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U.S. Department of Health and Human Services

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Enforcement Report for April 29, 2009

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.

 

April 29, 2009
09-17

 

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I

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PRODUCT 
a) SunSprouts 100% Natural Alfalfa Sprouts, packaged in 4-oz. plastic containers (bar code 815098001088), 6/4-oz. or 12/4-oz. containers per case, and bulk 2.5-, 5-, and 20-lb. cases, Recall # F-193-9;

 

b) SunSprouts 100% Natural Onion Sprouts, a blend of alfalfa and onion sprouts, packaged in 4-oz. plastic containers (barcode 815098002054), 6/4-oz. or 12/4-oz. containers per case, Recall # F-194-9;

 

c) SunSprouts 100% Natural Gourmet Sprouts, a blend of alfalfa, cabbage, clover and fennel sprouts, packaged in 4-oz. plastic containers (barcode 817180000153), 6/4-oz. or 12/4-oz. containers per case, Recall #F-195-9
CODE
Sell by dates 30209 or MAR 02 2009, 30409 or MAR 04 2009, 30709 or MAR 07 2009, 30909 or MAR 09 2009, 31109 or MAR 11 2009, and 31409 or MAR 14 2009. The lot numbers, which are printed only on the shipping case, include: 3102, 3202, 3302, 4102, 4202, and 4302
RECALLING FIRM/MANUFACTURER
C. W. Sprouts, Inc., Omaha, NE, by e-mail on March 3, 2009 and by e-mail and press release on March 4, 2009. Firm initiated recall is ongoing.
REASON
Sprouts are associated with an outbreak of Salmonella saintpaul.
VOLUME OF PRODUCT IN COMMERCE
9,670 lbs. alfalfa sprouts (6,000 lbs. was in 20-lb. bulk cases), 50.4 lbs. onion sprouts, and 48.8 lbs. gourmet sprouts
DISTRIBUTION
IA, NE
___________________________________
PRODUCT 
Solid Milk Chocolate Cross, Harry London brand, 3 oz. size. The product is individually packed in paper cartons with clear plastic fronts. The product is distributed in shipping cases and each case contains 12 cartons 912 candy crosses. The Julian Date of manufacturer is: 8023 (January 23, 2008). UPC: 2179500352, Recall # F-196-9
CODE
Item # 352
RECALLING FIRM/MANUFACTURER
Harry London Candies, Inc., North Canton, OH, by telephone on February 18, 2009 and by press release on February 20, 2009. Firm initiated recall is ongoing.
REASON
The recalled candy contains egg white, a food allergen, which is not identified on the product label.
VOLUME OF PRODUCT IN COMMERCE
208 cases
DISTRIBUTION
MI, CA, OH

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II

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PRODUCT 
a) Joe Brown’s Cheese Corn. Popcorn in bags. Label reads Joe Brown’s Since 1932 Hand Made – one batch at a time – cheese corn, Recall # F-197-9;

 

b) Joe Brown’s Carmel Corn. Popcorn in bags. Label reads Joe Brown’s Since 1932 Hand Made – one batch at a time – carmel corn, Recall # F-198-9
CODE
a) Bar codes: 3 oz (6 47517 00008 8); 5 oz (6 47517 00005 7); and 12 oz (6 47517 00012 5);

 

b) Bar codes: 2.25 oz (6 47517 00002 6), 3 oz (6 47517 00003 3) and 6.5 oz bags (6 47517 00002 6)
RECALLING FIRM/MANUFACTURER
Joe Brown’s Carmel Corm, Portland, OR, by visit beginning on January 28, 2009. Firm initiated recall is ongoing.
REASON
The product lists butter as an ingredient but does not list milk as the source of the butter or soy as the source of the soy lecithin as required by FALCPA (Food Allergen Labeling and Consumer Protection Act).
VOLUME OF PRODUCT IN COMMERCE
1,450 bags
DISTRIBUTION
OR, WA, ID, UT
___________________________________
PRODUCT 
Archer Farms Salad & Pasta seasoning packaged in 3.8-oz. glass bottles, Recall # F-199-9  
CODE
Lot numbers: 1570802A, 1840801A, 2180809A, 2940805A, 3090806A, 3390803A, and 1840801M
RECALLING FIRM/MANUFACTURER
Recalling Firm: Target Corp., Minneapolis, MN, by telephone on January 5, 2009, and by e-mails dated January 6 and January 8, 2009. Firm initiated recall is complete.
REASON
The ingredient statement lacks some of the ingredients, including dairy ingredients and sesame seeds, but the allergen "Contains" statement lists dairy.
VOLUME OF PRODUCT IN COMMERCE
1,632/3.8-oz. glass bottles
DISTRIBUTION
MN, AR, CO, GA, WI, IN, VA, TX, AL, AZ, IA, CA, SC, TX, KS, and IL

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II

___________________________________
PRODUCT 
Calan, verapamil hydrochloride tablets, 80 mg, 100 tablet bottles, Rx only; NDC 0025-1851-31, Recall # D-237-2009
CODE
Lot number: C061194, Exp Date: December 2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pfizer, Inc., New York, NY, by letter on February 18, 2009.
Manufacturer: Pfizer, Inc., Carolina, PR. Firm initiated recall is ongoing.
REASON
Product does not meet dissolution specifications on stability.
VOLUME OF PRODUCT IN COMMERCE
9,445 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0713-09
CODE
Unit: 72H74831X
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Wiregrass Region, Dothan, AL, by facsimile on September 15, 2008.
Manufacturer: LifeSouth Community Blood Centers, Montgomery Region, Montgomery, AL. 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-0749-09
CODE
Unit: 72F810310
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile on May 28, 2008.
Manufacturer: LifeSouth Community Blood Centers, Inc., Dunwoody, GA. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT 
a) Red Blood Cells Leukocytes Reduced, Recall # B-0761-09;
b) Recovered Plasma, Recall # B-0762-09
CODE
a) and b) Unit: 30GY76950
RECALLING FIRM/MANUFACTURER
American Red Cross, Northeastern, Ashley, PA, by telephone on November 19, 2008 and by letter dated November 21, 2008. Firm initiated recall is complete.
REASON
Blood products, which tested negative for the hepatitis C virus (HCV), but were collected from a donor who was previously deferred for testing positive for HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA, CT
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0763-09
CODE
Unit: 72J25547X
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc., Birmingham Region, Birmingham, AL, by facsimile on December 30, 2008 and by telephone on January 3, 2009.
Manufacturer: LifeSouth Community Blood Centers, Inc., Shelby Talladega, Alabaster, AL. 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-0764-09
CODE
Unit: 72J028456
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by facsimile on December 30, 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 
a) Red Blood Cells Leukocytes Reduced, Recall # B-0767-09;
b) Plasma Frozen, Recall # B-0768-09
CODE
a) and b) Unit: W0415080155477
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lubbock Center, Lubbock, TX, by telephone and facsimile on November 25, 2008 and by letter dated January 2, 2009. Firm initiated recall is complete.
REASON
Blood products, which tested negative for hepatitis but were collected from a donor who was previously tested positive for hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0769-09
CODE
Unit: 6584251
RECALLING FIRM/MANUFACTURER
Carter BloodCare/ WE & Lela 1 Stewart Blood Center, Inc., Tyler, TX, by letter dated March 17, 2009 and by telephone on March 27, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0772-09
CODE
Unit: 72J230806
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by Fax on January 6, 2009. 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 Leukocytes Reduced, Recall # B-0775-09
CODE
Unit: 3562325
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services, Inc., Jackson, MS, by fax on March 12, 2009 and by e-mail on March 17, 2009. 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
MS
___________________________________
PRODUCT 
a) Fresh Frozen Plasma, Recall # B-0777-09;
b) Red Blood Cells, Recall # B-0778-09
CODE
a) and b) Unit: 7019457
RECALLING FIRM/MANUFACTURER
HemaCare, Corp., Van Nuys, CA, by telephone and letter dated February 19, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT 
Red Blood Cells, Recall # B-0779-09
CODE
Unit: W089808101991
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Blood Donor Services, Sterling, VA, by letter dated January 23, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0780-09
CODE
Unit: 72J80271X
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Brooksville, FL, by facsimile on January 15, 2009. 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 
Platelets Pheresis Leukocytes Reduced, Recall # B-0781-09
CODE
Unit: 72J732658
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile on January 2, 2009. 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 
Platelets Pheresis Leukocytes Reduced, Recall # B-0782-09
CODE
Unit: 72J799054
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Wiregrass Region, Dothan, AL, by facsimile on January 1, 2009.
Manufacturer: LifeSouth Community Blood Centers, Montgomery Region, Montgomery, AL. 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-0783-09
CODE
Unit: 72J802604
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile on January 19, 2009.
Manufacturer: LifeSouth Community Blood Centers, Inc., Brooksville, FL. 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, Recall # B-0784-09
CODE
Unit: 1660162
RECALLING FIRM/MANUFACTURER
Blood Bank of Hawaii, Honolulu, Hawaii, by letter dated February 1, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Hawaii
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0786-09
CODE
Unit: 004GK06929
RECALLING FIRM/MANUFACTURER
ARC Blood Services, New England Region, Dedham, MA, by telephone and email on February 11, 2009 followed by a letter dated February 12, 2009. 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
MA
___________________________________
PRODUCT 
a) Red Blood Cells Leukocytes Reduced, Recall # B-0788-09;
b) Red Blood Cells, Recall # B-0789-09;
c) Cryoprecipitated AHF, Recall # B-0790-09
CODE
a) Unit: 01GN27196;
b) and c) Units: 01E93836, 01KT23744
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, West Henrietta, NY, by fax, telephone  and/or e-mail on November 26, 2008.
Manufacturer: American Red Cross Blood Services, Syracuse, NY. 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
5 units
DISTRIBUTION
MA, NY, TX, PA
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-0795-09
CODE
Unit: W037909556683
RECALLING FIRM/MANUFACTURER
Blood Center of Iowa, Des Moines, IA, by telephone on March 9, 2009. Firm initiated recall is complete.
REASON
Blood products, possibly contaminated with air, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IA
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0796-09
CODE
Unit: 3998658 (part 1 and 2)
RECALLING FIRM/MANUFACTURER
Ogden Medical Center, Inc., Ogden, UT, by letter and fax on January 5, 2009 followed by an email and telephone on March 25, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had taken aspirin, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
UT
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0797-09
CODE
Units: 01FC79563, 01FC81521, 01FF00879, 01KY85424
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, West Henrietta, NY, by fax on December 8, 2008 and by follow-up letter dated January 9, 2009.
Manufacturer: American Red Cross Blood Services, Syracuse, NY. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
NY
___________________________________
PRODUCT 
a) Red Blood Cells Leukocytes Reduced, Recall # B-0798-09;
b) Recovered Plasma, Recall # B-0799-09
CODE
a) and b) Unit: R45567
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Saginaw, MI, by fax and e-mail on October 22, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI and Switzerland
___________________________________
PRODUCT 
a) Red Blood Cells Leukocytes Reduced, Recall # B-0802-09;
b) Fresh Frozen Plasma, Recall # B-0803-09
CODE
a) and b) Unit: 3092369
RECALLING FIRM/MANUFACTURER
Community Blood Center, Inc., Appleton, WI, by letter dated December 5, 2008. Firm initiated recall is complete.
REASON
Blood products, which tested negative for the antibody to the human immunodeficiency virus (anti-HIV-1/2), but were collected from a donor who previously tested repeat reactive for anti-HIV-1/2, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WI, MI
___________________________________
PRODUCT 
a) Platelets, Recall # B-0805-09;
b) Red Blood Cells, Leukocytes Reduced, Recall # B-0806-09
CODE
a) Unit: 2531436;
b) Units: 2531436, 2543150
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by letter dated March 10, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
KY
___________________________________
PRODUCT 
Red Blood Cells, Leukocytes Reduced, Recall # B-0807-09
CODE
Unit: 6221162
RECALLING FIRM/MANUFACTURER
HemaCare Corp., Van Nuys, CA, by telephone on February 16, 2009 and by letter dated March 11, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT 
a) Red Blood Cells, Recall # B-0808-09;
b) Platelets, Recall # B-0809-09
CODE
a) and b) Unit: 1692488
RECALLING FIRM/MANUFACTURER
Blood Bank of Hawaii, Honolulu, Hawaii, by letter dated January 20, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Hawaii
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0810-09
CODE
Unit: 2911794
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter dated October 23, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who visited a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KY
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0811-09
CODE
Unit: 2914694
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by telephone and letter dated May 30, 2008. Firm initiated recall is complete.
REASON
Blood processed from a low volume unit of whole blood, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT 
Fresh Frozen Plasma, Recall # B-0814-09
CODE
Unit: Q38595
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Saginaw, MI, by fax on October 31, 2008. 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
MI
___________________________________
PRODUCT 
a) Red Blood Cells, Recall # B-0815-09;
b) Platelets, Recall # B-0816-09
CODE
a) and b) Unit: K29779
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Grand Rapids, MI, by faxes on October 20, 2008 and November 7, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported living in a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI
___________________________________
PRODUCT 
Red Blood Cells Irradiated, Recall # B-0817-09
CODE
Units: W067108024260, W067108024400
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by fax on September 12, 2008. Firm initiated recall is complete.
REASON
Blood products, labeled “leukoreduced”, but which had not undergone leukoreduction, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
LA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0819-09
CODE
Unit: W087909801100
RECALLING FIRM/MANUFACTURER
Community Blood Bank of Lancaster County Medical Society, Lincoln, NE, by fax on January 29, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NE
___________________________________
PRODUCT 
Red Blood Cells, Recall # B-0823-09
CODE
Unit: 1454666
RECALLING FIRM/MANUFACTURER
Recalling Firm: Memorial Blood Centers, Saint Paul, MN, by e-mail on February 6, 2009 and by letter on February 10, 2009.
Manufacturer: Memorial Blood Centers - Duluth, Duluth, MN. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0825-09
CODE
Units: 16GQ47649; 16GQ47657
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Columbus, OH, by telephone on December 8, 2008 and letter on December 17, 2008. Firm initiated recall is complete.
REASON
Red Blood Cells collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0765-09
CODE
Units: 21FP46089, 21LP01219, 21KT47258
RECALLING FIRM/MANUFACTURER
American National Red Cross, Portland, OR, by facsimile on November 7, 2008. Firm initiated recall is complete.
REASON
Blood products, for which the documentation of the time returned to controlled storage following irradiation was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
WA, OR
___________________________________
PRODUCT 
Platelets Pooled Leukocytes Reduced, Recall # B-0771-09
CODE
Units: Y24712; Y24716; Y24715; Y24714
RECALLING FIRM/MANUFACTURER
Community Blood Center of Carolinas, Charlotte, NC, by telephone and fax on January 12, 2009 and follow-up e-mail on February 3, 2009. Firm initiated recall is complete.
REASON
Blood products, prepared from whole blood units stored at an unacceptable temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
NC

___________________________________
PRODUCT 
a) Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0773-09;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0774-09
CODE
a) Unit: 4775004;
b) Unit: 2037777
RECALLING FIRM/MANUFACTURER
Indiana Blood Center, Indianapolis, IN, by telephone on July 17, 2006 and July 28, 20008. Firm initiated recall is complete.
REASON
Blood products, manufactured without additive solution, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IN
___________________________________
PRODUCT 
Recovered Plasma, Recall # B-0776-09
CODE
Unit: 3562325
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services, Inc., Jackson, MS, by fax on March 12, 2009 and by e-mail on March 17, 2009. 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
Switzerland
___________________________________
PRODUCT 
Source Plasma, Recall # B-0785-09
CODE
Unit: HP195252
RECALLING FIRM/MANUFACTURER
Interstate Blood Bank Inc., of Chicago, Chicago, IL, by facsimile on January 7, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Germany
___________________________________
PRODUCT 
Recovered Plasma, Recall # B-0787-09
CODE
Unit: 004GK06929
RECALLING FIRM/MANUFACTURER
ARC Blood Services, New England Region, Dedham, MA, by telephone and email on February 11, 2009 followed by a letter dated February 12, 2009. 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
CA
___________________________________
PRODUCT 
Recovered Plasma, Recall # B-0791-09
CODE
Units: 01E93836, 01GN27196, 01KT23744
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, West Henrietta, NY, by fax, telephone  and/or e-mail on November 26, 2008.
Manufacturer: American Red Cross Blood Services, Syracuse, NY. 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
3 units
DISTRIBUTION
MA, CA, NY, TX, PA
___________________________________
PRODUCT 
a) Plasma Cryoprecipitate Reduced, Recall # B-0800-09;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0801-09
CODE
a) and b) Unit: F75554
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Grand Rapids, MI, by facsimile on December 22, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking the drug Celebrex at the time of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0812-09
CODE
Units: W067108002025, W067108013697, W067108013610, W067108002021, W067108005642, W067108013683, W067108012895, W067108005645, W067108013653, W067108013633, W067108012894, W067108009058, W067108012027
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone beginning on June 23, 2008. Firm initiated recall is complete.
REASON
Blood products, documented as being out of controlled storage for more than 30 minutes, were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
LA, AL
___________________________________
PRODUCT 
Platelets, Recall # B-0813-09
CODE
Units: W067108004466, W067108004467, W067108004468, W067108004469, W067108004470, W067108004480
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on August 6, 2008. Firm initiated recall is complete.
REASON
Blood products, processed from Whole Blood collected at an unacceptable temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
LA, MS
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0818-09
CODE
Unit: W071208007813
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by telephone on June 4, 2008 and follow-up letter dated June 6, 2008. Firm initiated recall is complete.
REASON
Blood product, found to contain clots during leukoreduction filtration, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT 
Recovered Plasma, Recall # B-0822-09
CODE
Unit: 1454666
RECALLING FIRM/MANUFACTURER
Recalling Firm: Memorial Blood Centers, Saint Paul, MN, by e-mail on February 6, 2009 and by letter on February 10, 2009.
Manufacturer: Memorial Blood Centers - Duluth, Duluth, MN. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0824-09
CODE
Unit: W149508300472
RECALLING FIRM/MANUFACTURER
Northern California Community Blood Bank, Eureka, CA, by fax on January 2, 2009. Firm initiated recall is complete.
REASON
Blood product, prepared without the appropriate amount of additive solution (OPTISOL), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

___________________________________
PRODUCT 
a) AxSYM HBsAg Reagent Pack; AxSYM HBsAg is a microparticle enzyme immunoassay (MEIA) intended for the qualitative detection of hepatitis B surface antigen (HBsAg) in neonatal serum, and adult and pediatric serum (including serum collected in serum separator tubes) or plasma (collected in potassium EDTA, sodium citrate, sodium heparin, lithium heparin, or plasma separator tubes); list 9B01-20; Recall # Z-1046-2009;

 

b) AxSYM CMV IgG Reagent Pack; The AxSYM CMV IgG assay is a Microparticle Enzyme Immunoassay (MEIA) for the semi-quantitative measurement of IgG antibodies to cytomegalovirus in human serum and plasma (EDTA, heparin or sodium citrate) as an indication of past or current infection with cytomegalovirus; list 4B47-20; Recall # Z-1047-2009;

 

c) AxSYM CORE 2.0 Reagent Pack; AxSYM CORE 2.0 is a microparticle enzyme immunoassay (MEIA) intended for the qualitative detection of total antibodies (IgG and IgM) to hepatitis B virus core antigen (anti-HBc) in adult and pediatric serum (including serum collected in serum separator tubes) or plasma (collected in potassium EDTA, sodium citrate, sodium heparin, lithium heparin, or plasma separator tubes containing lithium heparin); list 8B88-20; Recall # Z-1048-2009;

 

d) AxSYM Folate Reagent Pack; AxSYM Folate is an ion capture assay for the quantitative determination of folate in human serum, plasma or red blood cells on the AxSYM System; list 3C81-20; Recall #  Z-1049-2009;

 

e) AxSYM Myoglobin Reagent Pack, AxSYM Myoglobin is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of myoglobin in human serum or plasma on the AxSYM System; list 3E43-20; Recall # Z-1050-2009;

 

f) AxSYM Troponin-I ADV Reagent Pack,; AxSYM Troponin-I ADV is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of cardiac troponin-I (cTnI) in human serum or plasma on the AxSYM System; list 2J44-22; Recall #  Z-1051-2009
CODE
a) Lot Number: 66495M100;
b) Lot Number: 66577M100;
c) Lot Number: 66253M200;
d) Lot Number: 68537M100; 
e) Lot Number: 63493M200; 
f) Lot Numbers: 67320M100 and 67320M101 
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Abbott Park, IL, by letter on January 19, 2009. Firm initiated recall is ongoing.
REASON
Defective caps: Customers have observed reagent bottles not opening appropriately, which could lead to a probe crash on the instrument.
VOLUME OF PRODUCT IN COMMERCE
10,123 kits
DISTRIBUTION
Nationwide, Germany, Mexico, Hong Kong, and Japan
___________________________________
PRODUCT 
Hematology Reagent Syringe, List number 08H49-02, used on the CELL-DYN Sapphire Automated Hematology Analyzer, List Number 08H00-01; Recall # Z-1069-2009
CODE
Barcode numbers Starting with SYR-S12E-, and ending with 0066, 0074, 0078, 0079, 0097, 0100, 0244, 0130, 0134, 0144, 0145, 0146, 0147, 0245, 0148, 0153, 0211, 0213, 0216, 0217, 0247, 0218, 0222, 0224, 0225, 0232, 0234, 0248, 0235, 0236, 0237, 0239, 0240, and 0243
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Santa Clara, CA, by letter on December 10, 2008. Firm initiated recall is ongoing.
REASON
Some syringes were improperly assembled and are therefore not usable, due to an incorrect nut on the syringe shell.
VOLUME OF PRODUCT IN COMMERCE
30 units
DISTRIBUTION
Nationwide, Australia, Canada and Germany
___________________________________
PRODUCT 
Operon Electrical Operating Room Table. The device is used as an electrical operating room table; Recall # Z-1123-2009
CODE
Lot Numbers: D 850, D750, D 752 and B 810
RECALLING FIRM/MANUFACTURER
Recalling Firm: Berchtold Corp., N Charleston, SC, by letter dated February 3, 2009. 
Manufacturer: Berchtold Medizin Elektronik, Tuttlingen, Germany. Firm initiated recall is ongoing.
REASON
Difficulty in pressing the button needed to release a bed part resulted in an injury to a caregiver’s finger which became stuck in metal latch under the gas cylinder of the bed piece.
VOLUME OF PRODUCT IN COMMERCE
453 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT 
a) Pointe Scientific Liquid Auto HDL Cholesterol Reagent Set, Catalog Numbers: 10-H7545-80, 12-H7545-162, 3-H7545-L, 7-H7545-1000, 7-H7545-320, 7-H7545-40, 7-H7545-80, H7545-1000, H7545-320, H7545-40, H7545-80, HH945-240, and HH945-480. The product is used for In vitro diagnostic for the quantitative determination of high-density lipoprotein cholesterol in human serum or plasma; Recall # Z-1200-2009;

  

b) Pointe Scientific Liquid Auto HDL Cholesterol Reagent Set, Catalog Numbers: 10-H7545-80, 12-H7545-162, 3-H7545-L, 7-H7545-1000, 7-H7545-320, 7-H7545-40, 7-H7545-80, H7545-1000, H7545-320, H7545-40, H7545-80, HH945-240 and HH945-480. The product is used for In vitro diagnostic for the quantitative determination of high-density lipoprotein cholesterol in human serum or plasma; Recall # Z-1201-2009
CODE
a) Lot Number: 810703, exp. 10/09;
b) Lot Number: 818202, exp. 12/09
RECALLING FIRM/MANUFACTURER
Pointe Scientific, Inc., Canton, MI, by letter dated January 29, 2009. Firm initiated recall is ongoing.
REASON
The R1 reagent has microbial contamination.
VOLUME OF PRODUCT IN COMMERCE
1,214 kits plus 257 L
DISTRIBUTION
Nationwide and Chile, Dominican Republic, Egypt, Ghana, Greece, India, Israel, Italy, Jamaica-West Indies, Korea, Malaysia, Mexico, Philippines, Poland, Romania, Serbia, Trinidad-West Indies, Turkey and Venezuela
___________________________________
PRODUCT
PLAC Test Calibrator Kit, Five-level liquid calibrator set for use with the diaDexus PLAC Test Reagent Kit, assembled in a kit box with an outer label, Catalog numbers 90108 and 10-0108. Intended to establish points of reference that are used in the determination of values in the determination of Lp-PLA2 by the PLAC Test Reagent Kit. Recall # Z-1205-2009
CODE
Lot number: 048091, expiration date 2009-09
RECALLING FIRM/MANUFACTURER
DiaDexus, Inc., South San Francisco, CA, by telephone, letter and e-mail on February 26, 2009. Firm initiated recall is ongoing.
REASON
Premature Expiration-- the product is projected to fall short of expected shelf life, and may result in inaccurate results.
VOLUME OF PRODUCT IN COMMERCE
105 kits
DISTRIBUTION
Nationwide and Venezuela, Israel, Greece, Spain, UK, and Germany

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

___________________________________
PRODUCT 
a) Cyberonics VNS Therapy Demipulse Generator, Model 103; an implantable, multiprogrammable, vagus nerve stimulator; Recall # Z-0994-2009;

 

b) Cyberonics VNS Therapy Demipulse Duo Generator, Model 104; an implantable, multiprogrammable, vagus nerve stimulator; Recall # Z-0995-2009
CODE
All lots
RECALLING FIRM/MANUFACTURER
Cyberonics, Inc., Houston, TX, by letter on February 7, 2009. Firm initiated recall is ongoing.
REASON
Reset/disabling of the VNS Therapy Demipulse Generator and Demipulse Duo Generator due to magnet interference, resulting in the loss of stimulation.
VOLUME OF PRODUCT IN COMMERCE
795 units
DISTRIBUTION
Nationwide, Belgium, Germany, Norway, Spain, Sweden, The Netherlands, and United Kingdom

RECALLS AND FIELD CORRECTIONS:  VETENERARY - CLASS II

___________________________________
PRODUCT 
Smiths Medical Surgivet Advisor Vital Signs Monitor, Model 9200, Recall # V-138-2009
CODE
Lot numbers: AM08070022, AM08090088, AM08100137, AM08100046, AM08100047, AM08100048, AM08100049, AM08100050, AM08100059, AM08090031,  AM08090032, AM08090033, AM08090034, AM08100113, AM08080085, AM08100124, AM08100121, AM08110062, AM08110061, AM08080028, AM08080080, AM08080081, AM08080082, AM08080086, AM8090005, AM08090040, AM08090035, AM08090038, AM08090043, AM08090044, AM08090045, AM08090047, AM08090048, AM08090050, AM08090054, AM08100060, AM08100065, AM08100069, AM08100067, AM08100070, AM08100074, AM08100125, AM08100123, AM08100138, AM08100034, AM08110060, AM08110063, AM08080091, AM08090016, AM08090018, AM089090100, AM08090099, AM08090102, AM08090103, AM08090098, AM08090104, AM08090106, AM08090107, AM08100027, AM08100128, AM08100129, AM08100130, AM08100133, AM008100134, AM08100136, AM08100029, AM08100032, AM08100132, AM08100135, AM08080031, AM8090064, AM08090105, AM08070018, AM08100139, AM08090052, AM08090008, AM08090015, AM08090019, AM08080000, AM08090020, AM08100115, AM08090068, AM08090057, AM08090065, AM08100030, AM08100114, AM08100023, AM08100073, AM08100028, AM08100031, AM08100036, AM08080023, AM08080088, AM08090046, AM08090049, AM08080003, AM08080022, AM08090006, AM08110070, AM08110052, AM08100144, AM08110052, AM8100144, AM08100143, AM08100145, AM08100064, AM08100063, AM08110038, AM08100009, AM08110064, AM08070021, AM08090009, AM08090011, AM08090012, AM08090021, AM08090051, AM08100041, AM08100040, AM08090067, AM08090101, AM08080029, AM08080069, AM08100058, AM08080024, AM0800025, AM08090002, AM08090037, AM08100068, AM08090010, AM08090014, AM08090022, AM08090053, AM08090039, AM08090066, AM08080089, AM08080090, AM08100140, AM08100140, AM08090091, AM08090089, AM08080002, AM08110039, AM08100122, AM08100061, AM08100062, AM08100066, AM08080068, AM08080070, AM08080071, AM08080072, AM08080092, AM08090017, AM08090013, AM08090055, AM08090056, AM08070016, AM08070020, AM08080020, AM08090090, AM08100057, AM08100119, AM08080001, AM08080084, AM08080083, AM08080021, AM08090000, AM08090003, AM08090007, AM08090001, AM08090004, AM08090036, AM08090041, AM08090042, AM08100010, AM08100011, AM08100012, AM08100013, AM08100015, AM08100014, AM8100016, AM08100017, AM08100018, AM08100019, AM08100020, AM08100021, AM08100022, AM08100024, AM08100025, AM08100026, AM08100071, AM08070017, AM08070019, AM08080026, AM08080087, AM08100131, AM08100147
RECALLING FIRM/MANUFACTURER
Smiths Medical PM, Inc., Waukesha, WI, by letter dated December 22, 2008 and January 16, 2009. Firm initiated recall is ongoing.
REASON
Recent improvements were made to the Advisor case plastic in July 2008. The change resulted in the inserts being deeply embedded into the plastic. This affects the ability of the monitor to be secured on the wall mount bracket or roll stand bracket. If the appropriate hardware is not used there is a risk the monitor may not be adequately secured to the roll stand or wall mount, resulting in the monitor falling off. There have been no adverse events or injuries reported.
VOLUME OF PRODUCT IN COMMERCE
196 units
DISTRIBUTION
AL, AZ, CA, CO, FL, GA, IL, IN, IA, KS, ME, MD, MA, MI, MN, MO, NV, NJ. NY, NC, OH, OR, PA, SC, TX, VA, WA, WI, France, Spain, Mexico, Germany, Venezuela, Finland, Australia, Canada, United Kingdom, Greece

END OF ENFORCEMENT REPORT FOR APRIL 29, 2009

 

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