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The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.
August 18, 2004
04-33
_______________________________
PRODUCT
a) Argires Tropical Mix, packaged in 16 oz. plastic tubs. Recall # F-356-4;
b) Argires Whole Raw Almond. Recall # F-357-4.
CODE
a) All product shipped between 04/16/04 and 05/28/04.
b) All product shipped between 12/17/03 and 2/19/04.
RECALLING FIRM/MANUFACTURER
Anton Argires, Co, by telephone on June 2/3/2004, and by press release on June 4, 2004. Firm initiated recall is complete.
REASON
The products were manufactured using almonds that were recalled by Paramount Farms due to their association with an outbreak of Salmonella enteritidis infection.
VOLUME OF PRODUCT IN COMMERCE
866 lbs.
DISTRIBUTION
IL.
_______________________________
PRODUCT
Edy's Grand Ice Cream, in 1.75 quart size cartons. The lower "cup" portion of the carton identifies the ice cream as "Toffee Bar Crunch" while the upper "lid" portion of the carton identifies the ice cream as "Peanut Butter Cup". The ice cream variety inside the carton is Peanut Butter Cup. Recall # F-358-4.
CODE
18-1644 11 27 6B and 18-1644 11 27 6D.
RECALLING FIRM/MANUFACTURER
Dreyers Grand Ice Cream, Inc., by telephone on March 16, and March 17, 2004. Firm initiated recall is complete.
REASON
Undeclared peanuts; the "cup" portion of the package identified the product as Toffee Bar Crunch, a variety that does not contain peanut ingredients. The ice cream inside the package is actually Peanut Butter Crunch.
VOLUME OF PRODUCT IN COMMERCE
15,756 packages.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
King Harvest brand Spinach Hummus in 7 oz. clear plastic tubs labeled KING HARVEST KEEP REFRIGERATED, recall # F-345-4.
CODE
USE BY 6/14/04 and USE BY 6/21/04.
RECALLING FIRM/MANUFACTURER
King Harvest Natural Foods, Inc., Portland, OR, by visit beginning June 9, 2004. Firm initiated recall is complete
REASON
The product contains undeclared wheat.
VOLUME OF PRODUCT IN COMMERCE
168/7 oz. containers.
DISTRIBUTION
OR, WA.
_______________________________
PRODUCT
DSM Lidocaine, USP, BP, & Ph. Eur, Acetamide, 2-(diethylamino)-N-(2,6-dimethylpheny), net wt. 25.00 KG. Recall # D-247-4.
CODE
Lot LA-03E18-C.
RECALLING FIRM/MANUFACTURER
DSM Pharma Chemicals South Haven, Inc., South Haven, MI, by letter on May 4, 2004. Firm initiated recall is complete.
REASON
Presence of foreign particles: Failed USP chloride limit test.
VOLUME OF PRODUCT IN COMMERCE
75 kg.
DISTRIBUTION
MI, and Japan.
_______________________________
PRODUCT
Human Cornea Tissues for Transplantation. Recall # B-1639-4.
CODE
Tissue # 0222-00-01 and # 0222-00-02.
RECALLING FIRM/MANUFACTURER
North Carolina Eye Bank, Winston Salem, North Carolina, by letter dated March 31, 2000. Firm initiated recall is complete.
REASON
Human tissue for transplantation, which was subsequently found to test repeatedly reactive for the hepatitis B surface antigen (HBsAg), was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Source Plasma. Recall # B-0594-4.
CODE
unit numbers CRN006404, CRA013672, CRA013804, CRA014241, CRA014376, CRA014493, CRA014723, CRA014896, CRA014980, CRA015218, CRA015380, CRA015669, CRA015764, CRA015933, CRA016006, CRA016230, CRA016458, CRA016641, CRA019569, 100001234, 100004985, 100005266, 100006053, 100006510, 100007968, and 100008221.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Clearfield, UT, by facsimile on March 5, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from a donor that was subsequently determined to have multiple risk factors for increased incidence of infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
26 units.
DISTRIBUTION
Spain.
_______________________________
PRODUCT
Recovered Plasma. Recall # B-0616-4.
CODE
Unit number 004KV10124.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by e-mail on March 23, 2004. Firm initiated recall is complete
REASON
Blood product, collected from an unsuitable donor due to a history of residing in an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Platelet Pheresis, Leukoreduced. Recall # B-1596-4.
CODE
Units 53P93539, 53P93597, 53P94126.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Baltimore, MD., by letter on February 18, 2004. Firm initiated recall is complete.
REASON
Blood Products, collected in apheresis collection kits where the set up time exceeded the manufacturer's acceptable time period for use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 products from 3 split units.
DISTRIBUTION
MD and DC.
_______________________________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced. Recall # B-1659-4.
CODE
71 W58273-4 (split unit).
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Gainsville, FL, by facsimile dated January 6, 2004. Firm initiated recall is complete.
REASON
Platelets, prepared with an insufficient plasma volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
FL.
_______________________________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced. Recall # B-1709-4.
CODE
Unit 71 W57537-4 (split #1).
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Gainsville, FL, by facsimile dated January 20, 2004. Firm initiated recall is complete.
REASON
Platelets, prepared with an insufficient plasma volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.
_______________________________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced. Recall # B-1710-4.
CODE
Unit 71 W58014-X (split #2).
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Gainsville, FL, by facsimile dated April 6, 2004. Firm initiated recall is complete.
REASON
Platelets, prepared with an insufficient plasma volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.
_______________________________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced. Recall # B-1711-4.
CODE
Unit 71 W43194-4 (split #1).
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Gainsville, FL, by facsimile dated January 20, 2004. Firm initiated recall is complete.
REASON
Platelets, prepared with an insufficient plasma volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.
_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1726-4;
Fresh Frozen Plasma. Recall # B-1727-4.
CODE
a) and b)Units 01KK92055, 01KK92024, 01KH71656, and 01KM21212.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, West Henrietta, NY, by telephone on August 5, 2003 and by letter dated August 5, 2003. Firm initiated recall is complete.
REASON
Blood products, in which the corresponding platelets were possibly contaminated with E.Coli and K. Pneumoniae, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units.
DISTRIBUTION
NY.
____________________________
PRODUCT
a) Red Blood Cells. Recall # B-1779-4;
b) Recovered Plasma. Recall # B-1780-4.
CODE
a) and b) Unit number 3346461.
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile on September 18 and 29, 2003, and October 3, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to behavior known to increase risk of infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX and NJ.
_______________________________
PRODUCT
Source Plasma. Recall # B-1782-4.
CODE
Unit numbers SR081897, SR082193, and SR082295.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Sumter, SC, by facsimile on July 26, 2002. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from an unsuitable donor due to the application of a tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Human Tissue for Transplantation, Corneas. Recall # B-1783-4.
CODE
Numbers OD0308019L-1 and OD0308019R-1.
RECALLING FIRM/MANUFACTURER
Tissue Banks International, Baltimore, MD, by letter on February 28, 2004. Firm initiated recall is complete.
REASON
Human tissue for transplantation was incorrectly tested for viral markers in that the blood sample used for testing was likely hemodiluted.
VOLUME OF PRODUCT IN COMMERCE
2 tissues.
DISTRIBUTION
MD, and NJ.
_______________________________
PRODUCT
Source Plasma. Recall # B-1786-4.
CODE
Units 03RMIB8685, 03RMIB8962, 03RMIB9197.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Grand Rapids, MI, by facsimile on December 31, 2003. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor who was at increased risk for Creutzfeldt-Jakob Disease (CJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Source Plasma, Recall # B-1787-4.
CODE
Units 0L0262MO, 4T5878MO, 4T6423MO, 0MV795MO, 4T2265MO, 4T9351MO, 4UA114MO, 4UA334MO, and 4T1120MO.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., St. Paul, MN, by facsimile on March 25, 1999. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who was previously deferred for engaging in high risk behaviors, was collected.
VOLUME OF PRODUCT IN COMMERCE
9 units.
DISTRIBUTION
IL, Germany, and France.
_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1788-4.
CODE
Units 33GE81141 and 33GF62507.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Farmington, CT, by telephone on March 21, 2003 and by letter dated March 25, 2003. Firm initiated recall is complete.
REASON
Blood products, in which the corresponding platelets were contaminated with Staphylococcus epidermidis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CT.
_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1789-4.
CODE
Units 33GL29969, 33GL29923, 33GL29954, and 33GL29917.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Farmington, CT, by telephone on November 24, 2003. Firm initiated recall is complete.
REASON
Blood products, in which the corresponding platelets were contaminated with Staphylococcus aureus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
CT.
____________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1790-4;
b) Fresh Frozen Plasma. Recall # B-1791-4.
CODE
a) Units 12FS03954, 12FS13948;
b) Unit 12FS03954.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Carolinas Region, Charlotte, NC, by telephone on May 30, 2003 and by letter dated June 2, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of morphea (a form of scleroderma), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1792-4.
CODE
Units 04GJ13730 (split 1 and split 2).
RECALLING FIRM/MANUFACTURER
American National Red Cross, New England Region, Dedham, MA, by telephone on March 27, 2004 and by letters dated March 30, 2004 and April 22, 2004. Firm initiated recall is complete.
REASON
Blood products, which were contaminated with Corynebacterium species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MA.
_______________________________
PRODUCT
a) Red Blood Cells, Leukoreduced. Recall # B-1793-4;
b) Red Blood Cells, Pheresis, Leukoreduced. Recall # B-1794-4.
CODE
a) Unit: 246300388;
b) Units: 246305421 (double collection).
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Rapid City, SD, by letter on November 14, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
AZ.
_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1797-4.
CODE
Unit 301882395.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fargo, ND, by telephone on September 25, 2003. Firm initiated recall is complete.
REASON
Blood product, which was incorrectly tested for infectious diseases, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
ND.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1799-4;
b) Platelets. Recall # B-1800-4.
CODE
a) and b) Unit numbers 4566067, 4511249, and 4455055.
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile on October 3, 6, and 8, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
TX.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1801-4;
b) Platelets Leukocytes Reduced. Recall # B-1802-4.
CODE
a) and b) Unit number 33GS48288.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Connecticut Region, Farmington, CT, by telephone and letter on May 17, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CT.
____________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1803-4;
b) Recovered Plasma. Recall # B-1804-4.
CODE
a) Unit numbers 004GF37844, 004KQ30741, 004R12425,
004T37441, and 004Y95368;
b) Unit numbers 004KQ30741, 004KW40279, and 004T37441.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by telephone on March 12, 2004, by fax on March 22, 2004, by letters on March 19 and 25, 2004, and electronically on March 16, 23, and 25, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jacob disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units.
DISTRIBUTION
CA, NY, MA, and VT.
_______________________________
PRODUCT
Source Plasma. Recall # B-1807-4.
CODE
Unit numbers 86824439, 86820561, and 86811668.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., San Antonio, TX, by facsimile on June 18, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from a donor that did not have the physical examination performed properly, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1816-4.
CODE
Unit 04KW45700.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Dedham, MA, by facsimile on May 7, 2004 and by letter dated May 11, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had lived in a malaria endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MA.
_______________________________
PRODUCT
Red Blood Cells. Recall # B-1817-4.
CODE
Unit FK36433.
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone on January 2, and 9, 2003. 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
1 unit.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1819-4.
CODE
Units 4663214, 4663219, 4663223, 4663224, 4663226, 4663228, 4663234, 4663235, 4663240, 4663243, 4663246, 4663248, 4665052, 4665054, 4665058, 4665060, 4665065, 4665067, 4665068, 4665071, 4665072, and 4665076.
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by telephone or facsimile on December 12, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.
VOLUME OF PRODUCT IN COMMERCE
22 units.
DISTRIBUTION
TX.
_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced. Recall # B-1689-4;
b) Platelets. Recall # B-1690-4.
CODE
a) and b) Unit 1974703.
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by letter dated March 18, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was at risk for Leishmania, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
KY.
_______________________________
PRODUCT
Source Plasma. Recall # B-1715-4.
CODE
Unit 90434242..
RECALLING FIRM/MANUFACTURER
Interstate Blood Bank, Inc., of Wisconsin, Milwaukee, WI, by facsimile transmission dated October 24, 2002. Firm initiated recall is complete.
REASON
Source Plasma, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Whole Blood, for Manufacturing Use Only. Recall # B-1725-4.
CODE
Units 0848080, 0849047.
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Minneapolis, MN, by telephone on June 14, 2001. Firm initiated recall is complete.
REASON
Blood products, collected in expired collection bags, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
GA.
_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1781-4.
CODE
Unit numbers 4583356 and 4488447.
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile on August 8, 2003, and by telephone on August 11, 2003. Firm initiated recall is complete.
REASON
Blood products, exposed to unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.
_______________________________
PRODUCT
Recovered Plasma. Recall # B-1795-4.
CODE
Unit 246300388.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Rapid City, SD, by fax on October 6, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Switzerland.
_______________________________
PRODUCT
Recovered Plasma. Recall # B-1818-4.
CODE
Unit FK36433.
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone on January 2, and 9, 2003. 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
1 unit.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Stockert 70 Radio Frequency Ablation Generator. Recall # Z-1328-04.
CODE
All generators except with version 1.034B.
RECALLING FIRM/MANUFACTURER
Biosense Webster, Inc., Irwindale, CA, by letter dated July 15, 2004. Firm initiated recall is ongoing.
REASON
Generator Failure resulting in increase of catheter temperature that could not be controlled by power reduction.
VOLUME OF PRODUCT IN COMMERCE
Unknown.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
a) Protégé GPS Biliary System (6Fr 10mm x 30mm) - Product
number SER6-10-30-135 (.018) (Biliary). Recall # Z-
1329-04.
b) Protege GPS Biliary System (6Fr 10mm x 30mm) - Product
number SERB65-10-30-120 (.035) (Biliary) . Recall # Z-
1330-04.
CODE
a) Lot # 672655.
b) Lot numbers: 257984, 257985, and 257986.
RECALLING FIRM/MANUFACTURER
Ev3, Plymouth, MN, by letter on July 9, 2004. Firm initiated recall is ongoing.
REASON
Ev3 had received customer complaints indicating that the stent device could
not be used with an .035' guidewire. An investigation found that 6Fr, 135 cm
(.018') stent system were labeled as a 120 cm (.035') stent system and that
6Fr 120 cm (.035') were labeled as 6Fr, 135 cm (.018').
VOLUME OF PRODUCT IN COMMERCE
a) 10 units.
b) 11 units.
DISTRIBUTION
Nationwide.
______________________________
PRODUCT
BD EdgeAhead Stiletto/MVR Knife 1.1mm (19g) REF 585240. Recall # Z-1344-04.
CODE
Lot Numbers: 3182770, 3231212, 3234243, 3238890, 3274064, 3281592, 3318026,
3325843, 3330607, 3344597, 3344633, 4012982, 4033079, 4049076, 4069650, 4084089,
4084102, 4106845, 4125046, 4141947, 4147817.
RECALLING FIRM/MANUFACTURER
BD Opthalmic Systems, Waltham, MA, by telephone the week of July 19, 2004. Firm
initiated recall is ongoing.
REASON
Blade may become detached from the handle.
VOLUME OF PRODUCT IN COMMERCE
6,945 units.
DISTRIBUTION
Nationwide.
END OF ENFORCEMENT REPORT FOR AUGUST 18, 2004
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