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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.
August 13, 2008
08-32
___________________________________
PRODUCT
Thai Basil shipped in 14 lb. cardboard cartons with 12 individual packages weighing approx.1.2 lbs. each in a clear, unmarked, plastic bags. The exterior cartons were labeled "AGRICOLA DALONG" " 16 DE SEPTIEMBRE S/N SANTA ROSA TAPACHULA NAYARIT, C.P. 63731" "Thai Basil" "Produce of Mexico", each carton has an attached sticker with Airway Bill #027 1947 0861, Recall # F-512-8
CODE
Airway Bill #027 1947 0861 labeled on each carton
RECALLING FIRM/MANUFACTURER
Recalling Firm: Lucky Green Trading, Inc., Garden Grove, CA, by telephone on July 8, 2008 and by press release and letter on July 10, 2008.
Manufacturer: Agricola Dalong SA de CV, Santa Rosa Tapachula, Mexico. Firm initiated recall is ongoing.
REASON
The product is contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
140 cartons
DISTRIBUTION
CA, AZ, NV
___________________________________
PRODUCT
Wild Alaskan Smoked Salmon in 3 oz. package, ready to eat product. Front label states in part Salmolux Gourmet Seafood Wild Alaskan Smoked Salmon Net Wt. 3 oz. Back label states Wild Alaska Smoked Salmon Nova Lox Net Wt. 3 oz. Serving Suggestion: Traditional Bagel & Lox Spread cream cheese on bagel, placed smoked salmon on bagel, garnish with tomatoes, onions & capers if desired. Product is sold 10/3 oz. packages per case, Recall # F-513-8
CODE
Lot #01418 SELL BY dates include Aug 21 and Aug 18. In addition, each retailer will indicate a SELL BY date when they thaw out the frozen salmon and offer for retail sale. Therefore, the SELL BY dates is varied.
RECALLING FIRM/MANUFACTURER
Salmolux, Inc., Federal Way, WA, by telephone and e-mail on July 8, 2008 and by press release on July 9, 2008. Firm initiated recall is ongoing.
REASON
The product is contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
1,148.18 lbs.
DISTRIBUTION
CA, PA
___________________________________
PRODUCT
5-lb. tubs and 2.5 lb. trays of cantaloupe cut into 1-inch cubes. There are two 2.5 lb trays per case. Product number shown for Vaughan Foods, Inc. Cantaloupe 5-lb. tubs is 9011016 with "Best By" dates of March 11, 2008 through March 31, 2008. Product number shown for Vaughan Foods, Inc. Cantaloupe 2/2.5# Tray Pack is 9011050 with "Best By" dates of March 11, 2008 through march 31, 2008. Item number shown for Melon Cantaloupe Chunks in 5-lb tubs is 6520878P with a date code specific to the consignee, Recall # F-514-8
CODE
Best By Dates: March 1 to March 21, 2008
RECALLING FIRM/MANUFACTURER
Vaughan Foods, Inc., Moore, OK, by e-mail and telephone on March 22, 2008. Firm initiated recall is complete.
REASON
Cantaloupes imported from a Honduran firm, Agropecuaria Montelibano, have been associated with an outbreak of Salmonella litchfield.
VOLUME OF PRODUCT IN COMMERCE
846 tubs and 601 cases of trays (2 trays per case)
DISTRIBUTION
OK, LA, TX, TN, IL, MO, AR, MS, NE
___________________________________
PRODUCT
Kroger Classic Chicken Noodle Condensed Soup; 10.5 oz. cans, 24 cans per case; UPC 0 11110 83703 5, Recall # F-515-8
CODE
Lot code 52104098, and a "best before" date code of 40910 (April 9, 2010)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bay Valley Foods, Westchester, IL, by e-mail on June 23, 2008 and by press release on June 24, 2008.
Manufacturer: Bay Valley Foods, LLC, Mendota, IL. Firm initiated recall is ongoing.
REASON
Some cans labeled as Chicken Noodle Soup actually contain another product, Cream of Celery soup, which contains milk. The label of the Chicken Noodle Soup does not list milk as an ingredient.
VOLUME OF PRODUCT IN COMMERCE
5 cases
DISTRIBUTION
KS, MO and NB
___________________________________
PRODUCT
Smoked Dried Fish, packaged 25 pounds and 35 pounds per container, in a poly plastic bag inside a wax coated carton, Recall # F-511-8
CODE
Batch numbers 47 through 78
RECALLING FIRM/MANUFACTURER
Hope Food Supply, Inc., Pasadena, TX, by letter on May 12, 2008. Firm initiated recall is complete.
REASON
Manufacturer of smoked dried fish has not developed an approved Hazard Analysis and Critical Control Point (HACCP) plan.
VOLUME OF PRODUCT IN COMMERCE
6,416 pounds
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Ziyad brand Country Style Green Cracked Olives in 48 oz. jars; Product of Turkey, Recall 3 F-516-8
CODE
All jars
RECALLING FIRM/MANUFACTURER
Jerusalem Manufacturing Natural Foods & Wholesalers, Inc., Dearborn, MI, by letter dated June 9, 2008. Firm initiated recall is ongoing.
REASON
FDA analysis of the olives showed a high level of decomposition.
VOLUME OF PRODUCT IN COMMERCE
360 jars
DISTRIBUTION
KY, MI, NY, OH, TN and Canada
___________________________________
PRODUCT
Alcohol-Free Mouthwash, a yellow liquid in a 4 oz. (118 mL) plastic bottle, 60 bottles per case; Made in USA; product code AG-210, bar code (01) 0 0380470 07119 0. Product was sold in cases of 60 bottles, but was also packaged as a component into custom ordered hospital admission kits, Recall # D-280-2008
CODE
Lots: 26228 and 26230
RECALLING FIRM/MANUFACTURER
Hydrox Chemical Co., Elgin, IL, by letters and press releases on May 1, 2008, May 2, 2008, May 5, 2008 and May 16, 2008. Firm initiated recall is ongoing.
REASON
Microbial contamination of a non-sterile product. The alcohol-free mouthwash was found to be contaminated with Burkholderia cepacia bacteria.
VOLUME OF PRODUCT IN COMMERCE
126,960 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Solodyn® Extended Release Tablets (Minocycline HCl USP) 90mg, 30 count bottles, Rx only, NDC 99207-461-30, Recall # D-281-2008
CODE
Lots B080037, Expiration Date 12/09 and B080038, Expiration Date: 12/09
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medicis Pharmaceutical Corp., Scottsdale, AZ, by telephone on May 8, 2008 and by press release and letters on May 13, 2008, and May 16, 2008.
Manufacturer: aaiPharma, Inc., Wilmington, NC. Firm initiated recall is ongoing.
REASON
Adulterated Presence of Foreign Tablets; bottles labeled to contain Solodyn® Extended Release Tablets (Minocycline HCl) 90mg actually contain Azasan® 75 mg Tablets (Azathioprine)
VOLUME OF PRODUCT IN COMMERCE
37,504 – 30 count bottles
DISTRIBUTION
AZ, CA, CO, HI, IL, OH, UT, WA and PR
___________________________________
PRODUCT
a) Heparin Sodium 25,000 Units in 5% Dextrose Injection, 250mL (NDC 0264-9587-20)
and 500mL (NDC 0264-9577-10) EXCEL Containers packaged 24 per case,
Recall # D-282-2008;
b) Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection in Full Fill 500mL
EXCEL Containers, NDC 0264-9872-10, CAN DIN 01935933, Recall # D-283-2008;
c) Heparin Sodium 20,000 Units in 5% Dextrose Injection, 500mL (CAN DIN 02209713)
EXCEL Containers packaged 24 per case, Recall # D-284-2008;
d) Heparin Sodium 25,000 Units in 5% Dextrose Injection, in 250mL (CAN DIN 02209721)
and 500mL (CAN DIN 01935941) EXCEL Containers packaged 24 per case, Recall # D-285-2008
CODE
a) Lot numbers: J7D490, J7C470, J7E494, J7N556, J7P476,
Lot numbers: J7C684, J7D496, J7E500, J7P404, J7N604;
b) Lot numbers: J7C611, J7C557, J7C477, J7C705, J7D485, J7E415, J7E416,
J7E489, J7N519, J7N676;
c) Lot numbers: J7D580;
d) Lot number: J7E420, Lot number: J7E577
RECALLING FIRM/MANUFACTURER
B, Braun Medical, Inc., Irvine, CA, by letter beginning March 20, 2008 and by press release on March 21, 2008. Firm initiated recall is ongoing.
REASON
Presence of foreign substance; active pharmaceutical ingredient found to be contaminated with over-sulfated chondroitin sulfate.
VOLUME OF PRODUCT IN COMMERCE
386,606 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
a) Digitek (digoxin tablets, USP) 125 mcg (0.125 mg), 100, 1000 and 5000 tablets bottles,
Rx only, NDC 62794-145-01, Recall # D-286-2008;
b) Digitek (digoxin tablets USP), 250 mcg (0.25 mg), 100, 1000 and 5000 tablet bottles,
Rx only, NDC: 62794-146-01, Recall # D-287-2008
CODE
a) 60236A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Apr-08
60371A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Apr-08
60372A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Apr-08
60373A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Apr-08
30399A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg May-08
60400A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg May-08
60401A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg May-08
60402A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg May-08
60416A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg May-08
60605A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jun-08
60606A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jun-08
60607A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jun-08
0608A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jul-08
60643A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jul-08
60644A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jul-08
60645A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jul-08
60756A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-08
60757A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-08
60758A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-08
60759A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-08
60776A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-08
60777A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-08
60929A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Oct-08
60930A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Oct-08
60931A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Oct-08
60932A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Oct-08
60991A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Nov-08
60992A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Nov-08
60993A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Nov-08
60994A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Nov-08
61092A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Dec-08
70023A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-09
70024A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-09
70025A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-09
70026A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-09
70027A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-09
70078A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-09
70079A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-09
70080A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-09
70081A1 (100 count), 70081A2 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-09
70082A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-09
70134A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Feb-09
70135A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Feb-09
70136A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Feb-09
70147A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Feb-09
70149A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Feb-09
70160A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Feb-09
70161A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Feb-09
70207A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Mar-09
70208A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Mar-09
70209A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Mar-09
70296A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Apr-09
70297A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Apr-09
70298A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Apr-09
70299A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Apr-09
70300A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Apr-09
70557A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jul-09
70558A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jul-09
70559A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jul-09
70560A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jul-09
70600A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jul-09
70601A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jul-09
70736A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-09
70737A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-09
70738A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-09
70753A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-09
70766A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-09
70767A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-09
70768A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-09
70769A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-09
70770A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-09
70924A2 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Nov-09
70925A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Nov-09
70926A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Nov-09
70949A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Nov-09
70950A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Nov-09
70951A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Nov-09
70952A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Nov-09
70953A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Nov-09
71004A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Dec-09
71005A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Dec-09
80044A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-10
80045A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-10
80046A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-10
80047A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-10
80189A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Feb-10
80190A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Mar-10
80227A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Mar-10
60776A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-08
60777A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-08
60929A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Oct-08
60930A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Oct-08
60931A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Oct-08
60932A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Oct-08
60991A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Nov-08
60992A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Nov-08
60993A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Nov-08
60994A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Nov-08
61092A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Dec-08
70023A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-09
70024A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-09
70025A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-09
70026A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-09
70027A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-09
70078A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-09
70079A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-09
70080A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-09
70081A1 (100 count), 70081A2 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-09
70082A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-09
70134A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Feb-09
70135A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Feb-09
70136A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Feb-09
70147A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Feb-09
70149A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Feb-09
70160A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Feb-09
70161A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Feb-09
70207A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Mar-09
70208A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Mar-09
70209A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Mar-09
70296A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Apr-09
70297A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Apr-09
70298A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Apr-09
70299A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Apr-09
70300A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Apr-09
70557A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jul-09
70558A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jul-09
70559A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jul-09
70560A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jul-09
70600A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jul-09
70601A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jul-09
70736A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-09
70737A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-09
70738A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-09
70753A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-09
70766A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-09
70767A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-09
70768A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-09
70769A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-09
70770A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Sep-09
70924A2 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Nov-09
70925A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Nov-09
70926A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Nov-09
70949A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Nov-09
70950A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Nov-09
70951A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Nov-09
70952A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Nov-09
70953A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Nov-09
71004A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Dec-09
71005A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Dec-09
80044A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-10
80045A1 (5000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-10
80046A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-10
80047A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Jan-10
80189A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Feb-10
80190A1 (100 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Mar-10
80227A1 (1000 count) 145 Digitek (digoxin tablets, USP) 0.125 mg Mar-10;
b) 60319A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Apr-08
60320A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Apr-08
60321A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Apr-08
60322A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Apr-08
60323A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg May-08
61098A1 (5000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Dec-08
61099A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Dec-08
61100A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Dec-08
61101A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Dec-08
61102A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Dec-08
61103A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Dec-08
61104A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Dec-08
70120A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Feb-09
70121A1 (5000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Feb-09
70122A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Feb-09
70174A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Feb-09
70175A1 (5000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Mar-09
70176A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Mar-09
70370A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg May-09
70371A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg May-09
70372A1 (5000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg May-09
70386A1 (5000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg May-09
70454A1 (5000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Jun-09
70455A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Jun-09
70456A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Jun-09
70457A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Jun-09
70458A1 (5000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Jun-09
70551A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Jul-09
70664A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Aug-09
70665A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Aug-09
70666A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Aug-09
70670A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Aug-09
70671A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Aug-09
70672A1 (5000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Aug-09
70673A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Aug-09
70811A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Oct-09
70812A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Oct-09
70813A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Oct-09
70832A1 (5000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Oct-09
70833A1 (5000 count)146 Digitek (digoxin tablets, USP) 0.25 mg Oct-09
70834A1 (5000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Oct-09
70835A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Oct-09
70836A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Oct-09
71032A1 (5000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Dec-09
71033A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Dec-09
71034A1 (5000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Dec-09
71035A1 (5000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Dec-09
71036A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Jan-10
71054A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Jan-10
80002A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Jan-10
80003A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Jan-10
80108A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Feb-10
80109A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Feb-10
80110A1 (5000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Feb-10
80111A1 (5000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Feb-10)
80112A1 (1000 count 146 Digitek (digoxin tablets, USP) 0.25 mg Feb-10
60497A1 (5000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg May-08
60498A1 (5000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg May-08
60499A1 (5000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Jun-08
60511A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Jun-08
60512A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Jun-08
60513A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Jun-08
60514A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Jun-08
60515A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Jun-08
60677A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Aug-08
60678A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Aug-08
60679A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Aug-08
60680A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Aug-08
60681A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Aug-08
60863A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Oct-08
60864A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Oct-08
60865A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Oct-08
61053A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Nov-08
61054A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Nov-08
61055A1 (1000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Dec-08
61056A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Dec-08
61057A1 (5000 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Dec-08
61097A1 (100 count) 146 Digitek (digoxin tablets, USP) 0.25 mg Dec-08
RECALLING FIRM/MANUFACTURER
Actavis Totowa LLC, Totowa, NJ, by letters on April 26, 2008 and April 30, 2008. Firm initiated recall is ongoing.
REASON
Superpotent; Tablets have a thickness approximately double to that required.
VOLUME OF PRODUCT IN COMMERCE
166 lots
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1713-08
CODE
Unit: 113074950
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc. dba United Blood Services, El Paso, TX, by telephone on May 21, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who received a human bite within 12 months of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1732-08
CODE
Unit: V69941
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc, Chattanooga, TN, by telephone on March 27, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1741-08
CODE
Unit: 72E651935
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc, Dunwoody, GA, by telephone on February 20, 2008. 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
GA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1742-08
CODE
Unit: 72E931724
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc, Dunwoody, GA, by telephone on February 27, 2008. Firm initiated recall is complete.
REASON
Blood product, with insufficient plasma volume to support the platelet concentration, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1743-08
CODE
Unit: 72E652225
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc, Dunwoody, GA, by telephone on March 8, 2008. Firm initiated recall is complete.
REASON
Blood product, with insufficient plasma volume to support the platelet concentration, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1746-08
CODE
Units: V82020 (2 units)
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by fax on May 14, 2007. Firm initiated recall is complete.
REASON
Blood products, associated with a unit that has a pH lower than the acceptance criteria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN
___________________________________
PRODUCT
Red Blood Cells, Recall # B-1757-08
CODE
Unit: KW05999
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile on April 14, 2008. 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
Source Plasma, Recall # B-1764-08
CODE
Unit: DQ038938
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Johnson City, TN, by facsimile on August 20, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not receive a complete physical examination, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT
a) Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1768-08;
b) Platelets Pheresis Leukocytes Reduced, Recall # B-1769-08
CODE
a) and b) Unit: 4083861
RECALLING FIRM/MANUFACTURER
Community Blood Center, Inc., Appleton, WI, by telephone on July 31, 2006 and by letter dated August 2, 2006. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WI
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1771-08
CODE
Unit: 0035789
RECALLING FIRM/MANUFACTURER
Community Blood Center, Inc., Appleton, WI, by letter dated August 4, 2006. Firm initiated recall is complete.
REASON
Blood product, with a platelet count that exceeded the firm’s specification, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1782-08
CODE
Unit: 72F350571
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by telephone on May 6, 2008. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1783-08
CODE
Unit: 72F415611
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Birmingham, AL, by telephone on May 14, 2008. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1786-08
CODE
Unit: 2349137
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter on October 19, 2007. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who lived in a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1787-08
CODE
Unit: 2241340
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter on October 22, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malarial, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1788-08
CODE
Unit: 72C576251
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Birmingham Region, Birmingham, AL, by facsimile on October 10, 2007. Firm initiated recall is complete.
REASON
Blood product, which did not meet the acceptable product specifications for release, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Irradiated, Recall # B-1789-08
CODE
Unit: 2093182
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter on October 15, 2007. Firm initiated recall is complete.
REASON
A blood product collected from a donor who traveled to an area considered endemic for malarial, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1791-08;
b) Cryoprecipitated AHF, Recall # B-1792-08
CODE
a), and b) Units: 9216368
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by letter on November 19, 2007 and by electronic mail on November 20, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose arm scrub procedure was performed incorrectly, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
LA, TX
___________________________________
PRODUCT
a) Fresh Frozen Plasma, Recall # B-1807-08;
b) Red Blood Cells Leukocytes Reduced, Recall # B-1808-08
CODE
a) and b) Unit: 6257214
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services, Inc., Jackson, MS, by fax on December 6, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MS
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1809-08
CODE
Units: 1935196, 4013536
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services, Inc., Jackson, MS, by fax or electronic mail on January 24, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had a history of taking the drug Tegison, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MS, FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0795-08
CODE
Units: 1407171, 1407160
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by telephone on February 21, 2006. Firm initiated recall is complete.
REASON
Blood products, which reached an unacceptable temperature during shipment, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MN
___________________________________
PRODUCT
Red Blood Cells, Recall # B-1744-08
CODE
Unit: 72E192081
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by telephone on December 31, 2007. Firm initiated recall is complete.
REASON
Blood product, associated with a plasma component that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1756-08
CODE
Units: 6780425 Part A, 6780428 Part A
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services, Inc., Jackson, MS, by telephone on December 28, 2006 and by fax on April 11, 2007. Firm initiated recall is complete.
REASON
Blood products, which were not labeled for an unexpected antibody, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MS
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B1760-08
CODE
Units: 72E147706 and 72E147811
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Birmingham Region, Birmingham, AL, by facsimile on February 8, 2008. Firm initiated recall is complete.
REASON
Blood products, labeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AL
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B1770-08
CODE
Units: 6203791 (Parts A & B), 6203806 (Parts A & B), 6203812 (Parts A & B)
RECALLING FIRM/MANUFACTURER
Community Blood Center, Inc., Appleton, WI, by letter dated August 2, 2006. Firm initiated recall is complete.
REASON
Blood products, collected on an apheresis machine for which the quality control testing was not documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
WI
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B1773-08
CODE
Units: 8216110, 8216113, 8216119, 8216125, 8216133, 8216138, 8216146, 8216151, 8216174
RECALLING FIRM/MANUFACTURER
Community Blood Center, Inc., Appleton, WI, by letter dated October 10, 2006. Firm initiated recall is complete.
REASON
Blood products, collected using trip scales for which the daily quality control testing was not documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
WI, MO, MS, DC
___________________________________
PRODUCT
Recovered Plasma, Recall # B-1790-08;
CODE
Unit: 9216368
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by letter on November 19, 2007 and by electronic mail on November 20, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm scrub procedure was performed incorrectly, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
___________________________________
PRODUCT
Recovered Plasma, Recall # B-1810-08
CODE
Unit: 4013536
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services, Inc., Jackson, MS, by fax or electronic mail on January 24, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had a history of taking the drug Tegison, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
___________________________________
PRODUCT
Hospira LifeCare PCA Label Utility, Version 1.0 CD. The installation/user guide is entitled "LifeCare PCA Barcode Label Utility Program." This software program is designed to allow entry of each drug concentration into a formulation library on a pharmacy computer for standardized printing of barcode labels for compounded drug product vials, Recall # Z-1181-2008
CODE
Version 1.0, all CDs
RECALLING FIRM/MANUFACTURER
Hospira, Inc., Lake Forest, IL, by letters dated January 3, 2008. Firm initiated recall is ongoing.
REASON
Incorrect dosage labels created: Customers have experienced independent changes in drug concentration (mg/mL to mcg/mL and vice versa) and expiration dates, and the addition of trailing zeros to the barcodes.
VOLUME OF PRODUCT IN COMMERCE
127 CDs
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
a) EvoTech Endoscope Cleaner & Reprocessor, Product Code 50004 Indicated for use with
high level disinfectant CIDEX OPA Concentrate and an enzymatic detergent,
CIDEZYME GI, to achieve cleaning and high level disinfection of heat sensitive
semi-critical endoscopes, Recall # Z-1368-2008;
b) EvoTech Endoscope Cleaner and Reprocessor, Product Code 50004-002 Indicated for use
with high level disinfectant CIDEX OPA Concentrate and an enzymatic detergent,
CIDEZYME GI, to achieve cleaning and high level disinfection of heat sensitive
semi-critical endoscopes, Recall # Z-1369-2008
CODE
a) Serial Numbers: 50004001070080, 50004001070082, 50004001070083, 50004001070043,
50004001070044, 50004001070046, 50004001070048, 50004001070023, 50004001070024,
50004001070021, 50004001070075, 50004001070045, 50004001070078, 50004001070079,
50004001070107, 50004001070110, 50004001070081, 50004001070062, 50004001070064,
50004001070063, 50004001070034, 50004001070025, 50004001070029, 50004001070047,
50004001070049, 50004001070061, 50004001070087, 50004001070088, 50004001070084,
50004001070077, 50004001070076, 50004001070085, 50004001070086, 50004001070090,
50004001070091, 50004001070094, 50004001070089, 50004001070092, 50004001070098,
50004001070097, 50004001070099, 50004001070100, 50004001070101, 50004001070105,
50004001070106, 50004001070108, 50004001070109, 50004001070102, 50004001070103,
50004001070104, 50004001070020, 50004001070031, 50004001070035, 50004001070036,
50004001070039, 50004001070042, 50004001070059, 50004001070065, 50004001070071,
50004001070072, 50004001070073, 50004001070074, 50004001070114;
b) Serial Numbers 50004002070001 and 50004002070004
RECALLING FIRM/MANUFACTURER
Recalling Firm: Advanced Sterilization Products, Irvine, CA, by letter on February 13, 2008.
Manufacturer: Jabil Circuit, Inc., Auburn Hills, MI. Firm initiated recall is ongoing.
REASON
Cleaning cycles are being cancelled. Specific issues are: a) Water heater tank is rusting resulting in the in-line 0.2 micron filter prematurely clogging, b) Interface board malfunction resulting in a premature lid opening, and c) Minor fluid leaks within the system (commonly at the 0.2 micron filter attachment points).
VOLUME OF PRODUCT IN COMMERCE
66 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Cytomics FC 500 Flow Cytometry System with Data Innovations Instrument Manager, Part Numbers 626553 and 6605628 A system for the qualitative and quantitative measurement of biological and physical properties of cells and other particles, Recall # Z-1529-2008
CODE
All Software Versions
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter dated August 16, 2007.
Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is complete.
REASON
Labeling provided by two integrated software systems are not clear enough to avoid potential demographic and sample type mismatches under certain conditions.
VOLUME OF PRODUCT IN COMMERCE
141 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
BD FACSDiva Software v6.0 and 6.1 with the HP XW4400 Computer System Model/Catalog number 642685 Software is used to simplify acquisition of flow cytometry data, Recall # Z-1530-2008
CODE
Material numbers 338960, 338962, and 339473
RECALLING FIRM/MANUFACTURER
BD Biosciences, San Jose, CA, by letter on December 21, 2007. Firm initiated recall is ongoing.
REASON
Values might not update in statistics views after certain functions are performed in a worksheet.
VOLUME OF PRODUCT IN COMMERCE
74 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
3M Comply EO Chemical Indicators Strips, Catalog #1251 The Comply 1251 Chemical Indicator Strip is a paper strip 1.5cm wide by 20 cm long (0.625 inches wide by 8 inches long) printed with a chemical indicator ink that turns from red to green when exposed to ethylene oxide (EO) sterilization process. It is designed to indicate whether EO has penetrated to the point of placement of the strip, usually the center of the pack. Each strip is perforated at the center if a shorter internal chemical indicator is preferred. An internal chemical indicator should be used inside each pack to be sterilized, Recall # Z-1568-2008
CODE
2008-02AA, 2008-03AA, 2008-04AA, 2008-05AA, 2008-08AA, 2008-10AA, 2008-10AB, 2008-12AA, 2009-02AA, 2009-02AB, 2009-04AA, 2009-05AA, 2009-08AA, 2009-09AA,
RECALLING FIRM/MANUFACTURER
Recalling Firm: 3M Company/Medical Division, South St Paul, MN, by letter dated March 17, 2008.
Manufacturer: Propper Manufacturing Company, Inc., Long Island City, NY. Firm initiated recall is ongoing.
REASON
A production specification discrepancy may cause the indicators to show an inaccurate result, which could incorrectly lead customers to conclude the sterilization cycle was adequate.
VOLUME OF PRODUCT IN COMMERCE
12,988 cases (4 boxes per case and 480 strips per box)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) STERRAD 100S Sterilization System, Product Code 10101 Used to sterilize heat
and moisture sensitive reusable medical devices, Recall # Z-1628-2008;
b) STERRAD 50 Sterilization System, Product Code 10050 Used to sterilize heat
and moisture sensitive reusable medical devices, Recall # Z-1629-2008;
c) STERRAD 200 Sterilization System, Product Code 10201 Used to sterilize heat and
moisture sensitive reusable medical devices, Recall # Z-1630-2008;
d) STERRAD NX Sterilizer, Product Code 10033 Used to sterilize heat and
moisture sensitive reusable medical devices, Recall # Z-1631-2008;
e) STERRAD 100NX Sterilizer, Product Code 10104 Used to sterilize heat and
moisture sensitive reusable medical devices, Recall # Z-1632-2008
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Advanced Sterilization Products, Irvine, CA, by letter dated April 23, 2008. Firm initiated recall is ongoing.
REASON
Oil mist filter fails allowing oil mist to be emitted into the vicinity of the sterilizer, which may result in the release of a mist, "haze," or "smoke."
VOLUME OF PRODUCT IN COMMERCE
9,950 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) VECTRA GENISYS, electromechanical therapeutic ultrasound device, Model No. 2759,
Chattanooga Group, Recall # Z-1636-2008;
b) INTELECT LEGEND XT, electromechanical therapeutic ultrasound and powered muscle
stimulation device, Model No. 2760, Chattanooga Group, Recall # Z-1637-2008;
c) VECTRA GENISYS, electromechanical therapeutic ultrasound and powered muscle
stimulation device, Model No. 2761, Chattanooga Group, Recall # Z-1638-2008;
d) INTELECT TRANSPORT ULTRASOUND, electromechanical therapeutic
ultrasound device, Model No. 2782, Chattanooga Group, Recall # Z-1638-2008
CODE
a) Serial numbers: 1000, 1002, 1003, 1004, 1005, 1007, 1008, 1010, 1011, 1012, 1013,
1014, 1015, 1016, 1017, 1018, 1019, 1021, 1025, 1026, 1028, 1029, 1030, 1031, 1032,
1034, 1035, 1036, 1037, 1039, 1040, 1042, 1043, 1044, 1045, 1046, 1047, 1050, 1051,
1054, 1056, 1058, 1059, 1060, 1061, 1062, 1064, 1066, 1067, 1069, 1071, 1073, 1074,
1075, 1076, 1077, 1078, 1079, 1081, 1082, 1083, 1085, 1086, 1087, 1088, 1089, 1091,
1095, 1096, 1097, 1100, 1102, 1103, 1112, 1114, 1120, 1121, 1122, 1123, 1124, 1125,
1130, 1135, 1137, 1138, 1141, 1142, 1143, 1145, 1146, 1147, 1148, 1149, 1150, 1153,
1157, 1158, 1162, 1163, 1168, 1169, 1171, 1176, 1177, 1178, 1180, 1181, 1186, 1191,
1193, 1194, 1195, 1196, 1197, 1198, 1200, 1201, 1203, 1206, 1207, 1208, 1209, 1210,
1211, 1213, 1215, 1216, 1217, 1220, 1221, 1222, 1225, 1226, 1227, 1228, 1229, 1231,
1232, 1233, 1235, 1236, 1237, 1238, 1239, 1240, 1241, 1247, 1248, 1249, 1254, 1255,
1256, 1259, 1261, 1262, 1266, 1269, 1273, 1275, 1277, 1278, 1279, 1280, 1281, 1282,
1283, 1285, 1286, 1289, 1291, 1293, 1294, 1295, 1296, 1300, 1301, 1302, 1303, 1304,
1305, 1307, 1308, 1309, 1310, 1313, 1314, 1319, 1320, 1329, 1330, 1333, 1339, 1341,
1344, 1346, 1348, 1349, 1351, 1359, 1360, 1361, 1362, 1363, 1364, 1369, 1370, and 1373;
b) Serial numbers: 1017, 1022, 1028, 1031, 1035, 1040, 1041, 1043, 1046, 1048, 1049,
1050, 1053, 1055, 1056, 1058, 1059, 1061, 1062, 1065, 1066, 1067, 1071, 1072, 1074,
1076, 1080, 1081, 1085, 1086, 1087, 1088, 1089, 1091, 1092, 1093, 1094, 1095, 1098,
1100, 1101, 1104, 1105, 1107, 1108, 1111, 1114, 1135, 1136, 1138, 1139, 1157, 1158,
1160, 1162, 1163, 1164, 1167, 1168, 1169, 1171, 1172, 1174, 1177, 1201, 1202, 1203,
1206, 1207, 1212, 1213, 1214, 1220, 1224, 1225, 1238, 1243, 1245, 1252, 1253, 1254,
1255, 1256, 1257, 1258, 1259, 1260, 1262, 1264, 1265, 1266, 1269, 1271, 1272, 1273,
1274, 1275, 1278, 1279, 1285, 1288, 1289, 1290, 1311, 1313, 1314, 1316, 1317, 1321,
1322, 1324, 1326, 1327, 1328, 1329, 1330, 1331, 1333, 1334, 1338, 1340, 1341, 1342,
1344, 1349, 1350, 1351, 1353, 1354, 1359, 1361, 1362, 1364, 1367, 1368, 1389, 1390,
1392, 1393, 1394, 1395, 1397, 1400, 1401, 1403, 1404, 1405, 1406, 1411, 1413, 1422,
1424, 1432, 1439, 1440, 1447, 1448, 1450, 1454, 1460, 1461, 1463, 1465, 1467, 1469,
1542, 1550, 1556, 1558, 1560, 1566, 1568, 1570, 1571, 1573, 1574, 1576, 1589, 1602,
1604, 1605, 1606, 1607, 1610, 1611, 1613, 1614, 1616, 1618, 1619, 1621, 1622, 1623,
1625, 1626, 1628, 1629, 1632, 1633, 1635, 1641, 1643, 1644, 1646, 1647, 1651, 1654,
1655, 1657, 1659, 1660, 1662, 1663, 1665, 1691, 1697, 1699, 1701, 1703, 1704, 1705,
1706, 1712, 1713, 1719, 1720, 1727, 1729, 1730, 1754, 1759, 1760, 1763, 1766, 1773,
1775, 1776, 1777, 1780, 1781, 1782, 1784, 1785, 1786, 1792, 1793, 1798, 1799, 1802,
1809, 1813, 1819, 1820, 1821, 1825, 1830, 1832, 1834, 1835, 1842, 1846, 1850, 1852,
1855, 1859, 1861, 1865, 1907, 1909, 1910, 1911, 1914, 1918, 1921, 1925, 1926, 1927,
1928, 1929, 1933, 1934, 1938, 1940, 1974, 1978, 1979, 1983, 1984, 1985, 1988, 1990,
1995, 1996, 1998, 2000, 2008, 2010, 2011, 2012, 2021, 2022, 2024, 2032, 2035, 2036,
2037, 2038, 2040, 2041, 2045, 2046, 2049, 2050, 2052, 2056, 2057, 2058, 2059, 2063,
2064, 2067, 2074, 2075, 2076, 2078, 2079, 2082, 2083, 2089, 2090, 2092, 2093, 2094,
2097, 2099, 2100, 2104, 2172, 2173, 2174, 2181, 2185, 2189, 2190, 2191, 2194, 2196,
2199, 2202, 2204, 2205, 2209, 2212, 2213, 2214, 2216, 2218, 2219, 2221, 2223, 2224,
2225, 2230, 2235, 2238, 2243, 2247, 2248, and 2282;
c) Serial numbers: 1037, 1038, 1041, 1042, 1045, 1049, 1050, 1055, 1056, 1061, 1062,
1063, 1064, 1066, 1067, 1068, 1071, 1073, 1074, 1075, 1076, 1117, 1119, 1122, 1123,
1124, 1128, 1129, 1130, 1131, 1132, 1133, 1135, 1137, 1138, 1139, 1140, 1141, 1143,
1144, 1145, 1146, 1148, 1149, 1150, 1153, 1155, 1156, 1207, 1208, 1209, 1212, 1215,
1222, 1223, 1224, 1226, 1228, 1229, 1230, 1231, 1232, 1233, 1234, 1235, 1236, 1238,
1240, 1242, 1244, 1245, 1247, 1248, 1250, 1251, 1253, 1254, 1256, 1257, 1258, 1260,
1262, 1265, 1266, 1362, 1364, 1365, 1366, 1370, 1372, 1374, 1375, 1377, 1378, 1381,
1382, 1383, 1384, 1413, 1414, 1415, 1416, 1417, 1421, 1422, 1424, 1425, 1427, 1428,
1429, 1430, 1433, 1434, 1435, 1436, 1464, 1467, 1468, 1470, 1472, 1473, 1474, 1480,
1481, 1485, 1486, 1487, 1489, 1491, 1492, 1493, 1494, 1495, 1497, 1499, 1500, 1502,
1503, 1504, 1505, 1507, 1508, 1509, 1510, 1563, 1565, 1570, 1573, 1574, 1578, 1579,
1586, 1612, 1613, 1615, 1616, 1616, 1617, 1618, 1619, 1620, 1625, 1626, 1627, 1630,
1632, 1634, 1635, 1636, 1638, 1639, 1642, 1643, 1644, 1645, 1667, 1668, 1669, 1670,
1672, 1673, 1675, 1677, 1679, 1680, 1683, 1685, 1737, 1738, 1741, 1742, 1743, 1744,
1745, 1746, 1747, 1748, 1749, 1753, 1754, 1755, 1756, 1757, 1759, 1761, 1762, 1763,
1764, 1765, 1767, 1775, 1776, 1777, 1779, 1780, 1784, 1785, 1787, 1788, 1789, 1790,
1791, 1818, 1819, 1820, 1821, 1822, 1826, 1828, 1830, 1832, 1834, 1835, 1836, 1838,
1840, 1846, 1847, 1848, 1852, 1853, 1855, 1857, 1858, 1861, 1862, 1864, 1865, 1867,
1868, 1869, 1870, 1872, 1874, 1876, 1878, 1881, 1882, 1887, 1889, 1891, 1892, 1894,
1898, 1900, 1902, 1954, 1956, 1957, 1961, 1964, 1965, 1967, 1972, 1975, 1976, 1977,
1979, 1980, 1983, 1985, 1989, 1990, 1992, 1995, 1996, 1997, 1998, 2000, 2001, 2005,
2007, 2008, 2011, 2012, 2013, 2014, 2017, 2018, 2019, 2020, 2025, 2028, 2036, 2037,
2039, 2041, 2118, 2128, 2129, 2131, 2133, 2136, 2139, 2141, 2144, 2145, 2146, 2148,
2150, 2152, 2156, 2158, 2160, 2162, 2163, 2164, 2166, 2168, 2170, 2172, 2175, 2177,
2181, 2186, 2187, 2197, 2198, 2199, 2201, 2203, 2205, 2207, 2211, 2214, 2217, 2222,
2223, 2224, 2227, 2230, 2237, 2239, 2240, 2241, 2246, 2248, 2253, 2254, 2256, 2259,
2260, 2290, 2293, 2295, 2296, 2298, 2303, 2376, 2378, 2381, 2383, 2384, 2391, 2392,
2393, 2394, 2396, 2397, 2398, 2399, 2401, 2402, 2404, 2407, 2411, 2412, 2414, 2417,
2419, 2425, 2432, 2435, 2436, 2439, 2445, 2446, 2448, 2453, 2457, 2458, 2461, 2464,
2469, 2475, 2478, 2481, 2482, 2490, 2494, 2498, 2505, 2575, 2727, 2731, 2735, 2740,
2747, 2750, 2756, 2763, 2776, 2778, 2779, 2784, 2792, 2793, 2796, 2814, 2815, 2816,
2819, 2867, 2889, 2892, 2898, 2982, 2988, 2989, 2990, 2994, 2995, 2999, 3000, 3003,
3005, 3006, 3008, 3009, 3011, 3013, 3014, 3015, 3018, 3021, 3083, 3092, and 3102;
d) Serial numbers: 1000, 1001, 1004, 1005, 1008, 1009, 1010, 1011, 1014, 1016, 1017,
1019, 1021, 1022, 1023, 1028, 1029, 1032, 1033, 1034, 1037, 1039, 1041, 1042, 1043,
1044, 1045, 1046, 1049, 1050, 1053, 1054, 1057, 1059, 1061, 1062, 1064, 1065, 1066,
1067, 1068, 1069, 1070, 1073, 1076, 1077, 1078, 1079, 1080, 1081, 1085, 1086, 1087,
1088, 1089, 1090, 1092, 1093, 1094, 1096, 1097, 1099, 1100, 1101, 1103, 1105, 1107,
1113, 1114, 1115, 1116, 1117, 1120, 1122, 1124, 1126, 1130, 1131, 1132, 1133, 1134,
1135, 1137, 1138, 1141, 1143, 1145, 1146, 1147, 1149, 1150, 1152, 1153, 1155, 1157,
1158, 1161, 1163, 1164, 1165, 1166, 1167, 1168, 1171, 1172, 1173, 1174, 1175, 1176,
1177, 1182, 1184, 1186, 1189, 1190, 1191, 1192, 1194, 1195, 1196, 1198, 1199, 1203,
1204, 1207, 1208, 1209, 1212, 1213, 1214, 1216, 1218, 1220, 1221, 1222, 1223, 1224,
1225, 1226, 1229, 1230, 1232, 1233, 1235, 1236, 1237, 1240, 1242, 1243, 1244, 1245,
1246, 1247, 1248, 1249, 1250, 1251, 1252, 1253, 1254, 1255, 1256, 1257, 1258, 1260,
1261, 1263, 1264, 1265, 1267, 1268, 1270, 1271, 1273, 1276, 1278, 1279, 1282, 1284,
1287, 1288, 1294, 1300, 1301, 1303, 1306, 1307, 1308, 1309, 1310, 1311, 1313, 1314,
1315, 1316, 1318, 1321, 1323, 1325, 1326, 1327, 1328, 1329, 1330, 1331, 1332, 1334,
1336, 1337, 1338, 1339, 1340, 1341, 1343, 1344, 1346, 1347, 1350, 1351, 1353, 1354,
1357, 1358, 1362, 1365, 1367, 1368, 1369, 1371, 1372, 1376, 1377, 1382, 1384, 1386,
1387, 1389, 1390, 1391, 1392, 1394, 1396, 1398, 1399, 1400, 1401, 1403, 1404, 1405,
1406, 1407, 1408, 1409, 1411, 1412, 1413, 1414, 1415, 1417, 1418, 1419, 1421, 1422,
1425, 1426, 1427, 1428, 1431, 1432, 1433, 1434, 1436, 1437, 1439, 1440, 1441, 1443,
1444, 1445, 1446, 1448, 1449, 1450, 1453, 1455, 1458, 1459, 1460, 1462, 1463, 1464,
1473, 1474, 1475, 1476, 1477, 1478, 1479, 1480, 1483, 1484, 1485, 1488, 1489, 1490,
1491, 1492, 1493, 1495, 1496, 1497, 1498, 1499, 1500, 1504, 1506, 1513, 1518, 1522,
1524, 1525, 1526, 1529, 1533, 1534, 1535, 1536, 1537, 1540, 1541, 1542, 1544, 1546,
1548, 1551, 1552, 1554, 1555, 1557, 1558, 1559, 1560, 1562, 1563, 1564, 1565, 1570,
1572, 1573, 1575, 1577, 1578, 1579, 1581, 1582, 1587, 1588, 1591, 1593, 1594, 1595,
1597, 1600, 1602, 1606, 1607, 1608, 1610, 1611, 1612, 1613, 1614, 1615, 1616, 1617,
1618, 1623, 1624, 1626, 1628, 1629, 1630, 1634, 1635, 1637, 1638, 1639, 1641, 1643,
1645, 1647, 1648, 1649, 1650, 1651, 1652, 1653, 1655, 1656, 1657, 1658, 1659, 1660,
1661, 1664, 1665, 1667, 1668, 1671, 1672, 1675, 1676, 1677, 1678, 1679, 1683, 1684,
1687, 1688, 1689, 1690, 1695, 1697, 1699, 1700, 1701, 1702, 1705, 1706, 1707, 1710,
1711, 1713, 1714, 1717, 1720, 1721, 1722, 1724, 1725, 1726, 1729, 1730, 1731, 1732,
1733, 1737, 1738, 1743, 1744, 1746, 1747, 1749, 1750, 1752, 1753, 1754, 1756, 1758,
1761, 1767, 1768, 1770, 1772, 1776, 1778, 1779, 1780, 1782, 1785, 1786, 1788, 1789,
1790, 1792, 1798, 1799, 1802, 1804, 1810, 1813, 1815, 1819, 1821, 1822, 1823, 1826,
1827, 1829, 1833, 1836, 1837, 1841, 1843, 1844, 1845, 1847, 1848, 1850, 1852, 1876,
1878, 1879, 1880, 1884, 1887, 1888, 1889, 1892, and 1893
RECALLING FIRM/MANUFACTURER
Chattanooga Corporation, Inc., Hixson, TN, by letter dated February 29, 2008 and March 11, 2008. Firm initiated recall is ongoing.
REASON
Device may fail to administer therapy during use.
VOLUME OF PRODUCT IN COMMERCE
1,565 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) BD DifcoTM Neisseria Meningitidis Antisera Group Y, 228811, 1mL, in vials, which
were labeled in part, 8019456 6250890 N. MEN. GP Y UNLABELED LYOPH,
The product is packaged in 1 vial units. For use in slide agglutination tests for
serotyping Neisseria Meningitidis, Recall # Z-1559-2008;
; BD DifcoTM Neisseria Meningitidis Antisera Group Y 228811, 1mL, in vials, which were labeled in part, 8019456 6250890 N. MEN. GP Y UNLABELED LYOPH. The product is packaged in 1 vial units. For use in slide agglutination tests for serotyping Neisseria Meningitidis, Recall # Z-1560-2008;
c) BD DifcoTM Neisseria Meningitidis Antisera Group Y 241113, 1mL, in vials, which
were labeled in part, 8019456 6250890 N. MEN. GP Y UNLABELED LYOPH.
The product is packaged in 100 vial units For use in slide agglutination tests for
serotyping Neisseria Meningitidis, Recall # Z-1561-2008;
d) BD DifcoTM Neisseria Meningitidis Antiserum Group Y 241113, 1mL, in vials, which
were labeled in part, 8019456 6250890 N. MEN. GP Y UNLABELED LYOPH.
The product is packaged in 100 vial units For use in slide agglutination tests for
serotyping Neisseria Meningitidis, Recall # Z-1562-2008
CODE
a) Lot #6311396, EXP 2009-09-19;
b) Lot #6250885, EXP 2009-02-26;
c) Lot #6104713, EXP 2009-02-26;
d) Lot #7136172, EXP 2009-09-19
RECALLING FIRM/MANUFACTURER
Recalling Firm: BD Diagnostic Systems / Lee Laboratories, Grayson, GA, by letter, dated September 2007.
Manufacturer: Becton Dickinson, Sparks, MD. Firm initiated recall is ongoing.
REASON
Exhibits cross reactivity with Neisseria meningitides Group W135
VOLUME OF PRODUCT IN COMMERCE
1,440 units
DISTRIBUTION
Nationwide and Internationally
END OF ENFORCEMENT REPORT FOR AUGUST 13, 2008
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