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U.S. Department of Health and Human Services

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Enforcement Report for September 12, 2007

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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September 12, 2007
07-37

RECALLS AND FIELD CORRECTIONS:  FOODS AND COSMETICS - CLASS I

___________________________________
PRODUCT
Frozen Monkfish, Gutted and Head-off, Product of China, net. Wt. 22 lbs, gross wt. 24.2 lbs., Recall # F-448-7
CODE
Product is not coded
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hong Chang Corp., Santa Fe Springs, CA, by telephone on May 22, 2007, press release on May 22, 2007 and by letters on May 24, 2007.
Manufacturer: Longhal Liancheng Freezing Co. Ltd., Longhai City, China (Mainland). Firm initiated recall is ongoing.
REASON
Product labeled as monkfish is actually puffer fish which may contain tetrodotoxin, a potent neurotoxin.
VOLUME OF PRODUCT IN COMMERCE
282 boxes/22 lb. boxes
DISTRIBUTION
HI, CA, and IL

RECALLS AND FIELD CORRECTIONS:  FOODS AND COSMETICS - CLASS II
___________________________________
PRODUCT
Gentle Rain Extra Mild Sensitive Skin Moisturizing Body Wash and Shampoo, 21 fl. oz. (621 ml), USA Product # 7233, UPC # 11701-041-26, Recall # F-501-7
CODE
1046669
RECALLING FIRM/MANUFACTURER
Recalling Firm: Coloplast Corp. Skin Care Div., Minneapolis, MN, by telephone beginning on August 6, 2007.
Manufacturer: Coloplast Corp. Skin Care Div., North Mankato, MN. Firm initiated recall is ongoing.
REASON
Gentle Rain Extra Mild might be contaminated with bacteria including Kiebsiella oxytoca.
VOLUME OF PRODUCT IN COMMERCE
5,412 units
DISTRIBUTION
AL, AR, CA, GA, IL, KY, MA, MD, ME, MN, NJ, PA, SC, TX, and WI
___________________________________
PRODUCT
a) Muncheros Chili Saladitos, (dried salted prunes with chili) UPC CODE
    #690166345727 Tia Linda Chili Saladitos, UPC CODE #690166364056,
    Recall # F-502-7;
b) Muncheros Salted Saladitos and Muncheros Saladitos Dried Salted Prunes 3.5oz,
    UPC # 690166345710, Tia Linda Saladitos Dried Salted Saladitos 3.5oz,
    UPC # 690166364063, Recall # F-503-7
CODE
a) All lot codes starting with 02321 (November 17, 2002) to present lot 06278
    (October 5, 2006);
b) Lot codes starting with 02321 (November 17, 2002) to present lot,
    06278 (October 5, 2006)
RECALLING FIRM/MANUFACTURER
Recalling Firm: New Century Snacks, LLC, City of Commerce, CA, by telephone on October 5, 2006, and by telephone and letter on October 11, 2006.
Manufacturer: Chia I Foods Co., Ltd., South El Monte, CA. Firm initiated recall is ongoing.
REASON
Samples collected during establishment inspection contained high levels of lead.
VOLUME OF PRODUCT IN COMMERCE
1,020,444  pkgs of Saladitos Chili; 1,486,188 pkgs of Saladitos
DISTRIBUTION
CA, AZ, TX, AR, UT, VA, OK, IL, NM and WI
___________________________________
PRODUCT
a) Salted Prunes (Saladitos). Packaged in fifty (50) pounds per case, Recall # F-504-7;
b) Saladitos con Chile. Packaged in fifty (50) pounds per case, Recall # F-505-7
CODE
a) Lot No. 06;
b) None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Chia I Foods Co. Ltd, South El Monte, CA, by telephone and letter November 22, 2006.
Manufacturer: Dong Bou Foodstuff Industrial Co., Ltd., Xinxing, China (Mainland). Firm initiated recall is ongoing.
REASON
Samples collected during inspection revealed high levels of lead.
VOLUME OF PRODUCT IN COMMERCE
1,183,962 pounds
DISTRIBUTION
CA, AZ, and ND
___________________________________
PRODUCT
French Style Green Beans, Net Wt 14.5 oz (411g), Ingredients: green beans, water, salt. Canned under the following labels:
1) Albertson's, Distributed by Albertsons, Inc., UPC # 4116341208;
2) Best Choice, Proudly distributed by Associated Wholesale Grocers, Inc.,
    UPC # 7003834775;
3) Bogopa, Distributed by Bogopa Service Corp., UPC # 5903200166;
4) Cub Foods, Distributed by SuperValu, Inc., UPC # 4113047065;
5) Dierbergs, Distributed by Dierbergs Markets, Inc., UPC # 2393310032;
6) Flavorite, Distributed by SuperValu, Inc., UPC # 4113006420;
7) Food Club, Distributed by Topco Associates LLC, UPC # 3680009514;
8) Happy Harvest, Distributed by Aldi, Inc., UPC # 4149812053;
9) HEB, Distributed by H-E-B, UPC # 4122024981;
10) Hill Country Fare, Distributed by H-E-B, UPC # 4122041266;
11) IGA, Distributed by IGA, Inc., UPC # 4127087480;
12) Kroger, Distributed by The Kroger Co., UPC # 1111080270;
13) Laura Lynn, fresh from the farm fancy sliced, Distributed by Ingles
       Markets, Inc., UPC # 8685401418;
14) North Pride, Distributed by Lakeside Foods, Inc., UPC # 9673200050;
15) Shop N Save, Distributed by SuperValu, Inc., UPC # 4113035282;
16) Shoppers Value, Distributed by SuperValu, Inc., UPC # 4113030471;
17) Schnucks, Distrituted by Schnuck Markets, Inc., UPC # 4131802003;
18) Thrifty Maid, Distributed by Win-Dixie Stores, Inc., UPC # 2114020802;
19) Valu Time, Distributed by Topco Associates, LLC, UPC # 1122541579;
20) This label was only distributed in Canada - No Name, Prepared for
       Loblaws, Inc., UPC # 6038303310, Recall # F-506-7
CODE
EAA5247, EAA5257, EAA5267, EAA5277, EAB5247, EAB5257, ECA5207, ECA5217, ECA5227, ECA5297, ECB5207, ECB5217, ECB5227 and ECB5307
RECALLING FIRM/MANUFACTURER
Lakeside Foods, Inc., Manitowac, WI, by press release, telephone and letter dated August 1, 2007. Firm initiated recall is ongoing.
REASON
It was discovered that some cans may have been under processed and some cans may have leaked. While no illnesses have been reported these cans have the potential to be contaminated with harmful organisms including Clostridium botulinum. No botulinum toxin has been found in any cans tested to date, however the company continues to test out of an abundance of caution.
VOLUME OF PRODUCT IN COMMERCE
Approximately 19,000 cases (24 cans per case)
DISTRIBUTION
Nationwide and Canada

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III

___________________________________
PRODUCT
a) Azithromycin, 250 mg, 30 tablets bottle, Rx only, NDC 50111-787-10,
    Recall # D-953-2007;
b) Azithromycin Tablets, 500 mg, 30 tablets bottles, Rx only, Inc.,
    NDC 50111-788-10, Recall # D-954-2007;
c) Azithromycin Tablets, 600 mg, 30 Tablets bottle, Rx only, NDC 50111-789-10,
    Recall # D-955-2007
CODE
a) Lot numbers: 337115A, 330125A, 361125A, 214056B, 315086A,313086B,
    312106A, 318106A, 700524, 303174;
b) Lot numbers: 224106A,401126A, 323125B, 356016A, 241046A, 213056B,
    282086A, 284086C, 700523;
c) Lot numbers: 316086A, 338125B, 339125B, 340125B, 700549
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pliva, Inc., East Hanover, NJ, by letters on May 31, 2007.
Manufacturer: Pliva Croatia, Ltd., Zabreb, Croatia. Firm initiated recall is ongoing.
REASON
Failed Impurity Specification (15 month stability).
VOLUME OF PRODUCT IN COMMERCE
211,256 bottles of 30 tablets each
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) A-Methapred, Methylprednisolone Sodium Succinate for Injection, USP,
    Sterile Powder for Injection, 40 mg Methylprednisolone Activity/mL
    (when mixed), single-dose vials, 10 vials per carton, 10 cartons per shipper,
    NDC 0409-3217-05, RX. Recall # D-971-2007;
b) A-Methapred, Methylprednisolone Sodium Succinate for Injection, USP,
    Sterile Powder for Injection, 125 mg Methylprednisolone Activity/2 mL
    (when mixed), single-dose vials, 10 vials per carton, 10 cartons per shipper,
    NDC 0409-3218-05, Rx, Recall # D-972-2007
CODE
a) Lot # 44-085-DD, Exp. 2-1-08; 45-005-DD, Exp. 3-1-08; 45-010-DD, Exp. 3-1-08;
    45-035-DD, Exp. 3-1-08; 45-410-DD, Exp. 3-1-08; 46-495-DD, Exp. 4-1-08;
    46-505-DD, Exp. 4-1-08; 47-455-DD, Exp. 5-1-08; 47-456-DD, Exp. 5-1-08;
    47-510-DD, Exp. 5-1-08; 48-480-DD, Exp. 6-1-08; 48-485-DD, Exp. 6-1-08;
    48-486-DD, Exp. 6-1-08; 51-025-DD, Exp. 9-1-08; 51-030-DD, Exp. 9-1-08;
    51-035-DD, Exp. 9-1-08;
b) Lot # 45-015-DD, Exp. 3-1-08; 45-420-DD, Exp. 3-1-08; 45-425-DD, Exp. 3-1-08; 
    45-470-DD, Exp. 3-1-08; 45-480-DD, Exp. 3-1-08; 47-005-DD, Exp. 5-1-08;
    47-010-DD, Exp. 5-1-08; 47-015-DD, Exp. 5-1-08; 47-460-DD, Exp. 5-1-08;
    47-465-DD, Exp. 5-1-08; 48-490-DD, Exp. 6-1-08; 48-495-DD, Exp. 6-1-08;
    48-505-DD, Exp. 6-1-08; 48-506-DD, Exp. 6-1-08; 49-440-DD, Exp. 7-1-08;
    49-441-DD, Exp. 7-1-08; 51-040-DD, Exp. 9-1-08; 51-045-DD, Exp. 9-1-08;
    51-530-DD, Exp. 9-1-08; 51-615-DD, Exp. 9-1-08; 51-620-DD, Exp. 9-1-08;
    51-625-DD, Exp. 9-1-08; 51-630-DD, Exp. 9-1-08; 51-715-DD, Exp. 9-1-08;
    53-020-DD, Exp. 11-1-08; 53-525-DD, Exp. 11-1-08; 53-530-DD, Exp. 11-1-08;
    53-535-DD, Exp. 11-1-08
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira Inc., Lake Forest, IL, by letters dated July 9, 2007.
Manufacturer: Hospira Inc., Mc Pherson, KS. Firm initiated recall is ongoing.
REASON
Product exceeded impurity specification during stability testing.
VOLUME OF PRODUCT IN COMMERCE
534,760/40 mg vials; 1,516,010/125 mg/vials
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1405-07
CODE
Unit: 163869885
RECALLING FIRM/MANUFACTURER
Blood Systems Inc, Scottsdale, AZ, by letter on April 27, 2006. Firm initiated recall is complete.
REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MS
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1406-07
CODE
Unit: 157397539
RECALLING FIRM/MANUFACTURER
Blood Systems Inc, Lubbock Center, Lubbock, TX, by telephone and letter dated November 28, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1407-07
CODE
Units: 157403764 and 150157219
RECALLING FIRM/MANUFACTURER
Blood Systems Inc, Lubbock Center, Lubbock, TX, by telephone and letter dated   August 8, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1408-07
CODE
Unit: 163863693
RECALLING FIRM/MANUFACTURER
Blood Systems Inc, Scottsdale, AZ, by telephone on November 11, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MS
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-1412-07;
b) Platelets, Recall # B-1413-07;
c) Fresh Frozen Plasma, Recall # B-1414-07
CODE
a), b), and c) 04LE69672
RECALLING FIRM/MANUFACTURER
ARC Blood Services, New England Region, Dedham, MA, by fax on January 17, 2007. Firm initiated recall is complete.
REASON
Blood product, which tested negative for the antibody to the human immunodeficiency virus (anti-HIV) but was collected from a donor who previously tested positive for anti-HIV, was distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
MA and ME
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-1415-07;
b) Fresh Frozen Plasma, Recall # B-1416-07
CODE
a) and b) Unit: 04LE66272
RECALLING FIRM/MANUFACTURER
ARC Blood Services, New England Region, Dedham, MA, by telephone on December 22, 2006 and by fax on December 26, 2006. Firm initiated recall is complete.
REASON
Blood product, which tested negative for the antibody to the human immunodeficiency virus (anti-HIV) but was collected from a donor who previously tested positive for anti-HIV, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY
___________________________________
PRODUCT
Source Plasma, Recall # B-1417-07
CODE
Unit: 04SMNB1663
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services LP, Deerfield, IL, by fax on April 28, 2004. 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
Austria

___________________________________
PRODUCT
a) Fresh Frozen Plasma, Recall # B-1418-07;
b) Red Blood Cells, Recall # B-1419-07
CODE
a) and b) Unit: 1036920
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter dated July 16, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MN
___________________________________
PRODUCT
Source Plasma, Recall # B-1421-07
CODE
Units: 03PWIF6155, 03PWIF6897, 03PWIF7706, 03PWIF8221, 03PWIF8997, 03PWIF9479
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services LP, Deerfield, IL, by fax on December 9, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received an MMR immunization, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1423-07
CODE
Unit: 9974212
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by telephone on May 29, 2006. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells Pheresis, Leukocytes Reduced, Recall # B-1424-07
CODE
Units: 112532254 (parts 1 & 2)
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc. dba United Blood Services, El Paso, TX, by telephone and fax on April 28, 2006.  Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may compromise the sterility of the products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX and NM
___________________________________
PRODUCT
Platelets, Recall # B-1426-07
CODE
Unit: FN03349
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by letter dated February 6, 2007. Firm initiated recall is complete.
REASON
Blood product, associated with a unit of Red Blood Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1460-07
CODE
Units: 150156060, 150159311, 150159974
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc - Lubbock Center, Lubbock, TX, by telephone on July 26, 2005. Firm initiated recall is complete.
REASON
Blood products, which tested negative for hepatitis, but were collected from a donor with a history of Hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TX
___________________________________
PRODUCT
Platelets, Recall # B-1464-07
CODE
Unit: N60150
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Grand Rapids, MI, by fax on March 13, 2007. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which an associated blood component contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-1465-07;
b) Cryoprecipitated AHF, Recall # B-1466-07;
c) Plasma Cryoprecipitate Reduced, Recall # B-1467-07
CODE
a), b), and c) Units: 3485683
RECALLING FIRM/MANUFACTURER
Lifesource, Glenview, Chicago, IL, by telephone on March 22 and 23, 2007. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor with a history of multiple high risk behaviors, was distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
IL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1471-07
CODE
Unit: 5619083
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Alexandria, LA, by fax on April 13, 2006. 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
LA
___________________________________
PRODUCT
Cryoprecipitated AHF, Recall # B-1472-07
CODE
Unit: KE84243
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by letter dated February 5, 2007. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which an associated blood component contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1480-07
CODE
Unit: 242457339
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone on December 12, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected in a manner that may have compromised the sterility of the collection system, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
SD
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-1481-07
CODE
Units: 2126749 (split unit)
RECALLING FIRM/MANUFACTURER
Central Jersey Blood Center, Shrewsbury, NJ, by fax on November 29, 2006. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NJ
___________________________________
PRODUCT
Platelets, Recall # B-1484-07
CODE
Unit: 1129542
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter dated February 3, 2004. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which an associated blood component contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1553-07
CODE
Unit: 4506920
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on October 10, 2002 and letter dated October 11, 2002. Firm initiated recall is complete.
REASON
Platelets, mislabeled as leukoreduced, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

___________________________________
PRODUCT
Source Plasma, Recall # B-1420-07
CODE
Units: 0010071827, 0010073024, 0010073061, 0010073110, 0010073324, 0010071744, 0010073926, 0010073426, 0010074009, 0010074158, 0010074295, 0010074594, 0010075158, 0010075438, 0010075459, 0010075614, 0010075619, 0010075862, 0010075896, 0010076106, 0010076452, 0010076455, 0010076461, 0010076679, 0010076809
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Allentown, PA, by fax on January 16, 2007. 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
25 units
DISTRIBUTION
Spain
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1456-07
CODE
Unit: 22LJ99237
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey, Philadelphia, PA, by fax on December 22, 2006. Firm initiated recall is complete.
REASON
Blood product, which was incorrectly labeled as to red cell antigen type, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
___________________________________
PRODUCT
a) Cryoprecipitated AHF, Recall # B-1457-07;
b) Plasma Cryoprecipitate Reduced, Recall # B-1458-07;
c) Fresh Frozen Plasma, Recall # B-1459-07
CODE
a) 032KC37300, 032KC37301, 032KC37302, 032KC37303, 032KC37304,
    032KC37305, 032KC37306, 032KC37307, 032KC37309, 032KC37310,
    032KC37311, 032KC37312, 032KC37313, 032KC37314, 032KC37315,
    032KC37316, 032KC37317, 032KC37318, 032KC37321, 032KC37322,
    032KC37324, 032KC37325, 032KC37326, 032KC37328, 032KC37329,
    032KC37330, 032KC37361, 032KC37362, 032KC37363, 032KC37364,
    032KC37365, 032KC37366, 032KC37367, 032KT27641, 032KT27642,
    032KT27644, 032KT27663, 032KT27664, 032KT27667, 032KT27668,
    032KT27672, 032KT27673, 032KT27674, 032KT27676, 032KT27678,
    032KT27679, 032KT27680, 032KT27683, 032KT27684, 032KT27685,
    032KT27687, 032KT27688, 032KT27689, 032KT27690, 032KT27691,
    032KT27694, 032KT27696, 032KY21510, 032KY21511, 032KY21512, 
    032KY21513, 032KY21516, 032KY21517, 032KY21519, 032KY21537,
    032KY21554, 032KY21557, 032KY21558;
b) 032KC37357, 032KT27623, 032KT27684, 032KT27691, 032KY21511,
    032KY21547;
c) Unit: 032KN22773
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Madison, WI, by fax on June 17, 2003. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly labeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
75 units
DISTRIBUTION
WI
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1462-07;
b) Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-1463-07
CODE
a) Units: 032FC57431, 032FC57495, 032FC57499, 032FC57502, 032FC57503,
    032FC57504, 032FC57632, 032FC57633, 032FC57638, 032FC57641, 032FC57653,
    032FC57655, 032FC58010, 032FC58285, 032FC58464, 032FC58476, 032FC58921,
    032FC59065, 032FC59067, 032FC59131, 032FC59135, 032FC59138, 032FC59378,
    032FC59526, 032FC59657, 032FC59670, 032FC59676, 032FC59883, 032FC59887,
    032FC59888, 032FC59890, 032FC59895, 032FC59899, 032FC60269, 032FJ20894,
    032FJ20901, 032FJ21423, 032FJ21429, 032FJ21758, 032FJ22548, 032FJ22692,
    032FJ22718, 032FJ22859, 032FJ23003, 032FJ23548, 032FJ25022, 032FJ25203,     
    032FJ25219, 032FJ25531, 032FJ25666, 032GC08497, 032GC08600, 032GC08607,
    032GC08609, 032GC08923, 032GC08924, 032GC08930, 032GC08935, 032GC08941,
    032GC09887, 032GC10336, 032GC10337, 032GC10685, 032GC12140, 032GC12675,
    032GC12676, 032GC12677, 032GC12680, 032GC12681, 032GC12683, 032GC12720,
    032GC12968, 032GE56073, 032GE56212, 032GE56306, 032GE56309, 032GE56314,
    032GE56328, 032GE56677, 032GE56691, 032GE57729, 032GE57733, 032GE57743,
    032GE57885, 032GE58032, 032GE58248, 032GF65144, 032GF65925, 032GF66352,   
    032GF67365, 032GF68305, 032GF68310, 032GM15678, 032GM15776, 032GM15795,
    032GM15798, 032GM16039, 032GM16040, 032GM16752, 032GM16756, 032GM16760,
    032GM16786, 032GM16884, 032GM16887, 032GM16888, 032GM16983, 032GM16985,
    032GM16995, 032GR82668, 032GR82888, 032GR82900, 032GR82908, 032GR84166,
    032GR84183, 032GR84186, 032GR84324, 032GR84601, 032GR84770, 032GR84771,
    032GR84962, 032GR85076, 032GR85586, 032GR89325, 032GR89380, 032GR89612,
    032GR89613, 032GR89617, 032GR89619, 032GR90495, 032GR90527, 032GR90528,
    032KC37680, 032KC38136, 032KC38138, 032KC39579, 032KC39588, 032KC39722,
    032KC39723, 032KC39728, 032KC39730, 032KC39759, 032KC40505, 032KC40506,
    032KC40823, 032KC40830, 032KC40836, 032KC40838, 032KC40842, 032KC40843,
    032KC41387, 032KC41495, 032KC41505, 032KC41528, 032KC41529, 032KC41530,
    032KC41531, 032KE80078, 032KE80111, 032KE82018, 032KE82312, 032KE82374,
    032KE82989, 032KE83006, 032KE83012, 032KE83259, 032KE83285, 032KE85830,
    032KE85831, 032KE85832, 032KE85843, 032KE85953, 032KE85956, 032KE86785,
    032KE87191, 032KE87192, 032KE87416, 032KE87471, 032KL13873, 032KN25769,
    032KN25772, 032KN25775, 032KN25786, 032KN27677, 032KN27679, 032KN27680,
    032KN27684, 032KN27685, 032KN27716, 032KN28079, 032KN28085, 032KN28138,
    032KN28139, 032KN28141, 032KN28148, 032KN28542, 032KN28544, 032KN29030,
    032KR16128, 032KR17057, 032KR17995, 032KR17997, 032KR17999, 032KR18000,
    032KR18115, 032KR18426, 032KR18427, 032KR18429, 032KR18431, 032KR18506,
    032KR19967, 032KR19969, 032KR19972, 032KR20177, 032KR20185, 032KR20224,
    032KR20226, 032KR20241, 032KR20334, 032KR20337, 032KR20345, 032KR20347,
    032KR20350, 032KR20359,032KR20360, 032KR20362, 032KR20424, 032KS04710,
    032KS04711, 032KS04720, 032KS04741, 032KS05044, 032KS05137, 032KS05140,
    032KS05142, 032KS05144, 032KS05145, 032KS05182, 032KS05185, 032KS05187,
    032KS05268, 032KS05837, 032KS05842, 032KS05954, 032KT28273, 032KT28275,
    032KT28280, 032KT28342, 032KT28343, 032KT28345, 032KT29614, 032KT29618,
    032KT29631, 032KT29632, 032KT29840, 032KT29860, 032KT29876, 032KT29900,
    032KT29902, 032KT29904, 032KT29911, 032KT30087, 032KT30090, 032KT30114,
    032KT30121, 032KT30210, 032KT30234, 032KT30237, 032KT30349, 032KT31242,  
    032KT31259, 032KT31681, 032KT31688, 032KT32203, 032KT32329, 032KT32369,
    032KT32376, 032KT32388, 032KT32415, 032KT32830, 032KT32845, 032KT32876,
    032KT33022, 032KT33826, 032KT36190, 032KT36192, 032KT36193, 032KT36218,
    032KT37008, 032KT37029, 032KT37420, 032KT38560, 032KT38561, 032KT38562,
    032KT38568, 032KV10643, 032KV11843, 032KV13082, 032KV13103, 032KV13542,
    032KV13618, 032KV13619, 032KV13623, 032KV13630, 032KV13873, 032KV13876,
    032KV13877, 032KV13879, 032KV13881, 032KV13905, 032KV13911, 032KV13919,
    032KZ00288, 032KZ00619, 032KZ00647, 032KZ00990, 032KZ00992, 032KZ00995,
    032KZ01000, 032KZ01008, 032LE09742, 032LE09744, 032LF57613, 032LF57924,
    032LF57928, 032LF58085, 032LF58088, 032LF58200, 032LF58201, 032LF58202,
    032LF58204, 032LF58692, 032LF58713, 032LF58714, 032LF58715, 032LF58716,
    032LF58737, 032LF58902, 032LF58997, 032LF59001, 032LF59668, 032LF59670,
    032LF59676, 032LF59685, 032LF59757, 032LF59759, 032LF59937, 032LF59959,
    032LF60012, 032LF60277, 032LF60283, 032LF60287, 032LF60289, 032LF60292,
    032LF60571, 032LF60573, 032LG08327, 032LG08669, 032LG08964, 032LG09049,
    032LG09121, 032LJ11842, 032LJ12066, 032LJ12071, 032LJ12073, 032LJ12075,
    032LJ12079, 032LJ12113, 032LJ12126, 032LJ12275, 032LJ12602, 032LJ12874,
    032LV26335, 032LW16104, 032LX37772, 032LX38637, 032LX38674, 032LX38676,
    032LX38689, 032LX38706, 032LX38722, 032LX38829, 032LX39764, 032LX42218,
    032LX42219, 032LX42358, 032LX43294, 032LX43297, 032LX43304 032LX43363,
    032LX43831, 032LX43868, 032LX43921;
b) Units: 032FC58463, 032FC59784, 032FJ25213, 032GC08507, 032GC08597,
    032GC08606, 032GC09144, 032GC09994, 032GC10696, 032GC11632, 032GC11641,
    032GC12986, 032GF65137, 032GM16091, 032GM16754, 032GR85581, 032GR85597,
    032KC38135, 032KC39295, 032KC39428, 032KC41504, 032KE80254, 032KE83260,
    032KE87190, 032KL14771, 032KL14788, 032KL14856, 032KN25779, 032KN28084,
    032KR17055, 032KR17996, 032KR18436, 032KS05821, 032KT30065, 032KT30075,
    032KT30201, 032KT30209, 032KT31136, 032KT31143, 032KT33646, 032KT33654,
    032KT33829, 032KT33839, 032KT37007, 032KV10639, 032KV11216, 032KZ00294,
    032KZ00630, 032LF58521, 032LF58723, 032LF59802, 032LF59925, 032LJ12112,
    032LJ12430, 032LX37162, 032LX38827, 032LX40706, 032LX43801
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Madison, WI, by fax beginning September 10, 2003. Firm initiated recall is complete.
REASON
Blood products, which failed to meet the minimum specification for hematocrit and red blood cell recovery, were distributed.
VOLUME OF PRODUCT IN COMMERCE
450 units
DISTRIBUTION
WI, IL, MA, and PA
___________________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-1469-07
CODE
Unit: 4632058
RECALLING FIRM/MANUFACTURER
Anne Arundel Medical Center Blood Bank, Annapolis, MD, by letter dated January 12, 2005. Firm initiated recall is complete.
REASON
Blood product, which was not manufactured in accordance to current Good Manufacturing Practices, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD

___________________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-1470-07
CODE
Unit: 4632215
RECALLING FIRM/MANUFACTURER
Anne Arundel Medical Center Blood Bank, Annapolis, MD, by letter dated January 12, 2005. Firm initiated recall is complete.
REASON
Blood product, which was not manufactured in accordance to current Good Manufacturing Practices, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS II

___________________________________
PRODUCT
BD Vacutainer Safety-Lok Blood Collection Set with Preattached Holder. Color green. 21 Gauge. Translucent, integrated protective shield that provides one-handed activation immediately after use, 0.75 in needle length, 12 in tubing, Luer adapter and holder, wings, sterile, Catalog # 368652, Recall # Z-0777-2007
CODE
Lot Numbers: 5236082; 5236093; 5236095
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ, by letter on March 20, 2007.
Manufacturer: BD Medical Systems Infusion Therapy, Nogales, Sonora, Mexico. Firm initiated recall is complete.
REASON
The BD Vacutainer Safety-Lok Blood Collection Set with Preattached Holder has a problem where the non-patient needle (in the holder) may become separated from the hub and remain the stopper of an evacuated blood collection tube.
VOLUME OF PRODUCT IN COMMERCE
147,200 units
DISTRIBUTION
Nationwide and Canada.
___________________________________
PRODUCT
OneTouch Ultra Test strip, a component of the following OneTouch Ultra Glucose monitoring systems: a)OneTouch Ultra, b) OneTouch InDuo, c) OneTouch Ultra2, d) OneTouch UltraMini, e) OneTouch UltraSmart. 25 strips per vial. Product comes in packs of 100 and 50. (Part numbers: 020-245-07 (100 pack), 020-244-07 (50 pack), 020-963-01(50 pack mail order)), Recall # Z-1042-2007
CODE
Expiration dates 08/2007 through 11/2008
RECALLING FIRM/MANUFACTURER
LifeScan, Inc., Milpitas, CA, by letter on April 23, 2007.  Firm initiated recall is ongoing.
REASON
Damaged Vials/Inaccurate test results: a manufacturing equipment problem on one of the packaging lines had the potential to puncture vials, causing a single hole in the side of the vial below the rim. This result of this defect may produce inaccurately high or low blood glucose test results or error message readings.
VOLUME OF PRODUCT IN COMMERCE
33 million vials
DISTRIBUTION
Worldwide; USA, Europe, Middle East, Africa, Latin America and Canada.
 ___________________________________
PRODUCT
Intellivue Central Station Software for the: Intellivue Information Center, Philips Information Center, Central Station Models: M3145, M3150, M3154, M3155, M3169, Recall # Z-1182-2007
CODE
Software versions: J.00.23 and J.00.24
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Andover, MA, by letter dated July 2007. Firm initiated recall is ongoing.
REASON
Incorrect Patient Assignment: The information center will in most cases be associated with the “incorrect” patient.
VOLUME OF PRODUCT IN COMMERCE
26 units
DISTRIBUTION
NJ, NY, OK, MI, UT, Australia, Finland, France, Netherlands, and UK
___________________________________
PRODUCT
Kion Anesthesia Workstation, Article number: 6454800, Recall # Z-1203-2007
CODE
Serial #: 1719, 2034, 3078, 3416, 3417, 3418, 3419, 3420, 3027
RECALLING FIRM/MANUFACTURER
Recalling Firm: Maquet, Inc., Bridgewater, NJ, by letters on September 1, 2007.
Manufacturer: Maquet Critical Care AB, Solna, Sweden. Firm initiated recall is ongoing.
REASON
Overcharging of batteries and the release of acid fumes.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Biogel Skinsense Polyisoprene Surgical Gloves, Non-Latex, Sterile, (Size 8), Recall # Z-1219-2007
CODE
Lot #: 07B026, Size 8
RECALLING FIRM/MANUFACTURER
Recalling Firm: Molnlycke Health Care, Inc., Norcross, GA, by letter on July 23, 2007.
Manufacturer: Regent Hospital Products, Sdn Bhd, Kulim, Kedah Darulaman, Malaysia. Firm initiated recall is  ongoing.
REASON
Sterility compromised (package integrity): The primary packaging for a portion of the lot may contain gloves that were not sealed properly.
VOLUME OF PRODUCT IN COMMERCE
6,000 pair
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS III

___________________________________
PRODUCT
a) BioHorizons 0.035 Hex Driver, REF 300-377, non-sterile, Rx only,
    REF 300-377, 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;
d) BioHorizons 0.050 Hex Driver, Regular, REF 134-350, non-sterile, Rx only.
    The product is part of a Prosthetic Instrumentation system Kit 51-K,
    Recall # Z-1164-2007
CODE
a) Lot No 09040003
b) Lot No. 06060009
c) Lot Number: 08060239;
d) Lot Number: 11060189
RECALLING FIRM/MANUFACTURER
BioHorizons Implant Systems, Inc., Birmingham, AL, by letters and visit on March 12, 2007. Firm initiated recall is complete.
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
a) Avazzia Tennant Biomodulator®; Model: BEST AV-1; P/N #TB04303-103,
    Recall # Z-1207-2007;
b) Avazzia BEST-RSI; Model: BEST AV-1; P/N #RS04303-103,
    Recall # Z-1208-2007;
c) Avazzia Med-Best Therapeutic Massager; Model: BEST AV-1;
    P/N #MB04182-103, Recall # Z-1209-2007;
d) Avazzia Med-Sport Massager; Model: BEST AV-1; P/N #MS04182-103,
    Recall # Z-1210-2007
CODE
a) Lot # TB07120-AC024;
b) Lot # RS07120-AC024;
c) Lot # MB07120-AC024;
d) Lot # MS07120-AC024
RECALLING FIRM/MANUFACTURER
Avazzia, Inc., Dallas, TX, by letter on June 29, 2007. Firm initiated recall is ongoing.
REASON
Plastic Cases may crack due to manufacturing by the supplier not meeting specifications.
VOLUME OF PRODUCT IN COMMERCE
278 units
DISTRIBUTION
TX, PA, LA, WY, and CA

RECALLS AND FIELD CORRECTIONS:  VETERINARY MEDICINES - CLASS I

__________________________________
PRODUCT
a) Dingo brand CHICK'N JERKY for dogs, 3.5 ounce, 8 ounce and
    100 gram packages, Recall # V-069-2007;
b) Dingo brand CHICK'N JERKY for cats, 1.5 ounce package,
    Recall # V-070-2007;
c) Dingo brand CHICK'N JERKY for ferrets, 1.5 ounce package,
    Recall # V-071-2007
CODE
All codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: United Pet Group Inc., Cincinnati, OH, by press release and letter on March 30, 2007.
Manufacturer: Shanghai Peidi Brand Intl. Co. Ltd., Shanghai, China (Mainland). Firm initiated recall is ongoing.
REASON
The treats have the potential to be contaminated with Salmonella.
VOLUME  OF PRODUCT IN COMMERCE
143,163 packs
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  VETERINARY MEDICINES - CLASS III

__________________________________
PRODUCT
a) Bulk Kent HP Calf Creep LTD 30R Medicated, containing 30 g/ton Monensin
    (as Monensin Sodium), Recall # V-072-2007;
b) Kent First Rate Show Goat 20R Medicated, packaged in 50-lb. bags, containing 20 g/ton
    Monensin, Recall # V-073-2007;
c) Kent 16% Goat 20R Medicated, packaged in 50-lb. bags, containing 20 g/ton Monensin,
    Recall # V-074-2007
CODE
All product without an expiration date
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kent Feeds, Inc., Muscatine, IA, by telephone on or about July 23, 2007, and by letter dated July 24, 2007.
Manufacturer: Kent Feeds, Inc., Marshall, MO. Firm initiated recall is complete.
REASON
Labeling is inadequate due to lack of expiration date.
VOLUME OF PRODUCT IN COMMERCE
4,315/50-lb. bags and 39.46 bulk tons
DISTRIBUTION
MO and KS
__________________________________
PRODUCT
ResiPROX Leave-on Conditioner, 8oz.; Active ingredient: Pramoxine HCl 1.5%; Recall # V-075-2007
CODE
Lot # WG547, WA605, WF631, WK624 and WD735
RECALLING FIRM/MANUFACTURER
Virbac AH, Inc., Fort Worth, TX, by fax on July 27, 2007. Firm initiated recall is ongoing.
REASON
Topical conditioner for dogs and cats contaminated with bacteria.
VOLUME OF PRODUCT IN COMMERCE
22,752 units
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR SEPTEMBER 12, 2007

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