Enforcement Report

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

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January 3, 2007
07-01

RECALLS AND FIELD CORRECTIONS: FOOD and COSMETICS -- CLASS I

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PRODUCT
Hood Pasteurized 100% Apple Juice packaged in plastic half-gallon (1.39L) and pints (473mL)
Product Public Reason for Recall:, Recall # F-082-7
CODE
Sell By Date: NOV 14/06 and plant code: 2508
RECALLING FIRM/MANUFACTURER
Recalling Firm: H. P. Hood Inc., Chelsea, MA, by telephone on October 16, 2006, and follow-up letter.
Manufacturer: H. P. Hood LLC, Agawam, MA. Firm initiated recall is ongoing.
REASON
Product contains undeclared milk protein
VOLUME OF PRODUCT IN COMMERCE
125 cases
DISTRIBUTION
MA, ME, NH, RI, VT and CT

RECALLS AND FIELD CORRECTIONS: FOOD and COSMETICS -- CLASS II

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PRODUCT
Anastasia Diabetic Skin Care Therapy Hand & Body Treatment, 4 oz. jar, Recall # F-083-7
CODE
Lot #2000D6
RECALLING FIRM/MANUFACTURER
Recalling Firm: Anastasia Marie Laboratories, Inc., Oklahoma City OK., by telephone and letter beginning October 13, 2006.
Manufacturer: American Pharmaceuticals & Cosmetics, Inc., Fort Worth, TX. Firm initiated recall is ongoing.
REASON
Hand & Body Cream is contaminated with Pseudomonas aeruginosa.
VOLUME OF PRODUCT IN COMMERCE
1,481- 4oz. jars
DISTRIBUTION
Nationwide

DRUGS -- CLASS II

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PRODUCT
Ketalar® CIII, ketamine hydrochloride for injection, USP, 10mg/mL, 20mL steri-vial®. 10 vials per package. Rx, NDC 61570-581-10, Recall # D-417-7
CODE
Lot Nos.: 29008 (exp 02/09), 30735 (exp 03/09), 31573 (exp 03/09), 32268 (exp 04/09), 32270 (exp 04/09), 32738 (exp 05/09)
RECALLING FIRM/MANUFACTURER
Recalling Firm: King Pharmaceuticals Inc., Bristol, TN., by letters on December 8, 2006.
Manufacturer: Parkedale Pharmaceuticals, Inc., Rochester, MI. Firm initiated recall is ongoing.
REASON
Lack of sterility assurance due to vial defect.
VOLUME OF PRODUCT IN COMMERCE
5,567 units (55,670 vials)
DISTRIBUTION
Nationwide and PR

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PRODUCT
a) Thyro-Tab 0.025 mg, packaged in 150,000-tablet bulk drums
intended for repackaging, RX, Recall # D-419-7;
b) Levothroid (levothyroxine sodium tablets, USP), 25 mcg,
packaged in 100 and 1,000-tablet bottles,
RX, NDC 0456-1320-01 (100-tab.) and
NDC 0456-1320-00 (1,000-tab.), Recall # D-420-7
CODE
a) Lot: HA35305;
b) Lot 010648 (100-tab.) and Lot 010652 (1,000-tab.), exp. January 2007
RECALLING FIRM/MANUFACTURER
Lloyd Inc of Iowa, Shenandoah IA, by e-mail dated November 29, 2006 and by letters dated November 29 and December 4, 2006. Firm initiated recall is ongoing.
REASON
Subpotent (9-month stability)
VOLUME OF PRODUCT IN COMMERCE
a) 1,947,208 bulk tablets;
b) 14,126/100-tab. bottles and 486/1,000-tab. bottles
DISTRIBUTION
Nationwide

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PRODUCT
Ketalar® CIII, ketamine hydrochloride for injection, USP, 10mg/mL, 20mL steri-vial®. 10 vials per package. Rx, Recall # D-421-7
CODE
Lot Nos.: 35150 (exp 07/09), 35151 (exp 07/09)
RECALLING FIRM/MANUFACTURER
Recalling Firm: King Pharmaceuticals Inc., Bristol, TN, by letters on December 18, 2006.
Manufacturer: Parkedale Pharmaceuticals, Inc., Rochester, MI. Firm initiated recall is ongoing.
REASON
Lack of sterility assurance due to vial defect.
VOLUME OF PRODUCT IN COMMERCE
18,950 vials
DISTRIBUTION
Nationwide and PR

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PRODUCT
Pink Eye Relief Drops, Homeopathic Remedy, (homeopathic): Euphrasia HPUS 6X, Hepar Sulphuris HPUS 12X, Belladonna HPUS 6X, 0.4 fl. oz. bottles, Alleviates inflammation, pain, redness and water discharge, packaged under the following labels:
1) select brand, Distributed By: Select Brand Distributors, NDC 15127-005-04;
2) Eckerd, Distributed by : Eckerd Corporation d/b/a/ Eckerd Pharmacy;
3) Brooks, Distributed By; Maxi Drug Inc., d/b/a Brooks Pharmacy;
4) Premier Value, Distributed By Chain Drug Consortium, LLC, NDC 68016-107-07;
5) Equaline, Distributed by Albertsons, Inc., NDC 41163-107-07,
Recall # D-422-7
CODE
150117, 150215, 151215, 151014, 1510141, 151102, 151105, 151106, 151110, 1511101, 1511102, 151204, 151212, 1512121, 1512123, 160101, 1601011, 160112, 160212
RECALLING FIRM/MANUFACTURER
Pharmaceuticals, Inc. dba Wendt Laboratories, Inc, Belle Plaine, MN, by letter on November 28, 2006. Firm initiated recall is ongoing.
REASON
Lack of assurance of sterility; not manufactured in accordance with current Good Manufacturing Practices Regulations
VOLUME OF PRODUCT IN COMMERCE
59,916 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

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PRODUCT
Dicyclomine Hydrochloride Tablets, USP, 20 mg, 100 Tablet bottle, Rx only, NDC 0143-1227-01, Recall # D-418-7
CODE
Lot number WWCN 59401A, Exp. 05/09 WW27 embossed on tablet.
RECALLING FIRM/MANUFACTURER
West-Ward Pharmaceutical Corp., Eatontown, NJ, by letter on November 15, 2006. Firm initiated recall is ongoing.
REASON
Subpotent (12-month stability)
VOLUME OF PRODUCT IN COMMERCE
28,112 bottles of 100 count
DISTRIBUTION
Nationwide

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PRODUCT
PREMPRO™ (conjugated estrogens/medroxyprogesterone acetate tablets) 0.3 mg/1.5 mg, Rx only, cartons of 3 EZ-DIAL® Dispensers, NDC 0046-0938-09, Recall # D-423-7
CODE
B14984 (exp. 1/07)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wyeth Pharmaceuticals, Philadelphia, PA, by letters dated December 1, 2006.
Manufacturer: Wyeth Pharmaceuticals, Inc. Rouses Point NY. Firm initiated recall is ongoing.
REASON
Failed USP Dissolution Requirement.
VOLUME OF PRODUCT IN COMMERCE
50,302 cartons (each carton contains 3 EZ-DIAL dispensers)
DISTRIBUTION
Nationwide and PR

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

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PRODUCT
a) Platelets Pheresis Leukocytes Reduced, Recall # B-0292-7;
b) Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-0293-7
CODE
a) Units: R64065 (distributed as split product);
b) Unit: R64065
RECALLING FIRM/MANUFACTURER
Coastal Bend Blood Center, Corpus Christi, TX, by fax on May 2, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had previously donated a syphilis reactive unit, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TX

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PRODUCT
a) Red Blood Cells, Recall # B-0493-7;
b) Cryoprecipitated AHF, Recall # B-0494-7
CODE
a) and b) Unit: 0207692
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA., by telephone and fax on May 5, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening regarding high risk behavior was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA and LA

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PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0496-7;
b) Fresh Frozen Plasma, Recall # B-0497-7
CODE
a) and b) Unit 2020616
RECALLING FIRM/MANUFACTURER
Medic Inc., Knoxville, TN, by telephone and fax on December 23, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor taking the drug Avodart, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN

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PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0498-7
CODE
Unit: 71x18918-4
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc., Huntsville, AL, by fax on March 16, 2005. Firm initiated recall is complete.
REASON
Blood Product, prepared in insufficient plasma to support the platelet yield, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL

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PRODUCT
Platelet Pheresis Leukocytes Reduced, Recall # B-0499-7
CODE
Units: 71X134867 (distributed as split product)
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc., Birmingham, AL, by fax on April 26, 2005. Firm initiated recall is complete.
REASON
Blood products, possibly contaminated with air, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AL

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PRODUCT
Fresh Frozen Plasma, Recall # B-0500-7
CODE
Unit: 2520384
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by fax on January 19, 2005. Firm initiated recall is complete.
REASON
Blood product, processed from an overweight unit of whole blood, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN

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PRODUCT
Fresh Frozen Plasma, Recall # B-0501-7
CODE
Unit: 2133698
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by fax on January 3, 2005. Firm initiated recall is complete.
REASON
Blood product, without documentation of freezing time, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0503-7;
b) Fresh Frozen Plasma, Recall # B-0504-7
CODE
a) and b) Unit: 2228266
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by telephone on May 10, 2005 and fax on May 18, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred due to positive HIV test results, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN

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PRODUCT
Fresh Frozen Plasma, Recall # B-0505-7
CODE
Unit: 2707153
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by telephone and fax on May 9, 2005. Firm initiated recall is complete.
REASON
Blood product, associated with a red cell component which contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN

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PRODUCT
a) Fresh Frozen Plasma, Recall # B-0506-7;
b) Cryoprecipitated AHF, Recall # B-0507-7;
c) Platelet,s Leukocytes Reduced, Recall # B-0508-7
CODE
a) Units: 032FC57794, 032KE79017, 032KM36343, 032KR19775;
b) Units: 032KE80431, 032KL13744, 032KR15474, 032KT27278, 032KV12927;
c) Units: 032KM36343, 032KR19775
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Badger-Hawkeye Region , Madison, WI, by letters dated October 22, 2003. Firm initiated recall is complete.
REASON
Blood products, associated with red cell components which contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
IL, OH, and WI

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PRODUCT
Fresh Frozen Plasma, Recall # B-0509-7
CODE
Unit: 2140706
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by telephone on April 28, 2005and fax on May 3, 2005. Firm initiated recall is complete.
REASON
Blood product, associated with red cell components which contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0516-7;
b) Recovered Plasma, Recall # B-0517-7
CODE
a) and b) Unit: 4971898
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on March 28, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to use of the medication Methotrexate, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OK and Switzerland

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PRODUCT
Source Plasma, Recall # B-0518-7
CODE
Units: CD0178766, CD0178912, CD0179278, CD0179974, CD0180171, CD0180461, CD0180886, CD0181071, CD0182670, CD0182905, CD0183077, CD0183376, CD0184085, CD0184324, CD0185217, CD0185644, CD0185877, CD0186599
RECALLING FIRM/MANUFACTURER
DCI Biologicals Carbondale, LLC, Carbondale, IL, by facsimile dated June 9, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a previously deferred donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
18 units
DISTRIBUTION
NC

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0522-7;
b) Platelets, Recall # B-0523-7;
c) Fresh Frozen Plasma, Recall # B-0524-7
CODE
a), b), and c) Unit: 0264526
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on June 22, 2005 and follow up letter on June 29, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
LA

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PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0527-7
CODE
Units: 5640195 (parts 1 and 2)
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by telephone and facsimile on May 2, 2006. Firm initiated recall is complete.
REASON
Blood products, which were possibly contaminated with Corynebacterium species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NJ

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0539-7
CODE
Unit: 5244696
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on April 20, 2006. 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
OK

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0540-7
CODE
Unit: 5345213
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on July 13, 2005. 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
OK

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PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0541-7
CODE
Unit: 5251437
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by telephone and facsimile on March 11, 2005. Firm initiated recall is complete.
REASON
Platelets, which was possibly contaminated with Staphylococcus epidermidis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0542-7
CODE
Unit: 5266394
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on July 19, 2005. 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
OK

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0543-7
CODE
Units: 5406703 and 5318318
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on October 20, 2005. 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
OK

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-0544-7;
b) Red Blood Cells, (Apheresis), Leukocytes Reduced, Recall # B-0545-7;
c) Cryoprecipitate, AHF, Recall # B-0546-7;
d) Fresh Frozen Plasma, (Apheresis), Recall # B-0547-7;
e) Recovered Plasma, Recall # B-0548-7
CODE
a), c) and e) Unit: 5409082;
b) and d) Unit: 5277238
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on December 6, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had received a body piercing within twelve months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
OK and Switzerland

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0551-7
CODE
Unit: 22KV88204
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone on July 26, 2006 and by letter dated July 31, 2006. Firm initiated recall is complete.
REASON
Blood product, corresponding to a unit of Platelets that was possibly contaminated with Staphylococcus species, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0554-7
CODE
Unit: 4315420
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on September 16, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with a history of lymphoma, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK

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PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0560-7
CODE
Units: 0401852 and 0401872A
RECALLING FIRM/MANUFACTURER
Metrowest Medical Center, Framingham, MA, by telephone and letter between September 26, 2006 and September 27, 2006. Firm initiated recall is complete.
REASON
Blood products, labeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MA

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PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0562-7
CODE
Unit: 5620500
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on April 20, 2006. Firm initiated recall is complete.
REASON
Blood product, which was possibly contaminated with Moraxella species, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AR

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PRODUCT
a) Platelets Pheresis, Leukocytes Reduced, Recall # B-0626-7;
b) Platelets Pheresis, Leukocytes Reduced, Irradiated, Recall # B-0627-7
CODE
a) Unit: 9609264 (Part 1);
b) Units: 9609264 (Parts 2 and 3);
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on May 21, 2006. Firm initiated recall is complete.
REASON
Platelets, which were possibly contaminated with Propionibacterium species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CO and TN

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

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PRODUCT
Recovered Plasma, Recall # B-0495-7
CODE
Unit: 0207692
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA., by fax on May 16, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening regarding high risk behavior was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland

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PRODUCT
Platelets Pheresis, Leukocytes Reduced, Irradiated, Recall # B-0510-7
CODE
Unit: 2056181
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by telephone on February 9, 2005 and fax on February 11, 2005. Firm initiated recall is complete.
REASON
Blood product, exposed to unacceptable temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN

______________________________
PRODUCT
Red Blood Cells, Deglycerolized Leukocytes Reduced, Irradiated, Recall # B-0511-7
CODE
Unit: 2061311
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter dated June 13, 2005. Firm initiated recall is complete.
REASON
Blood product, that was irradiated twice, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN

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PRODUCT
Platelets, Recall # B-0552-7
CODE
Unit: 5319057
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on March 30, 2005. Firm initiated recall is complete.
REASON
Blood product, manufactured from a unit of Whole Blood with an extended collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY

______________________________
PRODUCT
Recovered Plasma, Recall # B-0555-7
CODE
Unit: 4315420
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on October 11, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with a history of lymphoma, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I

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PRODUCT
a) OneTouch Ultra- Blood Glucose test strips. For use with
One Touch Brand Meters blood glucose meters, Recall # Z-0264-2007;
b) OneTouch Basic/Profile Blood Glucose test strips. For use with
One Touch Brand Meters blood glucose meters, Recall # Z-0265-2007
CODE
a) Lot # 2691191 and 2691261;
b) Lot # 272894A, 2619932, 2606340, and 2615211
RECALLING FIRM/MANUFACTURER
Recalling Firm: Royal Global Wholesale, Boynton Beach, FL, by telephone and letter on November 3, 2006.
Manufacturer: Unknown, Milpitas, CA. Firm initiated recall is ongoing.
REASON
Counterfeit Glucose Test Strips
VOLUME OF PRODUCT IN COMMERCE
11,716 devices
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

______________________________
PRODUCT
a) Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker),
50/60 Hz (20A power source required); Model 801763, Recall # Z-0306-2007;
b) Terumo Advanced Perfusion System 1; 220V -240V; Model 801764
(sold outside of the U.S. only), Recall # Z-0307-2007
CODE
a) All units. Serial numbers 0011 through 0499;
b) Units 0006 through 0213.
RECALLING FIRM/MANUFACTURER:
Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by letter dated November 10, 2006. Firm initiated recall is ongoing.
REASON
Improperly adjusting the occlusion setting may result in a pump jam error and pump stoppage.
VOLUME OF PRODUCT IN COMMERCE
696 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
a) Endologix Infrarenal Bifurcated Powerlink System with Visifiex
Delivery System (endovascular graft). Model Number 25-16-155BL,
Recall # Z-0309-2007;
b) Endologix Infrarenal Bifurcated Powerlink System with Visifiex
Delivery System (endovascular graft), Model Number 28-16-155BL,
Recall # Z-0310-2007
CODE
a) Lot Numbers: W06-0333, W06-0392, W06-0500, W06-0553,
W06-0621, W06-1100 & W06-1152;
b) Lot Numbers: W06-0079, W06-0334, W06-0393, W06-0501,
W06-0658, W06-0773, W06-0988 & W06-1196
RECALLING FIRM/MANUFACTURER
Endologix Inc., Irvine, CA, by telephone on November 8, 2006 and by letters on November 9, 2006. Firm initiated recall is ongoing.
REASON
Recall was initiated after a clinical incident involving separation of the front sheath, preventing deployment of the stent graft. This required the physician to convert the patient to conventional open repair.
VOLUME OF PRODUCT IN COMMERCE
30 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Solara Replacement Turbine, Autochuck End Cap, for dental handpiece, part number 064900, Recall # Z-0313-2007
CODE
Lot numbers 1694789, 1697998, 1699566, and 1703516.0
RECALLING FIRM/MANUFACTURER
Stardental Division, Lancaster PA, by letters on December 6, 2006. Firm initiated recall is ongoing.
REASON
End cap component can disassemble.
VOLUME OF PRODUCT IN COMMERCE
2756 end caps
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
a) Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker),
50/60 Hz (20A power source required); Models 801763, Recall # Z-0314-2007;
b) Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker),
50/60 Hz (10A power source required); Model 801764.
(Not distributed within the United States), Recall # Z-0315-2007
CODE
a) Serial numbers 0093 and 0104 through 0114;
b) Serial numbers 0040 through 0044
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by visits between May 2004 and November 2005. Firm initiated recall is ongoing.
REASON
The gas system may fail calibration prior to use due to incorrect gas system flowmeter software.
VOLUME OF PRODUCT IN COMMERCE
17 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Posterior Acetabular Retractor-Left with Light Cord Bracket, Model #BIO-1-1050-A, and Posterior Acetabular Retractor-Right with Light Cord Bracket, Model #BIO-1-1051-A, packaged 1 retractor (left or right retractor) per plastic bag, Recall # Z-0316-2007
CODE
Lot #P0835-1
RECALLING FIRM/MANUFACTURER
Recalling Firm: Whiteside Biomechanics, St. Louis, MO, by telephone on September 15, 2006.
Manufacturer: Friedrich Daniels, Solingen, Germany. Firm initiated recall is ongoing.
REASON
The soft tissue pin in the retractor can break off and become embedded in the tissue.
VOLUME OF PRODUCT IN COMMERCE
10 retractors
DISTRIBUTION
MD and MO
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PRODUCT
FC 500 MPL Flow Cytometry System with MXP Software Version 2.0 & 2.1, Part Number 626554 FC 500 MPL 733313 MPL Hardware Upgrade Kit, Recall # Z-0317-2007
CODE
System with MXP Software Version 2.0 & 2.1
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter on Oct 17, 2006.
Manufacturer: Applied Cytometry, Sheffield, UK. Firm initiated recall is ongoing.
REASON
The ratio parameter assignments (numerator and denominator) of a protocol may inadvertently change after the Parameter Selection Dialog box is accessed. Issue limited only to protocols utilizing the Ratio parameter such as LeukoSure and DNA Cell Cycle.
VOLUME OF PRODUCT IN COMMERCE
37 in the US; 4 to Canada
DISTRIBUTION
Nationwide and Canada

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

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PRODUCT
Histochemical PAS (Periodic Acid Schiff) Reaction Set. Class I medical device. Product size configuration: Set of 4 bottles including Schiff Reagent 225mL, Light Green SF Yellowish Stain 225mL, Sodium Carbonate Solution 225mL, and Periodic Acid Solution 225mL. Each kit provides reagents sufficient for a maximum of 100 tests, Item Number 64945/93, Recall # Z-0305-2007
CODE
Lot # 5341, Exp. Date: May 31, 2007.
RECALLING FIRM/MANUFACTURER
EMD Chemicals Inc., Gibbstown NJ, by letter on July 27, 2006. Firm initiated recall is complete.
REASON
Due to loose caps, the SO2 levels dropped significantly from release levels causing the product not to perform properly.
VOLUME OF PRODUCT IN COMMERCE
74 kits
DISTRIBUTION
Nationwide

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PRODUCT
a) Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker),
50/60 Hz (20A power source required) base; Model 801763,
Recall # Z-0311-2007;
b) Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker),
50/60 Hz (10A power source required) base; Model 801764.
(Not distributed within the United States), Recall # Z-0312-2007
CODE
a) Serial numbers 0011 through 0039 and 0041 through 0170;
b) Serial numbers 0006 through 0066
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp., Ann Arbor MI, by visits between May 2004 and November 2005. Firm initiated recall is ongoing.
REASON
The battery status light on the front panel may not accurately reflect the actual status of the battery. The battery may contain more charge than indicated.
VOLUME OF PRODUCT IN COMMERCE
269 devices
DISTRIBUTION
Nationwide and Internationally

END OF ENFORCEMENT REPORT FOR JANUARY 3, 2007

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