805587 50905550 50905561 51005546 51005554 51105815 51205392 A0106597 A0705912 A0705963 A0805233 A0805244 A0905962 A1005455 A1005561 A1105236 A1105263 A1205426 A1205750 X0106500 X0206179 X0805947 X0805953 X0905815 X0905822 X1005379 X1105609 X1105923 Y0805731 40106154 40905232 50306109 50805922 A0905135 A1005282 A1205155 A1205933 X0106562 X0106863 X0206509 X0705315 X1005734 Y0605090 40106381 40106565 40206344 40206387 40206395 40705918 40805727 40905018 40905023 40905852 40905860 41005247 41005516 41105191 41105877 41105945 50106799 50206115 50206267 50705175 50705187 50805868 50905551 51005547 51005737 51105743 51105819 51205393 A0106232 A0206450 A0206584 A0306631 A0306632 A0705914 A0705965 A0805246 A0805248 A0805752 A0905086 A0905103 A1005456 A1105229 A1205760 X0106087 X0106374 X0106505 X0206158 X0206173 X0805729 X0805954 X0905816 X0905823 X1005202 X1005380 X1105682 X1105689 X1105791 X1205562 Y0605091 40106574 40206396 40805488 40905020 40905066 40905854 40905861 41005248 41005517 41105192 41105243 41105878 41105946 50206116 50206268 50705182 50705189 50805822 50905552 50905562 51005548 51005659 51105744 51105820 51205394 51205871 A0106233 A0206449 A0206585 A0306454 A0705915 A0705966 A0805235 A0805461 A0905088 A1005457 A1105230 A1205751 A1205761 X0106375 X0206180 X0705260 X0805948 X0805949 X0905695 X0905709 X1005136 X1005381 X1105683 X1105690 X1205563 X1205564 Y0605092 40805641 41005249 50705190 50905458 51005549 51105745 X1005137 Y0605093 40106566 40805728 40905028 40905789 41105879 50705191 50905459 51005550 A0705916 A0805236 A1005388 A1105231 A1205752 X0106250 X0206174 X0206489 X0705261 X0805955 X0905696 X1105033 X1105684 Y0605094 40805758 40905790 50206117 50705192 50905460 A0106234 A0705917 A1005458 X0805800 X0905697 Y0605095 40106423 40206345 40905017 40905853 41005250 41105880 50705090 50805588 50905884 50905961 51005626 51105746 51205395 A0106974 A0206296 A0206597 A0306834 A0705913 A0805245 A0805980 A0905089 A1105264 A1205652 X0106501 X0206324 X0206998 X0705333 X0805536 X0905698 X1005134 X1105604 X1205305 Y0605017 40106373 40805731 41105881 50705091 50905643 51005627 A0705919 A0905951 A1005459 A1105265 A1205753 X0206175 X0805956 X0905699 X1205567 Y0605096 40206346 40905855 41005251 41105322 41105545 50206118 50805823 51105816 51205261 51205396 A0106470 A0705920 A0805232 A0905090 A1105232 X0106376 X0705334 X0805957 X1005203 X1105605 X1105922 40106374 40805759 41005252 41105193 41105237 50805824 50905553 A0106905 A0705921 A0805237 A0905952 X0206176 X0705335 X0905817 X1005373
RECALLING FIRM/MANUFACTURER
Cordis Corporation, Miami Lakes, FL, by letter in June 2006. Firm initiated recall is ongoing.
REASON
The tip of the catheter may separate from the body during operation.
VOLUME OF PRODUCT IN COMMERCE
338,270 devices
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Coulter LH500 Hematology Analyzer; Part Numbers 178832, 178833 and 178834, Recall # Z-1245-06
CODE
All software versions
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letter sent week of April 17, 2006.
Manufacturer: Beckman Coulter, Inc., Miami, FL.Firm initiated recall is ongoing.
REASON
Beckman has confirmed that erroneous results could be reported when the workstation data base crashes.
VOLUME OF PRODUCT IN COMMERCE
759 units
DISTRIBUTION
Nationwide and Canada

______________________________
PRODUCT
a) HemosIL RecombiPlasTin. Prothrombin Time Test. Each RecombiPlasTin kit
consists of: RecombiPlasTin (RTF): 5 x 8 mL or 20 mL vials of lyophilized
recombinant human tissue factor, synthetic phospholipids with stabilizers,
preservative and buffer; and RecombiPlasTin Diluent (RTF Diluent): 5 x 8 or
20 mL vials of an aqueous solution of calcium chloride, polybrene and a
preservative. --- FOR IN VITRO DIAGNOSTIC USE, Product No.0020002900
(8mL), Part No. 0020003000 (20 mL), Recall # Z-1246-06;
b) Hemoliance RecombiPlasTin. Prothrombin Time Test. The product is
available as a kit of 25 vials of Hemoliance® RecombiPlasTin matched with
25 vials of Hemoliance® RecombiPlasTin Diluent. Hemoliance® RecombiPlas
Tin after reconstitution with Hemoliance® RecombiPlasTin Diluent is a liposomal
preparation of recombinant human tissue factor and purified phospholipids, calcium
chloride, buffer and a preservative. The use of recombinant human tissue factor and
purified phospholipids assures uniformity in reagent purity, ISI values and
performance from lot to lot. Once reconstituted, it is ready for use in the one-stage PT
test. Hemoliance® RecombiPlasTin Diluent is an aqueous solution of calcium chloride
and a preservative. --- FOR IN VITRO DIAGNOSTIC USE. Product No.49732750 (5
mL):Product No. 49732720 (20 mL), Recall # Z-1247-06
CODE
a) Lots N0649021, N0253072, N0253739, N1150411;
Lots N0347531, N0447950, N0740293, N1040969, N1141498, N0152736,
N0453415, N0454252, N0756711, N0958473, N1150445, N1250485,
N1250619, N0160792;
b) Lots N0448239, N0549190, N0940581, N0353406, N0857200, N1050152;
Lots N0347895, N0548959, N0749495, N0940543, N0940586, N1242409,
N0353410, N0454257, N0857199, N1050143
RECALLING FIRM/MANUFACTURER
Recalling Firm: Instrumentation Laboratory Co., Lexington, MA, by letters on March 7, 2006.
Manufacturer: Instrumentation Lab Co., Orangeburg, NY.Firm initiated recall is ongoing.
REASON
Firm received 2 complaints concerning incorrect prothrombin time (PT) results while using the reagents on samples of patients taking the antibiotic CUBICIN (Daptomycin for injection).
VOLUME OF PRODUCT IN COMMERCE
HemosIL: 8 mL - 10,473; 20 mL - 5110; Hemoliance: 5 mL - 3870; 20 mL - 29,007
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Prolieve™ Thermodilatation® Kit, consisting of a Prolieve Thermodilatation Catheter, Prolieve Heat Exchanger cartridge and 500 ml bag of sterile water, Catalog # 880-8023, packaged in single packs, Material Number M0068808022, and five packs, Material Number M0068808023, Recall # Z-1248-06
CODE
581451, 581452, 581464, 581465, 581468, 581471, 581472, 581473, 581474, 581475, 581476, 581477, 581478, 581479, 581480, 600145, 600146, 600147, 600408, 600538, 600540, 600630, 600692, 600771, 600814, 600815, 600874, 600875
RECALLING FIRM/MANUFACTURER
Recalling Firm: Celsion Corp., Columbia, MD, by letter on May 4, 2006.
Manufacturer: Accellent Juarez, Inc., Juarez, Mexico.Firm initiated recall is ongoing.
REASON
A medical device accessory used by healthcare practitioners in the invasive treatment of (BPH) benign prostatic hyperplasia may be defective. The catheter may fail to achieve or maintain recommended pressure.
VOLUME OF PRODUCT IN COMMERCE
2,930 kits
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

______________________________
PRODUCT
KinetDx 4.0 Ultrasound Image Management System, Recall # Z-1235-06
CODE
All units with software versions 4.0 and 4.1
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions, USA, Inc., Ann Arbor, MI, by visits in April 2006.
Manufacturer: Siemens Medical Solutions, USA, Inc., Malvern, PA.Firm initiated recall is ongoing.
REASON
The cardiologist's report comments may not be retained by the system due to a software bug.
VOLUME OF PRODUCT IN COMMERCE
244 systems
DISTRIBUTION
Nationwide

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PRODUCT
Boston Scientific Contour VL Injection Stent with Hydro Plus Coating, 6 FR (2.0 mm) x 22-30 cm (220-300 mm), sterile, UPN: M0061856300. Ureteral stent, Recall # Z-1238-06
CODE
Lot 8473180
RECALLING FIRM/MANUFACTURER
Boston Scientific Corp., Spencer, IN, by letter dated May 10, 2006. Firm initiated recall is ongoing.
REASON
Instructions on how to inject are not included in the package.
VOLUME OF PRODUCT IN COMMERCE
29 stents
DISTRIBUTION
NY and PA

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PRODUCT
CA 15-3 Controls, list 9C08-10; an In Vitro diagnostic for use with the AxSYM or IMx CA 15-3 reagents, calibrators and instruments; each kit contains 2 bottles with 115D8:DF3 reactive determinants (human) prepared in TRIS buffer with protein (bovine) stabilizers to yield the following assay values (U/ml): Control L - 35 and Control H -- 150, Recall # Z-1244-06
CODE
Lot number 29506M100, Exp. date July 5, 2006
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Abbott Park, IL, by letter dated June 12, 2006. Firm initiated recall is ongoing.
REASON
The CA 15-3 Controls replicates out of range high resulting in invalid runs.
VOLUME OF PRODUCT IN COMMERCE
1,794 kits
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II

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PRODUCT
a) Ol' Roy Chicken Flavor, 22 oz. can; Item #89762 (UPC #0068113189762) and
#34923 (UPC #072562349231). Recall # V-084-6;
b) Ol' Roy Beef Flavor, 22 oz. can; Item #89763 (UPC #0068113189763) and
#35023 (UPC #072562350237), Recall # V-085-6;
c) Ol' Roy Hearty Loaf with Chopped Beef, 22 oz. can; Item #89770
(UPC #0068113189770). Recall # V-086-6;
d) Ol' Roy Hearty Loaf Chopped Meaty Combo, 22 oz. can; Item #89771
(UPC #0068113189771). Recall # V-087-6;
e) Fit and Active Hearty Loaf with Beef, 22 oz. can; Item #32822
(UPC #072562328229). Recall # V-088-6;
f) Fit and Active Hearty Loaf with Chicken, 22 oz. can; Item #37822
(UPC #072562378224), Recall # V-089-6;
g) American Fare Chunky Dinner with Beef, 22 oz. can; Item #19341
(UPC #7200019341), Recall # V-090-6;
h) American Fare Dinner with Turkey and Bacon, 22 oz. can; Item #19342
(UPC #7200019342); Recall # V-091-6;
i) American Fare Country Stew with Beef, 22 oz. can; Item #19343
(UPC #7200019343), Recall # V-092-6;
j) American Fare Chunky Dinner with Beef and Bacon, 22 oz. can;
Item #19344 (UPC #7200019344); Recall # V-093-6;
k) Pot Luck Canned Pet Food, 22 oz. can; Item #32623
(UPC #72562326232), Recall # V-094-6;
l) Fred''s Canine Cuisine Dog Food Prime Entree Cuts with Beef, 22 oz. can;
Item #10016 (UPC #0845729100163); Recall # V-095-6;
m) Twin Pet Beef Flavor Dog Food, 22 oz. can; Item #24123
(UPC #071682241234), Recall # V-096-6;
n ) Twin Pet with Beef - Liver Flavor Dog & Puppy Food, 22 oz. can; Item #24133
(UPC #071682241333); Recall # V-097-6;
o) Strongheart Beef Flavor Dog Food, 22 oz. can; Item #64123
(UPC #071682641232); Recall # V-098-6
CODE
a) -- f) Use by dates between March16, 2008 and June 6, 2006.
g) -- j) Use by date: April 5, 2008
k) Use by dates between March16, 2008 and June 6, 2006
l) Use by date: March 12, 2008.
m) -- n) Use by dates between March16, 2008 and June 6, 2006.
o) Use by date: March 12, 2008
RECALLING FIRM/MANUFACTURER
Simmons Pet Food, Inc., Siloam Springs, AR, by telephone, letter and fax on May 23, 2006.Firm initiated recall is ongoing.
REASON
Inner enamel can lining flaking off into pet food.
VOLUME OF PRODUCT IN COMMERCE
5,136,192 cans
DISTRIBUTION
AL, AR, IL, OK, TN and TN

END OF ENFORCEMENT REPORT FOR July 26, 2006

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