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U.S. Department of Health and Human Services

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Enforcement Report for April 12, 2006

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.

April 12 , 2006
06-15

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS - CLASS I

______________________________
PRODUCT
Giant brand Chocolate Chip Chewy Granola Bars, 10 oz.  Contains: Wheat, Milk, Soy, Gluten. May Contain: Peanuts.  UPC 8826709890, Recall # F-126-6
CODE
May 20, 06 G1 2151523200
RECALLING FIRM/MANUFACTURER
Con Agra Store Brands, Lakeville, MN, by press release on December 2, 2005, firm initiated recall is ongoing.
REASON
Retail cartons of Giant brand Chocolate Chip Chewy Granola bars actually contain individually packaged/labeled Peanut Butter Chocolate Chunk Chewy Granola Bars.
VOLUME OF PRODUCT IN COMMERCE
990 cases.  Each case contains 12 retail packages
DISTRIBUTION
DE, MD, NY, PA, VA, WV, and D.C.

______________________________
PRODUCT
Showa Okonomiyaki Mix (Flour Mix) in 1.19 lb Flexible plastic package; 24 packages per case, UPC 11152-02300, Recall # F-127-6
CODE
“02300”, All products purchased within specified date range
RECALLING FIRM/MANUFACTURER
Recalling Firm:  JFC International, Inc., South San Francisco, CA, by letters on January 9, 2006 and by press release on January 25, 2006,
Manufacturer: Pacific Trading Co., Tokyo, Japan, firm initiated recall is ongoing.
REASON
The product contains undeclared powdered egg yolk.
VOLUME OF PRODUCT IN COMMERCE
4,714 packages
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Danube Herring, preserve, Net Wt. 45.86 oz (1300g) --- Ingredients: fish, salt, E211, water.  The product is labeled mainly in Russian.  According to New York State Department of Agriculture & Markets FL report, the fish are whole and 10-12 inches in length.  The product is packed in sealed cans.  UPC bar code # 8 50307 00061 2,  Recall # F-128-6
CODE
301006 (corresponds to “Best before date” of 10/30/2006)
RECALLING FIRM/MANUFACTURER
Recalling Firm:  Trilini International Import, LLC, Brooklyn, NY, by press release on November 30, 2005.
Manufacturer:  Izmail Fish Factory, Izmail, Ukraine, firm initiated recall is complete.
REASON
The product was found to be an uneviscerated fish which posed a health risk as it may be contaminated with Clostridium botulinum spores which can cause botulism.  Also, the product is packed in cans in which the soldered seams were found to contain lead (64%).  Both  findings are based on sampling & analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
205 cases (8 – 1250 gram cans per case)
DISTRIBUTION
NY and NJ

______________________________
PRODUCT
 a) Choxie double dark truffles, Net Wt. 4.95 oz (140g).  Package contains approximately
     10 individually wrapped truffle candies per container.  The individual truffle candy
     bears no labeling.  Recall # F-131-6;
b) Choxie milk chocolate truffles, Net Wt. 4.95 oz (140g).  Package contains approximately
     10 individually wrapped truffle candies per container.  The individual truffle candy
     bears no labeling.  Recall # F-132-6;
c) Choxie milk chocolate caramel balls, Net Wt. 4.95 oz (140g).  Package
    contains approximately 10 individually wrapped truffle candies per container. 
    The individual truffle candy bears no labeling.  Recall # F-133-6;
CODE
All codes
RECALLING FIRM/MANUFACTURER
Recalling Firm:  Ross Acquisitions Company, Hebron, KY, by e-mail on February 22, 2006.
Manufacturer: Madelaine Chocolates, Rockaway Beach, NY, firm initiated recall is ongoing.
REASON
The product may contain a different type of candy, Milk Chocolate Peanut Butter Balls, and the label does not list peanuts as an ingredient.
VOLUME OF PRODUCT IN COMMERCE
81,288/4.95 oz containers, which also include the 4th type of candy, F-134-6 Milk Chocolate Peanut Butter Balls (F-134-6 is listed under class III).
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) American Cheese Pasteurized, processed cheese products,
    sliced in 23 lb, 30 lb and 40 lb bulk pack, easy peel, Recall # F-137-6;
b) Cheddar Cheese Pasteurized, processed cheese products,
    sliced in 30 lb bulk pack, easy peel, Recall # F-138-6;
c) Swiss Cheese Pasteurized, processed cheese products,
    sliced in 30 lb bulk pack, easy peel, Recall # F-139-6;
d) Lite American Cheese Pasteurized, processed cheese products,
    sliced in 23 lb bulk pack, easy peel, Recall # F-140-6
CODE
a) 283CA USE BY JAN 08 06CA, 284CA USE BY JAN 09 06CA,
    285CA USE BY JAN 10 06CA, 286CA USE BY JAN 11 06CA,
    287CA USE BY JAN 12 06CA, 290CA USE BY JAN 15 06CA,
    291CA USE BY JAN 16 06CA, 292CA USE BY JAN 17 06CA,
    293CA USE BY JAN 18 06CA, 298CA USE BY JAN 23 06CA,
    299CA USE BY JAN 24 06CA, 306CA USE BY JAN 31 06CA,
    312CA USE BY FEB 06 06CA, 319CA USE BY FEB 13 06CA;
b) 283CA USE BY JAN 08 06CA, 326CA USE BY FEB 20 06CA;
c) 283CA USE BY JAN 08 06CA, 286CA USE BY JAN 11 06CA;
d) 283CA USE BY JAN 08 06CA, 284CA USE BY JAN 09 06CA,
    286CA USE BY JAN 11 06CA, 287CA USE BY JAN 12 06CA,
    290CA USE BY JAN 15 06CA, 291CA USE BY JAN 16 06CA,
    293CA USE BY JAN 18 06CA
RECALLING FIRM/MANUFACTURER
Recalling Firm:  Schreiber Foods, Inc., Green Bay, WI, by telephone beginning December 10, 2005 and by letter dated December 21, 2005.
Manufacturer:  Schreiber Foods, Inc., Carthage, MO, firm initiated recall is ongoing. 
REASON
Certain bulk pack snack sliced cheese products may contain Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
550,254 pounds
DISTRIBUTION
AL, IL, MO, MN, TX, and WA

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS - CLASS II

______________________________
PRODUCT
a)  Atlantic herring, preserve, Net Wt. 1250g --- Ingredients: fish, salt, E211, water. 
    The product is labeled mainly in Russian.  According to New York State Department
    of Agriculture & Markets FL report, the fish are whole and 10-12 inches in length, and
    the fish are eviscerated.  The product is packed in sealed cans, UPC bar code
    # 8 50307 00062 9, Recall # F-129-6;
b) Salmon fillet, preserve, Net Wt. 45.86 oz (1300g) --- Ingredients: fish, salt, E211, water. 
    The product is labeled mainly in Russian.  The product is packed in sealed cans, 
    UPC bar code #8 50307 00063 6, Recall # F-130-6
CODE
311205 (corresponds to “Best before date” of 12/31/2005)
RECALLING FIRM/MANUFACTURER
Recalling Firm:  Trilini International Import, LLC, Brooklyn, NY, by press release on November 30, 2005.
Manufacturer:  Izmail Fish Factory, Izmail, Ukraine, firm initiated recall is complete.
REASON
The product is packed in cans in which the soldered seams were found to contain lead (63%).  This finding is based on sampling & analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
a) 205 cases (8 – 1250 gram cans per case);
b) 50 cases (8 – 1300 gram cans per case)
DISTRIBUTION
NY and NJ

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS - CLASS III 
______________________________
PRODUCT
Choxie milk chocolate peanut butter balls truffles, Net Wt. 4.95 oz (140g).  Package     contains approximately 10 individually wrapped truffle candies per container.  The individual truffle candy bears no labeling.  Recall # F-134-6
CODE
All codes
RECALLING FIRM/MANUFACTURER
Recalling Firm:  Ross Acquisitions Company, Hebron, KY, by e-mail on February 22, 2006.
Manufacturer: Madelaine Chocolates, Rockaway Beach, NY, firm initiated recall is ongoing.
REASON
This product is labeled as Milk Chocolate Peanut Butter Balls and may contain a different product that does not have peanuts in it.
VOLUME OF PRODUCT IN COMMERCE
81,288/4.95 oz containers, which also include three other varieties of candy (F-131-6 Double Dark Truffles, F-132-6 Milk Chocolate Truffles, or F-133-6 Milk Chocolate Caramel Balls (F-131-6, F-132-6 and F-133-6 is listed under class I).
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) Sharon’s Sorbet gourmet chocolate, one pint (473 ML). The product is packaged
    in a one pint plastic cup container with black and white lettering labeled in part, "***
    SHARON'S Sorbet *** PARVE *** gourmet *** CHOCOLATE *** ONE PINT
    (473ML) *** UPC # 0 09073 10231 4 ***". Labeling on lid in part: "*** CHOCOLATE ***
    dairy free *** all natural *** fat free *** cholesterol free, Recall # F-135-6;
b) Sharon’s Sorbet gourmet coconut, one pint (473 ML). The product is packaged
    in a one pint plastic container cup with black and white lettering labeled in part, "***
    SHARON'S Sorbet *** PARVE *** gourmet *** COCONUT *** ONE PINT
    (473ML) *** UPC # 0 09073 10231 4 ***". Labeling on lid in part: "*** COCONUT ***
    dairy free *** wholesome *** fat free *** cholesterol free, Recall # F-136-6
CODE
a) Code 3185.  Code on bottom of container cup reads: "3185 23:xx" (first line)
    and "0905 41776" (second line);
b) Code 3465. Code on bottom of container cup reads: "3465 xx:xx" (first line)
    and "xxxx xxxx" (second line)
RECALLING FIRM/MANUFACTURER
Recalling Firm:  Sharon’s Sorbet, New York, NY, by letter dated February 10, 2006, and by telephone.
Manufacturer:  H. P. Hood, Inc., Suffield, CT, firm initiated recall is ongoing.
REASON
The firm noticed that recent samples of the chocolate and coconut sorbets received by the manufacturer had been mislabeled as "fat free". The container lids are labeled as "fat free" while the plastic pint container cups bear the nutritional facts panel with the fat content.
VOLUME OF PRODUCT IN COMMERCE
a) 509 gallons (8 X 1 pint);
b) 364 gallons (8 X 1 pint)
DISTRIBUTION
NY

 RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I

______________________________
PRODUCT
Cefazolin for Injection, USP, 1 g/10 mL vials, single use vials, 25 single use vials per carton, Rx only. Distributed under the Watson Laboratories Inc. label: NDC 0591-2365-69 (carton) and NDC 0591-2365-79 (vial), Cefazolin for Injection, USP, 1 gram, For IM or IV Use, Rx only, distributed under the SANDOZ label: NDC 0781-3157-96 (carton) and NDC 0781-3157-70 (vial), Cefazolin for Injection, USP, 1 gram, For IM or IV Use, Rx only,  Recall # D-218-6
CODE
Sandoz lots: C4650 (exp. OCT 2007) and C4537 (exp. AUG 2007), NDC 0781-3157-96 (carton) and NDC 0781-3157-70 (vial); Watson lots: C4689 (exp. SEP 2007) and C4665 (exp. AUG 2007), NDC 0591-2365-69 (carton) and NDC 0591-2365-79 (vial)
RECALLING FIRM/MANUFACTURER
G. C. Hanford Manufacturing Co., Syracuse, NY, by press release and letters on February 24, 2006, firm initiated recall is ongoing.
REASON
Non Sterility:  Finished product lots lack sterility assurance because certain lots of the bulk API were found to haave microbial contamination.
VOLUME OF PRODUCT IN COMMERCE
379,975 – 1 g/10mL vials
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) Miracle II, by Tedco, Neutralizer Gel, Nature’s Miracle for the Total Body,
    Sopi’ H20, Biodegradable, 8 oz (232mL), 22 oz, 1 gal, 5 gal, and 15 gal,
    Recall # D-219-6;
b) Miracle II, by Tedco, Neutralizer Gel, Nature’s Miracle for the Total Body,
    Sopi’ H20, Biodegradable, 8 oz (232mL), 7X, 8 oz, 22 oz, and 1 gallon, 
    Recall # D-220-6;
c) Miracle II, by Tedco, Neutralizer, Nature’s Miracle for the Total Body,
    Sopi’ H20, Biodegradable, 22 oz (638mL), 1 gal, 5 gal, and 15 gal, and 55 gal,
    Recall # D-221-6;
d) Miracle II, by Tedco, Neutralizer, Nature’s Miracle for the Total Body,
    Sopi’ H20, Biodegradable, 2X, 22 oz and 1 gal, Recall # D-222-6;
e) Miracle II, by Tedco, Neutralizer, Nature’s Miracle for the Total Body,
    Sopi’ H20, Biodegradable, 3X, 22 oz and 1 gal, Recall # D-223-6
CODE
All codes
RECALLING FIRM/MANUFACTURER
Tedco, Inc., West Monroe, LA, by letters on January 20, 2006, firm initiated recall is ongoing.
REASON
Microbial contamination
VOLUME OF PRODUCT IN COMMERCE
284,734 units
DISTRIBUTION
Nationwide, Canada, Germany, Australia, UK, and Spain

______________________________
PRODUCT
Morphine Sulfate, 1 mg/mL in 0.9% Sodium Chloride, Rx only, Total Dose 100 mg/100mL, 100 mL Medication Cassette Reservoir, NDC 61553-821-48, Recall # D-224-6
CODE
Lot number 053570081, Service code number 2K8821
RECALLING FIRM/MANUFACTURER
PharMEDium Services, LLC, Cleveland, MS, by telephone on January 12, 2006, and by letter dated January 16, 2006, firm initiated recall is ongoing.
REASON
Mislabeling:  Product labeled as Morphine Sulfate contained Fentanyl Citrate/Bupivacaine HC1.
VOLUME OF PRODUCT IN COMMERCE
120 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Fentanyl Citrate, 2 mcg/mL and 0.125% Bupivacaine HC1 in 0.9% Sodium Chloride, Rx only, Total Dose 200 mcg/100mL Fentanyl Citrate, 100 mL Medication Cassette Reservoir, NDC 61553-861-48, Recall # D-225-6
CODE
Lot number 053570083, Service code number 2K8861
RECALLING FIRM/MANUFACTURER
PharMEDium Services, LLC, Cleveland, MS, by telephone on January 12, 2006, and by letter dated January 16, 2006, firm initiated recall is complete.
REASON
Mislabeling:  Product labeled as Fentanyl Citrate/Bupivacaine contained Morphine.
VOLUME OF PRODUCT IN COMMERCE
120 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

______________________________
PRODUCT
Benylin Pediatric Oral Solution, in each 5mL (dextromethorphan HBr) 7.5mg, supplied in 4 fl oz (118 mL) bottles, Cough Suppressant, Alcohol Free, Sugar Free, Great Grape Flavor, Recall # D-217-6
CODE
Unit Lot numbers 21934L, Exp. Feb 2006 and 403N4L, Exp. Oct 2006
RECALLING FIRM/MANUFACTURER
Recalling Firm:  Pfizer, Inc., Morris Plains, NY, by letters on February 25, 2006.
Manufacturer:  Pfizer, Inc., Lititz, PA, firm initiated recall is ongoing.
REASON
Product exceeds the maximum amount allowed per daily dose, under U.S. Food & Drug Administration regulation for the quanity of FD&C Red Dye No. 33.
VOLUME OF PRODUCT IN COMMERCE
57,412 bottles
DISTRIBUTION
Nationwide and PR

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS I

______________________________
PRODUCT
Human Tissue for Transplantation, Recall # B-0322-6;
a) Alloquent CC allograft (8, 9, & 10 mm) Amended to include 5, 6, and 7 mm;
b) Achilles Tendon;  
c) Cancellous, 4-10 mm (15 cc & 30 cc);
d) Patella Tendon-Hemi; 
e)  Tibialis Tendon; 
f)  Iliac Crest Wedge (14-17mm, 11-13 mm, <10 mm and 18+mm);
CODE
a) Product Code:  BS30-4008, ID# : GL2005-180-001, GL2005-180-002, GL2005-180-003, GL2005-180-004, GL2005-180-005, GL2005-180-006, GL2005-180-007, GL2005-180-008, GL2005-180-009; Amended to include: ID# : GL2005-139-013, GL2005-139-014, GL2005-176-001, GL2005-176-002, GL2005-176-003, GL2005-179-001, GL2005-179-002, GL2005-179-003, GL2005-179-004, GL2005-183-001, GL2005-183-002, GL2005-183-003, GL2005-183-004
Product Code: BS30-4009, ID#: GL2005-180-010; Amended to include: GL2005-127-015, GL2005-139-015, GL2005-143-012, GL2005-176-004, GL2005-176-005, GL2005-176-006, GL2005-176-007, GL2005-176-008, GL2005-176-009, GL2005-176-010, GL2005-179-007, GL2005-179-008, GL2005-179-009, GL2005-183-005, GL2005-183-006, GL2005-183-007, GL2005-183-008, GL2005-183-009, GL2005-183-010
Product Code: BS30-4010, ID#: GL2005-147-020, L2005-147-021, GL2005-161-017, GL2005-161-018, GL2005-164-013, GL2005-164-014, GL2005-165-015, GL2005-167-013, GL2005-167-014, GL2005-167-015, GL2005-167-016, GL2005-167-017, GL2005-168-013, GL2005-168-014, GL2005-168-015, GL2005-168-016; Amended to include: GL2005-139-016, GL2005-127-016, GL2005-143-013, GL2005-159-013, GL2005-181-018
Amended to include: Product Code BS30-4005, ID#: GL2005-133-005, GL2005-139-010, GL2005-143-008;
Product Code: BS30-4006, ID#: GL2005-127-010, GL2005-133-006, GL2005-133-007, GL2005-143-009, GL2005-143-010;
Product Code: BS30-4007, ID#: GL2005-127-011, GL2005-127-012, GL2005-127-013, GL2005-127-014, GL2005-133-008, GL2005-133-009, GL2005-139-011, GL2005-139-012, and GL2005-143-011

b) Product Code: LATM, ID#: GL2005-107-001, GL2005-108-001, GL2005-108-002, GL2005-109-001, GL2005-109-002, GL2005-114-002, GL2005-116-002, GL2005-118-001, GL2005-119-001, GL2005-119-002, GL2005-124-002, GL2005-130-001, GL2005-115-002, GL2005-116-001, GL2005-114-001, GL2005-120-003, GL2005-118-002, GL2005-124-001, and GL2005-115-001

c) Product Code: LCIPM, ID#: GL2005-107-003, GL2005-111-004, GL2005-113-004, GL2005-114-004, GL2005-115-004, GL2005-116-004, GL2005-122-004, T2005-034-005, T2005-049-014, T2005-064-003, T2005-078-005, T2005-057-002, T2005-072-003, GL2005-139-009
Product Code: LCISM, ID#: T2005-040-013, T2005-040-014, T2005-040-015, T2005-040-016, GL2005-108-003, GL2005-109-003, GL2005-111-003, GL2005-114-003, T2005-034-003, T2005-034-004, T2005-039-003, T2005-039-004, T2005-039-005, T2005-040-007, T2005-040-017, T2005-041-008, T2005-041-009, T2005-041-010, T2005-041-011, T2005-041-012, T2005-041-017, T2005-043-005, T2005-043-006, T2005-043-007, T2005-045-008, T2005-045-009, T2005-045-010, T2005-045-011, T2005-045-012, T2005-045-017, T2005-048-008, T2005-048-009, T2005-048-010, T2005-048-011, T2005-048-012, T2005-048-013, T2005-049-009, T2005-049-012, T2005-051-001, T2005-052-001, T2005-053-003, T2005-054-003, T2005-055-003, T2005-056-001, T2005-059-002, T2005-059-003, T2005-060-001, T2005-061-004, T2005-062-001, T2005-062-002, T2005-063-003, T2005-064-001, T2005-064-002, T2005-065-001, T2005-066-001, T2005-067-001, T2005-068-003, T2005-069-003, T2005-075-003, T2005-078-003, T2005-078-004, GL2005-107-002, GL2005-109-004, GL2005-110-004, GL2005-113-003, GL2005-115-003, GL2005-116-003, GL2005-117-003, GL2005-117-004, GL2005-118-003, GL2005-118-004, GL2005-120-001, GL2005-120-002, GL2005-122-003, GL2005-123-003, GL2005-123-004, GL2005-123-005, GL2005-124-003, GL2005-124-004, GL2005-127-007, GL2005-130-003, GL2005-139-007, GL2005-139-008, T2005-038-003, T2005-040-008, T2005-045-013, T2005-045-014, T2005-045-015, T2005-045-016, T2005-045-018, T2005-045-019, T2005-046-010, T2005-046-011, T2005-046-013, T2005-047-016, T2005-047-017, T2005-049-010, T2005-049-013, GL2005-119-003, GL2005-119-004, T2005-038-004, T2005-040-009, T2005-040-010, T2005-040-011, T2005-040-012, T2005-044-014, T2005-044-015, T2005-047-011, T2005-047-012, T2005-047-013, T2005-047-014, T2005-047-015, T2005-048-007, T2005-048-014, T2005-070-001, T2005-071-001, T2005-073-001, T2005-074-003, T2005-043-016, T2005-044-009, T2005-057-001, T2005-058-001, T2005-059-001, T2005-012-003, T2005-012-004, T2005-012-005, T2005-012-006, T2005-014-001, T2005-014-002, T2005-014-003, T2005-014-004, T2005-014-005, T2005-014-006, T2005-015-001, T2005-015-002, T2005-015-003, T2005-015-004, T2005-015-005, T2005-016-001, T2005-016-002, T2005-016-003, T2005-016-004, T2005-016-005, T2005-016-006, T2005-016-007, T2005-019-001, T2005-019-002, T2005-019-003, T2005-019-004, T2005-020-001, T2005-020-002, T2005-020-003, T2005-020-004, T2005-020-005, T2005-020-006, T2005-021-001, T2005-021-002, T2005-021-003, T2005-021-004, T2005-021-005, T2005-021-006, T2005-022-003, T2005-022-004, T2005-022-005, T2005-022-006, T2005-022-007, T2005-022-008, T2005-022-009, T2005-022-010, T2005-023-003, T2005-023-004, T2005-023-005, T2005-023-006

d) Product Code: LPTHM (Amended from LTTM), ID#: GL2005-147-003

e) Product Code: LTTM, ID#: GL2005-180-015, GL2005-183-014, GL2005-146-004, GL2005-133-014, GL2005-139-004, GL2005-139-005, GL2005-143-005, GL2005-143-006, GL2005-146-003, GL2005-161-003, GL2005-161-004, GL2005-164-003, GL2005-164-004, GL2005-167-003, GL2005-167-004, GL2005-168-004, GL2005-176-013, GL2005-176-015, GL2005-176-016, GL2005-179-012, GL2005-179-013, GL2005-179-015, GL2005-180-013, GL2005-180-014, GL2005-183-013, GL2005-183-016, Amended to include: ID#.GL2005-158-003, GL2005-158-004, GL2005-159-004

f) Product Code: LIWLM, ID#: T2005-034-008, T2005-038-005, T2005-010-009, T2005-019-010, T2005-020-010, T2005-021-014, T2005-022-019, T2005-022-020, T2005-023-011, T2005-023-012, T2005-038-009;
Product Code: LIWMM, ID#: T2005-021-010, T2005-021-011;
Product Code: LIWSM, ID#: T2005-010-002, T2005-015-006; 
Product Code: LIWXLM, ID#: T2005-034-007, T2005-045-023, T2005-045-024, T2005-045-022, T2005-034-006, T2005-045-020
RECALLING FIRM/MANUFACTURER
Recalling Firm:  Lost Mountain Tissue Bank, Kennesaw, GA, by letter dated October 12, 2005 and October 21, 2005.
Manufacturer:  Biomedical Tissue Services, Ltd., Fort Lee, NJ, firm initiated recall is complete.
REASON
Human tissues, procured from donors without adequate donor eligibility determinations, were distributed.
VOLUME OF PRODUCT IN COMMERCE
337 tissues
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0835-6;
b) Recovered Plasma, Recall # B-0836-6
CODE
a) and b) Unit numbers: 06FW75154, and 06FW78487
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern California Region, Pomona, CA, by telephone and letter on July 9, 2003, firm initiated recall is complete.
REASON
Blood products, which tested negative for hepatitis, but were collected from an ineligible donor due to a subsequent disclosure of previous positive hepatitis testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA
______________________________
PRODUCT
a) Red Blood Cells, Irradiated, Recall # B-0848-6;
b) Platelets, Recall # B-0849-6
CODE
a) and b) Unit number: 4127145
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH, by letter on June 3, 2005, firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor who had traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH
______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0861-6
CODE
Unit numbers:  9040689, 9041609, and 9041611
RECALLING FIRM/MANUFACTURER
The Blood Connection, Inc., Greenville, NC, by telephone on December 8, 2004, firm initiated recall is complete.
REASON
Platelets, not manufactured according to firm specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NC
______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0863-6;
b) Recovered Plasma, Recall # B-0864-6
CODE
a) and b) Recall # 12FN59020
RECALLING FIRM/MANUFACTURER
American Red Cross, Carolinas Blood Services Region, Charlotte, NC, by telephone and e-mail dated August 27, 2004, and by letter dated September 7, 2004, firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC and MA
______________________________
PRODUCT
BacT ALERT Classic 120 System and 240 System, Recall # B-0865-6
CODE
All Models
RECALLING FIRM/MANUFACTURER
bioMerieux, Inc., Durham, NC, by letter dated September 17, 2004, firm initiated recall is ongoing.
REASON
BacT/ALERT Classic Systems, with a software glitch or defect, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3,531 units
DISTRIBUTION
Nationwide and Internationally
______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0885-6;
b) Fresh Frozen Plasma, Recall # B-0886-6
CODE
a) and b) Unit number: 12FG08634
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Charlotte, NC, by telephone on September 13, 2004 and by letter dated September 23, 2004, firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC

______________________________
PRODUCT
 Red Blood Cells, Leukocytes Reduced, Recall # B-0887-6
CODE
Unit number: 12LW87797
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Charlotte, NC, by telephone on July 12, 2004 and by letter dated July 13, 2004, firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0888-6
CODE
Unit number: 12Y52574
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Charlotte, NC, by telephone on June 17, 2004 and by letter dated June 22, 2004, firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0889-6
CODE
Unit number:  R84677
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Community Blood Center of the Carolinas, Charlotte, NC, by letter dated June 3, 2005, firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC
______________________________
PRODUCT
Plasma, Frozen, Recall # B-0895-6
CODE
Unit numbers: 003FJ79310, 003GZ61817, and 003GZ61830
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern Region, Atlanta, GA, by telephone on September 23, 2004 and by letter dated September 28, 2004, firm initiated recall is complete.
REASON
Blood products, associated with units of Red Blood Cells that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
GA
______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0896-6
CODE
Unit number: 003KN18899
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern Region, Atlanta, GA, by telephone on May 21, 2004 and by letter dated November 22, 2004, firm initiated recall is complete.
REASON
Blood product, which yielded a platelet count that was below the acceptable limit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0912-6
CODE
Unit number: GM13510
RECALLING FIRM/MANUFACTURER
Blood Bank of San Bernardino and Riverside Counties, San Bernardino, CA, by letter dated November 10, 2003, firm initiated recall is complete.
REASON
Blood product, collected from a donor who had lived in an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
______________________________
PRODUCT
Red Blood Cells,  Leukocytes Reduced Irradiated, Recall # B-0917-6
CODE
Unit number: 126456483
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Albuquerque, NM, by telephone on January 11, 2006, firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NM
______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0947-6
CODE
Unit number: 03FK41070 (double unit)
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Atlanta, GA, by telephone on September 13, 2004, and by letter dated September 15, 2004, firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0859-6
CODE
Unit number: 03P51460
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern Region, Atlanta, GA, by facsimile dated July 9, 2004, and by letter dated July 26, 2004, firm initiated recall is complete.
REASON
Platelets, labeled as leukoreduced, but did not meet the requirements for a leukoreduced product, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
______________________________
PRODUCT
The Operator’s Manual for the Baxter Fenwal Amicus Separator Apheresis Device, Recall # B-0866-6
Amicus Separator Accessory kits containing an Operator’s Manual:
Product Code 4R2332
Product Usage: An automated apheresis device intended for the simultaneous collection of platelet concentrates, plasma and red blood cells.
- Amicus Separators (New and Refurbished) Product Codes 4R4580 and
4R4580R
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corporation / Fenwal, Deerfield, IL, by letter dated January 25, 2006.
Manufacturer: Baxter Healthcare Corporation, Largo, FL, firm initiated recall is complete.
REASON
Operator’s Manuals for the Baxter Fenwal Amicus Separator Apheresis Device, containing maintenance instructions that may cause a potential for red cell hemolysis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3,412 manuals
DISTRIBUTION
Nationwide and Internationally
______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0890-6;
b) Fresh Frozen Plasma, Recall # B-0891-6
CODE
a) and b) Unit number: R82182
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Community Blood Center of the Carolinas, Charlotte, NC, by letter dated May 3, 2005, firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had taken the medication Toprol, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC
______________________________
PRODUCT
Red Blood Cells Pheresis, Leukocytes Reduced, Recall # B-0897-6
CODE
Unit number: 012GT31999
RECALLING FIRM/MANUFACTURER
American National Red Cross, Carolinas Region, Charlotte, NC, by telephone on March 4, 2005 and by letter dated March 18, 2005, firm initiated recall is complete.
REASON
Blood product, which was not leukoreduced within the appropriate time period after collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0904-6
CODE
Unit number: 0887578
RECALLING FIRM/MANUFACTURER
The Blood Connection, Inc., Greenville, SC, by telephone on November 1, 2005, firm initiated recall is complete.
REASON
Blood product, which was out of controlled storage for more than 30 minutes, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
SC
______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0910-6;
b) Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-0911-6
CODE
a) Unit numbers: GM65615, GM60829, GM92690;
b) Unit numbers: GM70168, GW42852
RECALLING FIRM/MANUFACTURER
Blood Bank of San Bernardino and Riverside Counties, San Bernardino, CA, by letter dated June 30, 2004, firm initiated recall is complete.
REASON
Blood products, which were labeled leukoreduced, but had an unacceptable white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
CA
______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0913-6;
b) Fresh Frozen Plasma, Recall # B-0914-6;
c) Plasma, Recall # B-0915-6;
d) Cryoprecipitated AHF, Recall # B-0916-6
CODE
a) Unit numbers: 12FP61590 and 12GS23207;
b) Unit number: 12FP65190;
c) and d) Unit number: 12GS23207
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Charlotte, NC, by telephone on August 1, 2002 or by letter dated August 6, 2002, firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had taken an anti-viral medication, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
NC, GA, and PR

 

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_____________________________
PRODUCT
a) Stryker Epic Critical Care Bed, Model 2030,
Recall # Z-0554-06;
b) Stryker Epic Zoom Critical Care Bed, Model 2040,
Recall # Z-0555-06
CODE
a) Serial numbers 0512068638, 0512068639, 0512068640, 0512068641,
0512068642, 0512068667, 0512068668, 0512068669, 0512068670, 0512068725, 0512068726, 0512068727, 0512068728, 0512068740, 0512068750, 0512068751, 0409060679, 0409060680, 0409060681, 0409060682, 0409060683, 0409060684, 0409060685, 0409060686, 0409060687, 0512068643, 0512068644, 0512068645, 0512068646, 0512068647, 0512068648, 0512068649, 0512068650, 0512068651, 0512068652, 0512068653, 0512068654, 0512068655, 0512068656, 0512068657, 0512068658, 0512068659, 0512068660, 0512068661, 0512068662, 0512068779, 0512068780, 0512068781, 0512068782, 0512068783, 0512068784, 0512068785, 0512068709, 0512068710, 0512068711, 0512068712, 0512068713, 0512068714, 0512068715, 0512068716, 0512068717, 0512068718, 0512068719, 0512068720, 0512068721, 0512068722, 0512068723 and 0512068724;
b) Serial numbers 0512068663, 0512068664, 0512068665, 0512068666,
0512068681, 0512068682, 0512068741, 0512068742, 0512068743, 0512068744, 0512068745, 0512068746, 0512068747, 0512068748, 0512068749, 0512068762, 0512068763, 0512068759, 0512068760, 0512068764, 0512068765, 0512068766, 0512068767, 0512068768, 0512068769, 0512068770, 0512068771, 0512068772, 0512068773, 0512068774, 0512068775, 0512068776, 0512068777, 0512068778, 0601085035, 0601085036, 0601085064, 0601085141, 0601085142, 0601085143,0512068671, 0512068672, 0512068673, 0512068674, 0512068675, 0512068676, 0512068677, 0512068678, 0512068679 and 0512068680
RECALLING FIRM/MANUFACTURER
Stryker Medical, Kalamazoo, MI, by visit beginning on January 17, 2006, firm initiated recall is ongoing.
REASON
The bed exit may not alarm as appropriate.
VOLUME OF PRODUCT IN COMMERCE

118 beds
DISTRIBUTION
Nationwide and Internationally
______________________________
PRODUCT
a) Fischer Cone Biopsy Excisor – Small Model: 900-150,
Recall # Z-0614-06;
b) Fischer Cone Biopsy Excisor - Medium Model: 900-151,
Recall # Z-0615-06;
c) Fischer Cone Biopsy Excisor – Large Model: 900-152,
Recall # Z-0616-06;
d) Fischer Cone Biopsy Excisor – Medium - Ext Model: 900-154,
Recall # Z-0617-06;
e) Fischer Cone Biopsy Excisor – Large - Shallow Model: 900-155,
Recall # Z-0618-06;
f) Fischer Cone Biopsy Excisor – Dual Sets Model: 900-156,
Recall # Z-0619-06;
g) Fischer Cone Biopsy Excisor – Model: 900-157, Recall # Z-0620-06;
h) Fischer Cone Biopsy Excisor – Model: 900-158, Recall # Z-0621-06
CODE
a) Lot Numbers: A2001, D201702, D209314, D211316, D218411
D220313, D225216, D230104, D301326, D302104 C143D, C213H,
D307908, D313505, E193, D316303 G293, H213, I153C, J283,
K063L, L153N, A134F;
b) Lot Numbers: D201704, A2002, D201705, D201703, D205001, D209315,
D211317, D218412, D217007, D220314, D224801, D232202, D301327,
D302105, D304805, C143E, C213G, D307906, D093H, D311206,
D313506 E193A, D316304, D318111, H213A, I153B I153, J073A, J283A,
K063M, L043A, L153O A024, A134E;
c) Lot Numbers: D201706, D201708, D205002, A2003, D211318, D218914,
D217008, D223910, D223910, D232504, D233021, D302103, C143F,
C213F, D307907, D093K, D310620, E193B, D316305, G303A, H213B,
J073B, K063N, L043B, L153P, A134D;
d) Lot Numbers: D201709, D201707, D205003, A2004, D211319, D225404,
D233020, C143G, D307909, D310619, D316306, H213C, I153A, J283B,
L043C, A134C, A304;
e) Lot Numbers: D201710, A2005, D205004, D218913, D229701, D304806,
D307910, D316307, H213D, J073C, L153Q, A134B;
f) Lot Numbers: D201711, D202712, D205005, A2010, D217006, D233019,
D093J, D313507, H223F, J073D, L043D, A234I;
g) Lot Numbers: A2006, D205006;
h) Lot Numbers: A2007, D205007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Apple Medical Corporation, Marlborough, MA, by letters dated March 21, 2006.
Manufacturer: Geotec, Inc., Warwick, RI, firm initiated recall is ongoing.
REASON
Change in product material may be cause for wire breaking, and tip burning and melting during procedure. Broken pieces of the device may need to e retrieved from patient.
VOLUME OF PRODUCT IN COMMERCE
94,000 boxes
DISTRIBUTION
Nationwide and Internationally
______________________________
PRODUCT
a) Gambro Prisma M100 preset, Recall # Z-0705-06;
b) Gambro Prisma HF1000 preset, Recall # Z-0706-06
CODE
a) Lot numbers: 04K2692P, 05A0754P, 05D1571, 05F0763A, 05F0865,
05F0966, 05F1573G, 05F1574, 05F1675G, 05F2387G, 05F3098G,
05G0556G, 05G0760G, 05G1366G;
b) Lot number: 05F0864P
RECALLING FIRM/MANUFACTURER
Recalling Firm: Gambro Renal Products, Inc., Lakewood, CO, by letter on November 2, and November 3, 2005.
Manufacturer: Gambro Hospal Industrie, Meyzieu Cedex (Lyon), France, firm initiated recall is ongoing.
REASON
After dialysis machine is disconnected from the patient, blood leakage may occur while unloading the tubing sets from the machine.
VOLUME OF PRODUCT IN COMMERCE
29,942 units
DISTRIBUTION
Nationwide and Internationally
______________________________
PRODUCT
ev3 Protege GPS Self-Expanding Nitinol Stent Biliary System--- Sterilization with Ethylene Oxide Gas. The self-expanding stent is made of nickel titanium alloy (Nitinol) and comes pre-mounted on an over-the-wire delivery system. The stent is cut from a nitinol tube into an open lattice design and is designed with tantalum radiopaque markers at the proximal and distal ends of the stent. Upon deployment, the stent achieves its predetermined diameter and exerts a constant, gentle outward force to establish patency in the biliary ducts, Recall # Z-0707-06
CODE
Lot number: 1211723, expiration date: Nov 2007
RECALLING FIRM/MANUFACTURER
Ev3, Plymouth, MN, by visit beginning February 27, 2006, firm initiated recall is ongoing.
REASON
Mispackaging-Protege GPS SER6-9-60-125 devices were incorrectly packaged as SER6-7-80-135. Diameter is larger than expected.
VOLUME OF PRODUCT IN COMMERCE
4 stents
DISTRIBUTION
GA, OK, and TX
______________________________
PRODUCT
Fujinon Endoscope Insertion Tube included with lower gastrointestinal EVE and lower gastrointestinal electronic video endoscopes. Catalog Numbers: EC-450HL5; EC-450LP5; EC-250HL5; EC-250LP5; EC-450HL5-UP; EC-450LP5-UP; EC-250HL5-UP; EC-250LP5-UP, Recall # Z-0708-06
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fujinon, Inc., Wayne, NJ, by Bulletin on March 27, 2006.
Manufacturer: Fujinon Corporation, Saitama, Japan, firm initiated recall is ongoing.
REASON
Colonoscope insertion tube is not bending properly and is stiff.
VOLUME OF PRODUCT IN COMMERCE
2,335 units
DISTRIBUTION
Nationwide and Canada

______________________________
PRODUCT
Lifepak 12 defibrillator/monitor, Recall # Z-0710-06
CODE
Domestic Serial Numbers: 33884879, 33884872, 33884912, 33884871, 33884867, 33884866, 33829105, 33829090, 33950589, 33911492, 33946302, 33884898, 33951494, 33980272, 33986554, 33818744, 33818718, 33924702, 33881437, 33905482, 33894423, 33951266, 33905466, 33955767, 33900980, 33980275, 33980280, 33980287, 33980281, 33819680, 33829407, 33971829, 33986933, 33967385, 34011822, 34011819, 33894426, 33894572, 33900981, 33936889, 33884924, 33826068, 33981789, 33981799, 33981792, 33981805, 33981794, 33981796, 33981793, 33981795, 33981797, 33959538, 33938363, 34011821, 33894425, 33959550, 33938924, 33938921, 33922299, 33930122, 33933904, 33826017, 33955760, 33897337, 33955747, 33951295, 33951456, 33976455, 33951447, 33951275, 33979473, 33979470, 33979471, 33979472, 33979474, 33979469, 33976420, 33976429, 33976413, 33976414, 33976415, 33976416, 33976411, 33976418, 33976410, 33976424, 33976426, 33976427, 33976417, 33976412, 33976430, 33976406, 33976407, 33976408, 33976428, 33976431, 33976419, 33933878, 33946268, 33946277, 33897329, 33905622, 33905621, 33905609, 33911477, 33911470, 33911450, 33911449, 33911446, 33905590, 33905585, 33905581, 33911571, 33897342, 33897320, 33897322, 33905514, 33911528, 33911627, 33905518, 33955832, 33955765, 33955759, 33951605, 33951484, 33951059, 33951467, 33951473, 33951487, 33955761, 33894580, 33905444, 33951128, 33950588, 33951434, 33951273, 33951287, 33951551, 33826023, 33826022, 33826009, 33826008, 33826005, 33826003, 33826021, 33915964, 33915884, 33922357, 33911587, 33986931, 33997554, 33971953, 33955806, 33955833, 33826029, 33951560, 33955752, 33951589, 33951588, 33951586, 33951585, 33951583, 33951576, 33951595, 33951569, 33951580, 33951604, 33955751, 33955748, 33951592, 33951593, 33951601, 33951600, 33951599, 33951598, 33951597, 33951582, 33951409, 33951403, 33951293, 33951292, 33951468, 33951462, 33951553, 33951552, 33951535, 33951497, 33951518, 33959570, 33946296, 31014367, 33997567, 33904931, 33904929, 33904928, 33904926, 33904923, 33904921, 33904936, 33904917, 33904914, 33904913, 33904910, 33904922, 33905443, 33905441, 33905440, 33905434, 33905432, 33904933, 33905430, 33904932, 33905427, 33904938, 33904937, 33904876, 33905470, 33905488, 33905474, 33905473, 33901782, 33901777, 33901773, 33901771, 33901770, 33905451, 33901787, 33901762, 33901753, 33901761, 33911601, 33915916, 33915917, 33915910, 33915961, 33959578, 33959606, 33897319, 33905516, 33905507, 33922294, 33911635, 33911634, 33911632, 33911631, 33911611, 33911624, 33911614, 33917454, 33917452, 33917448, 33917447, 33917444, 33917443, 33917440, 33894289, 33905521, 33905520, 33917455, 33917453, 33917470, 33921055, 33921053, 33921052, 33921050, 33921049, 33921047, 33921046, 33917468, 33917467, 33917466, 33917465, 33917464, 33917463, 33917461, 33917457, 33917456, 33921045, 33955771, 33955762, 33955750, 33951603, 33986555, 33986346, 33986324, 33979488, 33980264, 33986878, 33986897, 33981778, 33169330, 33904924, 33911468, 33905495, 33905496, 33905459, 33905587, 33905497, 33933906, 33901735, 33894413, 33955802, 33955839, 33955831, 33955829, 33955827, 33955803, 33938926, 33951596, 33951426, 33951405, 33997552, 33986873, 33986877, 33905438, 33924704, 33904878, 33901737, 33950587, 33951298, 33951283, 33976463, 33980266, 33980290, 33980294, 33980278, 33980279, 33980291, 33980285, 33980301, 33980304, 33986548, 33976478, 33976479, 33976485, 33976477, 33976468, 33976470, 33976471, 33976456, 33976446, 33976447, 33819634, 33947249, 33947931, 33947264, 33915931, 33915930, 33915929, 33915928, 33915925, 33915889, 33915887, 33915888, 33915899, 33915898, 33915897, 33915895, 33915894, 33915893, 33915892, 33915890, 33911603, 33911602, 33911597, 33936877, 33936874, 33915914, 33915919, 33915922, 33915912, 33915911, 33915908, 33980268, 33980300, 33986563, 33986561, 33986564, 33986565, 33986562, 33986543, 33986351, 33986330, 33986342, 33986349, 33986348, 33986345, 33986338, 33986344, 33971910, 33971905, 33971901, 33971838, 33897350, 33897344, 33884882, 33884875, 33884911, 33990265, 34015699, 31368552, 33986913, 33911532, 33911535, 33936914, 33971950, 33894290, 33911625, 33986559, 33986549, 33986551, 33986323, 33911595, 33915885, 33933909, 33826019, 33826001, 33825999, 33826000, 33823372, 33823373, 33823375, 33823342, 33823340, 33823348, 33823367, 33823366, 33823358, 33823356, 33829111, 33823382, 33823386, 33823381, 33823378, 33823384, 33951602, 33951449, 33986558, 33986556, 33986553, 33986325, 33986339, 33818733, 33951572, 33951568, 33951439, 33951556, 33980297, 33897327, 33980274, 33915956, 33826048, 33951476, 31388033, 33905592, 33905589, 33990271, 34011832, 33933911, 33905582, 33894597, 33955840, 33915926, 33915939, 33933931, 33884958, 33997573, 33997566, 33946303, 33930103, 33924697, 33924699, 33924696, 33924695, 33924703, 33924705, 33924706, 33924692, 33930102, 33930105, 33897353, 33924701, 33818749, 33946314, 33930107, 33924684, 33924682, 33955755, 33986911, 34011824, 34017741, 33980296, 33986546, 33986334, 33986343, 33986335, 33986337, 33915896, 33819582, 33823323, 33898439, 33898437, 33818727, 33951475, 33951517, 33980298, 33915962, 33901774, 33986894, 33986879, 33986880, 33971926, 33971913, 33818750, 33818774, 33986871, 33911512, 33936879, 33826056, 33819681, 33819669, 33951430, 33955775, 33884945, 33885006, 33884962, 33826069, 33826084, 33818739, 33971918, 33971867, 33986898, 33826097, 33900862, 33900986, 33900985, 33900983, 33901091, 33900859, 33900858, 33900763, 33900762, 33900864, 33900987, 33901090, 33900761, 33898455, 33900759, 33971921, 33986886, 33986901, 33900982, 33900979, 33900856, 33900765, 33901122, 33901120, 33901117, 33901100, 33901099, 33901098, 33901116, 33901127, 33901769, 33901768, 33901725, 33901733, 33901732, 33901731, 33901729, 33901726, 33901722, 33901720, 33901717, 33901128, 33905616, 33905603, 33905600, 33911445, 33905598, 33901785, 33911538, 33911516, 33911539, 31138863, 30559175, 33976453, 33986896, 33986567, 33986881, 33976464, 33976458, 33947259, 33946315, 33936899, 33967359, 33922369, 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International Serial Numbers: 33947246, 33947247, 33890408, 33892605, 33790557, 33819595, 33819594, 33894427, 33826015, 33823319, 33823313, 33946278, 33933874, 33946270, 33933948, 33933865, 33933882, 33950568, 33933892, 33933893, 33933895, 33933887, 33933912, 33933913, 33933898, 33933889, 33930119, 33933884, 33826079, 33819604, 33905620, 33823314, 33946287, 33889422, 33892602, 33884927, 33884920, 33884935, 33894575, 33894408, 33894407, 33894595, 33894576, 33905610, 33905613, 33911432, 33905605, 33950445, 33915942, 33915932, 33922354, 33915948, 33915934, 33819610, 33823315, 33946291, 33946292, 33946294, 33946295, 33976467, 33946290, 33881436, 33986796, 33986798, 33986801, 33959551, 33959548, 33976462, 33959557, 33979559, 33986803, 33976405, 33976466, 33980269, 33955843, 33986812, 33986813, 33955783, 33980292, 33976473, 33976469, 33986875, 33976438, 33976439, 33986805, 33946309, 33976442, 33986806, 33976444, 33976484, 33980284, 33976449, 33986810, 33890389, 33890402, 33890398, 33890397, 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33933875, 33924670, 33922373, 33922380, 33922381, 33924667, 33933871, 33933934, 33933951, 33946275, 33932735, 33922365, 33922366, 33933933, 33933862, 33933880, 33951127, 33950578, 33951103, 33950576, 33951122, 33955777, 33950456, 33947932, 33950447, 33950452, 33950453, 33950579, 33950455, 33950457, 33950570, 33950572, 33950573, 33950575, 33950454, 33922297, 33951271, 33947892, 33955850, 33959541, 33959543, 33915946, 33915959, 33951402, 33951401, 33971930, 33971931, 33971929, 33933908, 33971915, 33971912, 33936858, 33971958, 33971957, 33971952, 33971951, 33936900, 33930126, 33947881, 33947882, 33947885, 33947887, 33947888, 33936882, 33947878, 33951591, 33951587, 33971960, 33947889, 33947870, 33936901, 33947869, 33947879, 33947871, 33947872, 33947873, 33947874, 33936890, 33986326, 33955834, 33955811, 33976481, 33955810, 33976482, 33976480, 33955808, 33976483, 33889425, 33889434, 33881406, 33881393, 33881362, 33881372, 33881369, 33881366, 33881363, 33881375, 33881361, 33881360, 33881359, 33881358, 33881357, 33881356, 33881355, 33881364, 33881374, 33881380, 33881379, 33881376, 33884909, 33881450, 33881445, 33884886, 33884884, 33884894, 33819598, 33819606, 33819608, 33829152, 33829149, 33829154, 33829153, 33829150, 33829148, 33819592, 33829146, 33829144, 33819596, 33932689, 33894390, 33894389, 33892593, 33894571, 33894386, 33932679, 33881331, 33894388, 33881354, 33881353, 33881352, 33881351, 33881350, 33881333, 33881330, 33881329, 33881327, 33830738, 33881349, 33894385, 33894384, 33894383, 33894381, 33894291, 33904919, 33826060, 33826072, 33818791, 33818742, 33818787, 33819655, 33819643, 33819667, 33819635, 33823336, 33823324, 33823331, 33823317, 33946282, 33933937, 33898446, 33898432, 33933944, 33894554, 33898435, 33898436, 33933942, 33933869, 33932741, 33933870, 33933868, 33933876, 33933872, 33933858, 33932744, 33946269, 33933863, 33933861, 33950583, 33950446, 33950449, 33950574, 33947930, 33921056, 33921048, 33921054, 33933886, 33947883, 33947886, 33936902, 33947875, 33894596, 33980270, 33980299, 33986794, 33976425, 33955823, 33959553, 33959545, 33959544, 33979505, 33991489, 33991484, 33991483, 33991478, 33991494, 33991477, 33991499, 33890401, 33890400, 33890399, 33890405, 33889503, 33889502, 33889501, 33889500, 33889499, 33890424, 33890413, 33890422, 33890421, 33890420, 33890418, 33890416, 33890414, 33890412, 33890411, 33890410, 33889496, 33890415, 33889428, 33889498, 33889486, 33889495, 33889494, 33889493, 33889492, 33889491, 33889490, 33889489, 33889487, 33889484, 33889483, 33889480, 33889479, 33889477, 33892588, 33889488, 34003578, 34003565, 33997578, 33997575, 34003593, 33890423, 34011834, 34022211, 34015723, 34011708, 34011705, 34011703, 34011696, 34003592, 34011829, 34011813, 33892603, 33892601, 33892595, 33892594, 33892590, 33892599, 33981790, 33959608, 33959607, 33959600, 33959566, 33892611, 33881407, 33881416, 33881415, 33881414, 33881412, 33881395, 33881419, 33881405, 33881400, 33881398, 33881397, 33881428, 34022212, 33881435, 33946286, 33881433, 33881432, 33881431, 33881417, 33881429, 33881427, 33881426, 33881425, 33881424, 33881423, 33881420, 33881430, 33881370, 33881368, 33881365, 33881392, 33881391, 33881390, 33881389, 33881388, 33881387, 33881386, 33881373, 33881384, 33881382, 33881381, 33881378, 33881377, 33881385, 33884917, 33884910, 33884908, 33884942, 34022198, 33884948, 33884946, 33884931, 33884938, 33884936, 33884934, 33884902, 33884944, 33884904, 33884874, 33884870, 33881455, 33881454, 33881453, 33884878, 33881451, 33881449, 33881448, 33881447, 33881446, 33881443, 33881442, 33881452, 33884892, 33881440, 33884901, 33884899, 33884897, 33884896, 33884903, 33884890, 33884888, 33884887, 33884881, 33829395, 33819600, 33819601, 33819607, 33819597, 33819613, 33829409, 33829406, 33829405, 33829404, 33829403, 33829401, 33819609, 33829399, 33829398, 33829396, 33829128, 33829402, 33829142, 33819588, 33829132, 33829131, 33829130, 33819586, 33829143, 33829410, 33814240, 33814239, 33829393, 33829392, 33819589, 33819590, 33829147, 33819591, 33819593, 33819614, 33930108, 33930115, 33932678, 33894551, 33830737, 33830736, 33829411, 33924700, 33826093, 33826077, 33826078, 33826080, 33826082, 33826083, 33823374, 33826085, 33826086, 33826089, 33826033, 33826092, 33826073, 33826094, 33829140, 33823361, 33819605, 33819603, 33819602, 33823380, 33819676, 33826039, 33829093, 33826043, 33829089, 33826049, 33826050, 33823383, 33826074, 33826058, 33826062, 33826063, 33826064, 33826065, 33826066, 33826067, 33826070, 33826071, 33817019, 33818757, 33818756, 33818748, 33818745, 33818740, 33818737, 33818725, 33818761, 33818763, 33818790, 33818789, 33818788, 33818786, 33818785, 33818784, 33818782, 33818759, 33818780, 33818775, 33818773, 33818772, 33818770, 33818769, 33818768, 33818766, 33818764, 33818781, 33819646, 33819648, 33819649, 33819650, 33829125, 33819652, 33819654, 33819656, 33826034, 33819660, 33819661, 33829124, 33819664, 33829123, 33819666, 33829122, 33829121, 33819670, 33819671, 33819617, 33819618, 33819620, 33819622, 33819624, 33819627, 33819645, 33819629, 33819631, 33819632, 33829127, 33829126, 33819638, 33819641, 33819674, 33819628, 33829120, 33829115, 33829114, 33826002, 33829110, 33826006, 33829106, 33826011, 33823334, 33826014, 33823333, 33826016, 33829102, 33826020, 33826025, 33826026, 33829097, 33826028, 33826031, 33826012, 33819675, 33819677, 33819679, 33829118, 33829117, 33823335, 33819673, 33823322, 33823325, 33823326, 33823328, 33823329, 33823330, 33823332, 33922359, 33946280, 33946283, 33933954, 33933952, 33933953, 33900686, 33933939, 33933955, 33933938, 33894553, 33933946, 33898429, 33898431, 33898449, 33933956, 33898441, 33898442, 33933941, 33924678, 33929476, 33924669, 33929477, 33922368, 33922367, 33933867, 33922370, 33922376, 33946267, 33933947, 33922382, 33922378, 33929479, 33933860, 33946273, 33922363, 33946276, 33933949, 33933950, 33922364, 33933864, 33933866, 33951115, 33950582, 33950585, 33950586, 33951064, 33951074, 33951116, 33951117, 33951119, 33951120, 33951123, 33951125, 33951084, 33951132, 33924676, 33951126, 33922375, 33924662, 33924665, 33924666, 33924671, 33924672, 33924674, 33922295, 33924680, 33924683, 33924691, 33930141, 33930100, 33930099, 33924673, 33915933, 33932722, 33947926, 33915943, 33915957, 33915960, 33933902, 33933891, 33933897, 33933903, 33930120, 33930123, 33933883, 33933885, 33947895, 33947891, 33947906, 33947911, 33947914, 33947918, 33947928, 33938358, 33938361, 33947880, 33947876, 33894387, 33979498, 33979556, 33979520, 33976422, 33933881, 33946310, 33889471, 33881371, 33884922, 33894568, 33894588, 33894581, 33894579, 33884928, 33826076, 33915902
RECALLING FIRM/MANUFACTURER
Medtronic Emergency Response Systems, Inc., Redmond, WA, by letters dated March 2006, firm initiated recall is ongoing.
REASON
Therapy connectors may have connector sockets that do not meet design specs - short drill depth. Interruption of the connections may cause unexpected, intermittent or complete loss of pacing and defibrillation functions.
VOLUME OF PRODUCT IN COMMERCE
942 Lifepak 12 devices; 2678 Lifepak 20 devices
DISTRIBUTION
Nationwide and Internationally
______________________________
PRODUCT
ECAT Emerge PET Scanners (distributed by Siemens Medical Solutions USA, Inc.), ECAT ART PET Scanners (distributed by Siemens Medical Solutions USA, Inc.) and Sceptre PET Scanners (distributed by Hitachi Medical Systems of America),
a) Software versions 7.2.2 rel 2, 7.2.2 rel 4A, 7.2.2 rel 5 and 7.3 Model: ART
Model Number: 3600066-00;
b) Model: ART Model Number: 3600078-00;
c) Model: ART Model Number: 3600082-00;
d) Model: ART Model Number: 3600084-00;
e) Model: ART 2000 Model Number: 3600090-00;
f) Model: EMERGE, EMERGE (Toshiba), EMERGE (Sceptre - Hitachi), EMERGE m
(Sceptre - Hitachi), PICO EMERGE (Sceptre-Hitachi), PICO EMERGEm (Sceptre –
Hitachi) Model Number: 3600099-00;
g) Model Number: PICO EMERGE (Sceptre-Hitachi) Model Number: P008060,
Recall # Z-0712-06
CODE
a) Serial numbers: 1001, 1002, 1003, 1004, 1005, 1006, 1007, 1008,
1009, 1010, 1012, 1013, 1014;
b) Serial numbers: 1001, 1002, 1003;
c) Serial numbers: 1002;
d) Serial numbers: 1001, 1002, 1003, 1004, 1005, 1006;
e) Serial numbers: 1001, 1002, 1003, 1004, 201005, 201006;
f) Serial numbers: 101001, 201002, 201003, 201004, 201005, 201006,
201007, 201008, 201009, 201010, 201011, 201012, 301013, 301014,
301015, 301016, 301017, 301018, 301019, 301020, 301022, 301023,
301024, 301025, 301026, 301027, 301028;
g) Serial number: 401001
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA Inc., Knoxville, TN, by letter beginning March 28, 2006, firm initiated recall is ongoing.
REASON
There is a potential for inaccurate, elevated SUVs (standardized uptake values). On follow-up scans, the elevated SUV could be misinterpreted, and inappropriately impact a patient's treatment plan.
VOLUME OF PRODUCT IN COMMERCE
57 devices
DISTRIBUTION
KS, WA, CA, OH, FL, TX, and Internationally
______________________________
PRODUCT
SonoCalc IMT 3.0, windows based software used in conjunction with images from high-resolution ultrasound systems (MicroMaxx, TITAN, and SonoSite180PLUS). This software generates a report with the patients intima media thickness (IMT) based on average thickness of the carotid artery, Recall # Z-0713-06
CODE
All SonoCalc IMT version 3.0
RECALLING FIRM/MANUFACTURER
Sonosite, Inc., Bothell, WA, by a User Guide Addendum on October 26, 2005, firm initiated recall is complete.
REASON

When SonoCalc IMT 3.0 software is used with the SonoSite 180Plus ultrasound system, the software miscalculates the intima-media-thickness, a measurement of risk for cardiovascular or cerebrovascular events. Under estimates percentage of stenosis, false negative result.
VOLUME OF PRODUCT IN COMMERCE
155 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

______________________________
PRODUCT
Blue Line Ultra Tracheostomy Tube 8.00mm Inner Cannula REF 100/858/080, Recall # Z-0714-06
CODE
Lot 490694
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smiths Medical ASD, Inc., Keene, NH, by letter dated March 7, 2006.
Manufacturer: Smiths Medical, Hythe, UK, firm initiated recall is ongoing.
REASON
Mislabeled Product labeled as 8.0mm inner cannula, may contain a 9.0mm
VOLUME OF PRODUCT IN COMMERCE
5,350 units (107 cases)
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS I

_______________________________
PRODUCT
Purina Layena Sunfresh Recipe Pellet Complete Food for laying Chickens, 50 lb. bag, catalog number 61R3C21 010, Recall # V-063-6
CODE
Lot number: 6JAN03SPK2
RECALLING FIRM/MANUFACTURER
Land O’Lakes Purina Feed LLC, Spokane, WA, by telephone on January 27, 2006 and by press release on February 3, 2005, firm initiated recall is complete.
REASON
Purina Layena Sunfresh Recipe Pellet complete feed for laying chickens contains excess salt.
VOLUME OF PRODUCT IN COMMERCE
488/50 lb bags
DISTRIBUTION

WA, OR, ID, MT

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS III

______________________________
PRODUCT
Strongid C*** [pyrantel tartate] ***Equine Anthelminitic*** Medicated for Continous Feeding*** Net Wt; 25 LB (11.3kg) *** For the prevention of strongylus vulgaris larval infestation in horses***, Recall # V-065-6
CODE
Lot number: AK00203371, Expires Oct. 2005
RECALLING FIRM/MANUFACTURER
Recalling Firm: Webster Veterinary Supply, Inc., Sterling, MA, by letter on January 20, 2006.
Manufacturer: Pfizer Animal Health, Exton, PA, firm initiated recall is ongoing.
REASON
Product was distributed with an expired expiration date.
VOLUME OF PRODUCT IN COMMERCE
10/25 lb. units
DISTRIBUTION
CT, MA, and NH

 

END OF ENFORCEMENT REPORT FOR APRIL 12, 2006

 

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