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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December 10, 2008
08-49

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
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PRODUCT
Sea Best 10 Raw Shrimp Skewers, Net Wt. 1.5 lbs, 41/50 Shrimp Per Pound, Keep Frozen Do Not Refreeze, UPC 0 75391 00017 5. Product of China ; Recall # F-042-9
CODE
Lot : 790181 and 819093
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beaver Street Fisheries, Inc., Jacksonville , FL , by fax and email on November 7, 2008.
Manufacturer: Yangjiang City Yelin Hoitat Quick Frozen Seafood Co., Ltd.
Yangjiang , China . Firm initiated recall is ongoing.
REASON
Product contains undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
1,735 cases
DISTRIBUTION
OH, TN, GA, PA, CA, TX, NC, MO, MD and Bahamas
___________________________________
PRODUCT
Cilantro from Mexico , repacked by Sanwa Fresh Produce Co., LLC. Sanwa Greenhouses twist tie, Product of Mexico. UPC: 7 37474 00101 0, Recall # F-043-9
CODE
07 01 08/3205
RECALLING FIRM/MANUFACTURER
Sanwa Fresh Produce Co., LLC, Tampa , FL , by letter on July 18, 2008. Firm initiated recall is complete.
REASON
Analysis results from the State of Florida indicated that the product was contaminated with salmonella bacteria .
VOLUME OF PRODUCT IN COMMERCE
300 cases
DISTRIBUTION
FL
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PRODUCT
a) Tuna Pecan Salad Kit, 5.2 lb Cardboard box containing: tuna pouch, veggie kit (celery, onion, pecans), and tuna dressing pouch, Recall # F-044-9;

b) Tuna Pecan Salad. Store prepared from kit for sale in store. Product placed in either plastic or styrofoam container w/in store stick on label. UPC 41070501007; Recall # F-045-9;

c) Tuna Stuffed Tomato. Store prepared from kit for sale in store. Product placed in either plastic or styrofoam container w/in store stick on label. UPC 24980900000; Recall # F-046-9;

d) Gourmet Tuna Wrap. Store prepared from kit for sale in store. Product wrapped in paper with stick on in store label and placed in paper bag for sale. UPC 4157304867; Recall # F-047-9;

e) Custom Prepared Half and Whole Sandwiches with Tuna Salad. Store prepared from kit for sale in store. Product wrapped in paper with stick on in store label and placed in paper bag for sale. UPC Whole Sandwiches 2870720000. UPC Half Sandwiches 24698000000; Recall # F-048-9
CODE
a) Mix by: Aug 29, 08;
b) and c) Sell by: Aug 29 – 30;
d) Sell by: Aug 27 and 28;
e) Prepared on Aug 25 and 26
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kroger Co., Cincinnati , OH , by press release, emails and placa rds on August 28, 2008.
Manufacturer: Quality Food Centers, Inc., Seattle , WA . Firm initiated recall is ongoing.
REASON
Products contain undeclared milk.
VOLUME OF PRODUCT IN COMMERCE
70 bulk kits
DISTRIBUTION
WA and OR

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
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PRODUCT
LL Bean Gummy Bait Tackle Box (stock number 5AW69 or GHP3), Catalog number: 57181; Recall # F-049-9
CODE
All lot codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: L L Bean, Inc, Freeport , ME , by letter on November 26, 2008.
Manufacturer: Flambeau Products, Middlefield , OH . Firm initiated recall is ongoing.
REASON
Candy may contain plastic fragments.
VOLUME OF PRODUCT IN COMMERCE
2,935 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III
___________________________________
PRODUCT
Nestle Nesquik Strawberry Powder, 21.8 oz, Production Codes: 82255880 and 82265880, Recall # F-050-9
CODE
Best by date: August 2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nestle USA , Glendale , CA , by press release, email, fax and hand delivered letter on November 7, 2008.
Manufacturer: Nestle USA Inc., Waverly, IA. Firm initiated recall is ongoing.
REASON
Product may contain small aluminum fragments.
VOLUME OF PRODUCT IN COMMERCE
14,320 cases (6 X 21.8 oz per Case)
DISTRIBUTION
Nationwide and PR

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I
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PRODUCT
Viapro Capsules Dietary Supplement (Prostancus HCl) 375mg, 1 and 2 count blister ca rds and 10 count bottles, For Men, Recall # D-138-2009
CODE
All lot numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: EG Labs, Odessa , FL , by press release on July 29, 2008.
Manufacturer: Innovative Products, Largo , FL. Firm initiated recall is ongoing.
REASON
Unapproved New Drug; product found to contain thio-methisosildenafil, an analog of sildenafil, an unapproved new drug. Sildenafil is the active pharmaceutical used in a FDA approved product for erectile dysfunction.
VOLUME OF PRODUCT IN COMMERCE
1.5 million Capsules
DISTRIBUTION
CA, TX, NC, MI, MD, KS and PR

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
Procrit (epoetin alfa) 10,000 U/mL, 4 x 2mL Multidose Vials, Sterile, Rx only; NDC 59676-312-00 is the individual vials and NDC 59676-312-04 is the 4 pack carton, Recall # D-128-2009
CODE
Lot number: P114942A exp. 12/10
RECALLING FIRM/MANUFACTURER
Recalling Firm: Gbsc, Horsham , PA , by press release and letters dated August 5, and August 6, 2008.
Manufacturer: Amgen, Inc., Thousand Oaks , CA. Firm initiated recall is ongoing.
REASON
Lack of assurance of sterility; vials have cracks at the neck.
VOLUME OF PRODUCT IN COMMERCE
44,292 vials
DISTRIBUTION
Nationwide
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PRODUCT
10% Benzoyl Peroxide Gel marketed under the following brand labels: 1) Equate Maximum Strength, 10% Benzoyl Peroxide Gel, 28g (Net Wt 1 oz); 2) Kroger Acne Gel, 10% Benzoyl Peroxide Acne Medication, Net Wt 1 oz (28g); 3) DG Maximum strength, Acne Medicated Gel, 10% Benzoyl Peroxide, Net Wt 1oz (28g); and 4) Hill Country Essentials, Medicated Acne Gel,10% Benzoyl Peroxide Acne Medication, Net Wt 1 oz (28g); Recall # D-129-2009
CODE
All lots
RECALLING FIRM/MANUFACTURER
CSI USA, Inc., Gallatin , TN , by letters on October 31, 2008 and November 13, 2008 and by press release on November 13, 2008. Firm initiated recall is ongoing.
REASON
Product may contain the bacteria Burkholderia cepacia.
VOLUME OF PRODUCT IN COMMERCE
741,314 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Bulk product in finished dosage form, packaged in plastic bags: Item # 500274, 20120 tablets, Rapid Disintegrating Zinc Tablets, Lot #CPI-115-XXX, Store between 15 and 25 degrees Celsius and humidity (RH) less than 60%, Mfg. Date: XXX YY, Exp Date: XXX YY; Recall # D-130-2009;

b) Bulk product in finished dosage form, packaged in plastic bags: Capricorn Pharma, Inc., 6900 English Muffin Way, Unit A, Frederick, MD 21703, Item # 500737, 20120 tablets, Zicam Rapidmelt With Zinc & Vit.C, Orange Flavor, Lot # CPI-138-XXX, Store between 15 and 25 degrees Celsius and humidity (RH) less than 60%, Mfg. Date: XXX YY, Exp Date: XXX YY; Recall # D-131-2009;

c) Bulk product in finished dosage form, packaged in plastic bags: Capricorn Pharma, Inc., 6900 English Muffin Way, Unit A, Frederick, MD 21703, Item # 500733, 7000 tablets, Zicam Chewmelts with Zinc and Cinnamon Flavor, Lot# CPI-139-XXX, Store between 15 and 25 degrees Celsius and humidity (RH) less than 60%, Mfg. Date: XXX YY, Exp. Date: XXX YY; Recall # D-132-2009
CODE
a) Lot #/Exp Date CPI-115-274, Dec2008; CPI-115-285, Feb2009; CPI-115-286, Feb2009; CPI-115-287, Feb2009; CPI-115-288, Feb2009; CPI-115-289, Feb2009; CPI-115-290, Feb2009; CPI-115-291, Feb2009; CPI-115-292, Feb2009; CPI-115-293, Feb2009; CPI-115-294, Feb2009; CPI-115-296, Feb2009; CPI-115-297, Mar2009; CPI-115-298, Mar2009; CPI-115-299, Mar2009; CPI-115-300, Mar2009; CPI-115-301, Mar2009; CPI-115-302, Mar2009; CPI-115-303, Mar2009; CPI-115-304, Mar2009; CPI-115-305, Mar2009; CPI-115-306, Mar2009; CPI-115-307, Mar2009; CPI-115-308, Apr2009; CPI-115-309, Apr2009; CPI-115-310, Apr2009; CPI-115-311, Apr2009; CPI-115-312, Apr2009; CPI-115-313, Apr2009; CPI-115-314, May2009; CPI-115-315, May2009; CPI-115-316, May2009; CPI-115-317, May2009; CPI-115-318, May2009; CPI-115-319, May2009; CPI-115-320, May2009;

b) Lot #/Exp Date CPI-138-028, Feb2008; CPI-138-029, Mar2008; CPI-138-030, Mar2008; CPI-138-031, Mar2008; CPI-138-032, Mar2008; CPI-138-033, Mar2008; CPI-138-034, Mar2008; CPI-138-035, Apr2008; CPI-138-036, Apr2008; CPI-138-037, Apr2008; CPI-138-038, May2008; CPI-138-039, May2008; CPI-138-040, May2008; CPI-138-041, May2008; CPI-138-042, May2008; CPI-138-043, Jun2008; CPI-138-044, Jul2008; CPI-138-045, Jul2008; CPI-138-046, Jan2009; CPI-138-047, Feb2009; CPI-138-048, Feb2009; CPI-138-049, Mar2009; CPI-138-050, Mar2009;

c) Lot #/Exp Date: CPI-139-VP-01, Jun2008; CPI-139-VP-02, Jun2008; CPI-139-VP-03, Jun2008; CPI-139-013, May2008; CPI-139-015, May2008; CPI-139-CCP-01, Jun2008; CPI-139-CCP-02, Jun2008; CPI-139-CCP-03, Jun2008; CPI-139-CCP-05, Jun2008; CPI-139-CCP-06, Jun2008; CPI-139-CCP-07, Jun2008; CPI-139-CCP-08, Jun2008; CPI-139-CCP-09, Jun2008; CPI-139-CCP-10, Jun2008; CPI-139-CCP-11, Jun2008; CPI-139-CCP-12, Jun2008; CPI-139-CCP-13, Jun2008; CPI-139-CCP-14, Jun2008; CPI-139-CCP-15, Jun2008; CPI-139-CCP-16, Jun2008; CPI-139-CCP-17, Jun2008; CPI-139-CCP-18, Jun2008; CPI-139-CCP-19, Jun2008; CPI-139-CCP-20, Jun2008; CPI-139-CCP-21, Jul2008; CPI-139-CCP-23, Jul2008; CPI-139-CCP-24, Jul2008; CPI-139-CCP-25, Jul2008; CPI-139-CCP-26, Jul2008; CPI-139-CCP-27, Jun2008; CPI-139-CCP-28, Jun2008; CPI-139-CCP-31, Jul2008; CPI-139-CCP-32, Jul2008; CPI-139-CCP-33, Jul2008; CPI-139-CCP-34, Jul2008; CPI-139-CCP-35, Jul2008; CPI-139-CCP-36, Jul2008; CPI-139-CCP-37, Jul2008; CPI-139-CCP-38, Jun2008; CPI-139-CCP-39, Jun2008; CPI-139-CCP-42, Jul2008; CPI-139-CCP-43, Jul2008; CPI-139-CCP-44, Jul2008; CPI-139-CCP-45, Jul2008; CPI-139-CCP-46, Jul2008; CPI-139-CCP-47, Jul2008; CPI-139-CCP-48, Jul2008; CPI-139-CCP-49, Jul2008; CPI-139-CCP-50, Jul2008; CPI-139-CCP-51, Jul2008; CPI-139-CCP-52, Jul2008; CPI-139-CCP-55, Aug2008; CPI-139-CCP-56, Aug2008; CPI-139-CCP-57, Aug2008; CPI-139-CCP-58, Jun2008; CPI-139-CCP-59, Aug2008; CPI-139-CCP-60, Aug2008; CPI-139-CCP-61, Aug2008; CPI-139-CCP-62, Aug2008; CPI-139-CCP-63, Aug2008; CPI-139-CCP-64, Aug2008; CPI-139-CCP-65, Aug2008; CPI-139-CCP-66, Aug2008; CPI-139-CCP-67, Aug2008; CPI-139-CCP-68, Aug2008; CPI-139-CCP-69, Aug2008; CPI-139-CCP-70, Aug2008; CPI-139-CCP-71, Aug2008; CPI-139-CCP-72, Aug2008; CPI-139-CCP-73, Aug2008; CPI-139-CCP-74, Aug2008; CPI-139-CCP-75, Aug2008; CPI-139-CCP-76, Aug2008; CPI-139-CCP-77, Aug2008; CPI-139-CCP-78, Aug2008; CPI-139-CCP-79, Aug2008; CPI-139-CCP-80, Aug2008; CPI-139-CCP-81, Aug2008; CPI-139-CCP-82, Aug2008; CPI-139-CCP-83, Aug2008; CPI-139-CCP-84, Aug2008; CPI-139-CCP-85, Aug2008; CPI-139-CCP-86, Aug2008; CPI-139-CCP-87, Aug2008; CPI-139-CCP-88, Aug2008; CPI-139-CCP-89, Aug2008; CPI-139-CCP-91, Aug2008; CPI-139-CCP-92, Aug2008; CPI-139-CCP-93, Aug2008; CPI-139-CCP-94, Aug2008; CPI-139-CCP-95, Aug2008; CPI-139-CCP-96, Aug2008; CPI-139-CCP-98, Aug2008; CPI-139-CCP-99, Aug2008; CPI-139-CCP-100, Aug2008; CPI-139-CCP-101, Aug2008; CPI-139-CCP-102, Aug2008; CPI-139-CCP-103, Aug2008; CPI-139-CCP-104, Aug2008; CPI-139-CCP-105, Aug2008; CPI-139-CCP-106, Aug2008; CPI-139-CCP-107, Aug2008; CPI-139-CCP-108, Aug2008; CPI-139-CCP-109, Aug2008; CPI-139-CCP-110, Aug2008; CPI-139-CCP-111, Aug2008; CPI-139-CCP-112, Aug2008; CPI-139-CCP-113, Aug2008; CPI-139-CCP-114, Aug2008; CPI-139-CCP-115, Aug2008; CPI-139-CCP-116, Aug2008; CPI-139-CCP-117, Aug2008; CPI-139-CCP-118, Aug2008; CPI-139-CCP-119, Aug2008; CPI-139-CCP-120, Aug2008; CPI-139-CCP-121, Sep2008; CPI-139-CCP-122, Sep2008; CPI-139-CCP-123, Sep2008; CPI-139-CCP-124, Sep2008; CPI-139-CCP-125, Sep2008; CPI-139-CCP-126, Sep2008; CPI-139-CCP-127, Sep2008; CPI-139-CCP-128, Sep2008; CPI-139-CCP-129, Sep2008; CPI-139-CCP-130, Sep2008; CPI-139-CCP-131, Sep2008; CPI-139-CCP-132, Sep2008; CPI-139-CCP-133, Sep2008; CPI-139-CCP-134, Sep2008; CPI-139-CCP-135, Sep2008; CPI-139-CCP-136, Sep2008; CPI-139-CCP-137, Sep2008; CPI-139-CCP-138, Sep2008; CPI-139-CCP-139, Sep2008; CPI-139-CCP-140, Sep2008; CPI-139-CCP-141, Aug2008; CPI-139-CCP-142, Aug2008; CPI-139-CCP-143, Sep2008; CPI-139-CCP-144, Sep2008; CPI-139-CCP-145, Sep2008; CPI-139-CCP-146, Sep2008; CPI-139-CCP-147, Sep2008; CPI-139-CCP-148, Sep2008; CPI-139-CCP-149, Sep2008; CPI-139-CCP-150, Sep2008; CPI-139-CCP-151, Sep2008; CPI-139-CCP-152, Sep2008; CPI-139-CCP-153, Sep2008; CPI-139-CCP-154, Sep2008; CPI-139-CCP-156, Sep2008; CPI-139-CCP-157, Sep2008; CPI-139-CCP-158, Sep2008; CPI-139-CCP-159, Sep2008; CPI-139-CCP-160, Sep2008; CPI-139-CCP-161, Sep2008; CPI-139-CCP-162, Sep2008; CPI-139-CCP-163, Sep2008; CPI-139-CCP-164, Sep2008; CPI-139-CCP-165, Sep2008; CPI-139-CCP-166, Sep2008
RECALLING FIRM/MANUFACTURER
Capricorn Pharma, Inc., Frederick, MD, by letter on June 27, 2008. Firm initiated recall is ongoing.
REASON
Bulk pharmaceutical distributed for re-packaging was not manufactured according to Good Manufacturing Practices and may contain metal fragments.
VOLUME OF PRODUCT IN COMMERCE
84,877,552 tablets
DISTRIBUTION
AZ
___________________________________
PRODUCT
Fentanyl Transdermal System, 75 mcg/h, packaged in cardboard cartons containing 5 pouches each, Carton NDC 0591-3213-72, pouch NDC is 0591-3213-54, Recall # D-133-2009
CODE
Lot number: 92461850, Exp 08/31/2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Watson Laboratories, Inc., Corona , CA , by letter on August 4, 2008.
Manufacturer: Watson Laboratories, Inc., Salt Lake City , UT. Firm initiated recall is ongoing.
REASON
Defective delivery system; patches may leak fentanyl gel.
VOLUME OF PRODUCT IN COMMERCE
25,412 cartons of 5 patches each
DISTRIBUTION
Nationwide
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PRODUCT
a) Hydroxyzine HCl Tablets USP, 10 mg, 100 tablets, Rx only, packaged in single tablet unit dose blister packs, NDC 51079-530-20; Recall # D-134-2009;

b) Hydroxyzine HCl Tablets USP, 25 mg, 100 tablets, Rx only, packaged in single tablet unit dose blister packs, NDC 51079-531-20; Recall # D-135-2009;

c) Hydroxyzine Hydrochloride Tablets USP, 50 mg, 100 tablets, Rx only, packaged in single tablet unit dose blister packs, NDC 51079-532-20; D-136-2009; Recall # 136-2009;

d) Ursodiol Capsules USP, 300 mg, 100 Capsules, Rx only, packaged in single capsule unit dose blister packs, NDC 51079-970-20; D-137-2009
CODE
a) Lot numbers: 7V205 and 8J089;
b) Lot numbers: 7V191, 8H820 and 8F750;
c) Lot numbers: 7V180, 8C603, 8F749, 8D951, 8D945;
d) Lot numbers: 7H143, 7K596, 7V154, 8F664, 8D981
RECALLING FIRM/MANUFACTURER
Recalling Firm: UDL Laboratories, Inc., Rockford , IL , by letter dated July 27, 2008.
Manufacturer: Activis Totowa, LLC, Totowa, NJ. Firm initiated recall is ongoing.
REASON
cGMP Deviations (by mfr Activis)
VOLUME OF PRODUCT IN COMMERCE
35,735 unit cartons
DISTRIBUTION
Nationwide, PR and Guam

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
Sunquest Laboratory Blood Bank and Blood Donor version 6.0.1 Distributed with Sunquest Laboratory 6.1 and 6.2 and Sunquest Laboratory Blood Bank and Blood Donor version 6.0.2 Distributed with Sunquest Laboratory 6.3, Recall # B-0149-09
CODE
Sunquest Laboratory Blood Bank and Blood Donor version 6.0.1 Distributed with Sunquest Laboratory 6.1 and 6.2 and Sunquest Laboratory Blood Bank and Blood Donor version 6.0.2 Distributed with Sunquest Laboratory 6.3
RECALLING FIRM/MANUFACTURER
Sunquest Information Systems, Inc., Tucson , AZ , by Product Safety Notice issued on September 30, 2008. Firm initiated recall is ongoing.
REASON
Software, with a glitch or defect, was distributed.
VOLUME OF PRODUCT IN COMMERCE
286 units
DISTRIBUTION
Nationwide, Canada , Bermuda , Ireland , United Kingdom , United Arab Emirates
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0292-09
CODE
Units: 4031925 (Part 1 and Part 2)
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford , TX , by telephone on February 19, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0293-09
CODE
Units: 7945475 (Part 1 and Part 2)
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford , TX , by telephone on July 16, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT
Platelets, Recall # B-0294-09
CODE
Unit: 3967550
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford , TX , by telephone on August 28, 2007 and by letter on August 30, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-0296-09
CODE
Units: 50KP11519 (Bag 1, Bag 2 and Bag 3)
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Central Ohio Region, Columbus, OH, by telephone on November 13, 2007 and follow-up letter on November 20, 2007. Firm initiated recall is complete.
REASON
Blood products, which had insufficient platelet yield were inappropriately split into three parts, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
OH
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0297-09
CODE
Units: 2141524, 2141362 (Part 1 and 2)
RECALLING FIRM/MANUFACTURER
Central Jersey Blood Center , Shrewsbury , NJ , by telephone on April 18, 2008. Firm initiated recall is complete.
REASON
Blood products, which were collected from a defective apheresis machine by WBC counts, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NJ
___________________________________
PRODUCT
Platelets, Recall # B-0307-09
CODE
Unit: 9034501
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford , TX , by telephone on February 27, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0325-09
CODE
Unit: 3734536
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on April 28, 2008. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who lived in a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Source Plasma, Recall # B-0295-09
CODE
Unit: 07KPT13384
RECALLING FIRM/MANUFACTURER
Advanced BioServices LLC, Kingsport , TN , by fax on January 3, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had subsequently tested reactive for anti-HCV, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
PRODUCT
GSI Audera (version 2.6 software) Viasys Healthcare, Inc. Part or (Catalog) Numbers: 2001-9700, 2001-9705, 2001-9715, 2001-9720 and 2001-9725. The GSI Audera is used as part of an audiometric test battery. It can be used to assess cochlear function, enable estimation of behavioral hearing thresholds by evoking auditory brainstem or steady state brainstem response and to aid in detection of lesions in the auditory pathway on neonates through adults, Recall # Z-0195-2009
CODE
Serial Numbers: AT040554 AT40565 AT040558 AT040560 AT040559 AT040566 AT040564 AT040570 AT040571 AT040591 AT040594 AT040596 AT050606 AT050619 AT040599 AT050622 AT050625 AT050634 AT050639 AT050640 AT050651 AT050654 AT050655 AT050652 AT050653 AT050657 AT050663 AT050674 AT050673 AT050675 AT050682 AT050680 AT050683 AT050708 AT050692 AT050690 AT050706 AT050707 AT050710 AT050732 AT050691 AT050752 AT050755 AT050743/AT050748 AT050765 AT050778 AT050776 AT050782 AT050784 AT050795 AT050801 AT050797 AT050799 AT050786 AT050805 AT050809 AT050812 AT050806 AT050816 AT050819 AT050818 AT050820 AT050829 AT050834 AT050836 AT050842 AT050852 AT050843 AT050855 AT050853 AT060859 AT060892 AT060862 AT060864 AT060868 AT060882 AT060885 AT060886 AT060883 AT060891 AT060894 AT060884 AT060903 AT060904 AT050691P AT060914 AT060911 AT060912 AT060913 AT060892 AT060925 AT060937 AT060926 AT060940 AT060941 AT060942 AT060938 AT060944 AT060945 AT060946 AT060949 AT070205 AT070206 AT070207 AT060938 AT070219 AT070218 AT070226 AT070227 AT070228 AT070230 AT070241 AT070200 AT070253 AF071624 AT070252 AT070257 AT070221 AT070220 AT070269 AT070272 AT070273 AT070274 AT070278 AT070280 AT070290 AT070292 AT070289 AT070299 AT070304 AT070310 AT070307 AT070314 AT070317 AT070333 AT070306 AT070331 AT070339 AT070340 AT070341 AT070350 AT070370 AT070352 AT070257 AT070369 AT070376 AT070360 AT070396 AT080399 20030241 20030338 AT080417 AT070339 AT070318 AT080418 AT080426 and AT080427. Additional serial numbers to be supplied later.
RECALLING FIRM/MANUFACTURER
Cardinal Health, Inc., Madison , WI , by letter dated September 16, 2008, September 22, and September 26, 2008, Firm initiated recall is ongoing.
REASON
GSI Audera systems require a system software update due to issues with the Split-Screen and the Vestibular Evoked Myogenic Potential (VEMP) functions. A. Split Screen Field Correction: GSI Audera units with version 2.6 software may mislabel Auditory Evoked Potential (AEP) waveform responses with respect to the identification of the stimulus ear. When using 2.6 software in split-screen mode, and switching data acquisition from right ear to the left ear, if the audiologist clicks back on the right ear to annotate or mark it, the data acquisition from the left ear is then assigned to the record of the right ear. The waveform is labeled as a right ear response even though the left ear was stimulated and vice versa. Mislabeling of the results could lead to a decision to fit a hearing aid on the incorrect ear and result in excessive hearing aid amplification and possible damage to the misdiagnosed ear. B. VEMP Marketing Correction: The US Food and Drug Administration is requiring the removal of the Vestibular Evoked Myogenic Potential (VEMP) function from the GSI Audera products in the field until this function has been granted FDA's clearance.
VOLUME OF PRODUCT IN COMMERCE
297 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Posey Synthetic Leather and Biothane Waist and Wrist Restraints, Catalog Numbers: 2217SL and 2217B, Recall # Z-0286-2009
CODE
All units
RECALLING FIRM/MANUFACTURER
J T Posey Co., Arcadia , CA , by letters on July 29, 2008. Firm initiated recall is ongoing.
REASON
Failure to restrain.
VOLUME OF PRODUCT IN COMMERCE
145 units
DISTRIBUTION
Nationwide, Australia , Canada , France & The Netherlands
___________________________________
PRODUCT
a) AXIOM Artis System dFC using software version VB31D with 30x40 cm2 flat detectors. ÿAXIOM Artis is a angiography system developed for single and biplane diagnostic imaging and interventional procedures. Model number 7412807, Recall # Z-0312-2009;

b) AXIOM Artis System dBA using software version VB31D with 30x40 cm2 flat detectors. ÿAXIOM Artis is a angiography system developed for single and biplane diagnostic imaging and interventional procedures. Model number 7555357;
Recall # Z-0313-2009;

c) AXIOM Artis System dFA using software version VB31D with 30x40 cm2 flat detectors. ÿAXIOM Artis is a angiography system developed for single and biplane diagnostic imaging and interventional procedures. Model number 7555373. Recall # Z-0314-2009;

d) AXIOM Artis System dTC using software version VB31D with 30x40 cm2 flat detectors. ÿAXIOM Artis is a angiography system developed for single and biplane diagnostic imaging and interventional procedures. Model number 7413078; Recall # Z-0315-2009;

e) AXIOM Artis System dTA using software version VB31D with 30x40 cm2 flat detectors. ÿAXIOM Artis is a angiography system developed for single and biplane diagnostic imaging and interventional procedures. Model number 7008605; Recall # Z-0316-2009;

f) AXIOM Artis System dMP using software version VB31D with 30x40 cm2 flat detectors. ÿAXIOM Artis is a angiography system developed for single and biplane diagnostic imaging and interventional procedures; Model number 7555365; Recall # Z-0317-2009
CODE
a) Serial numbers: 35302, 35678, 35909, and 35916;
b) Serial numbers: 53086, 53128, 53149, 53162, 53165, and 53194;
c) Serial numbers: 50176 and 51707;
d) Serial numbers: 55090, 55322, and 55469;
e) Serial numbers: 57076, 57187, and 57188
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern , PA , by letter dated August 20, 2008.
Manufacturer: Siemens AG, Medical Solution, Forchheim , Germany . Firm initiated recall is ongoing.
REASON
System may switch to emergency fluoroscopy mode.
VOLUME OF PRODUCT IN COMMERCE
21 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
AS3000 Anesthesia Delivery System. Datascope Patient Monitoring; A Mindray Global Company. The AS3000 is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation; Recall # Z-0319-2009
CODE
Serial Numbers: AN0804-001 and AN0804-006. Each AS3000 Anethesia Delivery System is labeled with a unique serial number
RECALLING FIRM/MANUFACTURER
Mindray DS USA, Inc., dba Datascope Patient Monitoring, Mahwah , NJ , by letters on October 7, 2008. Firm initiated recall is ongoing.
REASON
Two issues have been identified with the AS3000 unit. 1. The threadlocker of the caster (wheels) may not have been utilized, which may allow the caster to loosen and possibly separate from the unit. 2. The use of select brands of pre-pack absorber in the absorber canister of the AS3000 has been associated, in some cases, with gas leakage around the pre-pack, rather than through the absorber material.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
syngo MultiModality WorkPlace (MM WP). Software product (Model Number 10140720). The product is intended for use in picture archiving and communications system; Recall # Z-0324-2009
CODE
Serial numbers: 7826, 7951, 7981, 7989, 8011, 8056, 8109, 8161, 8209, 8312, 8213, 8341, 8361, 8393, 8405, 8409, 8413, 8430, 8433, 8511, 8526, 8536, 8548, 8637, 8638, 8657, 8670, 8688, 8701, 8707, 8773, 8774, 8781, 8793, 8829, 8862, 8879, 8881, 9043, 9044, 9046, 9080, 9097, 9081, 9105, 9137, 9149, 9152, 9154, 9188, 9191, 9206, 9218, 9219, 9232, 9243, 9244, 9248, 9283, 9291, 9316, 9322, 9351, 9360, 9361, 9368, 9388, 9394, 9395, 9413, 9414, 9416, 9417, 9429, 9452, 9488, 9498, 9504, 9508, 9520, 9521, 9532, 9536, and 9568
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern , PA , by visit beginning September 12, 2008.
Manufacturer: Siemens Medical Solutions Inc., Erlangen , Germany . Firm initiated recall is ongoing.
REASON
Values derived from Dynamic CT data sets may be incorrect. The corresponding images are not affected.
VOLUME OF PRODUCT IN COMMERCE
84 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Terumo Sarns Sternal Saw II System Power Unit, 115 V; Catalog # 15670. Indicated for use in medial sternotomies. The Sarns Sternal Saw II system consists of a disposable blade, saw, flexible drive shaft, motor and foot control; Recall # Z-0358-2009;

b) Terumo Sarns Sternal Saw II System Power Unit, 220/240 V; Catalog # 7084. Note: This product was not sold in the U.S. Indicated for use in medial sternotomies. The Sarns Sternal Saw II system consists of a disposable blade, saw, flexible drive shaft, motor and foot control; Recall # Z-0359-2009
CODE
a) Serial numbers 5866 through 5887;
b) Serial numbers 1877 through 1925
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp., Ann Arbor , MI , by letter dated February 14, 2008. Firm initiated recall is ongoing.
REASON
The drive power cable cannot be fully inserted into the power unit or can only be inserted with difficulty, resulting in the device not being operational.
VOLUME OF PRODUCT IN COMMERCE
69 units
DISTRIBUTION
Nationwide, Belgium , China , Columbia , Malaysia , Philippines , United Arab Emirates , and Venezuela
___________________________________
PRODUCT
a) 5 F BardSelect 11 cm Percutaneous Catheter Introducer Set Ref: 050A11 Percutaneous catheter introducer sets, including sheath, dilator, guide wire and needle, are used to facilitate placing a catheter through the skin into a vein or artery. Percutaneous introducers are recommended for initial percutaneous introduction or the exchange of intravascular devices. Guide wire introducer needles are used for percutaneous puncture and insertion into the blood vessel. The guide wire is then inserted through the cannula of the introducer needle at the puncture site. The cannula is then removed to allow insertion of the percutaneous catheter introducer following removal of the guide wire introducer needle, Recall # Z-0441-2009;

b) 6 F BardSelect 11cm Percutaneous Catheter Introducer Set Ref: 060A11 Percutaneous catheter introducer sets, including sheath, dilator, guide wire and needle, are used to facilitate placing a catheter through the skin into a vein or artery. Percutaneous introducers are recommended for initial percutaneous introduction or the exchange of intravascular devices. Guide wire introducer needles are used for percutaneous puncture and insertion into the blood vessel. The guide wire is then inserted through the cannula of the introducer needle at the puncture site. The cannula is then removed to allow insertion of the percutaneous catheter introducer following removal of the guide wire introducer needle, Recall # Z-0442-2009;

c) 7 F BardSelect 11cm Percutaneous Catheter Introducer Set Ref: 070A11 Percutaneous catheter introducer sets, including sheath, dilator, guide wire and needle, are used to facilitate placing a catheter through the skin into a vein or artery. Percutaneous introducers are recommended for initial percutaneous introduction or the exchange of intravascular devices. Guide wire introducer needles are used for percutaneous puncture and insertion into the blood vessel. The guide wire is then inserted through the cannula of the introducer needle at the puncture site. The cannula is then removed to allow insertion of the percutaneous catheter introducer following removal of the guide wire introducer needle; Recall # Z-0443-2009;

d) Medtronic Input TS 7F 11 cm Ref: 071102A Percutaneous catheter introducer sets, including sheath, dilator, guide wire and needle, are used to facilitate placing a catheter through the skin into a vein or artery. Percutaneous introducers are recommended for initial percutaneous introduction or the exchange of intravascular devices. Guide wire introducer needles are used for percutaneous puncture and insertion into the blood vessel. The guide wire is then inserted through the cannula of the introducer needle at the puncture site. The cannula is then removed to allow insertion of the percutaneous catheter introducer following removal of the guide wire introducer needle, Recall # Z-0444-2009
CODE
a) Lot Number: 20111256;
b) Lot Number: 20105869 and 20111254;
c) Lot Number: 21111255;
d) Lot Number: 20105895
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic, Inc, Danvers , MA , by letter on October 7, 2008.
Manufacturer: Thomas Medical Products, Inc., Malvern , PA. Firm initiated recall is ongoing.
REASON
Failure to insert the guidewire through the 18 gauge introducer needle.
VOLUME OF PRODUCT IN COMMERCE
6,555 units
DISTRIBUTION
Nationwide, Belgium , Honduras , and Germany
___________________________________
PRODUCT
GE Healthcare Centricity Perinatal (formerly Quantitative Sentinel) System - Alert and Reminder software; automatic patient data management providing clinical information at the bedside in Labor & Delivery, Mother-Baby and the Neonatal Intensive Care Unit; GE Healthcare Integrated IT Solutions, Barrington, IL 60010 Intended for use as a clinical data management system; Recall # -0456-2009
CODE
S oftware version 6.80.0 only with Alert and Reminder feature activated
RECALLING FIRM/MANUFACTURER
GE Healthcare Integrated IT Solutions, Barrington , IL , by letter dated August 29, 2008. Firm initiated recall is complete.
REASON
Software anomalies in the Alert and Reminder feature could result in a delay of treatment. When attempting to select the last visible alert or reminder choice, the next choice on the list below the desired choice is selected, and an inconsistent color may be displayed for the same clinical element across a set of work stations.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
___________________________________
PRODUCT
Calibration 1 Solution for the ABL700 series. P/N S1720, 944-024 Intended for in vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, potassium, sodium, calcium, chloride, glucose, lactate, total bilirubin, and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb, FHbF). Also, intended for in vitro testing of samples of expired air for the parameters pO2 and pCO2. P/N S1720, 944-024; Recall # Z-0457-2009
CODE
Lot : WA-04
RECALLING FIRM/MANUFACTURER
Recalling Firm: Radiometer America Inc., Westlake , OH , by letters on September 2, 2008.
Manufacturer: Radiometer Medical ApS, Bronshoj , Denmark . Firm initiated recall is ongoing.
REASON
For this particular lot the barcode, used for entering the characteristics of CAL1 Solution into the analyzer, does not reflect the actual values of the solution. As a consequence, the calibration curves for these parameters and thereby the measured results for patient samples and quality controls will be biased.
VOLUME OF PRODUCT IN COMMERCE
3,200/200 ml bottles
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
STERRAD NX Sterilizer, Product Code 10033 Low temperature sterilizers that use hydrogen peroxide gas plasma to inactivate microorganisms on a broad range of medical and surgical instruments; Recall # Z-0484-2009
CODE
Serial Numbers: 0033081006, 0033081007, 0033081016, 0033081017, 0033081019, 0033081020, 0033081022- 0033081029, 0033081036, 0033081039, 0033081048, 0033081059, 0033081080, 0033081082, 0033081086, 0033081088, 0033081089, 0033081091, 0033081095, 10033060892, 10033060379, 100330050671, 10033070576,10033080067,10033050663, and 10033050661
RECALLING FIRM/MANUFACTURER
Advanced Sterilization Products, Irvine , CA , by letter dated October 6, 2008. Firm initiated recall is ongoing.
REASON
ASP has discovered a component defect in some of the UV lamp power supplies used in certain STERRAD NX Sterilizers. This defect can potentially cause the Hydrogen Peroxide Monitor to give inaccurate readings.
VOLUME OF PRODUCT IN COMMERCE
47 units
DISTRIBUTION
Nationwide, Ecuador , China , Israel , Japan , Korea , Middle East , Australia , Czech Republic , Spain , Brazil , and Russia

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III
___________________________________
PRODUCT
Toddler Chair Hip Strap (Belt). The hip belt is made with nylon webbing and a plastic buckle. 510(k) exempt, Medical Device Listing # R061877. The product is used as a hip strap chair for children, Recall # Z-0318-2009
CODE
Serial Numbers: E77020080701AE, E77020080701AF, E78020080703AB, E78020080703AC, E77020080701AC, E78020080703AD, E77020080701AD, E77020080701AA, E77020080701AB, E76020080704AA, E78020080704AA, E77020080704AE, E77020080704AA, E77020080704AB, E77020080704AC, E78020080703AA, E78020080705AB, E78020080705AA, E76020080709AB, E78020080709AA, E76020080709AA, E78020080709AB, E77020080709AA, E77020080709AB, E77020080709AC, E77020080709AD, E78020080712AD, E77020080711AA, E77020080712AA, E77020080709AE, E78020080711AB, E78020080712AC, E76020080712AA, E78020080711AA, E78020080712AA, E78020080712AB, E77020080704AD, E78020080715AD, E76020080716AC, E77020080716AF, E78020080715AE, E78020080715AF, E78020080715AG, E78020080716AA, E76020080716AB, E77020080716AA, E77020080716AB, E78020080716AC, E76020080716AA, E78020080716AB, E77020080714AA, E77020080714AB, E77020080714AC, E77020080714AD, E77020080714AE, E78020080707AA, E78020080715AA, E78020080715AB, E78020080715AC, E78020080719AA, E77020080716AC, E77020080716AD, E76020080722AA, E78020080719AB, E78020080723AA, E77020080723AB, E77020080723AA, E78020080722AA, E77020080722AA, E77020080723AC, E77020080723AD, E77020080716AE, E77020080716AG, E78020080724AD, E78020080724AE, E78020080724AB, E76020080723AA, E77020080723AE, E78020080724AA, E77020080724AA, E78020080724AC, E78020080723AB, E78020080723AC, E77020080724AB, E77020080725AC, E78020080725AA, E77020080725AA, E77020080725AB, E78020080728AB, E77020080728AA, E78020080728AA, E76020080730AA, E77020080730AA, E76020080730AB, E77020080731AB, E78020080802AB, E77020080802AD, E78020080802AA, E78020080802AC, E78020080801AB, E77020080802AB, E77020080802AC, E78020080801AC, E77020080801AF, E77020080801AA, E78020080716AD, E78020080801AA, E78020080802AD, E77020080801AB, E77020080801AC, E77020080801AD, E77020080801AE, E77020080804AA, E78020080802AE, E77020080804AC, E78020080804AB, E78020080804AA, E77020080804AB, E77020080806AA, E76020080731AA, E77020080731AA, E77020080802AA, E77020080809AA, E77020080809AB, E78020080806AF, E77020080806AB, E78020080806AA, E77020080809AC, E78020080809AC, E78020080809AA, E78020080806AB, E78020080806AC, E78020080806AD, E78020080806AE, E78020080809AB, E76020080809AA, E76020080811AA, E77020080811AA, E78020080812AA, E78020080812AB, E78020080812AC, E78020080812AD, E78020080812AF, E78020080811AA, E78020080812AE, E78020080812AG and E78020080812AH. The code is located underneath the seat of the chair
RECALLING FIRM/MANUFACTURER
Recalling Firm: Community Products, LLC, Rifton , NY , by telephone on September 12, 2008.
Manufacturer : Community Products, LLC, Elka Park , NY . Firm initiated recall is ongoing.
REASON
Some hip straps were assembled incorrectly by threading the buckle on the strap upside down. If a child were left unattended in spite of the warnings on the product and in the manual, a defective hip strap could loosen, allowing the child to slip down in the chair and this could create a choking hazard.
VOLUME OF PRODUCT IN COMMERCE
Potentially 147 units
DISTRIBUTION
Nationwide, Spain and Great Britain
___________________________________
PRODUCT
a) PALINDROME EMERALD SPORT PACK Cuffed Dual Lumen Catheter with Pre-curved Shaft and Heparin Coating, REF 8888123411, Size 14.5Fr/Ch (4.85mm) x 23cm. NOTE: Both the "sport pack" and "kit" package configurations include the catheter, Venetrac insertion stylets, pull apart sheath, and other accessories necessary for placement. The Venetrac insertion stylet is an optional accessory. The 510k for the Venetrac accessory is K051584. The 510k for the catheter is K060509, Recall # Z-0408-2009;

b) PALINDROME EMERALD SPORT PACK Cuffed Dual Lumen Catheter with Pre-curved Shaft and Heparin Coating, REF 8888128461, Size 14.5Fr/Ch (4.85mm) x 28cm. NOTE: Both the "sport pack" and "kit" package configurations include the catheter, Venetrac insertion stylets, pull apart sheath, and other accessories necessary for placement. The Venetrac insertion stylet is an optional accessory. The 510k for the Venetrac accessory is K051584. The 510k for the catheter is K060509; Recall # Z-0409-2009;

c) PALINDROME EMERALD Kit - Cuffed Dual Lumen Catheter with Pre-curved Shaft and Heparin Coating, REF 8888145069, 14.5 Fr/CH (4.85mm) x 23cm. NOTE: Both the "sport pack" and "kit" package configurations include the catheter, Venetrac insertion stylets, pull apart sheath, and other accessories necessary for placement. The kit includes additional components that would also be available at the hospital, such as a scalpel, wound dressing, etc. The Venetrac insertion stylet is an optional accessory. The 510k for the Venetrac accessory is K051584. The 510k for the catheter is K060509, Recall # Z-0410-2009;

d) PALINDROME EMERALD Kit - Cuffed Dual Lumen Catheter with Pre-cuffed Shaft and Heparin Coating, REF 8888145070, 14.5 FR/CH (4.85mm) x 28 cm. NOTE: Both the "sport pack" and "kit" package configurations include the catheter, Venetrac insertion stylets, pull apart sheath, and other accessories necessary for placement. The kit includes additional components that would also be available at the hospital, such as a scalpel, wound dressing, etc. The Venetrac insertion stylet is an optional accessory. The 510k for the Venetrac accessory is K051584. The 510k for the catheter is K060509, Recall # Z-0411-2009
CODE
a) Lot No: 809403 and 811762;
b) Lot No. 809405;
c) Lot No: 809404 and 811763;
d) Lot No. 809406 and 818002
RECALLING FIRM/MANUFACTURER
Covidien, Argyle, NY, by visit beginning September 19, 2008. Firm initiated recall is complete.
REASON
Incorrect size of the Venetrac stylets (an optional accessory). They are too short and cannot be used.
VOLUME OF PRODUCT IN COMMERCE
117 units
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR DECEMBER 10, 2008

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