Enforcement Report

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.

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March 15, 2006
06-11

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS - CLASS I

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PRODUCT
Korica brand Dried Potato, net wt. 7 oz (200 g), Ingredients: POTATO --- Serving size 1/2 cup (30 g) --- Servings per container about 6. The product is packed in a heat-sealed plastic bag. The packaging is labeled partly in English and partly in a foreign language, UPC bar code # 6 868978 722201, Recall # F-085-6
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Korica International Inc, Brooklyn , NY , by letters, dated November 23, 2005 , firm initiated recall is complete.
REASON
The product contained undeclared sulfites (576 ppm) based on sampling & analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
NY, MA, VA, IL, and FL
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PRODUCT
Assorted chocolates packaged in a large, inedible, foil-covered Easter egg, net weight 5 1/2 oz. , 11 pieces per egg (2 being Peanut Butter Crunch covered in milk chocolate), 4 eggs/case, UPC #77260 00397. The assorted chocolates are not individually wrapped or identified. The eggs are packaged 4 per case. Each egg is packaged in a clear plastic box labeled on the front as Russell Stover Assorted Chocolates and labeled on the back with the ingredient statement, Recall # F-086-6
CODE
Z3377, Z3617, Z437, and Z4577
RECALLING FIRM/MANUFACTURER
Recalling Firm: Russell Stover Candies, Inc., Kansas City , MO , by telephone and e-mail on January 19, 2006 .
Manufacturer: Russell Stover Candies, Inc., Cookeville , TN , firm initiated recall is ongoing.
REASON
Assorted Chocolates contain peanut butter, which is not listed in the ingredient statement of the product.
VOLUME OF PRODUCT IN COMMERCE
4,734/4/5 ½-oz. egg cases
DISTRIBUTION
VA, AL, TN, SC, TX, IN, FL, NJ, RI, PA, and VT
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PRODUCT
The 9" Old Fashion Apple Pie is an in-store baked product that is purchased from Swann's Bakery. The product is baked at store level and topped with cinnamon streusel, caramel icing, and walnuts at the in-store bakery. Prior to notification, the product was labeled using either the manufacturer provided label, and labeled in part, "OLD FASHIONED APPLE PIE NET WT. 33 OZ” or a label generated at store level using a Hobart Quantum Scale, labeled in part, "ingles bakery DEEP DISH APPLE PIE 1, 55 oz”. Product is then packaged in a clear plastic container and sold with a 4 day shelf life, Recall # F-087-6
CODE
All Old Fashion Apple Pie with "sell by" date up to and including January 31, 2006 .
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ingles Market Inc., Black Mountain , NC , by e-mail on January 27, 2006 and by press release on February 3, 2006 .
Manufacturer: Schwan’s Bakery Inc, Suwanee , GA , firm initiated recall is ongoing.
REASON
Product contains undeclared walnuts.
VOLUME OF PRODUCT IN COMMERCE
Unknown (all affected pies sold before 01/27/2006 )
DISTRIBUTION
AL, GA, NC, SC, TN and VA
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PRODUCT
DRIED LILY FLOWER, NET WT. 6 oz.(170 g) --- Product of China, Serving Size 17g --- Serving per container 10 --- The product is packed in a sealed plastic package labeled in Chinese and English. UPC bar code # 6 43719 11301 4UPC bar code # 6 43719 11301 4, Recall # F-088-6
CODE
No coding
RECALLING FIRM/MANUFACTURER
Recalling Firm: Allied Imports Inc. Brooklyn NY, by letters on December 12, 2005 and NYSDAM issued a Food Safety Alert on/about December 12, 2005 .
Manufacturer: Zhong Shan Dragon Trading Co., Ltd., Zhong Shan , China , firm initiated recall is complete.
REASON
The product contained undeclared sulfites (8329 ppm) based on sampling and analysis by the New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
44 cases (100-6 oz. packages per case
DISTRIBUTION
NY
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PRODUCT
SWAD --- BEST TASTE IN TOWN --- DRY DATES --- NET WT. 7 OZ. (200 Gms) and NET WT. 14 OZ. (400 GM) --- PRODUCT OF INDIA , Imported. The product is packed in a sealed, plastic bag. 20/7 oz. bags per case and 20/14 oz. bags per case. The 7 oz. bag does not have a UPC code, while the 14 oz. bag has UPC 51179-19180, Recall # F-089-6
CODE
The bags have no production code or use by date. The 14 oz. bags have and item #29205
RECALLING FIRM/MANUFACTURER
Recalling Firm: Raja Foods, Skokie , IL , by press release and letters dated February 2, 2006 , and the New York State Department of Agriculture & Markets issued a Food Safety Alert on January 25, 2006 .
Manufacturer: Ramdev Exports, Ahmedabad , India , firm initiated recall is ongoing.
REASON
The product contained undeclared sulfites (1950 ppm) based on sampling and analysis by the New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
282 cases – 7 oz. and 359 cases – 14 oz
DISTRIBUTION
Nationwide, Panama and Jamaica

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS - CLASS II
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PRODUCT
Sweet Cured Plums, SHUN TAI PRESERVED FRUITS, Weight: 60 g. The product is stored in a pink cellophane plastic package. There is a picture of a female face and upper portion of the body. There are Asian Characters written on the display panel. Ingredients: Prune, Salt, Sugar, Liquorice, Edible Spice. Validity: One year, UPC code 6 926750 320356,Recall # F-090-6
CODE
There is no manufacturing code on the bag.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Walong Marketing Inc, Buena Park , CA , by letter beginning on December 1, 2005 . Manufacturer: Shun Tai Food Co., LTD, Guantang Chaoan Guangdong , China , firm initiated recall is ongoing.
REASON
Routine sampling by the State of California Department of Health Services - Food & Drug Branch test results revealed the presence of high levels of lead in Shun Tai brand Sweet Cured Plums.
VOLUME OF PRODUCT IN COMMERCE
18 cases 100/60 gram individual packages per case
DISTRIBUTION
CA, NM, AZ, and WA
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PRODUCT
Pepsi Cola in 12 fl. oz. cans, 24 cans per cube case; UPC 120130 on can, 120170 on case, Recall # F-091-6
CODE
Can code: NOV 13 06 xx:xxBG020863B, case code: NOV 13 06 xx:xxBG020863, Note: xx:xx is the military time of production.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pepsi Americas, Inc., Schaumburg , IL , by telephone, visit, and memo beginning, on February 20, 2006 .
Manufacturer: Pepsi Americas, Inc., Chicago , IL , firm initiated recall is complete.
REASON
The Pepsi Cola has a Chlorine-type odor and a lighter than normal caramel color due to contamination with cleaning solution.
VOLUME OF PRODUCT IN COMMERCE
9,676 cases
DISTRIBUTION
IL, IN, and WI
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PRODUCT
Del Rey White Flour Tortillas; all sizes, the tortillas are packaged 12 tortillas per plastic bag, 40 packs per case for 5” and 6” tortillas, 24 packs per case for 8 tortillas, and 10 packs per case for 10", 12", 13" and 14" tortillas; the tortillas are labeled as follows:
A) Del Rey Tortillas de Harina (5" and 6"), 12 Flour Tortillas, Net Wt. 12 Oz. (340g), For Soft Shell Tacos, UPC 52771-20001;
B) Del Rey Tortillas de Harina (8”), 12 Flour Tortillas, Net Wt. 15 Oz. (425g), Fajita Size, UPC 52771-20003;
C) Del Rey Burritos #2 (10”), 12 Tortillas, Net Wt. 27 oz. (765g), UPC 52771-40001;
D) Del Rey Burritos #3 (12”), 12 Tortillas, Net Wt. 34 oz. (964g), UPC 52771-00001;
E) Del Rey Burritos #3-1/2 (13”), 12 Tortillas, Net Wt. 42 oz. (1191 g), UPC 52771-50001
F) Del Rey Burritos #4 (14”), 12 Tortillas, Net Wt. 54 oz. (1.534 Kg), UPC 52771-50002, Recall # F-094-6
CODE
All sizes and types of flour tortillas with the brand name Del Rey and use-by date codes of March 06, 2006 or earlier
RECALLING FIRM/MANUFACTURER
Del Rey Torilleria, Inc., Chicago , IL , by press release on January 25, 2006 , by telephone on January 24/25, 2006 and by letters dated January 26, 2006 . Firm initiated recall is ongoing.
REASON
Consumption of the flour tortillas has been associated with a series of food borne illness outbreaks among individuals, mostly children, who complained of stomach pains, vomiting, diarrhea, nausea, and headaches. These reported symptoms typically occurred very soon after consuming the flour tortillas and resolved within one day. There does not appear to be any long-term adverse health effects.
VOLUME OF PRODUCT IN COMMERCE
15,431 cases
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
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PRODUCT
Diovan 80 mg, valsartan, 90 Tablets, Rx only, NOVARTIS, NDC 0078-0358-34, [NOTE: The recalled bottles with the printing error lack the “80 mg” and “90 Tablets” in green text on the label], Recall # D-193-6.
CODE
Lots F0182, exp. OCT 2007; F0183, exp. NOV 2007; F0184, exp. NOV 2007; F0185, exp. NOV 2007; F0185 W1, exp. NOV 2007
RECALLING FIRM/MANUFACTURER
Novartis Pharmaceuticals Corp., Suffern, NY, by letter on February 10, 2006 and February 13, 2006, firm initiated recall is ongoing.
REASON
Labeling: labels on a small quantity of bottles may lack the product strength and tablet count information.
VOLUME OF PRODUCT IN COMMERCE
239,568 bottles (total of 5 lots)
DISTRIBUTION
Nationwide and PR
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PRODUCT
Ultane® (sevoflurane) Inhalation Anesthetic, 250mL bottles, Rx only, NDC 0074-4458-04, Recall # D-194-6
CODE
Lot numbers: 34482DK, 34483DK and 34484DK
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories, North Chicago , IL , by letter, on or about February 10, 2006 .
Manufacturer: Hospira, Inc., Rocky Mount , NC , firm initiated recall is ongoing.
REASON
Defective container; bottles may have pinholes which could cause product to leak or evaporate.
VOLUME OF PRODUCT IN COMMERCE
53,442 bottles
DISTRIBUTION
Nationwide, PR, Jamaica , Bermuda , and the Bahamas
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PRODUCT
a) Levothyroxine Sodium Tablets USP, 50 mcg
(0.05mg), 100 count bottles, Rx only,
NDC 0781-5181-01, Recall # D-195-6
b) Levothyroxine Sodium Tablets USP, 88 mcg
(0.088mg), 100 count bottles, Rx only,
NDC 0781-5183-01, Recall # D-196-6;
c) Levothyroxine Sodium Tablets USP, 100 mcg
(0.1mg), 100 count bottles, Rx only,
NDC 0781-5184-01, Recall # D-197-6
CODE
a) Lot # 04T0971A Exp. Mar 06;
b) 03T4661A Exp 12/05, 03T6151A Exp 03/06,
03T6161A Exp 03/06, 03T6171A Exp 03/06,
04T1800 Exp 03/06, C0T0071A Exp 03/06
04T1821A Exp 03/06, 04T1841A Exp 03/06
04T1851A Exp 03/06;
c) 03T4191A Exp 02/06, 03T4161A Exp 02/06,
03T4211A Exp 02/06, 04T0500 Exp 03/06,
04T0750 Exp 03/06, 04T0760 Exp 03/06,
C04T0041A Exp 03/06, 04T0831A Exp 03/06
RECALLING FIRM/MANUFACTURER
Recalling Firm: Alara Pharmaceutical Corp, Caguas , PR, by letter on February 9, 2006 .
Manufacturer: Mova Pharmaceutical Corp, Caguas , PR, firm initiated recall is ongoing.
REASON
Subpotent; (21 month stability)
VOLUME OF PRODUCT IN COMMERCE
148,928 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
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PRODUCT
Sufentanil Citrate U.S.P. C-II 500 mg CAS 60561-17-3, Recall # D-187-6
CODE
Lot 315-05054-014, Expiration Date 03/31/06
RECALLING FIRM/MANUFACTURER
Cody Laboratories, Inc., Cody , WY , by telephone on January 16 and January 17, 2006 and by letters on January 20, 2006 , firm initiated recall is ongoing.
REASON
The level of acetone within sufentanil citrate was found to be out of specification.
VOLUME OF PRODUCT IN COMMERCE
17.9 grams
DISTRIBUTION
Nationwide
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PRODUCT
Prenatal Optima Advance Tablets, 10 Tablets per 10 Blister Strips per 100 count package, Recall # D-191-6
CODE
Lot numbers: 131518A exp 02/2006,
133208A exp 06/2006 and 133210A exp 05/2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals, USA , Sellersville , PA , by letters on January 16, 2006 .
Manufacturer: Novopharm Limited Toronto, Canada, firm initiated recall is ongoing.
REASON
Disintegration Failure
VOLUME OF PRODUCT IN COMMERCE
14,421 cartons of 100 tablets (10 Blister Strips of 10 Tablets per carton)
DISTRIBUTION
Nationwide
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PRODUCT
Ranitidine Tablets USP, 150 mg. The product is sold in 1000, 500, and 60 count bottles, Recall # D-192-6
CODE
Lot numbers 139432A exp 7/07, 139412A exp 7/07, and 139413A exp 7/07
RECALLING FIRM/MANUFACTURER
Recalling Firm: TEVA Pharmaceuticals USA, Sellersville , PA , by letters on January 26, 2006 .
Manufacturer: Novopharm Ltd., Toronto , Canada , firm initiated recall is ongoing.
REASON
Discoloration
VOLUME OF PRODUCT IN COMMERCE
84,485 bottles
DISTRIBUTION
Nationwide
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PRODUCT
a) Pramosone Cream 1% (hydrocortisone acetate
1% and pramoxine HCl 1%), 3 gram
professional sample size metal tubes,
12 tubes, Rx only, NDC 0496-0716-33,
Recall # D-198-6;
b) Analpram HC Cream 2.5% (hydrocortisone
acetate 2.5% and pramoxine HCl 1%) Net
Wt. 1 oz tubes, Rx only, NDC 0496-0800-04,
Recall # D-199-6
CODE
a) Lot 04107A; Exp. 7/07;
b) Lot 04139A; Exp. 08/06
RECALLING FIRM/MANUFACTURER
Ferndale Laboratories, Inc., Ferndale , MI , by letters on February 17, 2006 , firm initiated recall is ongoing.
REASON
Defective container; the metal tubes may have pinhole defects, which would result in a superpotent product.
VOLUME OF PRODUCT IN COMMERCE
194,383 tubes
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
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PRODUCT
Source Plasma, Recall # B-0387-6
CODE
Units: 390026474, 390026862, 390027539, 390027961, 390028191, 390028598, 390028885, 390033114, 390034877
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston , TX , by facsimile on January 6, 2005 . Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
Spain
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PRODUCT
Source Plasma, Recall # B-0388-6
CODE
Units: 390023514, 390023791, 390032331, 390032554, 390033079, 390033363, 390033574
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston , TX , by facsimile on January 6, 2005 . Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
Spain
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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0638-6
CODE
Unit: 011GR53659
RECALLING FIRM/MANUFACTURER
American National Red Cross, Missouri-Illinois Region, St, Louis, MO, by telephone on February 15, 2005, and by letter on March 1, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MO
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PRODUCT
a) Red Blood Cells, Recall # B-0648-6;
b) Platelets, Leukocytes Reduced, Recall # B-0649-6;
c) Fresh Frozen Plasma, Recall # B-0650-6
CODE
a) Unit numbers: 7963144, 7963155, 7963151, 7963148,
7963449, 2242167, 7963430, 7963437, 7963147;
b) Unit numbers 7963144, 7963148, 7963151, 7963155,
2242167;
c) Unit numbers: 7963144, 7963155, 2242167
RECALLING FIRM/MANUFACTURER
Life Source, Glenview , IL , by telephone on October 4, 2005 . Firm initiated recall is complete.
REASON
Blood products, collected from donors whose health history screening was inadequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
17 units
DISTRIBUTION
IL and PA
_______________________________
PRODUCT
Red Blood Cells,, Recall # B-0652-6
CODE
Unit number: S27452
RECALLING FIRM/MANUFACTURER
Central Illinois Community Blood Center , Springfield , IL , by facsimile and letter on September 22, 2005 . 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
IL
_______________________________
PRODUCT
a) Red Blood Cells, Recall B-0653-6;
b) Red Blood Cells Leukocytes Reduced
Recall # B-0654-6;
c) Platelets Leukocytes Reduced,
Recall # B-0655-6
CODE
a) Unit number: 0869833;
b) Unit numbers: 0958904, 0951844, 0927972,
0899403;
c) Unit numbers: 0951844, 0927972, 0899403
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center , Cincinnati , OH , by letter dated October 10, 2003 . Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had emigrated from a country with malarial endemic areas, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
OH, IN, and KY
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PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0667-6 (1 unit)
CODE
Unit number: 1158274 (half of double unit)
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center , Cincinnati , OH , by letter dated September 6, 2005 . Firm initiated recall is complete.
REASON
Blood product, corresponding to a red cell apheresis unit which was contaminated with alpha hemolytic streptococcus and involved in a transfusion reaction, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
_______________________________
PRODUCT
Platelets Pheresis, Recall # B-0683-6
CODE
Unit number: 71X17854X
RECALLING FIRM/MANUFACTURER
Life South Community Blood Center , Gainesville , FL , by fax on March 8, 2005 . Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0684-6
CODE
Unit number: 11GR63308
RECALLING FIRM/MANUFACTURER
The American National Red Cross, St. Louis , MO , by telephone on February 11, 2005 and by letters dated February 11 and February 24, 2005 . Firm initiated recall is complete.
REASON
Blood product, collected from a donor who visited a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced,
Recall # B-0685-6;
b) Red Blood Cells Leukocytes Reduced
Irradiated, Recall # B-0686-6
CODE
a) Unit number: 9528228;
b) Unit number: 9527635
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center , Indianapolis , IN , by fax on December 7, 2005 and follow-up letter dated December 30, 2005 .
REASON
Blood products, collected from a donor who visited a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IN
_______________________________
PRODUCT
Red Blood Cells, Recall # B-0688-6
CODE
Unit number: 4204010
RECALLING FIRM/MANUFACTURER
Southeastern Community Blood Center , Tallahassee , FL , by telephone and follow-up letter on February 20, 2004 . Firm initiated recall is complete.
REASON
Blood product, collected from a donor who visited a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced,
Recall # B-0689-6;
b) Red Blood Cells, Recall # B-0690-6;
c) Fresh Frozen Plasma, Recall # B-0691-6;
d) Recovered Plasma, Recall, Recall # B-0692-6
CODE
a) Unit numbers: 55F01528, 55F03960, 55FK23434,
55FS07462, 55H00925, 55H03154, 55H74102,
55H80233, 55H81837, 55H95935, 55S17518,
55Y24058;
b) Unit numbers: 55F61764, 55F69702, 55FK03764,
55H43559, 55H45157, 55H53538, 55H55345,
55H61731, 55R05615, 55R92515, 55R96469,
55S81623, 55S98344;
c) Unit numbers: 55F01528, 55FK23434;
d) Unit numbers: 55F03960, 55H00925, 55H03154,
55H95935
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Ozarks-Arkansas Region, Little Rock , AK , by telephone on June 3, 2005 and follow-up letters dated June 8, 2005 . Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE
31 units
DISTRIBUTION
KY, AR, TN and MO
_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0695-6
CODE
Unit numbers: 55FM09792 (parts 1 & 2)
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Ozarks-Arkansas Region, Little Rock, AK, by telephone on December 16, 2004. Firm initiated recall is complete.
REASON
Platelets, which were possibly contaminated with Staphylococcus epidermidis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AR
_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0696-6
CODE
Unit number: 55P45338
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Ozarks-Arkansas Region, Little Rock, AK, by telephone on June 22, 2004. Firm initiated recall is complete.
REASON
Platelets, which were possibly contaminated with gram-negative bacilli, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AR
_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0697-6
CODE
Unit number: 55FP26004
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Ozarks-Arkansas Region, Little Rock, AK, by telephone on September 1, 2004. Firm initiated recall is complete.
REASON
Platelets, which were possibly contaminated with coagulase negative Staphylococcus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AR
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0700-6
CODE
Unit number: 1410880
RECALLING FIRM/MANUFACTURER
Coffee Memorial Blood Center, Inc., Amarillo , TX , by telephone on February 3, 2005 , firm initiated recall is complete.
REASON
Blood product, labeled with an incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0703-6;
b) Platelets, Recall # B-0704-6
CODE
a) Unit numbers: 19GF27969, 19GF30466;
b) Unit number: 19GF30466
RECALLING FIRM/MANUFACTURER
American National Red Cross, Tennessee Valley Region, Nashville , TN , by letter dated March 12, 1997 , firm initiated recall is complete.
REASON
Blood products, collected from a donor who emigrated from an area with increased risk for human immunodeficiency virus (HIV) Group O, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TN
_______________________________
PRODUCT
Red Blood Cells Pheresis, Recall # B-0705-6
CODE
Unit numbers: S49169, S49160
RECALLING FIRM/MANUFACTURER
HCSC Blood Center , Bethlehem , PA , by telephone on June 20, 2005, firm initiated recall is complete.
REASON
Blood products, which failed quality control specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA
_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0706-6
CODE
Unit number: 49FP18213 (part 2)
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southwest Region, Tulsa , OK , by telephone on August 30, 2004 , firm initiated recall is complete.
REASON
Blood product, associated with a unit of Platelets that was possibly contaminated with Staphylococcus epidermidis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0714-6
CODE
Unit number: S34191
RECALLING FIRM/MANUFACTURER
Central Illinois Community Blood Center , Springfield , IL , by facsimile and letter on September 27, 2005 , 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
IL
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0715-6
CODE
Unit number: 12K97726
RECALLING FIRM/MANUFACTURER
American National Red Cross, Carolinas Region, Charlotte , NC , by telephone on April 6, 2004 and by letter on April 17, 2004 , firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor who had lived in an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0717-6;
b) Platelets, Recall # B-0718-6
CODE
a) and b) Unit number: 36GQ13948
RECALLING FIRM/MANUFACTURER
American National Red Cross, South Carolina Region, Columbia , SC , by letter on June 25, 1998 , firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA and SC

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
_______________________________
PRODUCT
Source Plasma, Recall # B-0381-6
CODE
Unit number: F-04346-072
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, Long Beach , CA , by fax on December 31, 2002
REASON
Blood product, collected from a donor whose suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
_______________________________
PRODUCT
Cryoprecipitated AHF, Recall # B-0637-6
CODE
Unit number: 18FK93076
RECALLING FIRM/MANUFACTURER
American National Red Cross, Great Lakes Region, Lansing , MI , by telephone on January 3, 2005 and by letter dated March 15, 2005 , firm initiated recall is complete.
REASON
Blood product, prepared from a whole blood unit with a discrepant collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
_______________________________
PRODUCT
Recovered Plasma, Recall # B-0651-6
CODE
Unit numbers: 7963151, 7963148, 7963449, 7963430, 7963437, 7963147
RECALLING FIRM/MANUFACTURER
Life Source, Glenview , IL , by facsimile on November 23, 2004 . Firm initiated recall is complete.
REASON
Blood products, collected from donors whose health history screening was inadequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
Switzerland
_______________________________
PRODUCT
Source Plasma, Recall # B-0680-6
CODE
Unit numbers: 390026314, 390026908, 390029376, 390033936, 390034379, 390034585
RECALLING FIRM/MANUFACTURER
Biomat USA Inc., Houston , TX , by fax on January 6, 2005, firm initiated recall is complete.
REASON
Blood products, collected from a donor with an incomplete medical history, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
Spain
_______________________________
PRODUCT
Fresh Frozen Plasma (Apheresis), Recall # B-0682-6
CODE
Unit numbers: 16GJ32136, 16KF46738, 16KF46747, 16KF46753, 16KF46770, 16KF46772, 16KF46806, 16KF46807
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Western Lake Erie Region, Toledo , OH , by telephone on February 12, 2005 and follow-up letter on February 15, 2005 , firm initiated recall is complete.
REASON
Blood products, for which shipping conditions were undocumented, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
OH
_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0698-6
CODE
Unit number: 49GP23872
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southwest Region, Tulsa , OK , by telephone on April 22, 2005 , firm initiated recall is complete.
REASON
Blood product, which was labeled leukoreduced but was not tested to determine the white blood cell count as required in the firm’s standard operating procedures, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0699-6
CODE
Unit number: 6884226
RECALLING FIRM/MANUFACTURER
Coffee Memorial Blood Center, Inc., Amarillo , TX , by telephone on July 9, 2003 , firm initiated recall is complete.
REASON
Blood product, possibly out of controlled storage for more than 30 minutes during leukoreduction, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
_______________________________
PRODUCT
a) Platelets, Recall # B-0707-6;
b) Platelets, Irradiated, Recall # B-0708-6;
c) Cryoprecipitated AHF, Recall # B-0709-6;
d) Plasma, Recall # B-0710-6;
e) Plasma, Cryoprecipitate Reduced,
Recall # B-0711-6;
f) Fresh Frozen Plasma, Recall # B-0712-6
CODE
a) Unit numbers: 20LC35558, 20LY24982,
20J20759, 20M12427, 20V10216, 20E18737,
20L08344, 20L03871, 20LY25179, 20E24984,
20S16574, 20J23542, 20J31644, 20LC40479,
20LC42494, 20LC31887, 20S16175, 20W07749,
20Q06637, 20S18274, 20S19396, 20S20015,
20H22832, 20L05558, 20L10916, 20S20043;
b) Unit numbers: 20S16784, 20X06239;
c) Unit numbers: 20GM66644, 20GM52701,
20GC09770, 20GM47396, 20GM54517, 20GC11924,
20V66336, 20GZ06587, 20GM60477, 20GZ06044,
20GM47217, 20GM47402, 20GZ14241
d) Unit numbers: 20GM47217, 20GM47396, 20GZ06044,
20GZ06587, 20GC09770, 20GM47402
e) Unit numbers: 20GM54517, 20GM66644, 20GC17095,
20GM52701, 20GZ14241, 20V66336
f) Unit numbers: 20S08009, 20E24984, 20S07006,
20J36485, 20K18675, 20S07859, 20S11028,
20T14251, 20X06239, 20K42128, 20S21398,
20W07862, 20GM56473, 20GM58995, 20GM66973
20H45488, 20K35169, 20LC30798, 20T09180,
20LZ13098, 20K42415, 20Q16012, 20S16175,
20S16784, 20T13848, 20V29639, 20LC40479,
20LC42013, 20LC33359, 20GC10404, 20E17407,
20E20592, 20J22920, 20J24981, 20J35933,
20J47822, 20K21758, 20K66139, 20L03871,
20L08344, 20L08628, 20L11138, 20M08108,
20M10263, 20M10324, 20Q16011, 20S08862,
20S13057, 20S14546, 20S16574, 20S16850,
20S18274, 20S20043, 20S30521, 20T09509,
20V06863, 20V10216, 20V13835, 20V17474,
20H46307, 20W07753, 20LC42757, 20H23105,
20J19522, 20K39551, 20S11390, 20T39028,
20LS04670, 20K42979, 20LC31887, 20LC33589,
20LS04008, 20M23936, 20LC38741, 20LC41859,
20LC63078, 20LY24982, 20LY25179, 20L09196,
20K35154, 20LC35558, 20S20015, 20W07750,
20J23542, 20K21295, 20L10916, 20M12427,
20S16776, 20S27273, 20S49460, 20V06033,
20M15052, 20T09548
RECALLING FIRM/MANUFACTURER
American National Red Cross, Lewis and Clark Region, Boise , ID , by letters dated November 13, 2003 and November 14, 2003 , firm initiated recall is complete.
REASON
Blood products, prepared from whole blood units with a discrepant collection time, were distributed.
VOLUME OF PRODUCT IN COMMERCE
146 units
DISTRIBUTION
AZ, CA, ID, MT, NY, OR, and UT
_______________________________
PRODUCT
Platelets, Recall # B-0713-6
CODE
Unit number: 9421376
RECALLING FIRM/MANUFACTURER
Community Blood Centers of South Florida, Inc., Lauderhill , FL , by facsimile on March 20, 2001 , firm initiated recall is complete
REASON
Blood product, which tested negative for the antibody to the human immunodeficiency virus (anti-HIV), but was collected from a donor who previously tested repeatedly reactive for HIV and negative by Western blot test, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
_______________________________
PRODUCT
a) Easypump ST 100-1 infusion pump, Recall # Z-0584-06;
b) Easypump L T 60-24 infusion pump, Recall # Z-0585-06
CODE
a) Lot # 562791;
b) Lot # 562857
RECALLING FIRM/MANUFACTURER
I-Flow Corporation, Lake Forest , CA , by letter dated January 17, 2006 , firm initiated recall is ongoing.
REASON
The sterile pack may contain the wrong infusion pump inside.
VOLUME OF PRODUCT IN COMMERCE
1,179 units
DISTRIBUTION
France
_______________________________
PRODUCT
Natural Hip System Collarless Stem, porous, with HA coating for cementless use only, Zimmer brand, sterile, Size 3, Right; Ref 7356-02-103, Recall # Z-0597-06
CODE
Lot # 1648124
RECALLING FIRM/MANUFACTURER
Zimmer Inc., Warsaw , IN , by email on February 22, 2006, firm initiated recall is ongoing.
REASON
Misbranded, the package actually contains an APR hip system, HA porous stem, 12 mm, left.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
AR,WI and Australia
_______________________________
PRODUCT
MaxLock Screwdriver, part MXS-056. This is a surgical instrument used in conjunction with the MaxLock Plate and Screw System, Recall # Z-0598-06
CODE
Lot # 11298
RECALLING FIRM/MANUFACTURER
Recalling Firm: Orthohelix Surgical Designs, Inc., Akron , OH , by telephone and visits between November 1, and November 7, 2005 .
Manufacturer: Troy Innovative Instruments, Inc., Garrettsville , OH , firm initiated recall is ongoing.
REASON
Screwdriver pilot taper tip can break during surgery.
VOLUME OF PRODUCT IN COMMERCE
14 instruments
DISTRIBUTION
OH, MO, TX, SD, CO, NJ, GA and FL
_______________________________
PRODUCT
Baxter Auto Syringe AS40 and AS40A Infusion Pump, product code 1M8565 (pumps with drug library option) and product codes 1M8560 and 1M8560R (pumps without drug library option), Recall # Z-0599-06
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake , IL , by letters dated 2/8/06 .
Manufacturer: Baxter Healthcare Corp., Singapore , firm initiated recall is ongoing.
REASON
The occlusion detection and alarm may be delayed when the pumps are used with larger volume syringes at low flow rates.
VOLUME OF PRODUCT IN COMMERCE
17,400 pumps
DISTRIBUTION
Nationwide and Canada
______________________________
PRODUCT
Cook Zilver 635 Biliary Stent – Expanding Stent, delivery system length 80 cm, stent diameter 8.0 mm, stent length 40 mm, minimum guiding catheter 8.0 French, minimum sheath 6.0 French, recommended wire guide size .035 inch dia., sterile; Catalog # ZIB6-80-8.0-40, Recall # Z0600-06
CODE
Lot # 1557057
RECALLING FIRM/MANUFACTURER
Cook, Inc., Bloomington , IN , by telephone and fax on January 26, 2006 , firm initiated recall is ongoing.
REASON
The side of the boxes give incorrect sizes for these stents. The label front is correct.
VOLUME OF PRODUCT IN COMMERCE
5 stents
DISTRIBUTION
CA, PA, UT and Canada
______________________________
PRODUCT
Hospira LifeCare PCA3 Infusion System Software, versions 4.08 and 4.09, Recall # Z-0601-06
CODE
List numbers 12384-04, software version 4.08 and 4.09
RECALLING FIRM/MANUFACTURER
Hospira, Inc., Morgan Hill , CA , by letters on November 2, 2005 , firm initiated recall is ongoing.
REASON
Incorrect values for dosage, dose limit, concentration or rate of delivery may display on screen.
VOLUME OF PRODUCT IN COMMERCE
10,489 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III
_______________________________
PRODUCT
a) Thermoplastic templates, single tooth,
Catalog Number 040.526, Recall # Z-0602-06;
b) Thermoplastic templates, free-end situation,
Catalog Number 040.527, Recall # Z-0603-06
CODE
a) Lot # A2283;
b) Lot # A2284
RECALLING FIRM/MANUFACTURER
Recalling Firm: Straumann Manufacturing Inc., Andover , MA , by letter dated January 30, 2006 .
Manufacturer: Institut Straumann, AG, Basel , Switzerland , firm initiated recall is ongoing.
REASON
Pilot drills may not fully extend through drill guide in template products.
VOLUME OF PRODUCT IN COMMERCE
138 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: VETERNIARY MEDICINE - CLASS III
_______________________________
PRODUCT
Co-op 11% Sweet Horse Feed Course, net wt 50 lbs, Recall # V-062-06
CODE
Lot number 43125327
RECALLING FIRM/MANUFACTURER
Tennessee Farmers Cooperative, Rockford , TN , by telephone on January 27, 2006 . Firm initiated recall is complete.
REASON
Horse feed was found to contain monesin in trace levels not considered to be a health threat to horses.
VOLUME OF PRODUCT IN COMMERCE
524/50 pound bags
DISTRIBUTION
TN and NC

END OF ENFORCEMENT REPORT FOR MARCH 15 2006

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