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U.S. Department of Health and Human Services

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Enforcement Report for March 3, 2004

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.


March 3, 2004
04-09

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

______________________________
PRODUCT
ZhongShan Specialty brand Almond Cakes, net wt. 500 GR
(17.5 oz.). Product is packaged in a metal tin container.
UPC # 6904017691630. Recall # F-132-4.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Star Mark Management Inc., Brooklyn, NY, by an "Allergy Alert" and a letter dated July 29, 2003. New York State initiated recall is complete.
REASON
Product contains undeclared peanuts based on analysis & inspectional findings by New York State Department of Agriculture & Markets (NYSDAM). This was confirmed by the foreign manufacturer who provided the product formulation. The product also contained undeclared color, tartrazine (certifiable as Yellow #5).
VOLUME OF PRODUCT IN COMMERCE
14 cartons (24 containers per carton).
DISTRIBUTION
NY.

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II

_______________________________
PRODUCT
Hansens Classic Sparkling Cider Magnum, 50.7 ounces. Magnum
Glass Bottle, 6 per case. Recall # F-130-4
CODE
Lots: K0306P thru K0314P; K0317P thru K0319P UPC Code 70847-00590.
RECALLING FIRM/MANUFACTURER
Hansen Beverage Co., Corona, CA, by telephone on November 26, 2003 and December 2, 2003. Firm initiated recall is ongoing.
REASON
Product is unfit for food due to fermentation. Some bottles have broken due to excess gas formation from fermentation.
VOLUME OF PRODUCT IN COMMERCE
125,388 bottles.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Double Horses Brand Preserved Assorted Fruits in clear
plastic tubs, Net Wt. 8.8 oz. Recall # F-131-4.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
J & A Importer, Inc., Los Angeles, CA, by letters on December 29, 2003. New York State initiated recall is ongoing.
REASON
Product contains undeclared sulfites and undeclared color, tartrazine (certifiable as FD&C Yellow No. 5).
VOLUME OF PRODUCT IN COMMERCE
33 cases.
DISTRIBUTION
AZ, TX, CA, TN, UT, and WA.

_______________________________
PRODUCT
Fifty 50 brand Low Calorie-No Sugar Added Apricot Spread,
net wt. 12 oz., packed in glass jars. Recall # F-133-4.
CODE
All codes having a first digit reading: "4", "3", "2", or "1" are on recalled product. Five digit code is ink jet printed on lid top of 12 oz. jars.
RECALLING FIRM/MANUFACTURER
Chelton House Products, Bridgeport, NJ, by fax on January 14, 2004, and by press release on January 16, 2004. FDA initiated recall is ongoing.
REASON
Product contains undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
9,958 cases.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III

_______________________________
PRODUCT
a) Sweetened Nestea Iced Tea in 16 oz. PET bottles. The
product is packaged 24 bottles per case.
Recall # F-127-4;
b) Sweetened Raspberry Flavored Nestea Iced Tea in 16 oz.
PET bottles. The product is packaged 24 bottles per
case. Recall # F-128-4;
c) POWERade Mountain Blast in 32 fl. oz. PET bottles. The
product is packaged 12 bottles per case.
Recall # F-129-4;
CODE
a) Jun2104 MDA4, xxx CT677 (xxx=military time);
b) Jun1404 MDE4, xxxx CT677 (xxxx=Miliary time);
c) May3104 MDD5, xxxx CT677 (xxxx=military time).
RECALLING FIRM/MANUFACTURER
Coca Cola Enterprises, Atlanta, GA, by letter on October 30, 2003. Firm initiated recall is complete.
REASON
Beverages contain mold.
VOLUME OF PRODUCT IN COMMERCE
22,385 cases.
DISTRIBUTION
Nationwide, Guam and Saipan.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
Source Plasma. Recall # B-0435-4.
CODE
Units 0420978389, 0420975233, 0420974910, 0420974449, 0420972858, 0420972479, 0420972015, 0420970602, 0420970194, 0420969654, 0420969345, 0420968622, 0420968291, 0420963158, 0420962747, 0420962424, 0420961904, 0420961558, 0420959025, 0420958740, 0420958245, 0420958041, 0420957258, 0420956959, 0420954582, 0420954331, 0420953708, 0420953459, 0420952854, 0420952541, 0420951308, 0420950310, 0420949933, 0420949017, 0420948453, 0420948149, 0420945993, 0420945789, 0420943150, 0420942609, 0420942042, 0420941776, 0420941049, 0420923017, 0420922485, 0420921263, and 0420920733.
RECALLING FIRM/MANUFACTURER
ZLB Biolplasma, Inc., Lansing, MI, by facsimile on December 24, 2002. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had received a tattoo within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
47 units.
DISTRIBUTION
NC.

_______________________________
PRODUCT
a) Red Blood Cells . Recall # B-0442-4;
b) Recovered Plasma. Recall # B-0443-4.
CODE
a) and b) Unit number KT06328.
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Blood Donor Services, Annandale, VA, by letter on June 6, 2003. Firm initiated recall is complete.
REASON
Blood products 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).
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
VA, and NJ.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0444-4;
b) Recovered Plasma. Recall # B-0445-4.
CODE
a) and b) Unit number 29FJ50329.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Mid-Atlantic Region, Norfolk, VA, by telephone on June 25, 2003, letter on June 30, 2003, and by facsimile on July 3, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a subsequent disclosure of previous positive hepatitis testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NC, and CA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0700-4;
b) Platelets. Recall # B-0701-4.
CODE
a) Units 246305808, 246305337, 246306040;
b) Units 246305337, 246306040.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Dba United Blood Services, Scottsdale, AZ, by telephone on or about August 22 through 25, 2003. Firm initiated recall is complete.
REASON
Blood products, which tested reactive for West Nile Virus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
SD, AZ, and NE.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0713-4;
b) Cryoprecipitated AHF. Recall # B-0714-4;
c) Plasma. Recall # B-0715-4;
d) Recovered Plasma. Recall # B-0716-4.
CODE
a) Units LC23977, LC22485, LC19751, LC17960, LC12864,
FY70865;
b) and c) Unit LC23977;
d) Units LC22485, LC19751, LC17960, LC12864.
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Annandale, VA, by letters dated September 16, 2003 and September 17, 2003. Firm initiated recall is complete.
REASON
Blood products, which tested negative for hepatitis but were collected from a donor who disclosed a previous positive test for hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units.
DISTRIBUTION
VA, MD, and NJ.

_______________________________
PRODUCT
Source Plasma. Recall # B-0729-4.
CODE
Unit 02PVAA3172.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Portsmouth, VA, by facsimile dated May 20, 2002. Firm initiated recall is complete.
REASON
Source Plasma, incorrectly tested for antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.

_______________________________
PRODUCT
a) Red Blood Cells (Apheresis), Leukocytes Reduced.
Recall # B-0752-4;
b) Platelets Pheresis, Leukocytes Reduced.
Recall # B-0753-4.
CODE
a) and b) Unit number 0948696.
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, OH, by letters on July 10, 2003, and January 13, 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
OH.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0754-4.
CODE
Unit number 04KW25257.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by letters on October 2 and 7, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MA.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0755-4.
CODE 
Unit number 04KE39199.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by telephone on October 23, 2003 and by letter on October 24, 2003. Firm initiated recall is complete.
REASON
Platelets Pheresis with elevated platelet counts were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NY.

_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-0756.
CODE
Unit numbers 06FC06975, 06FS79355, 06GM22761, and 06GM22767.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southern California Region, Los Angeles, CA, by telephone and letter on October 27, 2003. Firm initiated recall is complete.
REASON
Blood products, associated with units of Red Blood Cells that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0757-4.
CODE
Unit 15695.
RECALLING FIRM/MANUFACTURER
St. Thomas More Hospital Blood Bank, Canon City, CO, by letter dated December 12, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose health history was inadequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CO.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0759-4;
b) Recovered Plasma. Recall # B-0760-4.
CODE
a) and b) Unit 6050919.
RECALLING FIRM/MANUFACTURER
West Tennessee Regional Blood Center, Inc., Jackson, TN, by facsimile dated June 21, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who engaged in high risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TN, and Switzerland.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0762-4.
CODE
Units 53GZ21743 and 53GC41788.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Baltimore, MD, by letter dated September 12, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had lived in a malarial endemic area, wee distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MD, and DC.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0769-4;
b) Recovered Plasma. Recall #B-0770-4.
CODE
a) and b) Unit 3402038.
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by letter dated October 2, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had body piercing within twelve months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Source Plasma. Recall # B-0771-4.
CODE
Units FBLSST, FBLSJF, FBKYRK.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Flint, MI, by facsimile transmission dated August 27, 2003. Firm initiated recall is complete.
REASON
Source Plasma, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
Germany.

_______________________________
PRODUCT
Red Blood Cells (Apheresis). Recall # B-0773-4.
CODE
Unit 04GR13046.
RECALLING FIRM/MANUFACTURER
American Red Cross, New England Region, Dedham, MA, by facsimile dated September 11, 2003, and by letter dated September 17, 2003. Firm initiated recall is complete.
REASON
Red Cells, which tested negative for the antibody to the human immunodeficiency virus, but were collected from a donor who provided post donation information regarding having previously tested reactive for the antibody, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0774-4;
b) Platelets. Recall #B-0775-4.
CODE
a) and b) Unit 13FV25284.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Detroit MI, by letters dated November 26, and December 9, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had lived in a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MI.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0776-4.
CODE
Unit 13GV46511.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Detroit MI, by telephone on September 19, 2003, and by letter dated September 24, 2003. 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
MI.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0778-4;
b) Recovered Plasma. Recall # B-0779-4.
CODE
a) and b) Unit 06LT35938.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Los Angeles, CA, by telephone, and by letter dated October 2, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who engaged in high risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0785-4;
b) Fresh Frozen Plasma. Recall # B-0786-4.
CODE
a) and b) Unit number 8939907.
RECALLING FIRM/MANUFACTURER
HemaCare Corporation, Sherman Oaks, CA, by letter on October 29, 2003. Firm initiated recall is complete.
REASON
Blood products collected from an unsuitable donor due to a history of residing in an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (vCJD).
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Source Plasma. Recall # B-0787-4.
CODE
Unit numbers N-13270-093, G-54002-093, G-54496-093, G-55011-093, and G-55527-093.
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, Brownsville, TX, by facsimile on May 2 and 21, 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
5 units.
DISTRIBUTION
Spain.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0788-4;
b) Recovered Plasma. Recall # B-0789-4.
CODE
a) and b) Unit number 84LP22212.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northern California Region, Oakland, CA, by letter and facsimile on March 11, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to use of the medication Lupron, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0790-4.
CODE
Unit number 084FT45957.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northern California Region, Oakland, CA, by letter on March 11, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0791-4.
CODE
Unit number 84FT45660.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northern California Region, Oakland, CA, by letters on April 25, 2002, and June 4, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0792-4.
CODE
Unit number 2639592.
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by letter on May 31, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Removed. Recall # B-0793-4.
CODE
Unit number 18FX52571.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Great Lakes Region, Lansing, MI, by letter and telephone on June 10, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose health history regarding exposure to SARS was not adequately documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.

_______________________________
PRODUCT
a) CryoVein, Femoral Vein;
b) CryoVein, Saphenous Vein;
c) CryoGraft, Pulmonary Monocusp Hemi-Artery.
Recall # B-0794-4.
CODE
a) Serial no. 8070656, Model V060;
b) Serial no. 8070255, Model V010;
c) Serial no. 8024373, Model PH10.
RECALLING FIRM/MANUFACTURER
Cryolife, Inc., Kennesaw, GA, by letters dated January 16, 2004. Firm initiated recall is ongoing.
REASON
Human tissues intended for transplantation, which were collected from a donor whose pre-processing cultures tested positive for microorganisms, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
OH, CT, and MO.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0796-4.
CODE
Unit 1041-7834.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Dba United Blood Services, Scottsdale, AZ, by telephone on November 19, 2003, and by letter dated December 3, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not have a complete medical history interview, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AZ.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0798-4;
b) Plasma. Recall # B-0799-4.
CODE
a) and b) Unit 10042-5484.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Dba United Blood Services, Scottsdale, AZ, by telephone on November 10, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
AZ.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Removed. Recall # B-0800-4;
b) Fresh Frozen Plasma. Recall # B-0801-4.
CODE
a) Unit numbers: 12FS13948, 12FS03954;
b) Unit number: 12FS03954.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Carolinas Region, Charlotte, NC, by letter, dated June 2, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who has a history of morphea, a form of scleroderma, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
NC.

_______________________________
PRODUCT
Source Plasma. Recall # B-0802-4.
CODE
Unit number 04958451.
RECALLING FIRM/MANUFACTURER
Bio-Blood Components, Inc., Columbus, OH, by facsimile dated December 12, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0804-4.
CODE
Unit number 2882508.
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by letter on June 14, 2001. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0806-4;
b) Fresh Frozen Plasma. Recall # B-0807-4;
c) Recovered Plasma. Recall # B-0808-4.
CODE
a) and c) Unit number 2888101;
b) Unit number 2013059.
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by letter on September 4, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to use of the medication Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0809-4.
CODE
Unit number 042KP09616.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northern Ohio Region, Cleveland, OH, by letter on December 18, 2003. Firm initiated recall is complete.
REASON
Blood product, manufactured in a manner that may have compromised the sterility of the unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0810-4;
b) Red Blood Cells, Leukocytes Reduced, Irradiated. Recall
# B-0811-4;
c) Fresh Frozen Plasma. Recall # B-0812-4.
CODE
a) Units 004KF65892, 004KV07716, 004KF65868, 004FK43292,
004FR73008, 004GF30699, 004C71218, 004F05735,
004KK79280, 004F05772, 004FJ65467, 004FR73078,
004R02059, 004R01595, 004GF30901;
b) Unit 004FV30630;
c) Unit 004GF30699.
RECALLING FIRM/MANUFACTURER
The American Red Cross, New England Region, Dedham, MA, by telephone or by facsimile between July 16 and 31, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from ineligible donors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 15 units;
b) 1 unit;
c) 1 unit.
DISTRIBUTION
MA, ME, NY, and NH.

_______________________________
PRODUCT
Platelets. Recall # B-0816-4.
CODE
Unit number 1974538.
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc, Lexington, KY, by letter, dated December 17, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was taking an aspirin-like medication at the time of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0818-4.
CODE
Unit 9220088.
RECALLING FIRM/MANUFACTURER
Ogden Medical Center, Inc, Ogden, UT, by letter dated December 15, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had received a body piercing 12 months prior to donation, was collected.
VOLUME OF PRODUCT IN COMMERCE
1 Unit.
DISTRIBUTION
GA.

_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0819-4;
b) Platelets Leukocytes Reduced. Recall # B-0820-4.
CODE
a) and b) Unit 13GR47550.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Detroit, MI, by telephone on October 16, 2003. Firm initiated recall is complete.
REASON
Blood products, which were prepared from an overweight whole blood unit, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MI.

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0821-4.
CODE
Unit 13LH02168.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Detroit, MI, by telephone on December 17, 2003, and letter dated December 22, 2003. 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
MI.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0822-4;
b) Platelets Leukocytes Reduced. Recall # B-0823-4;
c) Fresh Frozen Plasma. Recall # B-0824-4.
CODE
a), b), and c) Unit 33GL22229.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Farmington, CT, by telephone on December 4, 2003, and by letters dated December 2, 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
3 units.
DISTRIBUTION
PA, and CT.

_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced. Recall # B-0825-4;
b) Fresh Frozen Plasma. Recall # B-0826-4.
CODE
a) and b) Unit 33GY59666.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Farmington, CT, by letters dated December 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
2 units.
DISTRIBUTION
CT.

_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced. Recall # B-0829-4;
b) Platelets Leukocytes Reduced. Recall # B-0830-4;
c) Fresh Frozen Plasma. Recall # B-0831-4.
CODE
a), b) and c) Unit 33GY58765.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Farmington, CT, by letters dated December 2, 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
3 units.
DISTRIBUTION
VA and CT.

_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced. Recall # B-0832-4;
b) Platelets Leukocytes Reduced. Recall # B-0833-4;
c) Fresh Frozen Plasma. Recall # B-0834-4.
CODE
a), b) and c) Unit 33GS35546.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Farmington, CT, by telephone on November 21, 2003, and by letters dated December 1, 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
3 units.
DISTRIBUTION
CT.

_______________________________
PRODUCT
"Softbank II" Laboratory Information System. Recall # B-0841-4.
CODE
V.19, V.21, and V.22; Release 3.1.3.
RECALLING FIRM/MANUFACTURER
Soft Computer Consultants, Inc., Palm Harbor, FL, by telephone and e-mail on March 21, 2003. Firm initiated recall is complete.
REASON
Defects in the design of blood bank software program could result in incorrect patient laboratory records.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL, and AL.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0842-4.
CODE
Unit 18233-2040.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on October 8, 2003.
Manufacturer: Blood Systems, Inc., Cheyenne, WY. Firm initiated recall is complete.
REASON
Blood product, not properly quarantined after the receipt of post donation information related to recent body piercing, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WY.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0854-4.
CODE
Unit numbers 38W30830, 38W30810, and 38W30815.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN, by telephone on November 21, 2003. Firm initiated recall is complete.
REASON
Blood products, manufactured from overweight units of Whole Blood, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
IN.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0446-4;
b) Cryoprecipitated AHF. Recall # B-0447-4;
c) Recovered Plasma. Recall # B-0448-4.
CODE
a) and b) Unit number 9006306;
c) Unit number 9005724.
RECALLING FIRM/MANUFACTURER
Wellmont Health System, Community Blood Bank of Norton, Norton, VA, by telephone and letter on June 12, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for antibodies to human immunodeficiency virus (anti-HIV), but were collected from a donor that previously tested repeatedly reactive for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
VA, and MD.

______________________________________
PRODUCT
a) Red Blood Cells. Recall # B-0449-4;
b) Red Blood Cells, Leukocytes Reduced. Recall # B-0450-4;
c) Platelets. Recall # B-0451-4;
d) Platelets, Irradiated. Recall # B-0452-4;
e) Fresh Frozen Plasma. Recall # B-0453-4.
CODE
a) and c) Unit numbers T25121, R51206, and T46866;
b) Unit number T42906;
d) Unit number K62019;
e) Unit numbers K62019, R51220, and R51206.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter on August 7, 2003. Firm initiated recall is complete.
REASON
Blood products, incorrectly tested for human immunodeficiency virus (HIV) and hepatitis C virus (HCV) by the nucleic acid test (NAT) method, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units.
DISTRIBUTION
VA.

_______________________________
PRODUCT
Platelets Pheresis. Recall # B-0750-4.
CODE
Unit 1031237.
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center UC Medical Center, Cincinnati, OH, by telephone on August 6, 2003. Firm initiated recall is complete.
REASON
Blood product, which was untested for West Nile Virus (WNV) but subsequently tested negative for WNV, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-0758-4.
CODE
Unit 15695.
RECALLING FIRM/MANUFACTURER
St. Thomas More Hospital Blood Bank, Canon City, CO, by letter dated December 12, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose health history was inadequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CO.

_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-0783-4.
CODE
13FC37030, 13FC37035, 13FE24768, 13FE24771, 13FE24772, 13FE24773, 13FE24777, 13FE24782, 13FE24794, 13FE24795, 13FE24798, 13FE24802, 13FE24803, 13FF39717, 13FF39721, 13FF39725, 13FF39726, 13FF39730, 13FF39733, 13FF39736, 13FF39739, 13FF39741, 13FK12870, 13FK12874, 13FM91263, 13FM91267, 13FM91268, 13FP07677, 13FP07686, 13FQ18161, 13FQ18165, 13FQ18167, 13FQ18170, 13FQ18174, 13FQ18175, 13FQ18176, 13FQ18179, 13FR52896, 13FR52897, 13FR52898, 13FR52903, 13FR52905, 13FR52906, 13FR52918, 13FV19442, 13FW05407, 13FW05408, 13FX00470, 13FX00472, 13FX00480, 13FX00482, 13FX00484, 13FX00486, 13FX00487, 13FX00488, 13FX00492, 13FX00501, 13FX00502, 13FX00505, 13FX00506, 13FX00507, 13GE12212, 13GE12213, 13GE12215, 13GE12218, 13GE12219, 13GE12224, 13GF02642, 13GF02643, 13GF02652, 13GF02653, 13GF02658, 13GL14617, 13GL14619, 13GM78641, 13GM78647, 13GM78648, 13GM78649, 13GM78651, 13GM78653, 13GM78658, 13GM78664, 13GM78665, 13GM78666, 13GM78667, 13GM78670, 13GM78672, 13GM78675, 13GM78678, 13GM78679, 13GM78682, 13GM78684, 13GM78686, 13GM78687, 13GM78689, 13GM78694, 13GM78695, 13GM78698, 13GM78701, 13GM78702, 13GM78703, 13GM78706, 13GM78709, 13GM78711, 13GM78712, 13GQ62931, 13GQ62935, 13GQ62936, 13GR42397, 13GR42399, 13GV40701, 13GV40704, 13GV40710, 13GV40712, 13GV40714, 13GV40719, 13GV40721, 13GW26620, 13GW26623, 13GW26624, 13GX63620, 13GX63621, 13GX63622, 13GX63626, 13GX63629, 13GX63631, 13GX63632, 13GX63633, 13GX63634, 13GX63636, 13GX63637, 13GX63638, 13GX63640, 13GX63645, and 13GX63646.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Detroit, MI, by facsimile on June 16, 2003, and by letter dated July 16, 2003. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly labeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
135 units.
DISTRIBUTION
MI and PA.

_______________________________
PRODUCT
Platelets Leukocytes Reduced. Recall # B-0784-4.
CODE
Unit 13GL18353.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Detroit, MI, by facsimile on November 1, 2003, and by letter dated December 8, 2003. Firm initiated recall is complete.
REASON
Blood product, in which the corresponding Red Blood Cells were contaminated with gram positive bacilli, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0795-4.
CODE
Unit numbers: 4230033, 4229052.
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Indianapolis, IN, by facsimile and telephone on August 23, 2003 and September 5, 2003. Firm initiated recall is complete.
REASON
Blood products were distributed although syphilis quality control was not correctly documented or performed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IN.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0797-4.
CODE
Unit 0821949.
RECALLING FIRM/MANUFACTURER
Florida Blood Services, Inc., St. Petersburg, FL, by facsimile dated May 21, 2003. Firm initiated recall is complete.
REASON
Blood product, incorrectly tested for the presence of unexpected antibodies, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated. Recall # B-0805-4.
CODE
Unit numbers 2885115, 2903443, and 2886168.
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by letter on July 6, 2001. Firm initiated recall is complete.
REASON
Blood products that were out of controlled storage for more than 30 minutes were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Removed. Recall # B-0817-4.
CODE
Unit number 1993880.
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by letter, dated December 17, 21003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose body temperature exceeded the acceptable range, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.

_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced. Recall # B-0835-4;
b) Platelets Leukocytes Reduced. Recall # B-0836-4;
c) Fresh Frozen Plasma. Recall # B-0837-4.
CODE
a), b), and c) Unit 33GE64292.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Farmington, CT, by telephone on December 4, 2003, and by letters dated December 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
3 units.
DISTRIBUTION
VA, and CT.

_______________________________
PRODUCT
Platelets Leukocytes Reduced. Recall # B-0838-4.
CODE
Unit 33GY52343.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Farmington, CT, by telephone, and by letter dated December 3, 2003. Firm initiated recall is complete.
REASON
Blood product, which was prepared from a whole blood unit with a discrepant collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CT.

_______________________________
PRODUCT
Red Blood Cells, Deglycerolized. Recall # B-0839-4.
CODE
Unit 12K67133.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southeastern Michigan Region, Detroit, MI, by telephone on June 13, 2003. Firm initiated recall is complete.
REASON
Blood product, possibly exposed to mercury contamination, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Removed. Recall # B-0840-4.
CODE
Unit numbers: 13FN87530, 13LG95446, 13FR52029, 13FV17503, 13FW04225, 13FY85275, 13GL13560, 13GE11203, 13GL13774, 13FJ99508, 13FM90076, 13GM77935, 13LG96518, 13T97823, 13T97838, 13FM90415, 13GF02331, 13GX63325, 13FE24181, 13FR52205, 13GL13690, 13GQ61447, 13GX63333, 13T97752, 13FW04760, 13FW04586, 13GE11201, 13GE11309, 13FC39622, 13GL13702, 13FJ98466, 13FP06544, 13FR52018, 13FR52032, 13FV17517, 13GL13689, 13FN87174, 13GL13646, 13FW04601, 13FY85658, 13FY85682, 13GE11135, 13FM90399, 13GQ62497, 13FJ99400, 13FM90009, 13FC39608, 13FE24218, 13FE24229, 13FE24325, 13FJ99687, 13FJ99987, 13FM89279, 13FM89667, 13FM90402, 13FM94760, 13FN87525, 13FN87526, 13FP06413, 13FP06550, 13FP06815, 13FQ16689, 13FQ17666, 13FQ17667, 13FQ17668, 13FR52030, 13FR52069, 13FR52122, 13FR52430, 13FV17512, 13FW04188, 13FW04194, 13FW04211, 13FW04292, 13FW04293, 13FW04297, 13FW04298, 13FW04554, 13FW04583, 13FW04757, 13FW04761, 13FX04498, 13FY85244, 13FY85387, 13FY85389, 13FY85420, 13FY85664, 13FY85673, 13FY86746, 13GE11147, 13GE11625, 13GE11664, 13GF02332, 13GL13682, 13GL13712, 13GL13813, 13GM77407, 13GM77414, 13GM78416, 13GQ62365, 13GQ62375, 13GQ62376, 13GQ62378, 13GV39984, 13GX62117, 13GX63326, 13GX63340, 13LG96103, 13LG97037, 13T97615, 13T97624, 13T97951, 13FJ97919, 13GL13659, 13GQ61374, 13FJ99501, 13FM89586 and 13LG96221.
RECALLING FIRM/MANUFACTURER
American Red Cross, Southeastern Michigan Region, Detroit, MI, by facsimile on August 15, 2003. Firm initiated recall is complete.
REASON
Blood products, incorrectly antigen typed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
118 units.
DISTRIBUTION
GA, IN, MI, OH, and TN.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0851-4;
b) Red Blood Cells, Leukocytes Reduced, Irradiated. Recall
# B-0852-4.
CODE
a) Units (01KM16559; 01KM16561; 01KM16563; 01KM16564;
01KM16565; 01KM16566; 01KM16568; 01KM17452; 01W99382;
01W99385; 01W99386; 01W99387; 01W99388; 01W99390;
01W99391; 01W99392; 01W99393; 01W99394; 01W99395;
01W99396;
b) Unit 01KM16567.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, West Henrietta, NY, by facsimile, dated February 5, 2003. Firm initiated recall is complete.
REASON
Blood products, possibly prepared more than eight hours after collection of the corresponding whole blood units, were distributed.
VOLUME OF PRODUCT IN COMMERCE
21 units.
DISTRIBUTION
NY.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0855-4;
b) Red Blood Cells, Leukocytes Reduced. Recall # B-0856-4.
CODE
a) Unit number 18FR58493;
b) Uunit numbers 18FW17194, 18FW17195, 18FW17196, 18FW17197, 18FW17198, 18FW17199, 18FW17200, 18FW17201, 18FW17202, 18FW17203, 18FW17204, 18FW17205, 18FW17206, 18FW17207, 18FW17208, 18FW17209, 18FW17210, 18FW17211, 18FW17212, 18FW17213, 18FW17214, 18FW17215, 18FW17216, 18FW17217, 18FW17218, 18FW17219, 18FW17220, 18FW17221, 18FW17225, 18FW17226, 18FW17228, 18FW17229, 18FW17230, 18FW17231, 18FW17232, 18FW17233, 18FW17234, 18FW17235, 18FW17236, 18FW17238, 18FW17239, 18FW17241, 18FW17242, 18FW17243, 18FW17244, 18FW17245, 18FW17246, 18FW17247, 18FW17248, 18FR58475, 18FR58476, 18FR58477, 18FR58478, 18FR58479, 18FR58481, 18FR58483, 18FW58484, 18FR58485, 18FR58486, 18FR58487, 18FR58488, 18FR58489, 18FR58490, 18FR58491, 18FR58492, 18FR58494, 18FR58496, 18FR58497, 18FR58498, 18FR58499, 18FR58500, 18FR58501, 18FR58502, 18FR58503, 18FR58505, 18FR58506, 18FR58508, 18FR58509, 18FR58510, 18FR58511, 18FR58512, 18FR58514, 18FR58515, 18FR58516, 18FR58517, 18FR58519, 18FR58520, 18FR58522, 18FR58523, 18FR58524, 18FR58525, 18FR58526, 18FR58527, 18FR58529, 18FR58532, 18FR58533, 18FR58534, 18FR58535, 18FR58536, 18FR58537, 18FR58538, 18FR58539, 18FR58540, 18FR58541, 18FR58542, 18FR58543, 18FR58545, 18FR58546, 18FR58547, 18FR58548, 18FR58549, 18FR58550, and 18FR58551.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Great Lakes Region, Lansing, MI, by letters on April 19, 2001, and May 29, 2001. Firm initiated recall is complete.
REASON
Problem: Blood products, manufactured using blood weight scales that had no quality control testing performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
114units.
DISTRIBUTION
MI, and CA.

 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
CO2 Laser coding/marking machine. Solar Jet:e-SolarMark Laser. Recall # Z-0153-04.
CODE
None.
RECALLING FIRM/MANUFACTURER
Weber Marking Systems, Arlington Heights, IL, by letter, on October 31, 2003. Firm initiated recall is complete.
REASON
Labels missing.
VOLUME OF PRODUCT IN COMMERCE
8 units.
DISTRIBUTION
IL.

_______________________________
PRODUCT
Quattro FAP System, Class IV multi-wavelength laser diode material processing machine. Recall # Z-0357-04.
CODE
None.
RECALLING FIRM/MANUFACTURER
Coherent, Inc, Santa Clara, CA, by technician visit to install software, by February 29, 2004. Firm initiated recall is complete.
REASON
Performance requirement-safety interlocks malfunction due to improper information included in the software operating the laser
VOLUME OF PRODUCT IN COMMERCE
52 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Magnivision UltraLights reading glasses which have the dioptic power on the label and "Magnivision and American Greetings Co. Recall # Z-0541-04.
CODE
Product is not coded. All product on the market at the time the recall is initiated.
RECALLING FIRM/MANUFACTURER
Magnivision, Inc., Miramar, FL, by e-mail dated April 16, 2003, and by telephone on May 2, 2003. Firm initiated recall is complete.
REASON
Possibility of eye injury from large tags on promotional sale product when customer tries them on in store.
VOLUME OF PRODUCT IN COMMERCE
145,884.
DISTRIBUTION
FL.

_______________________________
PRODUCT
18 Gauge thin wall needle as part of a Central Venous Catheter Kit. Recall # Z-0543-04.
CODE
List No. 414000413, Lot No. 02053SN, 02062SN, 03307SN, 04064SN, 05248SN, 05308SN, 06248SN, 93297SN, 96294SN.
List No. 414000415, Lot No. 04240SN, 04241SN.
List No. 414010423, Lot No. 02057SN, 02065SN, 03257SN, 04238SN, 05341SN, 06249SN, 93208SN, 94194SN, 95224SN, 96054SN.
List No. 414010425, Lot No. 02051SN, 02058SN.
List No. 414050415, Lot No. 04239SN, 06244SN, 07244SN, 95221SN.
List No. 414060423, Lot No. 02059SN, 03261SN, 06245SN, 93206SN, 95220SN, 95232SN.
List No. 414070423, Lot No. 02354SN, 03258SN, 95222SN.
List No. 414110423, Lot No. 02052SN, 03259SN, 05342SN, 07250SN, 93296SN, 94196SN, 95233SN.
List No. 414110425, Lot No. 02049SAN, 03260SAN, 93207SN. List No. 414130415, Lot No. 02050SN, 04065SN, 05249SN, 95223SN, 95229SN.
List No. 414140423, Lot No. 02061SN, 04063SN, 06247SN, 94195SN, 95231SN, 96056SN.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL, by FedEx letter on December 17, 2003. Firm initiated recall is ongoing.
REASON
18 gauge needles in Central Venous Catheter kits may be partially occluded.
VOLUME OF PRODUCT IN COMMERCE
93,564.
DISTRIBUTION
Nationwide, and Internationally.

_______________________________
PRODUCT
Multidex Powder, Maltodextrin Wound Dressing, Catalog
Numbers: 46-701, 46-702, 46-703, 46-704, 46-702-1,
46-703-1, 46-704-1; Type of Packaging: Tubes, dispenser
box. Recall # Z-0544-04.
CODE
Affected Lot Numbers: 66430, 68064, 89375, 93956, 103552, 110015, 106770, 346423, 354811, 387794, 492877, 492906.
RECALLING FIRM/MANUFACTURER
DeRoyal Surgical Tray, New Tazewell, TN, by letter on January 19, 2004. Firm initiated recall is ongoing.
REASON
Hydrophilic powder wound dressing, sterilized at a dosage which subsequently failed a sterility audit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2,495 units.
DISTRIBUTION
Nationwide and Internationally.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

_______________________________
PRODUCT
Nitrate Reagent A, Cat No. Z71; Nitrate Reagent B, Cat. No. A72. Recall # Z-0542-04.
CODE
Lot 3338.
RECALLING FIRM/MANUFACTURER
Hardy Media Inc., Dba Hardy Diag., Santa Maria, CA, by telephone and letter on December 31, 2003. Firm initiated recall is ongoing.
REASON
Mislabeled.
VOLUME OF PRODUCT IN COMMERCE
39 bottles of Z71 and 6 bottles of Z72.
DISTRIBUTION
TX, CA, ID, Puerto Rico, KS and WY.

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS III

_______________________________
PRODUCT
WT 13 Pellets with Rumensin. Recall # V-108-4.
CODE
Product code 9349394051.
RECALLING FIRM/MANUFACTURER
Tennessee Farmers Cooperative, LaVergne, TN, by telephone on December 17, 2003. Firm initiated recall is complete.
REASON
Non-medicated feed was inadvertently mixed with medicated feed and distributed.
VOLUME OF PRODUCT IN COMMERCE
23.1 tons.
DISTRIBUTION
TN.

END OF ENFORCEMENT REPORT FOR MARCH 3, 2004

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