• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

Enforcement Report for February 27, 2008

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.

February 27, 2008
08-09

 

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I

___________________________________
PRODUCT 
Golden Flower Dried Lily Bulb; Nt. Wt. 12  oz, (340 grams) Ing: Dried Lily Bulb; User Warnings: DO not eat as a snack. Raw food please wash under tap water at least 5 minutes before cooking. Cook in hot boiling water for 30 minutes before consuming. Item number 40365 No codes on bags except UPC: 6 470406 01070 9, Recall # F-201-8
CODE
No codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Prosperity Resources International Inc., Irvington, NJ, by letters on December 3, 2007 and press release on December 4, 2007.
Manufacturer: S & Y Company LTD, Gaoming City, China. Firm initiated recall is complete.
REASON
New York State Department of Agriculture and Markets randomly sampled the product and found sulfites at the level of 1962 ppm. Suflites were not declared on the ingredient label.
VOLUME OF PRODUCT IN COMMERCE
18 cases (50 x 12 oz packages)
DISTRIBUTION
RI, FL, NJ, NY, MD, IL, OH, VA and IN
___________________________________
PRODUCT 
Le Gourmet Connection Jack Cheese, Recall # F-202-8
CODE
Lot: 539
RECALLING FIRM/MANUFACTURER
Recalling Firm: Le Gourmet Connection, LLC, Lebanon, TN, by telephone on November 19, 2007 and press release on November 21, 2007.
Manufacturer: Sweetwater Valley Farm, Philadelphia, TN. Firm initiated recall is complete.
REASON
Product may be contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
36/10 oz. bars
DISTRIBUTION
OH
___________________________________
PRODUCT 
King brand Dried Turkish Apricots, 12.5 Kg (28 lbs.). The product is packaged in a plastic bulk bag packed inside a cardboard box. (Note: No bulk label available), Recall # F-203-8
CODE
Lot #: 35-105, expiration date: 15-07-2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kadouri International Foods, Inc., Brooklyn, NY, by letter and press release on December 12, 2007.
Manufacturer: Cevdet Aksut Ve Ogull. Koll. Sti., Nazilli, Turkey. Firm initiated recall is complete.
REASON
The product contained undeclared sulfites based on sampling and analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
1,398 cartons
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Stirrings Mojito Rimmer Cocktail Garnish, 3.5 oz. (99g). UPC 80999 00046 Ingredients: Sugar, Citric Acid, Spearmint An all natural blend of confections for the mouth of your mojo, Recall # F-204-8
CODE
Best by Codes: 102708; 103008; 112308; 120108; 120408; 010309
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stirrings, LLC, Fall River, MA, by press release and letter dated August 30, 2007.
Manufacturer: Van de Vries Spice Corporation, Avenel, NJ. Firm initiated recall is ongoing.
REASON
Product has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
34,710/3.5 oz.
DISTRIBUTION
Nationwide and UK

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II

___________________________________
PRODUCT 
Crab cakes packed five per clear plastic bag with stick-on label reading in part: "CRAB CAKES***Ingredients:***bread crumbs***" Ten bags per cardboard case labeled in part: "Pacific Seafood 142262 Crab Cakes 50/3 oz Net Wt 9.4 lbs FZ Pack Date: Sept. 27, 2007***", Recall # F-191-8
CODE
"Pack Date: Sept. 27, 2007" and all earlier pack dates back to and including June 14, 2007 for the crab cakes
RECALLING FIRM/MANUFACTURER
Pacific Seafood Co., Inc., Clackamas, OR, by telephone on December 11, 2007 and December 12, 2007. Firm initiated recall is complete.
REASON
The product label does not declare wheat as a sub-ingredient of bread crumbs.
VOLUME OF PRODUCT IN COMMERCE
358 cases
DISTRIBUTION
OR, WA, CA, NV and NM
___________________________________
PRODUCT 
Albacore Tuna Penne. Penne rigate pasta, Albacore tuna, sun-dried tomato pesto, chopped basil lemon zest, parmesan cheese, petite peas and sweet piquante peppers. Delivered Every Day. Net Weight 8.8 oz (249 g). Made Exclusively for Starbucks  Coffee Company, All Rights Reserved. FOO-994 NA1403R01, Recall # F-192-8
CODE
Made Daily Enjoy By 02 06 and 02 07
RECALLING FIRM/MANUFACTURER
Gretchen’s Shoebox Express, Seattle, WA, by telephone and e-mail on February 6, 2008. Firm initiated recall is complete.
REASON
Product contains undeclared wheat.
VOLUME OF PRODUCT IN COMMERCE
725
DISTRIBUTION
WA, OR

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS I

___________________________________
PRODUCT 
a) Zencore Tabs All Natural Male Enhancement Dietary Supplement, For Maximum
    Sexual Performance, packaged in a 2-count blister in a cardboard package, UPC Code
    for Individual Packet 859197001013 UPC Code for Display Box 859197001006;
    Recall # D-156-2008;
b) Encore Tabs For Maximum Sexual Performance All Natural Male Enhancement
    Dietary Supplement, packaged in a 2-count blister in a cardboard package,
    UPC Code for Individual Packet 859197001013 UPC Code for Display Box
    859197001006; Recall # D-157-2008
CODE
a) Lot Code: ZT500 (EXP 12/09), ZT010207 (EXP 12/09), ZTS100 (EXP 04/07);
b) Lot Code: 0C85
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bodee LLC, Century City, CA, by press release on August 31, 2007 and November 21, 2007 and letters via e-mail on September 14, 2007 and a 2nd recall letter dated December 7, 2007.
Manufacturer: North West Marketing Co., Inc., Brea, CA. Firm initiated recall is ongoing.
REASON
Unapproved New Drug; product found to contain an undeclared analog of an active ingredient used in a FDA approved product to treat erectile dysfunction.
VOLUME OF PRODUCT IN COMMERCE
962,627 units. Each unit contains 2 capsules
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II

___________________________________
PRODUCT 
a) Heparin Sodium Injection USP, 1000 units/1 mL, Each mL contains heparin sodium
    1000 USP units Sodium Chloride 8.6 mg Benzyl Alcohol 0.01 in water for injection,
    in 10 mL Multiple Dose Vial for IV or SC USE (vial) and 25 x 10 mL Multiple Dose
    Vials for Intravenous or Subcutaneous Use. (pack), Rx only, NDC 0641244045
    (on pack) NDC 0641244041 (on vial), Recall # D-159-2008;
b) Heparin Sodium Injection USP 1000 USP units/1mL, 30 mL multi dose vial
    For IVor SC use (vial) and 25 x 30 mL multi dose vials For IVor SC use (pack),
    Rx only NDC 0641245045 (on pack); NDC 0641245041 (on vial),
    Recall # D-160-2008
CODE
a) Lots numbers: 107054, Exp 10/2009; 117085, Exp 11/2009;
b) Lot numbers: 047056, Exp. 10/2008; 097081; Exp 09/2009; 107024, Exp 10/2009; 107064, Exp. 10/2009; 107066; Exp. 10/2009; 107074, Exp. 10/2009; 107111, Exp 10/2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters on January 17, 18, 22, 23, and January 24, 2008.
Manufacturer: Baxter Healthcare Corp., Cherry Hill, NJ. Firm initiated recall is ongoing.
REASON
Reports of Adverse Events; Increase of adverse patient reactions following the administration of certain lots of heparin at Dialysis Centers.
VOLUME OF PRODUCT IN COMMERCE
1,472,100 vials
DISTRIBUTION
Nationwide, Germany, Guam and American Samoa
___________________________________
PRODUCT 
a) INTERMUNE lnfergen Interferon alfacon-1, A recombinant consensus alpha
    interferon derived from E. coli, 9 mcg/0.3 mL, NDC 64116-039-06, For
    Subcutaneous Use Only Sterilie Solution - No preservatives, 6 - 0.3 mL Single-Use
    Vials, Recall # D-161-2008;
b) INTERMUNE lnfergen Interferon alfacon-1, A recombinant consensus alpha
    interferon derived from E. coli, 15 mcg/0.5mL, NDC 64116-031-06, For
    Subcutaneous Use Only Sterilie Solution - No preservatives, 6 - 0.5 mL Single-Use
    Vials, Recall # D-162-2008
CODE
a) Lot Codes: 1) 0 P057622A (original Exp - 11/30/2007, extended Exp - 11/30/2008)
    2) P062263A (original Exp - 10/31/2007, extended Exp - 10/31/2008),
    3) P063704A (original Exp - 02/28/2008, extended Exp- 02/28/2009);
b) Lots: 1) P057613A (original Exp - 11/30/2007, extended Exp - 11/30/2008) - 4,088
    units distributed
    2) P057614A (original Exp - 11/30/2007, extended Exp - 11/30/2008) - 4,818 units
    3) P057615A (original Exp - 11/30/2007, extended Exp - 11/30/2008) - 5,416 units
    4) P057619A (original Exp - 12/30/2007, extended Exp - 12/30/2008) - 2,431 units
    5) P057620A (original Exp - 11/30/2007, extended Exp - 11/30/2008) - 5,760 units
    6) P063699A (original Exp - 12/30/2007, extended Exp - 12/30/2008) - 3,160 units
    7) P065733A (original Exp - 02/28/2008, extended Exp - 02/28/2009) - 44 units
    8) P065734A (original Exp - 02/29/2008, extended Exp - 02/29/2009) - 761 units
    9) P065737A (original Exp - 03/30/2008, extended Exp - 03/30/2009) - 1 unit
   10) P066895A (original Exp - 03/30/2008, extended Exp - 03/30/2009) - 1 unit
   11) P068076A (original Exp - 03/30/2008, extended Exp - 03/30/2009) - 8 units
   12) P071927A (original Exp - 11/30/2007, extended Exp - 11/30/2008) - 6,076 units
   13) P073211A (original Exp - 12/31/2007, extended Exp - 12/31/2008) - 1,033 units
   14) P073966A (original Exp - 03/30/2008, extended Exp - 03/30/2009) - 3,777 units
   15) P077786A (original Exp - 04/30/2008, extended Exp - 04/30/2009) - 5 units
   16) P077787A (original Exp - 04/30/2008, extended Exp - 04/30/2009) - 7 units
RECALLING FIRM/MANUFACTURER
Recalling Firm: Valeant Pharmaceuticals International, Aliso Viejo, CA, by letters on December 5, and December 6, 2007.
Manufacturer: Amgen Inc., Thousand Oaks, CA. Firm initiated recall is ongoing.
REASON
Labeling; incorrect expiration date on vial. The cartons of some lots of Infergen were previously overstickered with an extended expiration date that added an additional 12 months of shelf-life to the product. The vial labels of the product in these lots, however, were not over-stickered with the extended expiration date.
VOLUME OF PRODUCT IN COMMERCE
45,089 units
DISTRIBUTION
Nationwide

___________________________________
PRODUCT 
OPTIMUM OYSTER SHELL CALCIUM 250 mg with Vitamin D Dietary Supplement, 100 count bottles, Product code 6460-100-01, Recall # D-163-2008
CODE
Lot # 334830 Expiration 06/08
RECALLING FIRM/MANUFACTURER
Magno Humphries Inc., Tigard, OR, by letter on February 8, 2008. Firm initiated recall is ongoing.
REASON
Presence of Foreign Tablet; acetominophen tablet was found.
VOLUME OF PRODUCT IN COMMERCE
154 bottles
DISTRIBUTION
OR, WA, MO

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III

___________________________________
PRODUCT 
a) PREMPRO® (conjugated estrogens/medroxyprogesterone acetate tablets)
    0.3 mg/1.5 mg, Rx only, One carton contains 3 EZ-DIAL® Dispensers of 28 tablets
    each: NDC 0046-0938-09. One EZ-DIAL® Dispenser (NDC 0046-0938-08)
    contains 28 cream PREMPRO® Tablets containing 0.3 mg of the conjugated
    estrogens found in PREMARIN® and 1.5 mg of medroxyprogesterone acetate,
    Recall # D-164-2008;
b) PREMPRO® (conjugated estrogen/medroxyprogesterone acetate tablets) 0.45
    mg/1.5 mg, Rx only, One carton contains 3 EZ-DIAL® Dispensers of 28 tablets
    each: NDC 0046-0937-09. One EZ-DIAL® Dispenser (NDC 0046-0937-08)
    contains 28 gold PREMPRO® Tablets containing 0.45 mg of the conjugated
    estrogens found in PREMARIN® and 1.5 mg of medroxyprogesterone acetate,
    Recall # D-165-2008
CODE
a) Lots B77279 and B78846 (exp. June 2008);
b) Lot C13834 (exp. September 2008)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wyeth Pharmaceuticals, Philadelphia, PA,  by letters dated January 24, 2008.
Manufacturer: Wyeth Pharmaceuticals, Inc., Rouses Point, NY. Firm initiated recall is ongoing.
REASON
Lot failed dissolution specification for NDA conjugated estrogens.
VOLUME OF PRODUCT IN COMMERCE
0.3/1.5 mg tablets: 49,488 cartons of 3 Dispensers; 0.45/1.5 mg tablets: 12,336 cartons of 3 Dispensers
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS II

___________________________________
PRODUCT 
Source Plasma, Recall # B-0741-08
CODE
Units: HRFMGK, HRFLYG, HRFKZY, HRFKNH, HRFJQD, HRFJHG, HRFRKH, HRFQZM, HRFQNZ, HRFPXR, HRFPVY, HRFNLF, and HRFNFJ
RECALLING FIRM/MANUFACTURER
ZLB Plasma, Lawton, OK, by facsimile on December 28, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose scheduled physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
IL and Germany
___________________________________
PRODUCT 
a) Red Blood Cells Leukocytes Reduced, Recall # B-0742-08;
b) Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0743-08
CODE
a) 04GF60953;
b) 04GF63137
RECALLING FIRM/MANUFACTURER
ARC Blood Services, New England Region, Dedham, MA, by facsimile on July 11, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on residing in an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MA and ME
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0856-08
CODE
72C101429
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc., Huntsville, AL, facsimile on July 25, 2007. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0857-08
CODE
72C179417
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc., Huntsville AL, by facsimile on July 18, 2007.  Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0858-08
CODE
Unit: 71X342275
RECALLING FIRM/MANUFACTURER
Lifesouth Community Blood Centers Inc - Birmingham Region, Birmingham, AL, by facsimile on February 9, 2006. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0859-08
CODE
Units: 71Z879418, 71Z879431
RECALLING FIRM/MANUFACTURER
Lifesouth Community Blood Centers Inc - Birmingham Region, Birmingham AL, by facsimile on June 28, 2006. Firm initiated recall is complete.
REASON
Blood products, which were leukoreduced greater than 72 hours after collection, were distributed
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0866-08
CODE
Unit; 163926420 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER
Blood Systems Inc/dba United Blood Services, Meridian, MS, by telephone on March 9, 2007. Firm initiated recall is complete.
REASON
Blood products, which were possibly contaminated with Corynebacterium species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0867-08
CODE
Unit: 208476427 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER
Blood Systems Inc, Lafayette, LA, by telephone on April 26, 2007. Firm initiated recall is complete.
REASON
Blood products, which were possibly contaminated with Corynebacterium species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
LA. TX
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0872-08
CODE
Unit: S92458
RECALLING FIRM/MANUFACTURER
Central Illinois Community Blood Center, Springfield, IL, by facsimile on September 10, 2007 and by follow-up letter dated September 10, 2007. Firm initiated recall is complete.
REASON
Blood product, which was labeled as leukoreduced, but was not tested to verify the White Blood Cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0883-08
CODE
Units: 71T412891; 71T602674; 71T423997; 71T67963X; 71T006932; 71T012441; 71T215938; 71T003536
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile on January 2, 2007. Firm initiated recall is complete.
REASON
Blood products, which were not manufactured in accordance to the manufacturer's instructions for leukocyte reduction, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
FL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0884-08
CODE
Units: 71X640499, 72C433762
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by facsimile on August 26, 2007. 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
GA
___________________________________
PRODUCT 
a) Red Blood Cells Leukocytes Reduced, Recall # B-885-08;
b) Platelets, Recall # B-0886-08
CODE
a) Units: 5802640, 5756352, 5778260, and 5801777;
b) Units: 5802640, 5801777, 5744015, and 5756352
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile on April 6, 2006.
Firm initiated recall is complete.
REASON
Blood products, were manufactured from units of Whole Blood that was unsuitable, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 components
DISTRIBUTION
TX
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0893-08
CODE
Units: 71T813625 and 71T814799
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile on January 29, 2007. Firm initiated recall is complete.
REASON
Blood products, which were not manufactured in accordance to the manufacturer's instructions for leukocyte reduction, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT 
a) Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0896-08;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0897-08;
c) Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0898-08;
d) Whole Blood CPD, Recall # B-0899-08;
e) Red Blood Cells, Recall # B-0900-08
CODE
a) Units: 200405292 (Parts 1 & 2), 200405527 (Parts 1 & 2), 200405531 (Parts 1 & 2),
    200405540 (Parts 1 & 2), 200405545 (Parts 1 & 2), 200405550 (Parts 1 & 2),
    200407714 (Parts 1 & 2), 200407748 (Parts 1 & 2), 200407749 (Parts 1 & 2),  
    200407754 (Parts 1 & 2), 200409595 (Parts 1 & 2), 200409597 (Parts 1 & 2),
    200411397 (Part 1), 200414857 (Parts 1 & 2), 200414868 (Parts 1 & 2), 200415214
    (Parts 1 & 2), 200415447 (Parts 1 & 2), 200415454 (Parts 1 & 2), 200415458 (Parts 1
    & 2), 200415459 (Parts 1 & 2), 200415469 (Parts 1 & 2), 200415591 (Parts 1 & 2),
    200416853 (Parts 1 & 2), 200416858 (Parts 1 & 2), 200416861 (Parts 1 & 2),
    200418284 (Parts 1 & 2), 200421535 (Parts 1 & 2), 200421751 (Parts 1 & 2),
    200421761 (Parts 1 & 2), 200425566 (Parts 1 & 2), 208478162 (Parts 1 & 2),
    208478165 (Parts 1 & 2), 208478166 (Parts 1 & 2), 200419609 (Part 2);
b) Units: 200405282, 200405283, 200405287, 200405291, 200405295, 200405528,
    200405537, 200405539, 200405543, 200405548, 200405549, 200405551, 200405556,
    200405559, 200407683, 200407684, 200407690, 200407693, 200407695, 200407696,
    200407709, 200407710, 200407712, 200407720, 200407722, 200407746, 200407747,
    200407751, 200407755, 200407756, 200407760, 200407762, 200407763, 200411395,
    200414727, 200414856, 200414858, 200414860, 200414861, 200414862, 200414863,
    200414864, 200414865, 200414866, 200414867, 200414872, 200414873, 200414875,
    200415206, 200415208, 200415209, 200415219, 200415230, 200415236, 200415240,
    200415241, 200415243, 200415251, 200415253, 200415390, 200415449, 200415452, 
    200415455, 200415460, 200415463, 200415464, 200415471, 200415473, 200415475,  
    200415501, 200415507, 200415508, 200415513, 200415515, 200415517, 200415522,
    200415524, 200415527, 200415530, 200415533, 200415563, 200415566, 200415571,
    200415573, 200415579, 200415586, 200415589, 200415594, 200415595, 200415598,
    200416855, 200416864, 200416866, 200416867, 200418206, 200418279, 200418280,
    200418281, 200418285, 200418286, 200418287, 200418288, 200418289, 200419606,
    200419610, 200419612, 200421205, 200421209, 200421211, 200421213, 200421219,
    200421221, 200421223, 200421224, 200421225, 200421478, 200421480, 200421530,
    200421533, 200421539, 200421540, 200421543, 200421544, 200421545, 200421754,
    200421755, 200421766, 200421769, 200421781, 200421785, 200421787, 200421788,
    200421790, 208478161, 208478164, 208478167, 208478172, 200405286, 200405293,
    200407764, 200415250, 200415518, 200416857, 200421778;
c) Unit: 208478169;
d) Unit: 200405294;
e) Units: 200405284, 200405288
RECALLING FIRM/MANUFACTURER
Blood Systems Inc, Lafayette, LA, by telephone on October 5, 2007. Firm initiated recall is complete.
REASON
Blood products, for which the sterility may have been compromised, were distributed.
VOLUME OF PRODUCT IN COMMERCE
214 units
DISTRIBUTION
LA, NC, NJ
___________________________________
PRODUCT 
Fresh Frozen Plasma, Recall # B-0901-08
CODE
Unit: 71R218865
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc - East Alabama Region, Opelika, AL, by facsimile on May 16, 2006.
REASON
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
___________________________________
PRODUCT 
Red Blood Cells Apheresis Leukocytes Reduced, Recall # B-0905-08
CODE
Unit: 5978523
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile on April 5, 2007. Firm initiated recall is complete.
REASON
Blood product, which was labeled as leukoreduced, but was not tested to verify the White Blood Cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

___________________________________
PRODUCT 
Red Blood Cells Apheresis Leukocytes Reduced, Recall # B-0907-08
CODE
Unit: 5917374 (Parts A & B)
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile on May 30, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who provided post donation information concerning a previous positive test for the human immunodeficiency virus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0915-08
CODE
Units: 2150346, 2151439
RECALLING FIRM/MANUFACTURER
Bergen Community Regional Blood Center, Paramus, NJ, by letter on March 8, 2006. Firm initiated recall is complete.
REASON
Blood products, with a low platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NJ, NY
___________________________________
PRODUCT 
a) Red Blood Cells, Recall # B-0917-08;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0918-08;
c) Plasma Frozen, Recall # B-0919-08;
d) Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0920-08
CODE
a) Units: 04G89928; 04E05730;
b) Units: 04L89860; 04LQ74775; 04G90614; 04LC40536; 04KT95900;
c) Units: 04G90614; 04J91124;
d) Unit: 04J91124;
RECALLING FIRM/MANUFACTURER
ARC Blood Services, New England Region, Dedham, MA, by telephone , facsimile, letter and electronic mail on June 21, 2007 and June 26, 2007. 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
10 units
DISTRIBUTION
MA, NY, NH, ME, VT, CA
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0922-08
CODE
Unit: 72C04768X
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile on August 13, 2007. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0923-08
CODE
Unit: 72C249239
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile on July 12, 2007. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT 
a) Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-0926-08;
b) Platelets Pheresis Leukocytes Reduced, Recall # B-0927-08
CODE
a) Units: 004P63177 Part1; 004P63177 Part 2;
b) Units: 004GP66536 Part 1; 004GP66536 Part 2
RECALLING FIRM/MANUFACTURER
ARC Blood Services, New England Region, Dedham, MA, by letter on 03/27/2007.
Firm initiated recall is complete.
REASON
Blood products, which did not meet the acceptable product specifications for release, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
VT, MA, NY

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS III

___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0868-08
CODE
Units: 163929653, 163925600
RECALLING FIRM/MANUFACTURER
Blood Systems Inc/dba United Blood Services, Meridian, MS, by telephone on May 23, 2007. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly tested for Lewis-b red cell antigen, but were labeled as negative for Lewis-b antigen, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MS
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0869-08
CODE
Unit: 71R510796
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by facsimile on February 21, 2006. Firm initiated recall is complete.
REASON
Blood product, which was not returned to controlled storage within eight hours following collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
a) Red Blood Cells Leukocytes Reduced, Recall # B-0870-08;
b) Fresh Frozen Plasma, Recall # B-0871-08
CODE
a) 71R631686, 71R639414, 71R639426
b) 71R639414
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by facsimile on February 22, 2006. Firm initiated recall is complete.
REASON
Blood products, which were not returned to controlled storage within eight hours following collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
AL
___________________________________
PRODUCT 
Platelet Pheresis Leukocytes Reduced, Recall # B-0873-08
CODE
Unit: 8107459
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Services, Elyria, OH. by letter dated June 1, 2004. Firm initiated recall is complete.
REASON
Platelets, which were not stored under continuous agitation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0888-08
CODE
Unit: 027KF16549
RECALLING FIRM/MANUFACTURER
ARC Greater Alleghenies, Johnstown, PA, by telephone on October 26, 2007 and by letter on October 29, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from donors with unacceptable hematocrit determinations, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
___________________________________
PRODUCT 
a) Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0890-08;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0889-08
CODE
a) Unit: 5979392;
b) Unit: 5942576
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile on February 27, 2007. Firm initiated recall is complete.
REASON
Blood products, which may have been exposed to unacceptable storage temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT 
Platelets, Pheresis, Leukocytes Reduced, Recall # B-0891-08
CODE
Units: 1543032 (split)
RECALLING FIRM/MANUFACTURER
Indiana Blood Center, Indianapolis, IN, by telephone on August 23, 2007 and by letter on October 8, 2007. Firm initiated recall is complete.
REASON
Blood products, with incomplete anti-HTLV testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IN
___________________________________
PRODUCT 
Red Blood Cells, Recall # B-0892-08
CODE
Unit: 72C156963
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, Fl, by facsimile dated August 15, 2007. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which an associated blood component contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0902-08
CODE
Unit: 71R973858
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Birmingham Region, Birmingham, AL, by facsimile on April 22, 2006. Firm initiated recall is complete.
REASON
Blood product, labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
Red Blood Cells, Recall # B-0903-08
CODE
Unit: 168878688
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc/dba United Blood Services, Meridian MS, by telephone on December 27, 2006.
Manufacturer: Blood Systems Inc/dba United Blood Services, Hattiesburg, MS. Firm initiated recall is complete.
REASON
Blood product, which may have reached an unacceptable temperature during shipment, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MS
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0906-08
CODE
Unit #: 5988171
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile on April 13, 2007. Firm initiated recall is complete.
REASON
Blood product, incorrectly labeled as to red cell antigen type, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT 
Source Plasma, Recall # B-0916-08
CODE
Units: 04PWIG0150, 04PWIG0725
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services LP, Deerfield, IL, by facsimile on January 14, 2005.
Manufacturer: Biolife Plasma Services, Stevens Point, WI. Firm initiated recall is complete.
REASON
Blood products, which were not quarantined subsequent to receiving information regarding a post donation illness, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT 
Recovered Plasma, Recall # B-0921-08
CODE
Units: 04G89928; 04L89860; 04LQ74775; 04E05730; 04LC40536; 04KT95900
RECALLING FIRM/MANUFACTURER
ARC Blood Services, New England Region, Dedham, MA, by telephone , facsimile, letter and electronic mail on June 21, 2007 and June 26, 2007. 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
6 units
DISTRIBUTION
MA, NY, NH, ME, VT, CA

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS II

___________________________________
PRODUCT 
Intuitive Surgical, daVinci S Surgical System, Model Number: IS2000, A5.1 P1 and A5.0 P5 software level, Surgical Endoscopic Instrument Control System, Model Number: IS 2000, Software Revision Numbers: A5.0 P5 and A5.1 P1, Recall # Z-0079-2008
CODE
System Numbers: all starting with "SG"-- 043, 156, 088, 128, 065, 104, 106, 132, 019, 051, 058, 083, 092, 096, 165, 170, 098, 105, 157, 050, 112, 125, 138, 149, 034, 061, 121, 030, 044, 052, 054, 068, 069, 123, 147, 151, 013, 113, 152, 014, 049, 077, 134, 136, 066, 085, 091, 129, 087, 139, 140, 042, 047, 031, 089, 017, 021, 022, 115, 116, 137, 155, 168, 169, 041, 095, 119, 163, 164, 114, 057, 060, 101, 117, 122, 029, 020, 028, 056, 093, 094, 141, 103, 072, 084, 011, 024, 036, 053, 059, 144, 145, 146, 026, 074, 154, 018, 027, 055, 070, 109, 110, 111, 118, 120, 135, 099, 232, 033, 082, 148, 012, 015, 039, 067, 102, 124, 161, 166, 037, 097, 040, 064, 090, 127, 133, 025, 062, 143, 160, 038, 153, 035, 071, 073, 107, 158, 167, 086, 131, 063, 080, 078, 159, 076, 045, 081, 108, 150, 046, 075, 130, 004, 005, 006, 007, 010, 048, and 126
RECALLING FIRM/MANUFACTURER
Intuitive Surgical, Inc., Sunnyvale, CA, by letter and software upgrade beginning on March 30, 2007. Firm initiated recall is ongoing.
REASON
System Lock-Up: Software anomalies could cause product failure during use, or on start-up. System transitions to a safe "soft-lock" state.
VOLUME OF PRODUCT IN COMMERCE
154 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
a) Intuitive brand da Vinci S Surgical System, Endoscopic Instrument Control System,
    Model IS1200 with Isolation Transformer (P/N: 952012) and Vision Cart (Model
    VS1000), Recall # Z-0151-2008;
b) Intuitive brand da Vinci S Surgical System, Endoscopic Instrument Control System,
    Model IS2000 with Isolation Transformer (P/N: 952012) and Vision Cart (Model:
    VS2000), Recall # Z-0152-2008
CODE
a) Lots: SG015, SG053, SG060, SG067, SG096, SG126, SG151, SG164, SG201,
    SG245, SG267, SG269, SG270, SG271, SG272, SG273, SG275, SG276, SG278, 
    SG280, SG282, SG283, SG285, SG286, SG287, SG288, SG289, SG290, SG291,
    SG292, SG293, SG294, SG295, SG296, SG297, SG298, SG299, SG300, SG301,
    SG302, SG303, SG309, SG312, SG313, SG314, SG315, SG316, SG317, SG318,
    SG319, SG323, SG324, SG325, SG326, SG329, and SG330;
b) Lots: SG015, SG053, SG060, SG067, SG096, SG126, SG151, SG164, SG201,
    SG245, SG267, SG269, SG270, SG271, SG272, SG273, SG275, SG276, SG278,
    SG280, SG282, SG283, SG285, SG286, SG287, SG288, SG289, SG290, SG291,
    SG292, SG293, SG294, SG295, SG296, SG297, SG298, SG299, SG300, SG301,
    SG302, SG303, SG309, SG312, SG313, SG314, SG315, SG316, SG317, SG318,
    SG319, SG323, SG324, SG325, SG326, SG329, and SG330
RECALLING FIRM/MANUFACTURER
Intuitive Surgical, Inc., Sunnyvale, CA, by letter on October 4, 2007 and e-mail on October 5, 2007. Firm initiated recall is ongoing.
REASON
Under-Rated Fuses--The Firm may have installed incorrect fuses. The daVinci Surgical System Vision Cart's isolation transformer requires a 10A fuse for 115V operation or a 5A fuse for 230V operation. Operation of this product with the use of an under-rated fuse will result in failure of the fuse and a loss of power to the vision cart, including the loss of power to any ancillary equipment that may be connected to the vision cart isolation transformer.
VOLUME OF PRODUCT IN COMMERCE
63 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
a) Hill-Rom Affinity Birthing Bed, Model P3600, Recall # Z-0581-2008;
b) Hill-Rom Affinity Birthing Bed, Model P3600, Recall # Z-0582-2008;
c) Hill-Rom Affinity Birthing Bed, Model P3700A, Recall # # Z-0583-2008;
d) Hill-Rom Affinity Birthing Bed, Model P3700B. Note: Not distributed in the U.S.,
    Recall # Z-0584-2008
CODE
All units (**Affinity beds manufactured with serial number 1290AA7395 or greater are not impacted by this correction.)
RECALLING FIRM/MANUFACTURER
Hill-Rom, Inc., Batesville, IN, by letter dated November 21, 2007. Firm initiated recall is ongoing.
REASON
Hole/opening on the labor bar -- Amputation of a finger could result, if a finger is placed into the opening, as the hole/opening creates a shear point when the mechanism is activated.
VOLUME OF PRODUCT IN COMMERCE
32,379 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
a) Nova - EZ CHEM Creatinine Meter: SRS Versions 5.1 and 5.2 P/N 9600,
    Recall # Z-0724-2008;
b) Nova - EZ CHEM Control Solution P/N 9612, Recall # Z-0725-2008;
c) Nova - EZ CHEM Linearity Solution P/N 9618, Recall # Z-0726-2008
CODE
a) Serial Numbers: 39000207226 39000207229 39000207256 39000207270
    39000307226 39000307229 39000307256 39000307270 39000407229
    39000407270 39000507226 39000507229 39000507270 39000607229
    39000607270 39000707229 39000707270 39000807226 39000807229
    39000907270 39001007229 39001007256 39001007270 39001107229
    39001107256 39001107270 39001207256 39001207270 39001307256
    39001307270 39001407256 39001407270 39001507256 39001507270
    39001607256 39001607270 39001707256 39001707270 39001807256
    39001807270 39001907256 39001907270 39002007256 39002007270
    39002107256 39002107270 39002207256 39002207270 39002307256
    39002307270 39002407256 39002407270 39002507256 39002507270
    39002607256 39002707256 39002907256 39003007256 39003107256
    39003207256 39003307256 39006207249 39006307249 39006407249
    39006507249 39006607249 39006607263 39006707249 39006707263
    39006807249 39006807263 39006907249 39006907263 39007007263
    39007107263 39007207263 39007307249 39007407249 39007507249
    39007807249 39007907249 39008007249 39008107249 39008207249
    39008307249 39008407249 39008507249 39008607249 39009607263
    39009707263 39009807263 39009907263 39010007263 39010507275
    39010607275 39010707275 39010807275 39010907275 39011007275
    39011107275 39011207275 39011507275 39011607275 39011707275
    39011807275 39011907275 39012007275 39012107275 39012307275
    39012807275 39012907275 39013007275 39013207275 39013307275
    39013407275 39013507275 39013607275 39013707275 39013807275
    39013907275 39014107275 39014207275 39014307275 39014407275
    39014507275 39014607275 39014707275 39014807275 39014907275
    39015007275 39015107275 39015207275 39015307275;
b) Lot Numbers: 4207225241 and 4207261241;
c) Lot Numbers: 4307236990 and 4307270990
RECALLING FIRM/MANUFACTURER
Nova Biomedical Corporation, Waltham, MA, by letter dated November 19, 2007. Firm initiated recall is complete.
REASON
Incorrect Results – Creatinine results were lower than the laboratory reference method.
VOLUME OF PRODUCT IN COMMERCE
133 meters
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Kodak DirectView Model DR 3000 System, Stationary X-ray System; Catalog #s     6551360, 6551386, 6552152, 6552160, 6551345, 6552319, 6552335, Recall # Z-0731-2008;
CODE
Serial Numbers: 30000032, 30001001, 30001004, 30001006, 30001016, 30001020, 30001024, 30001036, 30001038, 30001040, 30001039, 30001042, 30001048, 30001043, 30001049, 30001044, 30001045, 30001046, 30001021
RECALLING FIRM/MANUFACTURER
Recalling Firm: Carestream Heath Inc., Rochester, NY, by letters on December 21, 2007.
Manufacturer: Kodak Electronic Products (Shanghai) Co., Ltd., Shanghai, Pudong, China. Firm initiated recall is complete.
REASON
Unintended Positioner Movement - The U-Arm Positioner starts to move 1) without command from the operator and/or 2) can unexpectedly start movement if the system is powered down and re-energized after a collision has occurred with the Quantum Table.
VOLUME OF PRODUCT IN COMMERCE
19 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Siemens Syngo Imaging System with VB30A version of software. Model Number: 10014063, Recall # Z-0732-2008
CODE
Serial Numbers: 1005, 1065, 1076, 1112, 1202, 1242, 1269, 1278, 1279, and 1282
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter on November 27, 2007.
Manufacturer: Siemens Medical Solutions, Erlangen, Germany. Firm initiated recall is ongoing.
REASON
Inconsistent data - A buffer overflow may occur between information system and picture system if the system experiences a high load. (e.g. RIS/PACS communication is unusually high)
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
a) Siemens Primus Linear Accelerator System,
    PRIMART MX Linear Accelerator System;
    PRIMUS Mid, Part Number: 1940035 and
    PRIMART MX, Part Number: 5500371,
    Recall # Z-0850-2008;
b) Siemens Mevatron Linear Accelerator Systems:
    KD2, K 7767, K 8067, KD, KDS and KDS2,
    Mevatron KD2, Part No.: 1940753;
    Mevatron KD2, Part No.: 08515520;
    Mevatron KD2-Part No.: 9822685;
    Mevatron K 7767, Part No.: 5694302;
    Mevatron K 8067, Part No.: 5694401;
    Mevatron KD, Part No.: 8319857;
    Mevatron KDS, Part No.: 9401522;
    Mevatron KDS2, Part No.: 9411588; and
    Mevatron KDS2, Part No.: 9822693,
    Recall # Z-0851-2008;
c) Siemens Mevatron Linear Accelerator Systems;
    Mevatron M 7440, Part No.: 5672977;
    Mevatron M 6700, Part No.: 5693908;
    Mevatron M 6730, Part No.: 5694005;
    Mevatron M 7140, Part No.: 5694104;
    Mevatron M 7400, Part No.: 5694153;
    Mevatron M 7445, Part No.: 5694203;
    Mevatron M 6300, Part No.: 8317000;
    Mevatron M 6740, Part No.: 8319758;
    Mevatron MD, Part No.: 8319808;
    Mevatron ME, Part No.: 8490005;
    Mevatron MDX, Part No.: 8496200;
    Mevatron M2 6300, Part No.: 9401316;
Mevatron M2 6700, Part No.: 9401407;
Mevatron M2 6740, Part No.: 9401506;
Mevatron MD2, Part No.: 09401654; and
Mevatron MDX-2, Part No.: 9401746, Recall # Z-0852-2008
CODE
All Serial Numbers up to Serial Number: 3532
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Concord, CA, July 27, 2007 by visits. Firm initiated recall is ongoing.
REASON
Door Hinge failures; loose or falling off (Stationary Structure Doors).
VOLUME OF PRODUCT IN COMMERCE
1,284 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS III

___________________________________
PRODUCT 
Invictus-- Bionime Rightest Blood Glucose Monitoring System MODEL: GM300, Recall # Z-0728-2008
CODE
Lot Numbers: 1FF19C0001 to 1FF19C0020, 1FF05C0001 to 1FF05C5000, 2FH15C0001 to 2FH15C4800, 230GBB0001 to 230GBB0050, 230GFF0001 to 230GFF0600, 230GFF0601 to 230GFF1200, 230GFF1201 to 230GFF1996, 230GHC0001 to 230GHC3204, 230GHC3205 to 230GHC4204, 230GHJ0001 to 230GHJ5000, 230GHJ5001 to 230GHJ6992, and 230GIB0001 to 230GIB3008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Invictus Scientific Inc., San Diego, CA, by letter beginning on November 20, 2007.
Manufacturer: Bionime Corporatio, Dall City, Taiwan. Firm initiated recall is ongoing.
REASON
Abnormal Memory Recall: When the meter is fixed in 12 hour mode, the time frame display of all memory data will be shown incorrectly as AM or PM depending on when the user is recalling the memory stored in the meter. This will cause confusion as to when the last test was taken.
VOLUME OF PRODUCT IN COMMERCE
21,070
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
a) Centurion Healthcare Products Laceration Tray, sterile; The primary kit is labeled as
    containing 1 needle, 21G x 1-1/2", among other components, however some kits may
    contain a 21Gx1" needle. The label on the Kendall Monoject Magellan 21G Safety
    Needle itself is the correct size. (Reorder SUT8805A), Recall # Z-0729-2008;
b) Centurion Healthcare Products Laceration Tray, sterile; The primary kit is labeled as
    containing 1 needle, 21G x 1-1/2", among other components, however some kits may
    contain a 21Gx1" needle. The label on the Kendall Monoject Magellan 21G Safety
    Needle itself is the correct size. (Reorder SUT8805A), Recall # Z-0730-2008
CODE
a) Lot Number: 908207;
b) Lot Number: 907097
RECALLING FIRM/MANUFACTURER
Tri-State Hospital Supply Corporation, Howell, MI, by letter on October 25, 2007. Firm initiated recall is complete.
REASON
Incorrect Needle size: Some of the kits contain a 1 inch 21G needle instead of the 1-1/2 inch 21G needle specified on the kit label.
VOLUME OF PRODUCT IN COMMERCE
436 kits
DISTRIBUTION
Nationwide
_________________________________
PRODUCT 
a) First Aid Kits, soft canvas, plastic, and metal containers holding various products to
    include ibuprofen and other first aid supplies, in various sizes. Kits include:
    Labeled with First Aid Only, Inc: Recreational Sports First Aid, Item SM-134;
    Welder's First Aid Kit, Item 253-U;
    Vehicle First Aid Kit, Item 220-0;
    On-The-Road Auto First Aid, Item FAO-310;
    Auto First Aid Essentials, Item FAO-340;
    Auto First Aid Essentials, Item FDA-532;
    Auto First Aid Essentials, Item FDA-552;
    Vehicle First Aid Kit, Item 221-U;
    Outdoor First Aid Kit, Item FAO-410;
    Outdoor First Aid Kit, Item FAO-410
    Outdoor First Aid Kit, Item FAO-420;
    Outdoor First Aid Kit, Item FAO-430;
    Outdoor First Aid Kit, Item FAO-440;
    First Aid & Survival Kit, Item FA-462;
    First Aid Kit, FAO-422-06;
    First Aid Kit, 403-PC;
    First Aid Response Kit, FA-504;
    All Purpose First Aid Kit, Item FAO-112;
    All Purpose First Aid Kit, Item FAO-122;
    All Purpose First Aid Kit, Item FAO-142;
    All Purpose First Aid Kit, Item FAO-432;
    All Purpose First Aid Kit, Item FAO-444;
    All Purpose First Aid Kit, Item FAO-452;
    First Aid Essentials, Item FAO-130;
    First Aid Essentials, Item FAO-132;
    First Aid Essentials, Item FAO-134;
    First Aid Essentials, Item FAO-422;
    First Aid Essentials, Item FAO-428;
    First Aid Essentials, Item FAO-432;
    First Aid Essentials, Item FAO-442;
    Refillable First Aid Kit, FAO-490C;
    Refillable First Aid Kit, FAO-490C;
    Brite Stock first aid kits; Item FAO-130-BS; Item FAO-132-BS;
    Item FAO-134-BS;
    Lake & Trail Outdoor First Aid Kit, Item MJR-420;
    Lake & Trail Outdoor First Aid Kit, Item MJR440;
    First aid kits labeled: meijer First Aid Kit, Item MJR-130;
    meijer First Aid Kit, Item MJR-442;
    First Aid Kits labeled FIRST AID Exchange:
    General Purpose Home First Aid Kit,    Item 2800;
    Auto First Aid Kit, Item 2825;
    First Aid Kit: All purpose First Aid Kit, Item FAO-132-MS First Aid Kit;
    Ready Solutions: First Aid Kit, Item 90030;
    First Aid Kit labeled NORTHERN Safety Co., Inc.:
    First Aid Kit, Item FAO-442-NS;
    First Aid Kit: Grafco First Aid Kit, Item 1799-9133
    and First Aid Kit labeled -Provided by MOTURIS LTD- Custom Kit,
    Item 9099, Recall # Z-0853-2008;
b) First Aid Only brand cabinets (typically metal wall mount) containing ibuprofen
    tablets and a variety of other first aid supplies: Item 249-0/FAO Item 249-0/P Item
    249-RK/P First Aid Exchange brand cabinet: Item 1300-FAE-0103 Item 1300-FAE-
    0108 and Item 1300-PAT-0109, Recall # Z-0854-2008; 
c) Ibuprofen tablet refills in cardboard boxes or clear plastic bags for first aid kits and
    cabinets First Aid Only, Inc., Vancouver, WA. Ibuprofen Tablets, Item A405-WIP,
    Item A405-10 Ibuprofen Tablets, Item FAE-7014;; Ibuprofen Tablets, Item H430;
    Ibuprofen Tablets, Item I431; Ibuprofen Tablets, item J432 and Ibuprofen Tablets,
    item Z6100, Recall # Z-0855-2008
CODE
a)  Lot Numbers are for kits and cabinets: C0207, C0217, C0227, C0267, C0277, C0287,
    C0297, C0307, D0027, D0037, D0047, D0057, D0067, D0097, D0107, D0117,
    D0127, D0137, D0167, D0177, D0187, D0197, D0207, D0247, D0267, E0027,
    E0047, E0077, E0087, E0177, E0187, D0227, E0297, E0307, E0317, F0017,
    F0087, F0207, F0267, G0067, G0097, G0137, G0187, G0257, H0017, H0157,
    H0167, H0237, H0277, H0287, H0297, H0307, H0317, I0047, I0057, I0107,
    I0127, I0137, I0177, I0187, I0197, I0207, I0217, I0247, I0251, I0277, I0287,
    J0017, J0037, J0047, J0087, J0097, and J0117;
b) Lot Numbers are for kits and cabinets: C0207, C0217, C0227, C0267, C0277,
    C0287, C0297, C0307, D0027, D0037, D0047, D0057, D0067, D0097, D0107,
    D0117, D0127, D0137, D0167, D0177, D0187, D0197, D0207, D0247, D0267,
    E0027, E0047, E0077, E0087, E0177, E0187, D0227, E0297, E0307, E0317,
    F0017, F0087, F0207, F0267, G0067, G0097, G0137, G0187, G0257, H0017,
    H0157, H0167, H0237, H0277, H0287, H0297, H0307, H0317, I0047, I0057,
    I0107, I0127, I0137, I0177, I0187, I0197, I0207, I0217, I0247, I0251, I0277,
    I0287, J0017, J0037, J0047, J0087, J0097, and J0117;
c) Lot Code: HA09707 (exp. 12/09)
RECALLING FIRM/MANUFACTURER
First Aid Only, Inc., Vancouver, WA, by letter dated October 10, 2007. Firm initiated recall is ongoing.
REASON
Failed USP Impurity testing: the Ibuprofen supplied by its own manufacturer, used in these first aid kits, tablet refills, and cabinets, is being recalled for failing its USP limits for impurities during stability testing.
VOLUME OF PRODUCT IN COMMERCE
72,904 kits; 2,005 cabinets; 62,302 tablets
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS:  VETERINARY MEDICINE - CLASS II

___________________________________
PRODUCT 
Pharmacia & Upjohn Quartermaster Suspension, penicillin-dihydrostreptomycin in oil, each 10-mL disposable syringe contains 1,000,000 units of Procaine Penicillin G, micronized, and 1 gram of Dihydrostreptomycin base, as Dihydrostreptomycin Sulfate, in an extended action base, packaged 144 syringes/pail, RX, NADA 055-028, Recall # V-026-2008
CODE
DC-1499 and DC-1483
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pfizer Inc., New York, NY, by email and letter dated January 8, 2008 and by letter dated January 9, 2008.
Manufacturer: West Agro Inc., Hamilton, NY. Firm initiated recall is ongoing.
REASON
Quarantined product at distributor that was out of specification (high) was inadvertently distributed.
VOLUME OF PRODUCT IN COMMERCE
772 pails DC-1499 and 240 pails DC-1483
DISTRIBUTION
IA, CO, ID, NE and TX
___________________________________
PRODUCT 
Ivermectin Liquid for Horses, 10 mg per mL, ANDA 200-202, RX, packaged in 100- and 200-ml multi-dose vials under the following brand names/labels:
1) Am Tech Group, Inc. Phoenectin, NDC 59130-680-01 (100-ml) and 59130-680-2
    (200 ml);
2) Butler Parid EQ Oral Liquid, NDC 11695-3591-1 (100 ml) and 11695-3591-2
    (200 ml);
3) Phoenix Pharmaceutical, Inc. Ivercide, NDC 57319-400-05 (100 ml) and 57319-400-
    42 (200 ml);
4) VEDCO ProMectin E, NDC 50989-484-12 (100 ml) and 50989-484-34 (200 ml),
Recall # V-027-2008
CODE
100- and 200-ml sizes: 5010014, Exp. 01/08; 5121612, Exp. 12/08; 6071103, Exp. 07/09; 6101773, Exp. 10/09; 6122017, Exp. 12/09; 100-ml. only - 5020204, Exp. 02/08; 5050659, Exp. 05/08; 6010125, Exp. 01/09; 6040498, Exp. 04/09; 7030412, Exp. 03/10; 200-ml. only - 5040568, Exp. 04/08; and 7040594, Exp. 04/10
RECALLING FIRM/MANUFACTURER
IVX Animal Health Inc., Saint Joseph, MO, by telephone and letters dated January 16, 2008. Firm initiated recall is ongoing.
REASON
Precipitate forms after bottles have been opened.
VOLUME OF PRODUCT IN COMMERCE
100-ml - 100,041 vials; 200-ml - 40,974 vials
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  VETERINARY MEDICINE - CLASS III

___________________________________
PRODUCT 
Monofilament Polydioxanone Synthetic Absorbable (PDO), Sterile Suture (Violet Color) 0 (3.5 metric) 30" (75 cm) 1/2 37 mm Taper. Products were labeled: For Veterinarian Use Only. Product is distributed under the following labels: goDox brand; Mono-Dox brand; WEBMAXtm; Monovet; MONOSORB and MSA brand. Product code M340, Recall # V-028-2008.
CODE
Lot B06055110, EXP 2010-01
RECALLING FIRM/MANUFACTURER
C P Medical, Portland, OR, by letters dated June 8, 2006. Firm initiated recall is complete.
REASON
Monofilament sutures incorrectly labeled. Package is labeled with Suture Size 0 but may contain Suture Size 3/0.
VOLUME OF PRODUCT IN COMMERCE
547 boxes (each containing 12)
DISTRIBUTION
AZ, LA, MA, MI, MO, NC, OH and TX

END OF ENFORCEMENT REPORT FOR FEBRUARY 27, 2008

###