• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

Enforcement Report for April 9, 2008

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.

rule

April 9, 2008
08-15

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I

___________________________________
PRODUCT
The shipping carton identifies the product as FROZEN YELLOWFIN TUNA SAKU INDIVIDUALLY VACUUM PACKED, Net Wt. 22 Lbs (10Kg). The product is packaged for wholesale distribution therefore individual packages within the carton are not labeled (11 individual vacuum packed, sealed and frozen units of cubed tuna). This is a raw seafood product, Recall # F-264-8
CODE
Lot Number 0727408005899 with Production Dates of October 1, 2007 (01-Oct-07) and October 2, 2007 (02-Oct-07).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Choyce Products, Inc., Honolulu, HI, by telephone and press release on February 14, 2008.
Manufacturer: Pt. Bitung Mina Utama, Bitung Timur North Sulawesi, HI. FDA initiated recall is ongoing.
REASON
Product is contaminated with Salmonella based on FDA’s analysis.
VOLUME OF PRODUCT IN COMMERCE
The firm has not been able to determine the amount of product distributed.
DISTRIBUTION
Oahu, Hawaii
___________________________________
PRODUCT
GREAT WALL BRAND CHINESE WOLFBERRY, Net Wt: 7 oz. (198G), --- Nutrition Facts --- Serving Size 4 tsp(80g) --- Servings Per Container 4, Recall # F-265-8
CODE
No code
RECALLING FIRM/MANUFACTURER
Recalling Firm: Strong America Limited, Long Island City, NY, by press release on September 10, 2007.
Manufacturer: Tianjin Foodstuffs Imp. & Exp. Co., Ltd., Tianjin, China. Firm initiated recall is complete.
REASON
The product contained undeclared sulfites (4561 ppm) based on sampling and analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
Undetermined
DISTRIBUTION
NY, GA and TN

___________________________________
PRODUCT
See's Semi Sweet Chocolate Chips Net Wt 16 oz. (454g), Recall # F-266-8
CODE
Codes produced 30757, 31327, 32067, 33157 and 23397.
RECALLING FIRM/MANUFACTURER
Recalling Firm: See's Candies, Inc., South San Francisco, CA by e-mail and letter on February 8, 2008.
Manufacturer: Guittard Chocolate Co., Burlingame, CA. Firm initiated recall is ongoing.
REASON
Product contains undeclared milk.
VOLUME OF PRODUCT IN COMMERCE
41,664 bags
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Mayfield Vanilla, Classic Ice Cream, All Natural Flavor, Half Gal. (1.89L), Recall # F-267-8
CODE
01/30/09 CLK 47225
RECALLING FIRM/MANUFACTURER
Mayfield Dairy Farms, Athens, TN, by press release on February 21, 2008. Firm initiated recall is ongoing.
REASON
Butter Pecan Ice Cream is mislabeled as Vanilla Ice Cream.
VOLUME OF PRODUCT IN COMMERCE
116 units
DISTRIBUTION
AL, FL, GA, MS

___________________________________
PRODUCT
Organic Sesame Seeds, Natural - Unhulled, net wt 0.50, Recall # F-268-8
CODE
Packed on DEC 28
RECALLING FIRM/MANUFACTURER
Nutri Foods Inc., Royal Oak, MI, by press release on February 15, 2008. FDA initiated recall is complete.
REASON
FDA testing of a portion of this lot found it to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
12/0.5lb bags
DISTRIBUTION
MI
___________________________________
PRODUCT
LOTTE MARGARET brand KOREAN CRACKERS/GATEAU COREEN, LOTTE MARGARET SOFT COOKIES, Net Wt. 19 g, Item No. 00438, UPC 8 801062 241651, Recall # F-269-8
CODE
Code 08.08.06.B2 (stamped on side of box)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wang Globalnet, Inc., Brooklyn, NY, by press release on January 31, 2008.
Manufacturer: Samjin Globalnet Co., Ltd., Seoul, Korea. Firm initiated recall is complete.
REASON
The product contains undeclared eggs, peanuts, and milk allergens. This was confirmed during an establishment inspection by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
30 cartons
DISTRIBUTION
MA, NJ, NY
___________________________________
PRODUCT
Annie's Naturals brand Shiitake & Sesame Vinaigrette, in 8 fl. oz (236mL) glass bottles with UPC: 0 92325 33335 2. The recalled product bears an incorrect back label stating "Low Fat Honey Mustard Vinaigrette." The product is packed in cases with UPC: 1 00 92325 33335 9, Recall # F-273-8
CODE
Best By Dates of 02/20/09/1/E and 02/20/09/2/E
RECALLING FIRM/MANUFACTURER
Recalling Firm: Annie’s Home Grown Inc., Napa, CA, by press release and letters on February 11, 2008.
Manufacturer: Blanchard & Blanchard, Ltd., Wilder, VT. Firm initiated recall is complete.
REASON
The product contains undeclared soy and wheat.
VOLUME OF PRODUCT IN COMMERCE
686 cases, 6 bottles/case
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
Mung bean sprouts packaged as: 1) Fresh bean sprouts, Pyramid Sprouters, Net Wt. 8oz (227g). Keep Refrigerated. 2) Calco, Bean Sprouts, ISGA Certified Grower, Certification No. 10001, Calco has passed the HACCP Food Safety Certification Program. Keep refrigerated, Net Wt. 16 oz (454 g). 3) Calco, Bean Sprouts, ISGA Certified Grower, Certification No. 10001, Calco has passed the HACCP Food Safety Certification Program. Keep refrigerated, Net Wt. 8oz (227 g). Recall # F-275-8
CODE
No codes are used. All products packaged and distributed between April 20, 2007 and May 9, 2007.
RECALLING FIRM/MANUFACTURER
Calco Sprouts, Inc., Minneapolis, MN, by telephone on May 10, 2007. Minnesota initiated recall is complete.
REASON
FDA and the Minnesota Department of Agriculture found Listeria monocytogenes in bean sprouts manufactured by the firm and in the firm’s environment.
VOLUME OF PRODUCT IN COMMERCE
5,000 lbs mung beans/day
DISTRIBUTION
MN and WI
___________________________________
PRODUCT
Low Fat Caramel Gourmet Hot Air-Popped, 9 oz. bags, UPC code 1044932050, Recall # F-276-8
CODE
Any code less than D1231xx
RECALLING FIRM/MANUFACTURER
Recalling Firm: Front Range Snacks, Inc. Centennial, CO, by telephone beginning January 14, 2008 and press release on February 11, 2008.
Manufacturer: Condor Snack Company, Denver, CO. Firm initiated recall is complete.
REASON
Low fat caramel popcorn contains undeclared walnut derivative.
VOLUME OF PRODUCT IN COMMERCE
1603 units
DISTRIBUTION
CO, TX       
___________________________________
PRODUCT
Sun Ripened Apricots Nt. Wt. 12.oz (340.80 g) Valued Naturals, Dover, NJ 07801 Product of Turkey. UPC 790429213401, Recall # F-278-8
CODE
Best by 09/09/08
RECALLING FIRM/MANUFACTURER
Recalling Firm: International Foodsource, LLC, Dover, NJ, by letter on February 5, 2008 and press release on February 6, 2008. New York State Department of Agriculture and Markets issued a press release on February 7, 2008.
Manufacturer: Entegre Food Industry Co Incentegre Gida Sanayi As, Malatya, Turkey.  Firm initiated recall is complete.
REASON
New York State Department of Agriculture and Markets randomly sampled the product and found it to contain 3539 ppm sulfites. Sulfites are not declared on the label.
VOLUME OF PRODUCT IN COMMERCE
11,520 cello bags
DISTRIBUTION
TX, IA, PA, NJ and NY       

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II

___________________________________
PRODUCT
Custom Culinary PanRoast Gravy Low Sodium Chicken Flavored Gravy Mix, item 1740, UPC 0 96248 11740 2, net wt. 16 oz. pouches, 8 pouches per case, which may be labeled as Custom Culinary PanRoast Gravy Brown Gravy Mix, item 1764, UPC 0 96248 11764 8, Recall # F-270-8
CODE
Lot numbers: 82902134126 and 82902134127
RECALLING FIRM/MANUFACTURER
Custom Culinary, Oswego, IL, by telephone and letters on March 13, 2008. Firm initiated recall is ongoing.
REASON
The chicken flavored gravy mix is mislabeled as brown gravy mix, which does not declare the colors – FD&C Yellow # 5 and Yellow # 6 - on the label.
VOLUME OF PRODUCT IN COMMERCE
296 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Egg-shaped boxes labeled on the front as "Reese's Happy Easter" which have incorrect back label for "Whoppers Robin Eggs", Net Wt 2 oz., Hershey's. Each box contains 5-6 pieces of Reese's Peanut Butter Cup candy. Recall # F-274-8
CODE
Lot #’s: 036/330, 037/329, 043/323
RECALLING FIRM/MANUFACTURER
Creative Custom Confections, Inc., Draper, UT, by e-mail on February 28, 2008. Firm initiated recall is ongoing.
REASON
Packages labeled as "Robin Eggs" actually contain Peanut Butter Cups; however, candies inside the package are clearly labeled as peanut butter cup and bear the ingredient statement for the peanut butter cups.
VOLUME OF PRODUCT IN COMMERCE
1229 boxes
DISTRIBUTION
GA, IL, NY, PA, TX.

___________________________________
PRODUCT
Cinnamon Fat Free Popcorn Gourmet Hot Air-Popped, 9 oz. bags, UPC code 010449320515, Recall # F-277-8
CODE
Any product with an expiration date of 09 AUG 08 or earlier.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Front Range Snacks, Inc. Centennial, CO, by telephone beginning January 14, 2008.
Manufacturer: Condor Snack Company, Denver, CO. Firm initiated recall is complete.
REASON
Cinnamon fat free popcorn contains undeclared colors - FD&C Yellow No. 5 and Yellow No. 6.
VOLUME OF PRODUCT IN COMMERCE
1687 units
DISTRIBUTION
CA, CO, KS, KY, MA, MI, NM, TX, UT, WA

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS III

___________________________________
PRODUCT
a) Clear cellophane type bags containing various brand name candies including
    Butterfinger, Nestle Crunch, Baby Ruth, Kit Kat, Milk Duds, and Twix bars,
    Recall # F-271-8;
b) Clear cellophane type bags containing various flavors of Jolly Ranchers including
    Cherry/Orange and Lemon/Mango, Recall # F-272-8
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Midwood Distribution, Wood Ridge, NJ, by telephone on November 19, 2007.
Manufacturer: Superior Pack Group/On Time Contract Packaging, Cornwall, NY. North Firm initiated recall is ongoing.
REASON
a) Individual pieces of candy were distributed in clear plastic bags with no ingredient statement on the package. (Allergens were listed on individual pieces of candy).
b) Individual pieces of candy were distributed in clear plastic bags with no ingredient statement on the package.
VOLUME OF PRODUCT IN COMMERCE
1750 bags
DISTRIBUTION
NJ and NY

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II

___________________________________
PRODUCT
Fentanyl Transdermal System, 75 mcg/h, Each transdermal system contains; 7.5 mg fentanyl and 0.3 mL alcohol USP, Rx Only, NDC 0591-3213-54, UPC 305913213548. Packaged in boxes of five pouches with NDC 0591-3213-72, UPC 305913213722, Recall # D-195-2008
CODE
Lot No. 92461681
RECALLING FIRM/MANUFACTURER
Watson Laboratories, Inc., Salt Lake City, UT, by letter on March 21, 2008. Firm initiated recall is ongoing.
REASON
Superpotent; 6 month stability.
VOLUME OF PRODUCT IN COMMERCE
28416 cartons
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS II

___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-1049-08
CODE
Unit: FL24288
RECALLING FIRM/MANUFACTURER
Heartland Blood Centers, Aurora, IL, by telephone on November 29, 2007 and follow-up letter on December 11, 2007. Firm initiated recall is complete.
REASON
Blood product, with incomplete documentation of the irradiation process, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL
___________________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-1050-08
CODE
Unit: 40KG08429
RECALLING FIRM/MANUFACTURER
American National Red Cross HOA Blood Services Region, Peoria, IL, by telephone and follow-up letter on November 19, 2007, Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was previously deferred, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL
___________________________________
PRODUCT
a) Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1051-08;
b) Fresh Frozen Plasma, Recall # B-1052-08
CODE
a) Unit: 123795411;
b) Units: 123795411 Split 1, 123795411 Split 2
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc., Scottsdale, AZ, by facsimile on December 31, 2007 and letter on January 8, 2008.
Manufacturer: Blood Systems, Inc., Albuquerque, NM. Firm initiated recall is complete.
REASON
Blood products, which tested negative for HIV, but was collected from a donor who previously tested positive for HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NM
___________________________________
PRODUCT
Recovered Plasma, Recall # B-1055-08
CODE
Unit # LE77385
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, consignee by electronic mail on November 17, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt - Jakob disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1056-08;
b) Platelets Pheresis Leukocytes Reduced, Recall # B-1057-08
CODE
a) Units: 2802438; and 2689590;
b) Units: 7089263 Part 1; and 7089263 Part 2;
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX, by facsimile on January 5, 2006.
Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1064-08
CODE
Units: 0441884
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on August 17, 2007 and by letter dated September 4, 2007. Firm initiated recall is complete.
REASON
Blood product, which was labeled as leukoreduced, but exceeded the acceptable limit for white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1065-08
CODE
Unit: 3825816 (split unit)
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on May 22, 2006. Firm initiated recall is complete.
REASON
Blood products, which were labeled as leukoreduced, but were not tested to verify the White Blood Cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
LA
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1066-08
CODE
Units: 2679092 (split unit), 2675308 (split unit)
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX, by facsimile on March 2, 2005.
Firm initiated recall is complete.
REASON
Blood products, which were labeled as leukoreduced, but were not tested to verify the White Blood Cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1068-08
CODE
Unit: 033GL69350
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Farmington, CT, by telephone on February 23, 2007 and by letter dated March 1, 2007.
REASON
Blood product, manufactured from a Whole Blood unit that was overweight, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT
a) Platelets Pheresis Leukocytes Reduced, Recall # B-1069-08;
b) Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-1070-08
CODE
a) Units: 49GP24201 (2 units), 49GP20688 (2 units), 49GP24612 (2 units),
    49GP23239 (2 units), 49GP22095, 49GP23844, 49GP21536, 49GP22735 (2 units),
    49GP24850 (2 units), 49GP23293, 49GP23091, 49GP21559 (2 units), 49GP23183 (2
    units), 49GP24619 (2 units), 49GP23146 (2 units), 49GP22681 (2 units), 49GP17400
    (2 units), 49GP23242, 49GP23243 (2 units), 49GP23588 (2 units), 49GP24141,
    49GP23809, 49GP23238 (2 units), 49GP24446 (2 units), 49GP24477 (2 units);
b) Units: 49GP25337, 49GP22095, 49GP18659 (2 units), 49GP24141
RECALLING FIRM/MANUFACTURER
American National Red Cross SW Region – HT, Tulsa, OK, by telephone beginning July 14, 2005 and follow-up letters dated October 10, 2005. Firm initiated recall is complete.
REASON
Blood products, collected using apheresis kits that had exceeded the acceptable time periods for use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
47 units
DISTRIBUTION
TX, OK
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1073-08
CODE
Unit: 72C179491
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile on July 18, 2007.
Manufacturer: LifeSouth Community Blood Centers - Wiregrass Region, Dothan, AL. 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
AL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1074-08
CODE
Unit: 72C075235
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile on August 17, 2007.
Manufacturer: LifeSouth Community Blood Centers Inc., Huntsville, AL. 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
AL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1077-08
CODE
Unit: 71X528371
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile on March 9, 2007.
Manufacturer: LifeSouth Community Blood Centers Inc., Huntsville, AL. 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
AL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1078-08
CODE
Unit: 71X601185
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile on May 22, 2007.
Manufacturer: LifeSouth Community Blood Centers Inc., Huntsville, AL. 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
AL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1079-08
CODE
Unit: 71X67149X
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile on March 9, 2007.
Manufacturer: LifeSouth Community Blood Centers - Wiregrass Region, Dothan, AL. 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
AL
___________________________________
PRODUCT
Source Plasma, Recall # B-1084-08
CODE
Units: 05EWIE4335, 05EWIE5036, 05EWIE5864
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services LP, Deerfield IL, by fax on October 3, 2005. 
Manufacturer: BioLife Plasma Services, L.P., Eau Claire, WI. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with high risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Vienna, Austria
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1096-08
CODE
Units: 160290025; 160290036; 160290026; 160290029
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc., Scottsdale, AZ, by telephone on July 31, 2007.
Manufacturer: Blood Systems Inc/dba United Blood Services, Meridian MS. Firm initiated recall is complete.
REASON
Blood products, which may have been shipped under unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
MS
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1098-08
CODE
Unit: 71M33896X
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile on May/15,/2007.
Manufacturer: LifeSouth Community Blood Centers Inc., Huntsville, AL. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor with a history of malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelets Irradiated, Recall # B-1099-08
CODE
Unit: E31022
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Saint Joseph, MI, by facsimile on October 20, 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
Red Blood Cells Leukocytes Reduced, Recall # B-1100-08
CODE
Units: 4996088, 4996724, 4998468
RECALLING FIRM/MANUFACTURER
Coral Blood Services, Inc., Bangor, ME, by letters dated May 15, 2006 and May 16, 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
3 units
DISTRIBUTION
ME
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1101-08
CODE
Unit: 160295445
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on July 13, 2007.
Manufacturer: Blood Systems Inc/dba United Blood Services, Meridian, MS. 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
MS
___________________________________
PRODUCT
Platelets, Recall # B-1113-08
CODE
Unit: W73661
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Traverse City, MI, by facsimile on November 26, 2007. 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
MI
___________________________________
PRODUCT
Platelet Pheresis Leukocytes Reduced, Recall # B-1114-08
CODE
Unit: 72C089725
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile on July 3, 2007.
Manufacturer: LifeSouth Community Blood Centers Inc., Huntsville, AL. 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
AL
___________________________________
PRODUCT
Platelet Pheresis Leukocytes Reduced, Recall # B-1115-08
CODE
Unit: 72C347780
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile on August 21, 2007.
Manufacturer: LifeSouth Community Blood Centers Inc., Huntsville, AL. 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
AL
___________________________________
PRODUCT
a) Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1120-08;
b) Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated, Recall # B-1121-08
CODE
a) and b) Unit: 247491117
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc., Scottsdale, AZ, by telephone on December 22, 2004.
Manufacturer: Blood Systems Inc., Rapid City, SD. Firm initiated recall is complete.
REASON
Blood products, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MS, SD

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS III

___________________________________
PRODUCT
Red Blood Cells, Recall # B-0852-08
CODE
Unit: 71T859479
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by telephone and fax on March 12, 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
a) Red Blood Cells, Recall # B-0974-08;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0975-08
CODE
a) Unit: 71V107612;
b) Unit: 71T724585
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, GA, by telephone on March 6, 2007. Firm initiated recall is complete.
REASON
Blood products, which was manufactured from a whole blood unit in which an associated blood component contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1075-08
CODE
Unit: 314079473
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone on April 27, 2007.
Manufacturer: Blood Systems Inc/dba United Blood Services, Tupelo, MS. Firm initiated recall is complete.
REASON
Blood product, which may have been shipped under unacceptable temperatures, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MS
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1076-08
CODE
Unit: 200400758
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on June 15, 2007.
Manufacturer: Blood Systems Inc., Lafayette, LA. Firm initiated recall is complete.
REASON
Blood product, which was incorrectly labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-1097-08
CODE
Unit: 71M33896X
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile on May 15, 2007.
Manufacturer: LifeSouth Community Blood Centers Inc., Huntsville, AL. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor with a history of malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1116-08
CODE
Unit: 71V670447
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile on June 1, 2007.
Manufacturer: LifeSouth Community Blood Centers Inc., Huntsville, AL. 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
AL
___________________________________
PRODUCT
Recovered Plasma, Recall # B-1117-08
CODE
Unit: 247492364
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc., Scottsdale, AZ, by electronic notification on December 19, 2004.
Manufacturer: Blood Systems Inc., Mitchell, SD. 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
Switzerland
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1118-08;
b) Recovered Plasma, Recall # B-1119-08
CODE
a) and b) Unit: 307446984
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc., Scottsdale, AZ, by telephone on February 8, 2005 and by electronic notification on February 9, 2005, or by letter dated March 15, 2005.
Manufacturer: Blood Systems Inc., Fargo, ND. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA, Switzerland

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS II

___________________________________
PRODUCT
Hill-Rom Affinity 4 Birthing Bed; Model P3700B, Recall # Z-0617-2008
CODE
All units manufactured prior to November 20, 2007; all beds with serial numbers below 1232AA6856
RECALLING FIRM/MANUFACTURER
Hill-Rom, Inc., Batesville, IN, by letter dated September 6, 2007. Firm initiated recall is ongoing.
REASON
Brake failure: The brakes may not hold or lock properly.
VOLUME OF PRODUCT IN COMMERCE
1,796 beds
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Coloplast Elefant Suction/Irrigation Cannula for Laparoscopy Part Numbers: ASP 105,
    ASP 150, ASP 145, ASP 180, Recall # Z-0713-2008;
b) Coloplast Elefant Suction/Irrigation Cannula for Laparoscopy with Tube, Part
    Numbers: ASP 165, ASP 170, Recall # Z-0714-2008;
c) Coloplast Elefant Suction/Irrigation Tubing, Part Number: AST 307,
    Recall # Z-0715-2008
CODE
a) All un-expired lots are being recalled. ASP 105 ASP 145: Lot Serial # 7030294
    ASP14502001 ASP14504101517 ASP14504023142 ASP1455022514
    ASP1454110199 ASP14503019 ASP14502001 ASP14503019 ASP14503017   
    ASP14503019 ASP14503017 ASP14502001 ASP14503017 ASP14502001
    ASP14504023142 ASP14504101517 ASP14504023142 ASP14504101517     
    ASP14504110200 ASP1455022514 ASP1454110199 ASP1455031783
    ASP1454110199 ASP1455031783 ASP1455041217 ASP1454110199
    ASP1455041217 ASP1455052183 ASP1455041217 ASP1455033506
    ASP1455041217 ASP1455052183 ASP1455041217 ASP1454110199
    ASP1455041217 ASP1455052183 ASP1454110199 ASP1455052183 ASP 150:
    Lot serial # ASP15002001 ASP 180: Lot Serial #7044270 7044267 04041932;
b) All un-expired lots are being recalled. ASP 165: Lot Serial# 04023897 6120192
7021217 7053185 7062896 7062897 7062903 7070016 ASP16502002 ASP16502005 ASP16503040 ASP16503043 ASP16503101459 ASP16503110460 ASP16504023143 ASP16504023897 ASP16504033803 ASP16504061589 ASP16504064478 ASP16504070805 ASP16504074192 ASP1655021255 ASP1655030739 ASP1655031634 ASP1655042461 ASP1655051481 ASP1655052172 ASP1655052174 ASP1655052175 ASP1655052651 ASP1655053628 ASP1655060297 ASP1655060299 ASP1655062276 ASP1655062277 ASP1655070732 ASP1656100365 ASP1656100366 ASP1656120191 ASP1657010843 ASP1657021217 ASP 170: Lot Serial # ASP1701000;
c) All un-expired lots are being recalled. AST 307: Lot Serial# AST30702104
RECALLING FIRM/MANUFACTURER
Recalling Firm: Coloplast Corporation, Minneapolis, MN, by letter on November 12, 2007.
Manufacturer: Coloplast Manufacturing France SAS, Sarlat, France. Firm initiated recall is ongoing.
REASON
Lack of sterilization assurance: Sterilization of Elefant Suction-Irrigation Devices is not performed according to ISO 11135 standard.
VOLUME OF PRODUCT IN COMMERCE
717 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Stryker ACL Workstation slider, Model Number: 234-010-503, Recall # Z-1107-2008
CODE
Lot Numbers: 55-059169, 55-059965, 45165M-3, 44252M-1, and 44660M-1
RECALLING FIRM/MANUFACTURER
Stryker Endoscopy, San Jose, CA, by telephone on January 9, 2008 and by letter dated January 10, 2008. Firm initiated recall is ongoing.
REASON
Slider Lock Failure - The ACL Workstation slider, a component of the ACL workstation, does not consistently lock into the ACL Workstation Base.
VOLUME OF PRODUCT IN COMMERCE
142 sliders
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Agfa IMPAX CardioVascular Suite Results Management Nuclear Reporting Module, Outbound Report, Model/Catalog No.: L7W1P, Recall # Z-1349-2008
CODE
Software Versions: 2.04.17, 2.04.19 and 2.04.20
RECALLING FIRM/MANUFACTURER
AGFA Corporation, Greenville, SC, by telephone and letter on February 22, 2008. Firm initiated recall is ongoing.
REASON
Reporting Differences: The Outbound Report software produces an Outbound Report (text version) which does not contain all the clinical content elements present in the PDF version of the report, also generated on the Nuclear Cardiology Reporting Module.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
DC, NY, OH, TN, and VA
___________________________________
PRODUCT
Warfarin Metabolism Nucleic Acid Test Cartridge; Part Number: 20-006-002; an in vitro diagnostic drug metabolizing enzyme genotyping system, Recall # Z-1383-2008
CODE
Lot Numbers 121907002B, 010708002A, 012108002A, 012108002C, 012208002C, 012408002B, 012808002A, and 020608002A
RECALLING FIRM/MANUFACTURER
Nanosphere, Inc., Northbrook, IL, by letters dated February 25, 2008. Firm initiated recall is ongoing.
REASON
Aberrant Results: A warfarin 2C9*2 mutant capture signal was found to be high enough to result in an aberrant result (i.e., wild-type called heterozygous).
VOLUME OF PRODUCT IN COMMERCE
624 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Baxter HEP LOCK (Heparin Lock Flush Solution, USP) 10 u/mL-1mL vial, 25 Pack,
    NDC 0641-0392-25 (NDC 0641-0392-21; on vial), Recall Z-1384-2008;
b) Baxter HEP-LOCK (Heparin Lock Flush Solution, USP), 10 u/mL-2 mL vial, 25 pack,
    NDC-0641-0393-25, (NDC-0641-0393-21; on vial), Recall # Z-1385-2008;
c) Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 10 u/mL-10 mL vial; 25
    pack, NDC 0641-2438-45, (NDC 0641-2348-41; on vial), Recall #  Z-1386-2008;
d) Baxter HEP-LOCK (Heparin Lock Flush Solution, USP), 10 units/mL-30 mL vial; 25
    pack, NDC 0641-2442-45 (NDC 0641-2442-41; on vial), Recall #  Z-1387-2008;
e) Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 100 units/mL-2 mL vial, 25
    pack, NDC 0641-0387-25, (NDC 0641-0387-21; on vial), Recall #  Z-1388-2008;
f) Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 100 units/mL-1 mL vial, 25
    pack, NDC 0641-0389-25, (NDC 0641-0389-21: on vial), Recall #  Z-1389-2008;
g) Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 100 units/mL-10 mL vial, 25
    pack, NDC 0641-2436-45, (NDC 0641-2436-41; on vial), Recall #  Z-1390-2008;
h) Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 100 units/mL-30 mL vial, 25
    pack, NDC 0641-2443-45, (NDC 0641-2443-41; on vial), Recall #  Z-1391-2008;
i) Baxter HEP-LOCK (Preservative-Free Heparin Lock Flush Solution, USP) 10
    units/mL-1 mL vial, 25 pack, NDC 0641-0272-25 (NDC 0641-0272-21: on vial), 
    Recall # Z-1392-2008;
j) Baxter HEP-LOCK (Preservative-Free Heparin Lock Flush Solution, USP) 100
    units/mL-1 mL vial, 25 pack, NDC 0641-0273-25 (NDC 0641-0273-21; on vial),
    Recall # Z-1393-2008
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by Press Release on February 28, 2008, and letters on February 29, 2008, and March 7, 2008.
Manufacturer: Baxter Healthcare Corporation, Cherry Hill, NJ. Firm initiated recall is ongoing.
REASON
Due to an increase of adverse events in Baxter single and multi-dose Heparin for injection products, which used the same active pharmaceutical ingredient (API) source as the HEP LOCK products
VOLUME OF PRODUCT IN COMMERCE
4,603,297 vials
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Mevatron M2/PRIMUS MID Medical Linear Accelerator, Material Number:    
    019490035, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1,
    Recall # Z-1394-2008;
b) Mevatron KD2 Medical Linear Accelerator, Material Number: 01940753, with
    control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Recall # Z-1395-2008;
c) Primus Plus Medical Linear Accelerator, Material Number : 4504200, with control
    console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Recall # Z-1396-2008;
d) Oncor Impression Plus Medical Linear Accelerator, Material Number : 5857912, with
    control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Recall # Z-1397-2008;
e) Oncor Impression Medical Linear Accelerator, Material Number : 5857920, with
    control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Recall # Z-1398-2008;
f) Oncor Avante-Garde Medical Linear Accelerator, Material Number: 5857920, with    
    control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Recall # Z-1399-2008;
g) Oncor Expression Medical Linear Accelerator, Material Number: 07360717, with
    control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Recall # Z-1400-2008;
h) Mevatron KD-2 Medical Linear Accelerator, Material Number: 8515520, with
    control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Recall # Z-1401-2008;
i) Mevatron KDS-2 Medical Linear Accelerator, Material Number: 9822693, with
    control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Recall # Z-1402-2008;
j) Primart MX Medical Linear Accelerator, Material Number: 05500371, with control
    console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Recall # Z-1403-2008;
k) MEVATRON M-2 6300 Medical Linear Accelerator, Material Number: 09401316
    with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Recall # Z-1404-2008;
l) Mevatron MD2 Medical Linear Accelerator, Material Number: 09401654, with control
    console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Recall #Z-1405-2008;
m) Mevatron KDS-2 Medical Linear Accelerator, Material Number: 09411588, with
    control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Recall # Z-1406-2008;
n) Mevatron KDS-2 Medical Linear Accelerator, Material Number: 09822685, with
    control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Recall # Z-1407-2008
CODE
a) Serial Numbers: 3978 70-4188 3016 3512 3208 3873 2767 2792 2855 2959 3133
31623228 3296 3364 3439 3482 3702 3788 3986 3616 2526 2758 2847 3009 3103 3435 3541 3859 3931 3433 3805 3842 3618 70-4287 3055 3678 3495 3798 3258 3285 3294 3617 3736 3425 3748 70-4146 3084 2961 2955 70-4363 3383 2596 3089 3274 3448 2784 3316 3604 3629 3639 4018 5092 2722 2834 3756 2968 3353 3605 70-4316 2738 2845 2965 3136 5114 70-4323 2816 2913 3243 3138 3826 2901 3624 3699 2806 2875 3774 3557 2765 3303 3623 70-4178 3156 3458 3673 3246 3251 3491 3108 3857 3903 3911 3376 4063 2803 2804 3321 3394 3923 2673 2748 2822 2881 2953 2984 3015 3197 3314 3328 3363 3415 3885 3726 3869 3928 3196 3198 3252 3344 3508 3532 3563 3637 3874 4014 4023 4025 5009 5019 5051 5070 70-4104 70-4191 70-4261 4375 70-3388 4087 3352 3607 3613 3687 3849 3851 3921 3935 3992 4044 5075 5078 5106 5107 5111 70-4199 70-4211 70-4245 70-4259 70-4265 70-4286 70-4293 70-4294 70-4321 70-4337 70-4353 70-4355 70-4377 70-4382 70-4385 3659 3271 3551 3707 5067 70-4249 70-4254 70-4367 2895 3765 3566 70-4304 3374 3428 3445 3498 4056 5052 70-4182 3914 2947 3449 3293 3546 5071 70-4242 3496 and 5109;
b) Serial Numbers: 2568 2698 2589 2038 2448 2547 2681 2686 2781 2592 and 2726;
c) Serial Numbers: 3479 70-4347 3014 3574 2972 3365 3377 3564 2828 3942 3102 2941
3212 3215 3286 3305 3324 3342 3354 3418 3595 3667 4059 3272 3899 2839 2991 3154 3533 3572 3583 3679 3862 3922 3924 4036 2914 3168 3474 3542 3027 3153 3255 3318 3514 3622 3672 3675 3835 3423 3244 3524 3602 3696 3403 3471 3979 2911 3019 3114 3213 3049 3174 3179 3257 3731 3773 3832 3949 2996 3701 2836 2867 3087 3597 3068 3223 3601 2931 3484 2827 3075 3077 3142 3264 3427 3461 3519 3657 3004 3477 3547 2896 3112 3211 3651 3711 3745 4001 3105 3137 2934 3131 3186 3323 3417 3568 3292 2863 2894 3125 3134 3319 3349 3414 3504 3634 3695 3781 2768 3666 3825 3452 2701 2933 3039 3092 3402 3426 3569 2893 3069 3111 3079 3181 3565 70-4185 3239 3515 3516 3453 2899 3214 3751 2823 2846 2954 3456 3709 3203 3424 3245 3443 2912 2958 3261 3267 3297 3392 3413 3534 3241 3224 3829 2887 3011 2733 3727 3728 2956 2963 3579 3582 3663 2815 2964 3046 3217 3308 3724 3752 3042 3158 3191 3284 3291 3295 3356 3378 3382 3406 3407 3619 3638 3641 3645 3742 3919 70-4173 3612 3824 3995 2869 3219 3343 3502 2753 2987 3398 3522 3814 2782 2783 2796 2829 2832 2833 2938 2944 2945 2948 2973 2994 3033 3034 3072 3098 3106 3128 3144 3333 3348 3351 3362 3387 3399 3438 3467 3539 3549 3614 3693 4013 3444 3936 3499 3577 3725 3786 3794 3977 4042 2785 3408 3421 3475 4039 5036 70-4271 2844 3148 3189 3237 3262 3278 3336 3359 3436 3488 3529 3531 3677 3717 3813 3822 3839 3844 3867 3868 3872 3876 3902 3943 3985 3991 4033 4043 4047 4055 4057 4085 5010 5021 5050 5066 5077 5079 70-4102 70-4206 70-4219 70-4225 70-4247 70-4252 70-4275 70-4351 70-4364 70-4103 3347 3386 3389 3994 4045 3028 3722 70-4195 3483 3506 3562 3698 3489 3492 3248 3299 3455 3468 3646 3669 3762 3831 3915 3947 3976 5043 5047 5076 70-4116 70-4162 70-4198 70-4212 70-4237 70-4255 70-4279 70-4315 70-4318 70-4322 70-4341 70-4376 3594 3746 3384 3283 70-4282 3893 4004 3123 3216 3584 3734 2924 3024 3606 3608 3909 70-4139 70-4141 70-4251 2883 2986 3036 3095 3159 3242 3391 3454 3543 3553 3556 3621 3636 3653 3654 3661 3662 3772 3967 3969 4006 4028 5045 5046 70-4112 70-4192 70-4285 3017 2966 3064 3797 3008 3218 3375 3567 5097 3507 3759 4086 5003 5110 70-4256 3288 3113 3238 3405 3481 3691 3706 3708 3721 70-4302 3587 3592 3732 3861 70-4126 3767 3231 3332 3578 3686 3833 70-4308 3999 3369 3401 3412 3002 3273 3276 3005 3462 4076 2878 3329 3897 3493 3465 and 3719;
d) Serial Numbers: 4065 70-4306 3764 3964 3803 5093 70-4119 70-4144 70-4145
    70-4177 70-4343 3801 70-4222 3955 70-4161 4019 5033 70-4142 4067 70-4122
    3783 3901 3791 3793 70-4262 5096 3888 70-4172 70-4174 70-4317 70-4378 3802
    3953 3804 70-4354 70-4356 3815 3948 70-4135 3753 3846 3907 3975 3998 3761
    4072 3981 70-4166 4035 70-4345 70-4362 3989 70-4175 4015 70-4159 70-4157
    70-4349 3877 3754 3755 70-4129 3769 3957 5060 70-4183 3778 5088 5098 3855
    70-4379 4091 4011 70-4136 70-4154 70-4334 4024 3796 3799 3865 70-4361 3795
    5034 5057 5059 5105 3808 4022 4068 4081 5032 5058 5086 5102 70-4132 70-4147
    70-4149 70-4153 70-4189 70-4288 70-4331 70-4366 70-4158 3823 3965 5061 5091
    70-4124 70-4137 70-4329 70-4348 5068 70-4215 70-4253 70-4272 70-4305 70-4335
    70-4338 70-4176 70-4209 3816 4012 4053 70-4186 70-4241 70-4244 3858 3963
    4002 4027 70-4346 4071 3836 3827 4005 5039 5040 70-4231 5030 70-4328 70-4365
    4026 4009 3916 5084 70-4278 3925 3954 5027 5069 5104 70-4224 70-4295 70-4299
    5101 704093 3968 4037 70-4193 70-4292 70-4127 3841 4062 4064 4074 5002 4017
    4084 4096 5001 5011 5053 5087 5095 70-4107 5031 3983 5081 5085 5023 3776
    3848 70-4097 70-4258 70-4301 5004 3863 and 4008;
e) Serial numbers; 4078 70-4143 70-4257 3878 70-4344 70-4207 70-4235 4021 70-4296
    70-4165 70-4167 3729 5022 5035 5074 3811 3845 5108 70-4238 70-4386 3894 4048
    70-4276 70-4277 70-4281 70-4083 3974 3962 3973 70-4152 and 3883;
f) Serial Numbers: 3576 3938 70-4283 3738 3817 3987 3988 4095 70-4368 4016 3904
    3926 4079 4082 70-4077 70-4113 70-4197 3905 3934 3852 3737 3758 3856 3891
    3929 3937 70-4163 3895 3896 4049 70-4201 70-4184 5038 70-4213 70-4223 5012
    70-4311 3932 3739 3806 3884 3912 3941 70-4297 70-4314 and 70-4217;
g) Serial Numbers: 5120 5037 5041 5042 and 5094;
h) Serial Numbers: 2579 2756 2175 2645 2743 2614 2646 1938 2652 and 2376;
i) Serial Numbers: 2518 and 2289;
j) Serial Numbers: 3151 3163 3104 3371 and 3497;
k) Serial Number: 2703;
l) Serial Numbers: 2427 2661 and 2937;
m) Serial Number: 2453;
n) Serial Numbers: 2131 and 2444
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Concord, CA, by letters dated February 14, 2008. Firm initiated recall is ongoing.
REASON
Linear accelerator gantry may rotate in an unexpected direction and may cause patient injury on impact.
VOLUME OF PRODUCT IN COMMERCE
952 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS III

___________________________________
PRODUCT
BIOMET 3i, EP Healing Abutment, REF/Item Number: THA53, 4.1mm(D) X 5mm(P) X 3mm(H), Sterile, Recall # Z-1366-2008
CODE
Lot Number: 770147
RECALLING FIRM/MANUFACTURER
Biomet 3i, Inc., Palm Beach, FL, by telephone and letter dated February 25, 2008. Firm initiated recall is ongoing.
REASON
Mis-labeling: Labeled THA53 device packaging may contain ITHA53 devices (The ITHA53 is designed to be used with an internally hexed implant. The THA53 is used with an external hex platform).
VOLUME OF PRODUCT IN COMMERCE
254 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS:  VETERINARY MEDICINES - CLASS III

___________________________________
PRODUCT
a) Silver Moon Feeds MED-I-MIX NO 3 (SP 250) Special ASP Medicated 3934M,
    Type B medicated feed, containing 10 g/lb. chlortetracycline hydrochloride, 10 g/lb.
    (2.2%) sulfathiazole, and 5 g/lb. penicillin (from procaine penicillin), packaged in
    10-lb. bags, 5 bags/bale, Recall #: V-034-2008;
b) Silver Moon Feeds Pig Shine Medicated 3062P, For Starting Pigs Weighing 11 to 44
    Pounds, Type C medicated feed, containing 100 g/ton chlortetracycline hydrochloride,
    0.011% sulfathiazole, and 50 g/ton penicillin (from procaine penicillin, bulk feed and
    packaged in 50-lb. bags, Recall #: V-035-2008
CODE
a) Lot #’s: 03707, 17007, 26407, and 35407;
b) Lot #’s: 00207, 03807, 06007, 06507, 09507, 09307, 10607, 13707, 12907, 16207,
    22507, 27007, 27607, 29107, 32007, and 33407
RECALLING FIRM/MANUFACTURER
Milbank Mills, Inc, Chillicothe, MO, by letters dated February 22, 2008. Firm initiated recall is ongoing.
REASON
Incorrect bag tag used.
VOLUME OF PRODUCT IN COMMERCE
a) 73/10 lb. bags; b) Bulk – 47,760 lbs; bagged – 2,219/50 lb. bags
DISTRIBUTION
MO, IA

END OF ENFORCEMENT REPORT FOR APRIL 9, 2008

###