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U.S. Department of Health and Human Services

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Enforcement Report for January 14, 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.


January 14, 2004
04-02

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

_______________________________
PRODUCT
Deli Chef brand Sour Cream and Cheese Macaroni Salad, in 10
LB tubs. Recall # F-061-4.
CODE
Best If Used By: NOV 27 03; LINE NO. 1141.
RECALLING FIRM/MANUFACTURER
Kroger Co, Cincinnati, OH, by e-mail and fax on November 24, 2003. Georgia State initiated recall is complete.
REASON
The product is contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
215/10 LB. tubs.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) ROYAL BALTIC brand IMPERIAL-EUROPEAN STYLE SALMON, To be
weighed at point of sale (bulk weight). This product is
vacuum packed. Recall # F-069-4;
b) ROYAL BALTIC brand HERRING IN OIL, NET WT. 16 OZS.
(1 LB.) (454 Grams), packaged in glass jars.
Recall # F-070-4;
c) ROYAL BALTIC brand ASSORTED PRESLICED SMOKED FISH
SALMON, SEA BASS (a variety pack), NET WT. 8 OZ. (227
Grams), This product is vacuum packed. This product is
also labeled in English & Russian. Recall # F-071-4.
CODE
a) starting with codes 129xxxx through 203xxxx ("xxxx"
represents packaging dates);
b) 2140803 and 1740623; Barcode # 91589 16303;
c) Code "0521", or "PROD DATE 21 05 2003", "BEST BEFORE 21
09 2003", Barcode # 91589 82602.
RECALLING FIRM/MANUFACTURER
Royal Baltic Ltd, Brooklyn, NY, by press release and letters dated October 24, 2003. FDA initiated recall is ongoing.
REASON
Listeria monocytogenes contamination based on FDA's samplings & analyses.
VOLUME OF PRODUCT IN COMMERCE
a) Approximately 4500 lbs;
b) 1620 jars;
c) Approximately 454 packages.
DISTRIBUTION
NY, NJ, PA, MA, CT, IL, OH, VA, and MD.

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II

_______________________________
PRODUCT
a) Stop & Shop Bake Shop Chocolate Iced Loaf Cake, Net Wt.
14 oz. (397g) UPC002000-066949. Recall # F-062-4;
Stop & Shop Bake Shop Vanilla Iced Loaf Cake, Net Wt.
14 oz. (397g) UPC002000-066956. Recall # F-063-4.
CODE
All product codes on retail shelf.
RECALLING FIRM/MANUFACTURER
Shop & Shop Supermarket Company, Boston, MA, by e-mail on November 21, 2003. Firm initiated recall is ongoing.
REASON
Label fails to declare FD&C colors: Yellow #5, Yellow #6 and Red #3, Red #40, Blue #1, Blue #2.
VOLUME OF PRODUCT IN COMMERCE
51 cases.
DISTRIBUTION
MA, CT, RI, NY, NJ, and NH.

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III

_______________________________
PRODUCT
Pina Colada Mix, non-alcoholic, sold under the "Holland
House" and "Mr. & Mrs. T" label. Sold in 64 fl. oz. and 1
liter plastic bottles, unrefrigerated. The 64 oz. bottles
sold 6 per case. 1 Liter bottles sold 12 per case. Recall
# F-066-4.
CODE
Holland House 1 liter: (CORRECTED 10/16/03) WI30708, WI30709, WI30829, WI30830.
Holland House 64 fl. oz.: WJ30727, WJ30917.
Mr & Mrs T 1 liter: (CORRECTED 10/16/03) WI30712, WI30723, WI30814, WI30815, WI30903.
Mr & Mrs T 64 fl. oz: WJ30727.
RECALLING FIRM/MANUFACTURER
Mott's Inc., Williamson, NY, by letters dated October 1, 2003 and October 16, 2003. Firm initiated recall is ongoing.
REASON
Product contains yeast contamination.
VOLUME OF PRODUCT IN COMMERCE
37,825 cases.
DISTRIBUTION
Nationwide.

 RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I

_______________________________
PRODUCT
POTASSIUM ACETATE INJECTION, USP, 100 mEq (2 mEq/mL), FOR
IV USE ONLY AFTER DILUTION, Preservative Free, 50 mL,
Single Dose Vial, Rx only. NDC 63323-076-50.
Recall # D-084-4.
CODE
Lot Number 120998, exp. 02-28-05.
RECALLING FIRM/MANUFACTURER
American Pharmaceutical Partners, Inc., Melrose Park, IL, by letter dated September 23, 2003. Firm initiated recall is ongoing.
REASON
Non-Sterility Microbial contamination (Bacillus liceniformis).
VOLUME OF PRODUCT IN COMMERCE
21,600 vials.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

_______________________________
PRODUCT
TechneScan MAG3, Kit for the Preparation of Technetium Tc
99m Mertiatide, each kit contains 5 reaction vials in a
clamshell, each reaction vial contains 1 mg. Betiatide,
0.05 mg. (minimum) Stannous Chloride Dihydrate (SnCl2
2H2O), 0.2 mg. (maximum) Total Tin as Stannous Chloride
Dihydrate (SnCl2 2H2O), 40 mg. Sodium Tartrate Dihydrate,
and 20 mg. Lactose Monohydrate, Diagnostic for Renal
Imaging, Rx Only. NDC NO. 0019-N096-BO. Recall # D-083-4.
CODE
Lot No. 096-3009.
RECALLING FIRM/MANUFACTURER
Tyco Healthcare, Maryland Heights, MO, by letter dated November 11, 2003. Firm initiated recall is ongoing.
REASON
Failing radiochemical purity/altered bio-distribution; due to excessive oxygen reducing stannous ion effectiveness.
VOLUME OF PRODUCT IN COMMERCE
6,895 vials (1,379/5-vial kits).
DISTRIBUTION
Nationwide and Internationally.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
Platelets. Recall # B-0464-4.
CODE
Units V06573, C27625, V06578, V06581, V06576, V06572.
RECALLING FIRM/MANUFACTURER
HCSC Blood Center, Bethlehem, PA, by letter, dated September 23, 2002. Firm initiated recall is complete.
REASON
Platelets, manufactured with an incorrect centrifuge setting, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 unit.
DISTRIBUTION
PA.

_______________________________
PRODUCT
Platelets Pheresis Leukocytes Removed. Recall # B-0471-4.
CODE
Unit number: 21KP42835.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Pacific Northwest Region,
Portland, OR, by letter, dated January 14, 2003. Firm initiated recall is complete.
REASON
Blood product, labeled as leukocyte reduced but the white blood cell count was incorrectly performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OR.

_______________________________
PRODUCT
Source Plasma. Recall # B-0473-4.
CODE
Units 02RMIA1015 and 02RMIA1376.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Kentwood, MI., by facsimile on July 9, 2002. Firm initiated recall is complete.
REASON
Blood products, which were not tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Removed. Recall # B-0474-4.
CODE
Unit numbers: 4002986A, 4002843B, 002842A,4004765,4004949,
400517A, 4004987B, 4005129A, 6008748B, 1765445A,
6009234, 6008803B, 4004266A, 4004266B, 4004279B,
4002087A, 6009485B, 4003349A, 4003349B, 4004287A,
4003375A, 6009043A, 6010382A, 4004246B, 4005030A,
6009557B, 4002658A, 4002538B, 4003375B, 4003700B,
4004042A, 4004408, 4004419A, 4005026A, 4005026B,
4005098B, 6009674A, 6011097A, 6009485A, 4004891A,
4004891B, 6010424B, 4003436A, 4004372B, 4005010A,
1767930A, 1767930B, 6009184, 4002687, 4002538A,
4002842A, 4003566A, 4003700A, 4003943B, 4004449,
4004553B, 4005030B, 4004987A, 4005129B, 6008379,
6008743A, 6009642, 4002371B, 4003523A, 4003878,
4002161, 4003988A, 4004288A, 4005092A, 4005092B,
4002470A, 4002470B, 4002428A, 4002428B, 4002792A,
4002646A, 4002646B, 4002657B, 4002574A, 4002574B,
6009683A, 4002540B, 4002539A, 4002539B, 4002497A,
4002498, 4002674, 4002986B, 4002950, 4002952B,
4003601A, 4004045, 4004038A, 4004038B, 4004042B,
4003940A, 4003940B, 4003917, 4004372A, 4004394,
4004388A, 4004388B, 4004341A, 4004341B, 4004075A,
4004075B, 4004309A, 4004306, 4004317, 4004657B,
4004469A, 4004469B, 4004502, 4004499A, 4004446A,
4004446B, 4004448A, 4004448B, 4004431, 4004806B,
4004807B, 4004786A, 4004786B, 4004788, 4004611,
4004598A, 4004598B, 4004564, 4004553A, 4004669,
4004996A, 4004996B, 4004995A, 4004995B, 4005010B,
4005017B, 4005027A, 4005027B, 4005041A, 4005046A,
4005046B, 4005022A, 4005022B, 4005008A, 4005008B,
4004988A, 4004988B, 4004982A, 4004982B, 4005004A,
4005004B, 4005082, 4005087A, 4005087B, 4005115A,
4005115B, 4005116A, 4005116B, 4005117A, 4005117B,
4005118, 4005120A, 4005120B, 4005122A, 4005122B,
4005103A, 4005103B, 4005108A, 4005098A, 4005049A,
4005049B, 4005060B, 4005065B, 4005067A, 4005067B,
4005079A, 4005079B, 4005076A, 4005076B, 4002166A,
4002166B, 4002198A, 4002198B, 4002202A, 4002202B,
6009674B, 6009337A, 6009337B, 6008532A, 6008532B,
4002087B, 6010893A, 6010893B, 6009982A, 6009982B,
6010937A, 6010937B, 6008739A, 6008739B, 6008302A,
6008302B, 6009867, 6009240, 6009631, 4003297A,
4003297B, 4003843, 4003844B, 4003875, 4003817,
4004886A, 4004886B, 4004890A, 4004890B, 6010377A,
6010377B, 6101424A, 1762577A, 1762577B, 1762582A,
1762582B, 1764318A, 1764318B, 1766673, 4002755A,
4002755B, 4003034, 4003437B, 4004126A, 4004126B,
4004146A, 4004146B, 4004156A, 4004156B, 4004163A,
4004182A, 4004182B, 4004246A, 4004259A, 4004259B,
4004262A, 4004262B, 4004264A, 4004264B, 4004278A,
4004278B, 4004298A, 4004298B, 4005176A, 4005200A,
4006050.
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services, Jackson, MS, by letter dated June 3, 2002. Firm initiated recall is complete.
REASON
Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE
274 units.
DISTRIBUTION
MS and TN.

_______________________________
PRODUCT
Human Tissues for Transplantation. Recall # B-0475-4.
CODE
LA03-027 Cornea OD, Cornea OS
LA03-027 Saphenous Vein R, Saphenous Vein L
LA03-027 Fascia Lata R, Fascia Lata L
LA03-027 Anterior/Posterior Tibialis Tendons R, Anterior/Posterior Tibialis Tendons L
LA03-027 Leg En Bloc R, Leg En Bloc L
LA03-027 Achilles Tendon with Calcaneus and Talus R, Achilles Tendon with Calcaneus and Talus L
LA03-027 Hemipelvis R, Hemipelvis L.
FIRM/MANUFACTURER
Life Alaska, Inc., Anchorage, AK, by telephone on May 2 and 5, 2003. Firm initiated recall is complete.
REASON
Human tissues for transplantation, that tested negative for viral markers, but was procured from an ineligible donor due to a subsequent disclosure of high risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
14 Tissues.
DISTRIBUTION
GA, WA, and FL.

_______________________________
PRODUCT
Source Plasma. Recall # B-0476-4.
CODE
Unit numbers 03NVAA1115 and 03NVAA1333.
RECALLING FIRM/MANUFACTURER
Biolife Plasma Services L.P., Norfolk, VA, by facsimile on April 15, 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 routine physical examination performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0477-4;
b) Recovered Plasma. Recall # B-0478-4.
CODE
a) and b) Unit number 18FT74469.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Great Lakes Region, Lansing, MI., by facsimile and letter on October 3, 2003, and by electronic mail on October 30, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jacob disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MI and CA.

_______________________________
PRODUCT
Platelets. Recall # B-0484-4.
CODE
Unit number: 6496274
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA , by facsimile on November 13, 2001. Firm initiated recall is complete.
REASON
Platelets, manufactured from a unit of whole blood that was collected from a donor who had taken aspirin, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0485-4;
b) Red Blood Cells Leukocytes Reduced. Recall # B-0486-4;
c) Platelets. Recall # B-0487-4;
d) Platelets Pheresis Leukocytes Reduced. Recall # B-0488-4.
CODE
a) Units 8423901, 8272616, and 8422540;
b) Unit 4232060;
c) Unit 4232060;
d) Unit 4801387.
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Inc., Indianapolis, IN, by letter, telephone, and facsimile dated November 15, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from donors whose donor history screening was incomplete resulting in not adequately determining donor suitability, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
IN and Austria.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0490-4.
CODE
Unit number: 6591597.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Monroe, LA, by letter, dated April 1, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who lived in an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 Unit.
DISTRIBUTION
LA.

_______________________________
PRODUCT
Source Plasma. Recall # B-0491-4.
CODE
Units 46DCDDLNA and 46DCDDJJA.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Decatur, IL, by facsimile on August 13, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had received a body piercing within twelve months of the donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL.

_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-0493-4.
CODE
Unit number 07FQ12155.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Arizona Region, Tucson, AZ, by letter on October 15, 2003. Firm initiated recall is complete.
REASON
Blood product, associated with a unit of Red Blood Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AZ.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0494-4;
b) Red Blood Cells, Leukocytes Reduced Irradiated. Recall # B-0495-4.
CODE
a) Unit number 21KC55663;
b) Unit number 21KC62206.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pacific Northwest Region, Portland, OR, by letter on January 23, 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
2 units.
DISTRIBUTION
OR.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0496-4.
CODE
Unit number 21GL76580.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pacific Northwest Region, Portland, OR, by letter on October 16, 2002 and November 25, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Platelets. Recall # B-0497-4.
CODE
Unit number 1913835.
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services, Inc., Jackson, MS, by telephone on October 22, 2002. Firm initiated recall is complete.
REASON
Blood product, that tested negative for viral markers, but was collected from an unsuitable donor due to the application of a tattoo, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MS.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0498-4.
CODE
Unit numbers 6018055A and 6018055B.
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services, Inc., Jackson, MS, by telephone on October 8, 2002. Firm initiated recall is complete.
REASON
Blood products, that were labeled leukoreduced but were not tested to determine the white blood cell count as required in the firm's standard operating procedures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MS.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Removed. Recall # B-0501-4;
b) Recovered Plasma. Recall # B-0502-4.
CODE
a) and b) Unit number: 12L64147.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Carolinas Region, Charlotte, NC, by letter, dated April 9, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to a reported history of Hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NC and CA.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0470-4.
CODE
Units 55S20665, 55S20666, 55S20667, 55S20668, 55S20670, 55S20671, 55S20672, 55S20673, 55S20674, 55S20675, 55S20676, 55S20677, 55S20678, 55S20679, 55S20680, 55S20681, 55S20682, 55S20684, 55S20686, 55S20689, 55S20690, 55S20692, 55S20693, 55S20694, 55S20695, 55S20697, 55S20699, 55S20700, 55S20702, 55S20704.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Arkansas Region, Little Rock, AR, by facsimile with a beginning date of January 24, 2002. Firm initiated recall is complete.
REASON
Blood products, collected using trip scales that had not been properly quality controlled, were distributed.
VOLUME OF PRODUCT IN COMMERCE
30 units.
DISTRIBUTION
AR, PA, AL, and MO.

_______________________________
PRODUCT
Source Plasma. Recall #B-0472-4.
CODE
Unit MI041110.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Muncie, IN, by facsimile on July 6, 2001. Firm initiated recall is complete.
REASON
Blood product, which was not initially tested for syphilis, but was negative upon subsequent testing, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0479-4.
CODE
Unit numbers 18FK75848 and 18FK75849.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Great Lakes Region, Lansing, MI, by telephone on March 20, 2003. Firm initiated recall is complete.
REASON
Blood products that were possibly out of controlled storage for more time than allowable were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MI.

_______________________________
PRODUCT
Platelets, Leukocytes Reduced. Recall # B-0480-4.
CODE
Unit 33GR55016.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Connecticut Region,
Farmington, Connecticut, by telephone on September 17, 2003, and letter dated September 18, 2003. Firm initiated recall is complete.
REASON
Blood product, prepared from a donation that had discrepant start and stop collection times documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CT.

_______________________________
PRODUCT
Platelets, Leukocytes Reduced. Recall # B-0481-4;
Fresh Frozen Plasma. Recall # B-0482-4.
CODE
a) and b) 33GK46050.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Connecticut Region,
Farmington, Connecticut, by telephone on October 10, 2003, and letter dated October 14, 2003. Firm initiated recall is complete.
REASON
Blood product, prepared from a donation that had discrepant start and stop collection times documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 Units.
DISTRIBUTION
CT.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Removed, Irradiated. Recall # B-0483-4.
CODE
Unit number: 8144627.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone on February 26, 2002. Firm initiated recall is complete.
REASON
Blood product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 Unit.
DISTRIBUTION
LA.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-0489-4.
CODE
Units 8272616 and 4232060.
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Inc., Indianapolis, IN, by letter, telephone, and facsimile dated November 15, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from donors whose donor history screening was incomplete resulting in not adequately determining donor suitability, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IN and Austria.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Removed. Recall # B-0492-4.
CODE
Unit numbers: 12FV10267, 12FY77662.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Carolinas Region, Charlotte, NC, by letter, dated April 30, 2003. Firm initiated recall is complete.
REASON
Red Blood Cells, manufactured from a unit of Whole Blood more than eight hours after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 Units.
DISTRIBUTION
NC, and PA.

_______________________________
PRODUCT
Platelets. Recall # B-0499-4.
CODE
Unit numbers 013FC38664, 013FX03114, 013FX03130, 013GE13991, 013GE14003, and 013GE14013.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Great Lakes Region, Lansing, MI, by facsimile and letter on May 23, 2003. Firm initiated recall is complete.
REASON
Blood products, exposed to unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 Units.
DISTRIBUTION
MI.

_______________________________
PRODUCT
Human Tissue for Transplantation, Corneas. Recall # B-0500-4.
CODE
Tissue numbers 03-1409-100 and 03-1409-200.
RECALLING FIRM/MANUFACTURER
Rocky Mountain Lions Eye Bank, Aurora, CO, by letter on November 26, 2003. Firm initiated recall is complete.
REASON
Human tissue for transplantation, that tested repeatedly reactive for hepatitis B surface antigen (HBsAg) at a different facility, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 Tissues.
DISTRIBUTION
CO.

_______________________________
PRODUCT
Whole Blood. Recall # B-0504-4.
CODE
Unit numbers: 8209071, 8209106.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by letter, dated June 14, 2001. Firm initiated recall is complete.
REASON
Blood products, labeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 Units.
DISTRIBUTION
TX.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Removed. Recall # B-0506-4.
CODE
Unit numbers: 17201-2445, Parts 1 and 2.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., McAllen, TX, by telephone on May 22, 2003. Firm initiated recall is complete.
REASON
Plateletpheresis units, with incorrectly tested platelet counts, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 Units.
DISTRIBUTION
TX.

 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

****CORRECTION****

In the October 8, 2003 Enforcement Report, Recall # Z-1196-3, Disetronic H-TRON V100 Insulin Pump and Z-1197-3, Disetronic H-TRONplus Insulin Pump, and Z-1198-3, Disetronic D-TRONplus Insulin Pump, the recall actions were initiated by Roche Diagnostics Corp. not by FDA. Under RECALLING FIRM/MANUFACTURE the corrections are:
Recalling Firm: Roche Diagnostics, Corp, Indianapolis, IN, Manufacturer: Disetronic Medical Systems AG. Firm initiated recall is ongoing.

_______________________________
PRODUCT
HCMI operator control panels for chiropractic x-ray systems, Model #HF300, HF600, HF3SE, and HF3SEE. Recall # Z-0729-03.
CODE
Serial numbers 108, 111, 140, 153, 160, 180, 214, 217, 238, 242, 246, 247, 251 thru 254, 256 thru 267, 269 thru 272, 275, 276, 279, 280, 283, 284, 287, 288, 289, 302 thru 318, 321, 322, 323, 330 thru 334, 352, and 1001 thru 1407.
RECALLING FIRM/MANUFACTURER
Health Care Manufacturing, Inc., Springfield, MO, by telephone approximately May 15, 2003. FDA initiated recall is ongoing.
REASON
Required labeling (certification and manufacturer's label) was missing from the Operator Control Panels.
VOLUME OF PRODUCT IN COMMERCE
476 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) SurgAssist System Circular Stapler DLU 29mm.
Recall # Z-0252-04;
b) SurgAssist System Circular Stapler DLU 33mm.
Recall # Z-0253-04.
CODE
a) Product Code CS29, Lot numbers LC-000125, LC000126,
LC-000127, LC-000131, LC-000132, LC-000133, LC-000137,
LC-000139, LC-000139-1, LC-000142, and LC-000143;
b) Product Code CS33, Lot numbers LC-000134, LC-000135,
LC-000136, LC-000140, and LC-000144.
RECALLING FIRM/MANUFACTURER
Power Medical Interventions, New Hope, PA, by recall notices on November 20, 2003. Firm initiated recall is ongoing.
REASON
Improper staple formation or anvil jam.
VOLUME OF PRODUCT IN COMMERCE
1,514 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Spacelabs flat panel monitor, Model 91415-A. Recall # Z-0269-04.
CODE
Date code range: 0001xx through 0152xx. All defective power supplies fall within the date code of week 1, 2000 and week 52, 2001. The date code can be found on the underside of the power supply, embossed at the top of the text. It will be in the format of 0108A3, which means "01" is the year 2001, "08" is week 8 and "A3" is the line A3.
RECALLING FIRM/MANUFACTURER
Datex-Ohmeda, Inc., Issaquah, WA, by letter dated October 31, 2003 was sent on October 29-31, 2003. Firm initiated recall is ongoing.
REASON
Potential for power supply to fail resulting in failure of the audio (alarm tones) to fail.
VOLUME OF PRODUCT IN COMMERCE
2,734 units Nationwide and 1,099 units Internationally.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
a) Digital Diagnost VE. Recall # Z-0270-04;
b) Philips Digital Diagnost VT. Recall # Z-0271-04.
CODE
a) Site numbers: 82652, 82681, 82723, 82730, 83073, 85495,
85696, 85697, 85698, 86222, 86382, 86383, 86987, 86988,
100572, 100806, 101933, 102030, 102100, 102115, 102116,
102117, 102489, 102539, 102596, 102713, 102717, 102719,
102787, 102905, 103109, 103165, 103262, 103271, 103272,
103436, 103437, 103438, 103439, 103453, 103511, 103778,
103893, 103894, 103953, 103971, 103976, 104014, 104338,
104465, 104578, 104673, 104676, 104864, 104902, 104903,
104904, 104937, 104938, 105158, 105198, 105199, 105322,
105367, 105415, X1641, X1642, X1650, X1767, X1768. The
firm uses site numbers instead of serial numbers.
b) See list above. Site numbers could not be separated by
model.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems Sales & Service Region No. American, Bothell, WA, by letter on November 20, 2003. Firm initiated recall is ongoing.
REASON
The support chain attachment on the detector carriage may fail and cause the counter weights or detector to fall.
VOLUME OF PRODUCT IN COMMERCE
70 devices.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Remel QC-Slide Gram Stain Control, Catalog #40142, packaged
45/box. Recall # Z-0273-04.
CODE
Lot #001453, Exp. 2013-04-03.
RECALLING FIRM/MANUFACTURER
Remel, Inc., Lenexa, KS, by letters dated October 29, 2003. Firm initiated recall is complete.
REASON
Some slides contain sporadic fields of positive and/or negative control inoculum in the test specimen area.
VOLUME OF PRODUCT IN COMMERCE
25 boxes.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
The AXSYM System, Clinical Chemistry Analyzer.
Recall # Z-0274-04.
CODE
Lot Number: 07A83-01, 07A083-03, 07A83-95, 07A83-98; All serial numbers.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc., Irving, TX, by letter on October 29, 2003. Firm initiated recall is ongoing.
REASON
Potential for a contaminated Reaction Vessel (RV) or previously used RV to remain on the AxSYM System.
VOLUME OF PRODUCT IN COMMERCE
16,191.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
a) Hypoguard Advance Blood Glucose Strips, 10, 50, and 100
strip bottles. Recall # Z-0275-04;
b) Hypoguard Advance Blood Glucose Monitoring System,
includes Hypoguard Advance Blood Glucose Meter and 10
Hypoguard Advance Blood Glucose Strips.
Recall # Z-0276-04
CODE
a) 01143A, 01023A, 01173A, 01293A, 01293B, 01303A 01303B,
02263A, 02263B, 02273A, 02273B, 02273C, 03113A, 11182A,
12282A, 12302A, 03113A, 03213A, 03263A, 03283A, 03283B,
04153A, 05293B, 04153B, 05293C, 04213A, 05293A, 04303A,
06063A, 05293D, and 05303A;
b) Lots 01143A, 02263A, 03103A, 10222A, 12212A, 12312A,
03183A, 04293A, and 05273A.
RECALLING FIRM/MANUFACTURER
Hypoguard USA, Inc., Edina, MN, by letters dated November 26, 2003. Firm initiated recall is ongoing.
REASON
When actual blood glucose levels are in the low end of the blood glucose range, the recalled test strips may provide inaccurately high readings.
VOLUME OF PRODUCT IN COMMERCE
10-count bottles 6336; 50-count bottles 73,490; and 100-count bottles 221; kits which include monitors and affected strips 10,670.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Package Insert for TDx/TDxFLx and TDxFLx Carbamazepine
Reagents, REF 9515, item number 69-5121/R4.
Recall # Z-0277-04;
b) Package Insert for TDx/TDxFLx and TDxFLx Gentamicin
Reagents, REF 9512, item numbers 34-1074/R3 and
69-5120/R2. Recall # Z-0278-04;
c) Package Insert for TDx/TDxFLx and TDxFLx Phenobarbital
II Reagents, REF 9500, item number 69-5162/R4.
Recall # Z-0279-04;
d) Package Insert for TDx/TDxFLx and TDxFLx Vancomycin
Reagents, REF 9523, item number 69-5726/R4.
Recall # Z-0280-04.
CODE
a) Reagent List 9515-60, lot 03492Q100 and Reagent List
9515-85, lot 04530Q100 that contain insert item number
69-5121/R4;
b) Reagent List 9512-60,lots 06313Q100, 01368Q101,
95380Q100, 93579Q100, 90107Q100; and Reagent List 9512-
85, lots 06312Q100, 02010Q100, 96606Q100, 95106Q100,
90108Q100 that contain insert item numbers 34-1074/R3 or
69-5120/R2;
c) Reagent List 9500-60, lots 03136Q100, 92723Q102,
92723Q101, 92723Q100; and Reagent List 9500-85, lots
02285Q100, 92724Q100 that contain insert item number 69-
5162/R4;
d) Reagent List 9523-60, lots 05105Q100, 03122Q100,
01649Q101, 01649Q100, 01179Q102, 01179Q101,
01179Q100;and Reagent List 9523-85, lots 05576Q100,
01742Q100, 96817Q100, 92749Q100 that contain insert item
number 69-5726/R4.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL, by letter dated November 17, 2003. FDA initiated recall is ongoing.
REASON
The package inserts contain incorrect values for the alternate unit (?mol/L) Control Ranges.
VOLUME OF PRODUCT IN COMMERCE
26,316 kits.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Pediatric Air Aspirator Needle. Recall # Z-0281-04.
CODE
Part Number, 201015-000, Lot 278862.
RECALLING FIRM/MANUFACTURER
Novosci Corp., The Woodlands, TX, by telephone or email and letter on November 24, 2003. Firm initiated recall is ongoing.
REASON
The firm packaged Modified Air Aspirator Needles into Pediatric Air Aspirator Needle boxes.
VOLUME OF PRODUCT IN COMMERCE
200 units.
DISTRIBUTION
TX. IL, and Germany.

_______________________________
PRODUCT
Radiant Heater Door Vent for Ohmeda Medical's Giraffe (tm)
OmniBed neonate bed. Recall # Z-0288-04.
CODE
HDGDyyyyy HDGEyyyyy HDGFyyyyy HDGGyyyyy where "yyyyy" represents any number less than 60000.
RECALLING FIRM/MANUFACTURER
Ohmeda Medical, A Division of Datex-Ohmeda, Inc., Laurel, MD, by letter and e-mail dated October 17, 2003. Firm initiated recall is ongoing.
REASON
Heater vent door on neonatal incubator may malfunction.
VOLUME OF PRODUCT IN COMMERCE
1,404 beds.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
a) Pulsox-3Si. LCD, SpO2, PR, Pulse strength bar, Motion
artifact, Low battery message, Error message, Event
mark, Measuring range Sp02 (%) 0 to 100, Pulse rate 20
to 250, Measuring accuracy +/- 2% (70 to 100), Pulse
rate +/- 2%, Sp02 alarm, no, Probe type, finger, multi-
site, Patient range adult to neonatal, memory function
Approx. 24 hrs, printer/recorder optional accessory,
output RS232 w/optional interface module, power supply 2
AAA batteries, Battery life approx. 48 hours, size:
42x68x20mm, weight 42g. Recall # Z-0289-04;
b) Pulsox-3iA. LCD, Sp02, PR, Pulse strength bar, motion
artifact, low battery message, error message, low Sp02
message, event mark. Measuring range Sp02 0 to 100,
pulse rate 20 to 250, measuring accuracy Sp02 +/-2% (70
to 100), pulse rate +/- 2, Sp02 alarm, audible and
visible, probe type finger, multi-site, paitent range
adult to neonatal, memory function approx. 24 hrs,
printer/recorder optional accessory, output RS232
w/optional interface module, power supply 2 AAA
batteries, Battery life approx. 48 hrs, size 42x68x20mm,
weight 42g. Recall # Z-0290-04.
CODE
a) Model 3Si, Serial Nos: 22001453-22001469; 22001471-
22001512; 22001514-22001599; 22001600-22001626;
22001628-22001632; 22001635-22001643; 22001645-22001651;
22001653-22001659; 22001661-22001676; 22001678-22001683;
22001685-22001686; 22001688-22001691; 22001712-22001714;
22001717-22001719; 22001721-22001723; 22001725;
22001727-22001732; 22001734-22001737; 22001740-22001745;
22001747-22001765; 22001767-22001770; 22001772;
22001776; 22001860; 22001862; 22001865; 22001868;
22001879; 22001881; 22001882; 22001885; 22001887;
22001893; 22001897; 22001899; 22001905.
b) Model 3iA, Serial Nos.: 23001201; 23001204; 23001206;
23001210; 23001212-23001214; 23001216; 23001217.
RECALLING FIRM/MANUFACTURER
Minolta Corp., Ramsey, NJ, by telephone on November 14, 2003. Firm initiated recall is ongoing.
REASON
Error in the internal software. When a pulse level is high or subject has SPO2 of less than 80%, the data shifts.
VOLUME OF PRODUCT IN COMMERCE
300.
DISTRIBUTION
UT.

_______________________________
PRODUCT
Candela Smoothbeam Laser System Model Numbers: 9914-00-0820
9914-06-0820 9914-07-0820 9914-08-0820 9914-10-0820 Units
are the same except for color. Recall # Z-0291-04.
CODE
Serial Numbers: 9914-0820-0101 thru 9914-0820-0602 9914-0820-P2 9914-0820-P4 9914-0820-P5 9914-0820-P6.
RECALLING FIRM/MANUFACTURER
Candela Laser Corp, Wayland, MA, by letter dated November 25, 2003. Firm initiated recall is ongoing.
REASON
Laser may pulse and not dispense cryogen resulting in patient injury.
VOLUME OF PRODUCT IN COMMERCE
506 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Guidant Brand VasoView(r) 5 Harvesting Cannula System, Model
Number: VH-1000. Recall # Z-0292-04.
CODE
Lot-- Exp Date: 3081371-- 7/2004, 3081471-- 7/2004, 3081571-- 7/2004, 3081871-- 7/2004, 3081972-- 7/2004, 3082071-- 7/2004, 3082171-- 7/2004, 3082271-- 7/2004, 3082272-- 7/2004, 3082571-- 7/2004, 3082671-- 7/2004, 3082772-- 7/2004, 3082871-- 7/2004, 3082972-- 7/2004, 3090271-- 8/2004, 3090371-- 8/2004, 3090471-- 8/2004, 3090571-- 8/2004, 3090871-- 8/2004, 3090971-- 8/2004, 3091072-- 8/2004, 3091171-- 8/2004, 3091271-- 8/2004, 3091571-- 8/2004, 3091671-- 8/2004, 3091771-- 8/2004, 3091871-- 8/2004, 3091971-- 8/2004, 3092271-- 8/2004, 3092372-- 8/2004, 3092471-- 8/2004, 3092571-- 8/2004, 3092671-- 8/2004, 3100271-- 9/2004.
RECALLING FIRM/MANUFACTURER
Guidant Cardiac Surgery, Santa Clara, CA, by letters on November 19, 2003. Firm initiated recall is ongoing.
REASON
VasoView(r) 5 scissors are stiff and/or the scissor toggle has the potential to break during use.
VOLUME OF PRODUCT IN COMMERCE
2,597 units.
DISTRIBUTION
Nationwide and Internationally.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

_______________________________
PRODUCT
Edwards Lifesciences Vantex Central Venous Catheter Kit
with Oligon, Ref/model #: 3K20C1827, Rx only. Recall # Z-
0272-04.
CODE
Lot no. 973H0589 Exp. date 2/2005.
RECALLING FIRM/MANUFACTURER
Edwards Lifesciences Corp., of Puerto Rico, Anasco, PR, by Sales Representatives contact on October 8, 2003. Firm initiated recall is ongoing.
REASON
Lot is being recalled because some of the kits contain an incorrect guidewire.
VOLUME OF PRODUCT IN COMMERCE
315 UNITS.
DISTRIBUTION
MD and DC.

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE-CLASS II

_______________________________
PRODUCT
Grand Vite, Nutritional Supplement, in tubs. 5, 10 and 25 pounds. Designed for horses only. Recall # V-006-4.
CODE
Lot 1473.
RECALLING FIRM/MANUFACTURER
Grand Meadows, Inc., Orange, CA, by facsimile, on September 3, and September 5, 2003. FDA initiated recall is complete.
REASON
Product contains prohibited animal protein and is not labeled to prevent feeding to ruminants.
VOLUME OF PRODUCT IN COMMERCE
131 packages of 5, 10 and 25 pounds.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Halter 15% Pig Meal, in 50 pound paper bags.
Recall # V-008-4;
b) Halter 18% Layer Pellet, in 50 pound paper bags.
Recall # V-009-4.
CODE
No codes.
RECALLING FIRM/MANUFACTURER
Halter Feed & Grain Inc., Massillon, OH, by telephone and letter on December 3, 8, and 10, 2003. FDA initiated recall is ongoing.
REASON
Animal feed that contains protein derived from mammalian tissue was not labeled with the required BSE caution statement, "Do not feed to cattle and other ruminants".
VOLUME OF PRODUCT IN COMMERCE
80 bags (4 tons).
DISTRIBUTION
OH.

END OF ENFORCEMENT REPORT FOR January 14, 2004

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