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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April 18, 2007
07-16

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

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PRODUCT
Tuna & Garden Salad Mixer. Label includes 'Tuna & Garden Salad Mixer fresh from Gretchen's SHOEBOX EXPRESS 206.623.8194. Product is packaged in 10 oz, 6 inch x 9 inch x 1 inch container. The container is a black plastic semi-rigid bottom with a clear plastic semi-rigid top. The adhesive label is added to the top and bottom of the container and the salad is wrapped in clear polypropylene. Dressing is packaged in a separate 1.75 oz plastic container with a lid and packed in the salad container. Recall # F-183-7
CODE
Firm date codes product by numeric month and day. Each product is coded with the following ''Made Daily Enjoy By 3 04'', up to and including ''3 17''.
RECALLING FIRM/MANUFACTURER
Gretchen, Seattle, WA, by telephone on March 14, 2007 and by press release on March 15, 2007. Firm initiated recall is complete.
REASON
Product contains undeclared soybeans (edamames).
VOLUME OF PRODUCT IN COMMERCE
235 containers
DISTRIBUTION
WA

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PRODUCT
The Grainless Baker GFCF Sandwich Bread, Net Wt 18 oz. The product is Gluten Free and Casein Free Sandwich Bread that is packaged in a plastic bag, Recall # F-184-7
CODE
The bags are not coded
RECALLING FIRM/MANUFACTURER
The Grainless Baker, Lake Ariel, PA, by press release on February 5, 2007 and by letter on February 6, 2007. Firm initiated recall is ongoing.
REASON
Sandwich Bread contains undeclared milk protein.
VOLUME OF PRODUCT IN COMMERCE
48 bags
DISTRIBUTION
NY, CT and PA

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PRODUCT
Kaija Brand uneviscerated Herring in Special Brine. The product is packaged in an uncoded 1300 gram metal can. According to NYSDAM, the product appears to be labeled mainly in Cyrillic characters. There is no English labeling. --- According to NYSDAM'S lab report, the fish are whole, 11 inches long with six fish per can; UPC bar code 4 600349 64272 3, Recall # F-185-7
CODE
UPC bar code and no other coding
RECALLING FIRM/MANUFACTURER
Recalling Firm: East Coast Foods, Inc., Brooklyn, NY, by press release and letter dated November 28, 2006.
Manufacturer: Karavela, Riga, Latvia. New York State initiated recall is complete.
REASON
The product is an uneviscerated fish based on sampling and analysis by New York State Department and Markets. This product poses a health risk if consumed as it may contain Clostridium botulinum spores which can cause botulism.
VOLUME OF PRODUCT IN COMMERCE
48 cans
DISTRIBUTION
MN, MD, MA, NY, and FL

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PRODUCT
Sundia brand Fresh Mexican Cantaloupes, packed in cardboard boxes, Recall # F-186-7
CODE
None on the individual product. Distribution occurred between October 30th and November 6th, 2006. Pallets containing cantaloupes marked with pallet numbers: 7508294, 7508292, 7508293, 7508295, 7508296, 7508297, 7508307, 7508308, 7508309
RECALLING FIRM/MANUFACTURER
Recalling Firm: Timco Distributors, Inc, Woodland, CA, by telephone on November 8, 2006 and by press release and letter on November 14, 2006.
Manufacturer: Vinedos Alta, S.A. de C.V., Hermosillo, Sonora, Mexico. Firm initiated recall is ongoing.
REASON
Sample analysis by FDA labs found the product contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
504 cases
DISTRIBUTION
AZ, CO, FL, and TX

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PRODUCT
Fritos® Brand '75th Anniversary Edition' Original Corn Chips, Net Wt. 2 oz. (56.7 g); UPC #28400 04793, Recall # F-187-7
CODE
Product has a freshness date of ''MAY 8'' with a 10 digit code: 62730483692, 62730483592 or 62730483992
RECALLING FIRM/MANUFACTURER
Recalling Firm: Frito Lay, Inc., Plano, TX, by telephone, letter and press release on March 9, 2007.
Manufacturer: Frito Lay, Inc, Rosenberg, TX. Firm initiated recall is ongoing.
REASON
Undeclared milk and wheat; bags labeled as Fritos Original Corn Chips actually contained Fritos Chili Cheese flavored corn chips. The Chili Cheese flavor contains milk and wheat derived ingredients that are not listed on the label of the Original flavor bag.
VOLUME OF PRODUCT IN COMMERCE
240 cases (60 bags/case)
DISTRIBUTION
Nationwide

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PRODUCT
“Simply Fresh Fruit Fresh Cut Fruit Tray” with a sell by date of 2-26-07, Item#50683. ****Four types of fruit in a clear plastic tray with a clear plastic top. The fruit is divided in 4 portion parts separating the fruit. Portion parts consist of pineapples; strawberries; grapes and cantaloupes, Recall # F-188-7
CODE
Lot #22419, Sell by date of 2-26-07
RECALLING FIRM/MANUFACTURER
Simply Fresh Fruit, Inc. Vernon, CA, by fax and email on February 23, 2007 and by press release on March 1, 2007. Firm initiated recall is complete.
REASON
The fruit tray was manufactured using cantaloupes that FDA found contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
2,250 trays of 5 lbs of fresh cut fruit
DISTRIBUTION
CA

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PRODUCT
Pancake mix in cardboard box labeled GFS BUTTERMILK PANCAKE MIX MEZCLADELECHE DE MANTEQUILLA PARA PANCAKES NET WT 5 LBS; UPC 93901 24580, Recall # F-189-7
CODE
Codes beginning with KB6313, KB6314 printed on top flap
RECALLING FIRM/MANUFACTURER
Recalling Firm: Continental Mills, Inc, Kent, WA, by telephone and/or email and letter on March 8, 2007 and by press release on March 9, 2007.
Manufacturer: Continental Mills, Hopkinsville, KY. Firm initiated recall is complete.
REASON
Product contains undeclared eggs.
VOLUME OF PRODUCT IN COMMERCE
1,253 cases (6/5 lb cartons)
DISTRIBUTION
MI, OH, KY and FL

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PRODUCT
CASTLE PRODUCE CANTALOUPE MELONS ****The product was shipped in two types of cartons: (1) TOPIFRESH Brand & (2) FYFFES Brand Note: See description below. The cantaloupes have a light green color skin on the exterior, with orange flesh. The cantaloupes were distributed for sale in bulk in cardboard cartons, with 9, 12 or 15 cantaloupes to a carton. The recalled cartons are:
(1) A Brown cardboard box, with a handle hole in the top middle. There is a box on top and below this box with a pallet of boxes being shown in the upper left of the photo. Above the handle hole is a single line in green printed table with numbers, in green, '' 6, 9 12, 15th and 18th''. Above the table is the lettering in green, ''COUNT.'' Underneath the handle hole is a white label in black lettering and the United Product Code that reads ''TropiFresh Carrillo Lote: 010-02-007 Ano: 2007.'' Below this is the United Product Code lines which has the following numbers below the bars reading, ''100200703707.'' The white sticker covers up the ''Tropi'' green lettered name but the orange lettered ''fresh'' is shown. The green letter ''T'' in Tropifresh is actually a palm tree with the bottom of the truck continuing as a swish below the company full name. Under the swish in green letter reads, Quality Melons.'' Below the Tropifresh in the center appears the following green lettered printing reading, ''CANTALOUPES (Cucumis melo). Underneath this reads in green lettering, ''Produced and packed by Tropifresh de Costa Rica S.A. Cod. REG. MAG 2017.''
(2) They are Blue and White cardboard boxes with blue running left to right for 2/3rds length of the box then turning to white, that contains cantaloupes inside a clear plastic liner with vent holes on the left and the right. You can see the cantaloupes through the cut out. At the top of the box in white lettering reads, ''CANTALOUPES.'' On the right top side, just to the top left on the vent hole is a white label with black lettering and the United Product Code line symbol. The label reads top to bottom, ''TropiFresh Carrillo Lote: 010-02-009 Ano: 2007.'' The United Product Code lines follow with the numbers under the lines unreadable. There is a yellow circle in the left middle of the blue part of the box with the following word, ''fyffes.'' Below this word is a white banding strap that runs across the box, left to right and cuts through two cantaloupes one on top of the other. The first cantaloupe is yellow and green showing the skin and the second one is all yellow trimmed in green. The second vent hole cuts into the yellow cantaloupes.'' Recall # F-191-7
CODE
Master Code Bar Code 0100200902807 & 0100100102907
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tropical Produce, Inc., Los Angeles, CA, by telephone and/or fax and press release on February 23, 2007 and by letter on February 26, 2007.
Manufacturer: Tropifresh De Costa Rica S.A., Guanacaste, Costa Rica. Firm initiated recall is ongoing.
REASON
The product may be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
2,560 melons
DISTRIBUTION
CA

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PRODUCT
QUESADILLA. Net weight 2 oz. Ingredients: Wheat flour, sugar, yeast, salt, vanilla. Product is packaged in a sealed plastic wrap, Recall # F-192-7
CODE
Uncoded
RECALLING FIRM/MANUFACTURER
Ana's Bakery, Inc., Hempstead, NY, by press release on September 28, 2006. Firm initiated recall is complete.
REASON
The product contained undeclared milk ingredient based on sampling, analysis, and inspectional findings made by the New York State Department of Agriculture & Markets. During inspection, NYSDAM obtained the ingredient listing.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
NY

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PRODUCT
Imoto Mame Mix (Bean Cracker); a mixture of flavored crackers, cracker coated broad beans and cracker coated peanuts, packaged in a plastic tray within a plastic bag, Net Wt. 8.8 oz. (250 g), 15 bags per case; UPC 7 84145 22075 1, Product code: 22-3163; Recall # F-196-7
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Daiei Trading Chicago Corp., Inc., Carol Stream, IL, by press release, telephone and letters dated February 22, 2007.
Manufacturer: Imoto Toka Co., Ltd., Osaka, Japan. Firm Initiated recall is ongoing.
REASON
The product contains peanuts which are not declared as an ingredient on the label.
VOLUME OF PRODUCT IN COMMERCE
540 cases
DISTRIBUTION
Nationwide

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

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PRODUCT
Guida's Chocolate Lowfat Milk (1/2% Milkfat Vitamin A&D, Half Pint (236ml), Product Code: 138, Recall # F-190-7
CODE
Sell by Date: “APR13”
RECALLING FIRM/MANUFACTURER
Guida-Seibert Dairy Co., New Britain, CT., by telephone beginning March 28, 2007. Firm initiated recall is complete.
REASON
Product was contaminated with sanitizer agent.
VOLUME OF PRODUCT IN COMMERCE
518 cases
DISTRIBUTION
NY, CT, MA and RI

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

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PRODUCT
Publix Deli brand Sweetened Brewed Ice Tea packaged in a 1 gallon plastic bottle. Product is a liquid; Recall # F-194-7
CODE
NOV 13, PLT 12-506 xx:xx (package time) C3
RECALLING FIRM/MANUFACTURER
Publix Super Markets, Lakeland, FL, by Intranet on October 12, 2006. Firm initiated recall is complete.
REASON
Product is misbranded in that the front label correctly identified the product as “sweetened”, but the back label bore the ingredient statement and nutrition facts panel for the unsweetened ice tea.
VOLUME OF PRODUCT IN COMMERCE
9,362 cases (585 cases mislabeled)
DISTRIBUTION
FL, SC, GA, AL and TN

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PRODUCT
Meijer brand Natural Calcium with Vitamin D USP tablets, 1200 mg & D per serving, 300 coated caplets; UPC 4125003889; Recall # F-195-7
CODE
Lot: 5HN0384; Exp. 05/2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: L. Perrigo Co., Allegan, MI, by email on January 31, 2007.
Manufacturer: Perrigo Company of South Carolina, Greenville, SC. Firm initiated recall is ongoing.
REASON
The bottles may actually contain 400 IU Vitamin E gelcaps.
VOLUME OF PRODUCT IN COMMERCE
3,228 bottles
DISTRIBUTION
MI

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

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PRODUCT
Levoxyl, Levothyroxine Sodium Tablets, USP, 125mcg, 100 count bottles, Rx only, Recall # D-491-2007
CODE
Lot Nos.: 37187, expiration 04/2008 and 37188, expiration 04/2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: King Pharmaceuticals, Inc., Bristol, TN, by letter on March 20, 2007.
Manufacturer: King Pharmaceuticals, Inc, (St. Petersburg Facility), St. Petersburg, FL. Firm initiated recall is ongoing.
REASON
Adulterated presence of foreign tablet found in bottle (Levoxyl 50mcg)
VOLUME OF PRODUCT IN COMMERCE
44,979 bottles
DISTRIBUTION
Nationwide and PR

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

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PRODUCT
Senna Natural Laxative Tablets (sennosides) 8.6 mg, 100 count bottles, Distributed by Eckerd Drug Company, (SKU #: 516351 and 537765) and also Made for K-mart Corporation, (SKU #: 384466-124 and 384466-116); Recall # D-490-2007
CODE
Lot numbers: (Eckerd) 6DB0241, 6DB0641, 6NB0082, 6MB0167 and (K-mart) 6CB0936, 6EB0509, 6MB0283, 6MB0282.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Leiner Health Products LLC, Carson, CA, by letter on March 8, 2007.
Manufacturer: Time-Cap Labs, Farmingdale, NY. Firm initiated recall is ongoing.
REASON
Subpotent
VOLUME OF PRODUCT IN COMMERCE
4082.4 tablets
DISTRIBUTION
IL and RI

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PRODUCT
Fougera Amcinonide Ointment USP, 0.1%, NET WT 30 grams, Rx only, NDC 0168-0279-30; Recall # D-492-2007
CODE
Lots S784 (exp. 6/07), T787 (exp. 11/07), U987 (exp. 4/08), U988 (exp. 4/08)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Altana Inc., Melville NY, by letters on April 3, 2007.
Manufacturer: Altana Inc., Hicksville NY, Firm initiated recall is ongoing.
REASON
Subpotent; (amcinonide 9-month)
VOLUME OF PRODUCT IN COMMERCE
18,482 units
DISTRIBUTION
Nationwide and PR

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

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PRODUCT
Platelets Pheresis Leukocytes Reduced, Irradiated, Recall # B-0940-07
CODE
Unit: S67507
RECALLING FIRM/MANUFACTURER
Central Illinois Community Blood Center, Springfield, IL, by fax and follow-up recall notice on October 16, 2006. Firm initiated recall is complete.
REASON
Blood product, with incomplete documentation of the irradiation process, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0954-07
CODE
Unit: LM26190
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, DBA Rhode Island Blood Center, Providence, RI, by letter dated January 25, 2007. 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
MA

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PRODUCT
Source Plasma, Recall # B-0956-07
CODE
Units: 36400103l, l72059659, l72059482, l72058424, l72057063
RECALLING FIRM/MANUFACTURER
International BioResources L.L.C., Fort Worth, TX, by fax on August 8, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with unconfirmed dates of tattoo applications, were distributed
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
NC

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PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0967-07
CODE
Unit: 4142730
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Inc., Indianapolis, IN, by telephone on December 17, 2006 and by letter dated December 27, 2006. Firm initiated recall is complete.
REASON
Platelets, which were possibly contaminated with Propionibacterium acnes, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0986-07
CODE
Units: 17FM15362, 17FM15363, 17FM15364, 17FM15365, 17FM15366, 17FM15367, 17FM15368, 17FM15370, 17FM15371, 17FM15372
RECALLING FIRM/MANUFACTURER
American National Red Cross, North Central Region, St. Paul, MN, by telephone on April 16, 2004 or April 17, 2004 and by follow-up letter dated April 23, 2004. Firm initiated recall is complete.
REASON
Blood products, manufactured from units of Whole Blood which may have reached an unacceptable temperature during shipment, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
MA, MN, and WI

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1058-07
CODE
Unit: 21LE07874
RECALLING FIRM/MANUFACTURER
American National Red Cross, Pacific Northwest Region, Portland, OR, by telephone on July 12, 2005 and by letter dated July 15, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1065-07
CODE
Units: Y02485, Y02494
RECALLING FIRM/MANUFACTURER
Blood Assurance Inc., Chattanooga, TN, by telephone on July 26, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose eligibility to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AL

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1066-07
CODE
Unit: 21LV08602
RECALLING FIRM/MANUFACTURER
American National Red Cross, Pacific Northwest Region, Portland, OR, by telephone on July 18, 2005 and by letter dated July 21, 2005. Firm initiated recall is complete.
REASON
Blood product, which was not quarantined after receiving information regarding a post-donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OR

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PRODUCT
Human Corneas for Transplantation, Recall # B-1068-07
CODE
Tissues: IA-2007-02-048R1, IA-2007-02-048L1
RECALLING FIRM/MANUFACTURER
Iowa Lions Eye Bank, Iowa City, IA, by telephone on March 5, 2007. Firm initiated recall is complete.
REASON
Human tissues for transplantation, which tested negative for hepatitis prior to distribution, but were subsequently found to test repeatedly reactive for antibodies to hepatitis B core antigen (anti-HBc), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues
DISTRIBUTION
IA and NB

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1070-07
CODE
Unit: 20LC66740
RECALLING FIRM/MANUFACTURER
American National Red Cross, Lewis and Clark Region, Boise, ID, by facsimile on June 10, 2004. 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
ID

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-1073-07
CODE
Units: LN74138, FJ95639
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by facsimile on June 6, 2003. Firm initiated recall is complete.
REASON
Blood products, for which documentation of irradiation was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WI

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-1074-07
CODE
Unit: 3859513
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Inc., Indianapolis, IN, by telephone on January 7, 2007 and by letter dated March 2, 2007. Firm initiated recall is complete.
REASON
Blood products, for which documentation of irradiation was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN

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PRODUCT
Source Plasma, Recall # B-0956-07
CODE
Units: 364001031, 172059659, 172059482, 172058424, 172057063
RECALLING FIRM/MANUFACTURER
International BioResources L.L.C., Fort Worth, TX, by fax on August 8, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with unconfirmed dates of tattoo applications, were distributed
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
NC

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

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PRODUCT
Red Blood Cells Pheresis, Recall # B-0959-07
CODE
Unit: C77412
RECALLING FIRM/MANUFACTURER
HCSC Blood Center, Bethlehem, PA, by letter dated November 10, 2006. Firm initiated recall is complete.
REASON
Blood product, which had an unacceptable volume, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA

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PRODUCT
Red Blood Cells, Recall # B-1059-07
CODE
Unit: 7221486
RECALLING FIRM/MANUFACTURER
Land Memorial Blood Bank, Eugene, OR, by facsimile on December 14, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor due to a history of hemochromatosis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OR

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-1060-07
CODE
Units: 21LC19451, 21LC19480, 21LC19831, 21LC19443
RECALLING FIRM/MANUFACTURER
American National Red Cross, Pacific Northwest Region, Portland, OR, by telephone on June 17, 2004 and by letter dated June 21, 2004. Firm initiated recall is complete.
REASON
Blood products, for which there was no documentation for the time period out of controlled storage, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
OR

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1061-07;
b) Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-1062-07;
c) Platelets Pheresis, Recall # B-1063-07;
d) Platelets, Pooled, Leukocytes Reduced, Recall # B-1064-07
CODE
a) Units: R42756, R42757, R42771, R42773, C71453, C71455, C71456,
C71457, C71458, C71462, C71463, C71464, C71392, C71393, C71395,
H22161, H22162, H22165, H22175, H22177, H22178, N00268-01,
R42659, R42660, R42661, R42753, R42755, R42760, R42770, H22164,
H22179, H22180, H22231-61, R42654, R42656, R42657;
b) Unit: R42759;
c) Unit: P13546;
d) Units: R42752, R42754, H22165, R42760, C71453, H22162
RECALLING FIRM/MANUFACTURER
South Bend Medical Foundation, Inc., South Bend, IN, by letter dated July 19, 2006. Firm initiated recall is complete.
REASON
Blood products, improperly tested for hepatitis C virus (HCV) by the Nucleic Acid Test (NAT) method, were distributed.
Indiana consignees by
VOLUME OF PRODUCT IN COMMERCE
44 units
DISTRIBUTION
IN

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PRODUCT
Source Plasma, Recall # B-1067-07
CODE
Units: l7205843l, l72059l49, 364004l77
RECALLING FIRM/MANUFACTURER
International BioResources L.L.C., Fort Worth, TX, by facsimile on November 27, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NC

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

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PRODUCT
a) AMS DURA-II Distal Tips, 4 cm, Product Number 72009340, Sterile,
Recall # Z-0702-2007;
b) AMS DURA-II Universal Tips, 2 cm, Product Number 72009361, Sterile,
Recall # Z-0703-2007
CODE
a) Lot: 475177;
b) Lot: 475175
RECALLING FIRM/MANUFACTURER
American Medical Systems, Minnetonka, MN, by letter on February 7, 2007. Firm initiated recall is ongoing.
REASON
Mis-Labeling. The Dura-II 2 cm Universal Tips and the Dura-II 4 cm Distal Tips were incorrectly labeled with the opposite labels.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
Nationwide

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PRODUCT
Sea-Clens Wound Cleanser, 6 fl. oz., #11701-159-36, #1063, Recall # Z-0710-2007,
CODE
Lot #932502, box sequence numbers 299 to 953.
RECALLING FIRM/MANUFACTURER
Coloplast Corp Skin Care Division, North Mankato, MN, by telephone on February 14, 2007. Firm initiated recall is ongoing.
REASON
Coloplast Corp. is recalling Sea-Clens brands Sea-Clens wound cleaner which were found to have some particulates (foreign materials).
VOLUME OF PRODUCT IN COMMERCE
7,848 6 fl. oz. bottles
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
Sunrise Medical-Hoyer Advance Patient Lifts (Portable and Folding Patient Lift), Recall # Z-0727-2007
CODE
Model number Hoy - Advance - E Serial numbers: 0601L0433 through 0601L0441, 0603L0294 through 0603L0336, 0603L0493 through 0603L0501, 0603L1011 through 0603L1021, 0603L1139 through 0603L1187, 0603L1285 through 0603L1294, 0604L0394 through 0604L0411, 0604L0885 through 0604L0941, 0604L1002 through 0604L1012, 0606L0365 through 0606L0431, 0606L0789 through 0606L0818, 0606L1006 through 0606L1030, and 0607L0001 through 0607L0090 Model number Hoy - Advance - H Serial numbers: 0601L0442 through 0601L0459, 0603L0286 through 0603L0293, 0603L1022 through 0603L1041, 0603L1295 through 0603L1330, 0603L1519 through 0603L1572, 0605L0742 through 0605L0753, 0606L0049 through 0606L0142, 0606L0819 through 0606L0848, and 0606L1031 through 0606L1144
RECALLING FIRM/MANUFACTURER
Recalling Firm: Joerns Healthcare Inc., Stevens Point, WI., by telephone on February 21, 2007.
Manufacturer: Apex Health Care Mfg., Inc., Taiwan, Republic Of China. Firm initiated recall is ongoing.
REASON
Unapproved Design Change (by base supplier) consisting of a reduction in the number of mast-to-base welds (from four welds to two welds).
VOLUME OF PRODUCT IN COMMERCE
581 units
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
a) Flexxus™ Endoscopic Biliary Stent, 7.5 Fr 10mm diameter x 40 mm length,
Item Number: LXB10040, Recall # Z-0729-2007;
b) Flexxus™ Endoscopic Biliary Stent, 7.5 Fr 10 mm diameter x 60 mm length,
Item Number: LXB10060, Recall # Z-0730-2007
CODE
a) Lot Numbers: ANQJO636, ANQJO63;
b) Lot Number: ANQJ0639
RECALLING FIRM/MANUFACTURER
Recalling Firm: Conmed Endoscopic Technologies, Inc., Billerica, MA, by letter dated March 14, 2007.
Manufacturer: Angiomed GmbH & Co., Karlsruhe, Germany. Firm initiated recall is ongoing.
REASON
Blue safety clip incorrectly placed on the stent may prevent deployment
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
DE, OH, MI, DC, Belgium and Japan

___________________________________
PRODUCT
Bio-Rad-TOX/See Drug Screen Test (25 tests/box), Catalog number 194-5230; Recall # Z-0733-2007
CODE
DOA6120272
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bio-Rad Laboratories Inc., Hercules, CA., by fax and telephone on February 12, 2007.
Manufacturer: Inverness Medical Porfessional Diagnostics, San Diego, CA. Firm initiated recall is ongoing.
REASON
The product may produce a faint line which could be interpreted as a false negative test result.
VOLUME OF PRODUCT IN COMMERCE
177 kits
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
a) AmpliChip CYP450 Test-US IVD-M/N: 4591402190, Roche Molecular
Diagnostics, Recall # Z-0734-2007;
b) AmpliChip CYP450 Test, CE-IVD, M/N: 4381866190, Roche Molecular
Systems, Inc., Recall # Z-0735-2007
CODE
a) US Distribution: Batches: H08499, H10626, H13592, J00807, J00815;
b) European Distribution: Batches: H08500, H13591, H14242, J00383, J00814
RECALLING FIRM/MANUFACTURER
Roche Molecular Systems, Inc., Somerville, NJ, by letters on March 9, 2007. Firm initiated recall is ongoing.
REASON
The current package insert for the AmpliChip CYP 450 test, lists an incorrect part number for DNase I. The DNase is listed in the "Other Materials Required" section as 'DNase I rec., RNase-free, P/N 04716728001 (Roche Applied Science)". The Part Number listed for the DNase I listed is incorrect and of lower specific activity than the correct/validated DNase.
VOLUME OF PRODUCT IN COMMERCE
209
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
Roche COBAS Integra DIG, Digoxin Reagent for use on the COBAS INTEGRA models 400, 400 plus, 700 and 800 analyzers, as well as, Cobas c 501 analyzer; Catalog Number 20737836322, Recall # Z-0736-2007
CODE
Lots 67941901, exp. 4/30/07; 68139201, exp. 6/30/07 and 68156201, exp. 8/31/07
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letter dated March 16, 2007.
Manufacturer: Roche Diagnostics Gmbh, Mannheim, Germany. Firm initiated recall is ongoing.
REASON
The lower detection limit (LDL) may be a higher value than stated in the labeling.
VOLUME OF PRODUCT IN COMMERCE
4,735 units
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional use), Recall # Z-0737-2007
CODE
Lots 469A and 475A; exp. 6/30/2008
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corp., Indianapolis, IN, by telephone on/or about February 28, 2007, and by letters dated March 2, 2007 or March 5, 2007. Firm initiated recall is ongoing.
REASON
The product was erroneously distributed to home users in contrast to its use for healthcare professionals only.
VOLUME OF PRODUCT IN COMMERCE
10 packs
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
a) Vaxcel Implantable Vascular Access System -Titanium Standard Port
With 9F Polyurethane Catheter, Catalog/REF No. 45-315,
UPN/Material No. M001453150, Single Use Only, STERILE, EO.
The port is provided as a kit, with various single use, disposable items
necessary for achieving vascular access and implanting the port catheter.
Each kit is provided in a plastic (PETG) tray with a heat-sealed tyvek lid.
This inner tray is then placed in a second outer plastic (PETG) tray, along
with the Directions for Use, and also sealed with a tyvek lid which is then labeled.
The port kit is placed in a cardboard carton, with additional labels and sealed,
Recall # Z-0745-2007
b) Vaxcel Implantable Vascular Access System - Plastic Standard Port
With 9F Polyurethane Catheter, Catalog/REF No. 45-360, UPN/Material
No. M001453600, Single Use Only, STERILE, EO. The port is provided
as a kit, with various single use, disposable items necessary for achieving
vascular access and implanting the port catheter. Each kit is provided in
a plastic (PETG) tray with a heat-sealed tyvek lid. This inner tray is then
placed in a second outer plastic (PETG) tray, along with the Directions for
Use, and also sealed with a tyvek lid which is then labeled. The port kit is
placed in a cardboard carton, with additional labels and sealed,
Recall # Z-0746-2007
CODE
a) Lots 1103350 and 1113798;
b) Lots 1109717 and 1120230
RECALLING FIRM/MANUFACTURER
Boston Scientific Corp., Glens Falls, NY, by letters dated June 13, 2006. Firm initiated recall is complete.
REASON
Mispackaging: some kits of peelable sheaths/dilators may contain a 10F sheath instead of a 9F sheath--(Recalling Firm was notified by their supplier B. Braun Medical of the error)
VOLUME OF PRODUCT IN COMMERCE
27 units
DISTRIBUTION
NY, CA, MD, WA, and TN

___________________________________
PRODUCT
VITROS® Immunodiagnostics Products HBsAg Reagent Pack, Catalog # 6801322: 1 Reagent Pack box per sales unit (100 tests per box), and Catalog # 6802450: 5 Reagent Pack boxes per sales unit (100 tests per box), IVD, Recall # Z-0747-2007
CODE
Lots 6000 and 6030 thru 6120
RECALLING FIRM/MANUFACTURER
Ortho-Clinical Diagnostics, Cardiff, UK, by letter and email on February 1, 2007. Firm initiated recall is ongoing.
REASON
Complaints of an increase in ''Reactive'' results with patient samples collected in sodium citrate or EDTA plasma collection tubes when using these lots of VITROS HBsAg Reagent Pack compared to samples collected in other tube types.
VOLUME OF PRODUCT IN COMMERCE
15,886 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

___________________________________
PRODUCT
a) Biohorizons 0.035 Hex Driver, REF 300-377, non-sterile, Rx only, REF 300-377,
non-sterile, Rx only, Recall Z-0692-2007;
b) Biohorizons 0.050 Hex Driver, Regular, REF 300-350, non-sterile, Rx only,
Recall # Z-0693-2007;
c) Biohorizons 0.050 Hex Driver, Long, REF 300-351, non-sterile, Rx only,
Recall # Z-0694-2007
CODE
a) Lot No 09040003;
b) Lot No. 06060009;
c) Lot No. 08060239
RECALLING FIRM/MANUFACTURER
BioHorizons Implant Systems, Inc., Birmingham, AL, by letters and replacement drivers on March 12, 2007. Firm initiated recall is ongoing.
REASON
Premature Wear; The material from which the hex driver was made was improperly hardened during manufacturing and could lead to premature wear.
VOLUME OF PRODUCT IN COMMERCE
1,294 units
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
1,25-Dihydroxyvitamin D RIA Kit. For the quantitative determination of 1,25 Dihydroxyvitamin D in serum or EDTA plasma, Part #65100E, Recall # Z-0707-2007
CODE
Lot's: 117139, 117140, 1117141
RECALLING FIRM/MANUFACTURER
Diasorin, Inc., Stillwater, MN, by email or fax on June 1, 2006. Firm initiated recall is ongoing.
REASON
Potential for the DiaSorin Kit 1,25-Dihydroxyvitamin D RIA Kit Control 1 (lot 548520) & 2 (lot 548521) to recover out of the defined range, LOW. (If one or both of the kit controls recover outside the defined range, the run is considered invalid).
VOLUME OF PRODUCT IN COMMERCE
715 units
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
a) Mega Diagnostics Ammonia/Alcohol Controls (Cat.# A7504-CTL) packaged
in 5ml vials, Recall # Z-0743-2007;
b) Mega Diagnostics Alcohol Standard (Cat.# A7504-STD) packaged in 5ml vials,
Recall # Z-0744-2007
CODE
a) Lot# 522202;
b) Lot# 509102
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mega Diagnostics, Los Angeles, CA, by letter on March 9, 2007.
Manufacturer: Pointe Scientific, Inc., Canton, MI. Firm initiated recall is complete.
REASON
Potential for microorganism growth in the alcohol standard.
VOLUME OF PRODUCT IN COMMERCE
18 units
DISTRIBUTION
Indonesia

___________________________________
PRODUCT
DiaSorin TRYPSIK Kits, Catalog Number P2573-(assay used as a procedure for the quantitative determination of trypsin-like immunoreactiviy (TLI) in human serum or plasma samples), Recall # Z-0748-2007
CODE
Lot # 118532
RECALLING FIRM/MANUFACTURER
Diasorin, Inc., Stillwater, MN, by letter, fax or email on February 15, 2007. Firm initiated recall is ongoing.
REASON
Assay Failure: Assay failures may occur due to the kit control running outside of the established range (invalidating the assay).
VOLUME OF PRODUCT IN COMMERCE
100 kits
DISTRIBUTION
UT, CO, IN, NC, CA, FL, Canada, Spain, Germany, Belgium and Italy

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II

___________________________________
PRODUCT
Suther Feeds Excel-R-Ate L Mixer Medicated, containing 177.78 g/ton Lincomycin, packaged in 50 lb. bags; Recall # V-030-2007
CODE
Lot: GB18
RECALLING FIRM/MANUFACTURER
Suther Feeds, Inc., Frankfort, KS, by telephone on March 28, 2007. Firm initiated recall is complete.
REASON
Subpotent feed
VOLUME OF PRODUCT IN COMMERCE
50/50 lb. bags
DISTRIBUTION
KS

___________________________________
PRODUCT
Phenylzone Oral Paste (6 gram syringe). (phenylbutazone. Veterinary – For Horses Only, Net wt. 30g. Each syringe contains 6g phenylbutazone. Made in Ireland. NDC 0061-5045-01; Recall # V-031-2007
CODE
Lot # 028051, Exp. 04/2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Schering Plough Animal Health Corporation, Summit, NJ, by letters on March 23, 2007.
Manufacturer: Schering-Plough (Bray) Ltd., Wicklow, Ireland. Firm initiated recall is ongoing.
REASON
Several syringes of Phenylzone Paste (lot #028051) contained incorrect plungers calibrated in animal weight, rather than grams of phenylzone delivered.
VOLUME OF PRODUCT IN COMMERCE
12,774 syringes
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR APRIL 18, 2007

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