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U.S. Department of Health and Human Services

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Enforcement Report for March 28, 2012

 

March 28, 2012                                                                                                12-13
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
________________________________
PRODUCT
Publix brand Beef Stew Mix, 1.5 oz pouches, Ampacco Item Number: 900080204, further packaged in cartons labeled as Publix Brown Gravy with Onion Mix; pouches are labeled in part ***UPC 41415-03608. Recall # F-0926-2012
CODE
BEST BY DEC 09 13 H
RECALLING FIRM/MANUFACTURER
McCormick & Company, Inc., Hunt Valley, MD, by press release on March 9, 2012. Firm initiated recall is ongoing.
REASON
Food product was filled into incorrect pouches, which do not declare a milk ingredient on the label.
VOLUME OF PRODUCT IN COMMERCE
1,961 cases
DISTRIBUTION
FL, GA
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
___________________________________
PRODUCT
Backroad Country Caramel Puffcorn, a) 8 oz and b) 16 oz clear plastic bags. 8 oz UPC 0 49646 90176 0, 16 oz UPC 0 49646 90158 6. Recall # F-0925-2012
CODE
a) Sell By Date/Lot Code: 03/07/12 C1P16, 03/21/12, B2Y16, 05/16/12 B1X16, 05/30/12 B1X16 & 06/13/12 A3K16; b) Sell By Date/Lot Code: 03/07/12 C1P16, 03/21/12 B2Y16, 05/16/12 B1X16, 05/30/12 B1X16 & 06/13/12 A2R16 or A3K16
RECALLING FIRM/MANUFACTURER
Recalling Firm: Troyer Cheese, Inc., Millersburg, OH, by telephone on March 3, 2012 and letter on March 17, 2012.
Manufacturer: Axium Foods, Division of McCleary, Inc., South Beloit, IL. FDA initiated recall is ongoing.
REASON
During an FDA inspection the firm was notified that their ingredient stated lack the required "milk" declaration on their ingredient statement.
VOLUME OF PRODUCT IN COMMERCE
260 cs/8 oz plastic bags & 633 cs/16 oz plastic bags
DISTRIBUTION
Nationwide
________________________________
PRODUCT
Sea Wealth Frozen Whole Round Striped Bass, 500-800g. Recall # F-0927-2012
CODE
Lot #B74376
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sea Wealth Products, Inc., Alhambra, CA, by telephone on February 29, 2012 and by letters on March 9, 2012 and March 13, 2012.
Manufacturer: Union Development Frozen Foods Co., Ltd., Kaohsiung, Taiwan. Firm initiated recall is ongoing.
REASON
The frozen striped bass may be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
480 cartons
DISTRIBUTION
CA
___________________________________
PRODUCT
1) French Bread, Net Wt 16 oz (1 lb) 454 grams. UPC: 075551411469. Recall # F-0928-2012;
 
2) Bimbo Sourdough French Bread, clear label, 6 units per tray, Net Wt 16 ozs. (454 grams); UPC: 075551411490. Recall # F-0929-2012;
 
3) Ozark Hearth Sourdough Bread, Net Wt. 20 oz. (1 lb. 4 oz’s.) 567 G; UPC 075551500019. Recall # F-0930-2012;
 
4) Sourdough French Bread, Clear plastic bag with stick-on label, Net Wt 20 oz’s. (567 grams). UPC 075551411261. Recall # F-0931-2012
CODE
1) Lot Numbers: 026, 028, 029, 030, 031, 033, 035, and 038;
2) Lot numbers 022 and 026;
3) Use by date Feb 8, 10, 12 and 16, 2012;
4) Lot Number 029
RECALLING FIRM/MANUFACTURER
Harris Baking Co., Rogers, AR, by telephone on February 10, 2012. Firm initiated recall is ongoing.
REASON
The product has the potential to contain foreign material.
VOLUME OF PRODUCT IN COMMERCE
31,782 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Vita HERRING IN REAL SOUR CREAM KEEP REFRIGERATED, a) Net Wt 8 oz, UPC 022635400154; b) 30 oz UPC 022635417411. Recall # F-0932-2012;
 
2) Vita SLICED LUNCH HERRING KEEP REFRIGERATED PACKED IN U.S.A. Net Wt 8 oz. UPC 022635409744. Recall # F-0933-2012;
 
3) Vita HOMESTYLE HERRING KEEP REFRIGERATED PACKED IN U.S.A. Net Wt 32 oz. UPC 022635409805. Recall # F-0934-2012;
 
4) Vita Premium Horseradish Prepared KEEP REFRIGERATED. Net Wt. 5 oz. UPC 022635430120. Recall # F-0935-2012;
 
5) Vita HERRING IN WINE SAUCE KEEP REFRIGERATED PACKED IN U.S.A. NET WT. a) 8 oz., UPC: 022635400024; b) 12 oz, UPC 022635400031 and c) 32 oz. UPC 022635400116. Recall # F-0936-2012;
 
6) Tabatchnick Yankee Bean Soup Net Wt 15 oz. Keep Frozen,
UPC 071262294919. Recall # F-0937-2012;
 
7) Divina Olives Stuffed with Feta Cheese Net Drained Wt. 4 oz Keep Refrigerated Product of Greece. ITEM # 52780, UPC 631723527804. Recall # F-0938-2012;
 
8) Divina Olives Stuffed with Blue Cheese Net Drained Wt 4 oz Keep Refrigerated Product of Greece, Item # 52790, UPC 631723527903. Recall # F-0939-2012;
 
9) Gente Foods Black Bean Gorditas 3 Handmade Filled Thick Tortillas Net Wt 10 oz Perishable Keep Refrigerated, UPC 618032102021. Recall # F-0940-2012;
 
10) Albert's Famous Mexican Hot Sauce Mild Refrigerated For Freshness Net Weight 32 Ounces - UPC 073816-320143 Net Weight 16 ounces - UPC 073816-160138. Recall # F-0941-2012;
 
11) Albert's Famous Mexican Hot Sauce Medium Net Weight 16 ounces, UPC 073816-160152. Recall # F-0942-2012
CODE
1) a) Lot: 120128 30 oz; b) Lot code 120216;
2) Lot: 120819;
3) Lot: 120901;
4) Lots 111226 & 120826;
5) a) Lot: 120818; b) Lot: 120802: c) Lot: 120826;
6) Date code 05-04-14;
7) Best Used By: 11JAN2012 & 01FEB2012;
8) Best Used by: 11JAN2012, 01FEB2012, 15DEC2011, and 30DEC2011
9) Best Used By 11/06/11;
10) Exp date 05/16/12 and 06/02/12;
11) Exp date 06/27/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: UNFI General Corp., Providence, RI, by telephone on October 20, 2011 and press releases on November 9, 2011, November 10, 2011, November 14, 2011 and November 17, 2011.
Manufacturers: Foodmatch Inc., New York, NY;
Tabatchnick Fine Foods, Inc., Somerset, NJ;
Jananna Foods, Inc., Kilgore, TX;
Tortilleria El Molino, Concord, CA. Firm initiated recall is ongoing.
REASON
The product was not stored according to label directions and has the potential to be contaminated.
VOLUME OF PRODUCT IN COMMERCE
341 cases
DISTRIBUTION
TX, CA, AK, WA, OR, NV, CO, WY, SD, and AZ
___________________________________
PRODUCT
1) Custard Cream Bread Ingredients: Custard Cream, Flour (Bleached wheat flour, malted barley flour, niacin, reduced iron, thiamine mononitrate, riboflavin, folic acid), Butter (pasteurized cream natural flavoring), Sugar, Egg, Yeast, Salt. Net Wt 3oz. This item contains milk. Recall # F-0943-2012;
 
2) Taro Sponge Cake Taro, Flour, Sugar, Egg, Butter Wt 3.5 oz. Recall # F-0944-2012;
 
3) Taro Cream Bread - A label for this product could not be collected. The firm did not have labeling for this product during the inspection, and the investigator that conducted the inspection is no longer with the FDA. Recall # F-0945-2012;
 
4) Cream Cheese Bread Ingredients: Cream Cheese, Flour (Bleached wheat flour, malted barley, flour, niacin, reduced iron, thiamine mononitrate, riboflavin, folic acid), Butter (pasteurized cream natural flavoring), Sugar, Egg, Yeast, Salt. Net Wt 2 oz / 56 g. Recall # F-0946-2012
CODE
All products sold prior to 04/28/2011.
RECALLING FIRM/MANUFACTURER
Inchon Food Co., Irving, TX, by telephone on April 28, 2011. FDA initiated recall is ongoing.
REASON
The product contains undeclared Yellow # 5 and Yellow # 6, Red # 40 and Red # 3.
VOLUME OF PRODUCT IN COMMERCE
1) 80 units; 2) approximately 100 units; 3) approximately 90 units; 4) 100 units
DISTRIBUTION
TX
________________________________
PRODUCT
1) Creekside Grains, Heirloom Applesauce Cake, Nt. Wt 22 oz, Ingredients unbleached flour, sugar baking powder, baking soda, cinnamon, salt, and ginger. Packed on equipment with dairy, dried eggs, nuts, and wheat ingredients. Recall # F-0947-2012;
 
2) Creekside Grains, Kahlua and Cream Scone Baking Mix, Nt. Wt 16 oz, Ingredients: unbleached flour, sugar, chocolate chips( sugar chocolate, cocoa butter, milkfat, soy lecithin), baking powder, baking soda, raw sugar, salt. Packed on equipment with dairy, dried eggs, nuts, and wheat ingredients. Recall # F-0948-2012;
 
3) Creekside Grains, Apple Crisp Baking Mix, Nt. Wt 16 oz, Ingredients: unbleached flour, brown sugar, sugar, oats, cloves, cinnamon, nutmeg, ginger. Packed on equipment with dairy, dried eggs, nuts, and wheat ingredients. Recall # F-0949-2012;
 
4) Creekside Grains, Cherry Crunch Baking Mix, Nt. Wt 13 oz, Ingredients: unbleached flour, brown sugar, sugar, oats, pecans, ginger, cinnamon, salt, dried cherries. Packed on equipment with dairy, dried eggs, nuts, and wheat ingredients. Recall # F-0950-2012;
 
5) Creekside Grains, Blueberry Crunch Baking Mix, Nt. Wt 13 oz, Ingredients: unbleached flour, brown sugar, sugar, oats, pecans, ginger, cinnamon, salt, dried blueberries . Packed on equipment with dairy, dried eggs, nuts, and wheat ingredients. Recall # F-0951-2012;
 
6) Creekside Grains, Peach Crunch Baking Mix, Nt. Wt 13 oz, Ingredients: unbleached flour, brown sugar, sugar, oats, pecans, ginger, cinnamon, salt. Packed on equipment with dairy, dried eggs, nuts, and wheat ingredients. Recall # F-0952-2012;
 
7) Creekside Grains, Black Cherry Walnut Cookies Baking Mix, Nt. Wt 20 oz, Ingredients: unbleached flour, sugar, baking soda, baking powder, salt dried cherries, walnuts, black cherry extract (water artificial flavor, caramel color, sodium benzoate) . Packed on equipment with dairy, dried eggs, nuts, and wheat ingredients. Recall # F-0953-2012
CODE
Expiration date stamped on packages 07012012-03052013.
RECALLING FIRM/MANUFACTURER
Creekside Grains, Traverse City, MI, by telephone beginning March 5, 2012, E-mail, in person, or letter beginning March 12, 2012. Michigan initiated Recall is ongoing.
REASON
Some Creekside Grains Cake and Baking Mixes do not include wheat (an allergen) and malted barley as the source of the flour.
VOLUME OF PRODUCT IN COMMERCE
1.000 boxes of each product
DISTRIBUTION
Nationwide
 
The FDA begins a pilot program seeking to expedite notifications of human drug product recalls to the public. The agency will modify the drug product section of the Enforcement Report, published every Wednesday, to include actions that have been determined to be recalls, but that remain in the process of being classified as a Class I, II, or III action. Such recalls will be listed under the heading, “Recalls Pending Classification: DRUGS.” They will be reposted with their classification once that determination has been made. Send comments or suggestions to CDERRecallPilot@fda.hhs.gov.
 
RECALLS PENDING CLASSIFICATION: DRUGS
_______________________________________________
PRODUCT
 
NONE
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
1) Enoxaparin Sodium Injection, USP, 100 mg/mL, 1 mL pre-filled Single Dose Syringe in a blister (NDC 0781-3500-05) packaged in 10-count Syringes in a blister per carton (NDC 0781-3500-69), Rx Only. Recall # D-1274-2012;
 
2) Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL, 0.3 mL pre-filled Single Dose Syringe in a blister, NDC 0781-3133-01, packaged in 10-count Syringes in a blister per carton, NDC 0781-3133-63, Rx Only. Recall # D-1275-2012
CODE
1) Lot #: 917713, Exp 08/13;
2) Lot #: 917995, Exp 08/13
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sandoz Inc., Broomfield, CO, by letters on February 13, 2012.
Manufacturer: Baxter Pharmaceuticals Solutions, LLC, Bloomington, IN. Firm initiated recall is ongoing.
REASON
Defective Container: Small defects with stopper ribs.
VOLUME OF PRODUCT IN COMMERCE
100 mg: 27,059 cartons; 30 mg: 15,051 cartons
DISTRIBUTION
Nationwide and PR
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
1) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0567-12;
2) Fresh Frozen Plasma (Apheresis). Recall # B-0568-12
CODE
1) Units: W117011455969F Part A; W117011456611M Part A; W117011456611M Part B; W117011455969F Part B; W117011450914E Part A; W117011450914E Part B;
 
2) Units: W117011455969F; W117011456611M; W117011450914E
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific - Irwin Center, San Francisco, CA, by telephone and letter on January 3, 2012. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0569-12
CODE
Unit: W038111251841
RECALLING FIRM/MANUFACTURER
Recalling Firm: Florida's Blood Centers, Inc., Orlando, FL, by letter on December 27, 2011. 
Manufacturer: Florida's Blood Centers, Inc., Altamonte Springs, FL. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0829-12
CODE
Units: W036811205007 (part A); W036811205007 (part B)
RECALLING FIRM/MANUFACTURER
Community Blood Centers Laboratory Services, Inc., Lauderhill, FL, by telephone on September 8, 2011 and letter on September 13, 2011. Firm initiated recall is complete.
REASON
Blood products, which did not meet the acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Apheresis Platelet Leukoreduced Irradiated. Recall # B-0858-12
CODE
Unit: W044111132929
RECALLING FIRM/MANUFACTURER
LifeServe Blood Center, Des Moines, IA, consignee by telephone on January 6, 2012 and by letter on January 12, 2012. 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
IA
___________________________________
PRODUCT
Plasma Frozen within 24 hours (FP24). Recall # B-0859-12
CODE
Unit: 53GN94459
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake & Potomac Region, Baltimore, MD, by facsimile and telephone on December 14, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0862-12
CODE
Unit: W051511125558
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by facsimile on December 5, 2011. 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
NJ
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0863-12
CODE
Unit: W051511130331
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by facsimile on December 19, 2011. 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
Source Plasma. Recall # B-0869-12
CODE
Unit: 11HINC4208
RECALLING FIRM/MANUFACTURER
Bio-Blood Components, Inc., Hammond, IN, by fax on December 22, 2011. Firm initiated recall is complete.
REASON
Blood product collected from a donor whose scheduled physical exam had not been performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Source Plasma. Recall # B-0870-12
CODE
Unit: GZ081879
RECALLING FIRM/MANUFACTURER
Bio-Blood Components, Inc., Gary, IN, by fax on November 11, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was previously deferred for high risk behavior, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0871-12
CODE
Unit: W053311701819
RECALLING FIRM/MANUFACTURER
Community Blood Center, Inc., Appleton, WI, by letter dated January 13, 2012. Firm initiated recall is complete.
REASON
Blood Product, collected from a donor whose donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Wisconsin; Switzerland
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0875-12
CODE
Units: W043811009799; W043811009671
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Services, Elyria, OH, by telephone on December 19, 2011 and fax on December 28, 2011. Firm initiated recall is complete
REASON
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0876-12
CODE
Unit: W037711169932
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center UC Medical Center, Cincinnati, OH, by letter dated December 28, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malaria endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-0877-12;
2) Plasma Frozen within 24 hours (FP24). Recall # B-0878-12
CODE
1) and 2) Unit: W038111262848
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Melbourne, FL, by telephone and letter on December 20, 2011 and follow-up letter on January 26, 2012. Firm initiated recall is complete
REASON
Blood products, collected from a donor who engaged in multiple high risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
1) Fresh Frozen Plasma. Recall # B-0893-12;
2) Red Blood Cells. Recall # B-0894-12
CODE
1) Unit: 0013983;
2) Units: 2173901; 0013983
RECALLING FIRM/MANUFACTURER
Community Blood Centers of Florida, Inc., Miami, FL, by telephone and letter on January 11, 2012. Firm initiated recall is complete.  
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Cryoprecipitated AHF, Recall # B-0895-12
CODE
Units: W021611105475; W021611105476; W021611105477; W021611105480; W021611105481; W021611105499; W021611105484; W021611105490; W021611105510; W021611105515; W021611105527; W021611105525
RECALLING FIRM/MANUFACTURER
Department of the Navy, San Diego, CA, by telephone on November 24, 2011 and by letter on December 1, 2011. Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
AZ, NJ, CA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0896-12;
2) Plasma Frozen within 24 hours (FP24). Recall # B-0898-12
CODE
1) 29KL65329;
 
2) Units: 29KL65328; 29GT89842; 29GT91007; 29GY82425; 29GY82994; 29KE88471; 29KL65334
RECALLING FIRM/MANUFACTURER
American National Red Cross Mid Atlantic Region, Norfolk, VA, by telephone on December 8, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from donors who were not appropriately questioned regarding CJD risk, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
NC, VA
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0900-12
CODE
Unit: KP77977
RECALLING FIRM/MANUFACTURER
San Diego Blood Bank, San Diego, CA, by telephone on July 17, 2007. Firm initiated recall is complete.
REASON
Blood Product, collected from a donor whose donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0901-12
CODE
Unit: 9167276
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by telephone on June 12, 2006. Firm initiated recall is complete.
REASON
Blood product, for which there was incomplete documentation of the irradiation process, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO
___________________________________
PRODUCT
1) Fresh Frozen Plasma. Recall # B-0903-12; 
2) Fresh Frozen Plasma (Apheresis). Recall # B-0904-12;
3) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0905-12;
4) Red Blood Cells. Recall # B-0906-12;
5) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0907-12;
6) Platelets Pheresis Leukocytes Reduced. Recall # B-0908-12;
7) Red Blood Cells Leukocytes Reduced. Recall # B-0910-12
CODE
1) Unit: 6812209;
 
2) Units: 9175026, 9175027;
 
3) Unit: 9414035;
 
4) Units: 2107582, 2107583, 2107586, 2107587, 2107890, 2107892, 2107895, 2107900, 6803365, 6803371, 6804632, 6804640, 6808879, 6808880, 6808883, 6808884, 6808891, 6808892, 6808898, 6808900, 6809414, 6809416, 6809418, 6809419, 9129202, 9129203, 9129204, 9129205, 9129206, 9129207, 9129208, 9129209, 9129210, 9129211, 9129213, 9129214, 9129215, 9129216, 9129217, 9129218, 9129219, 9129220, 9129221, 9129222, 9129223, 9129225, 9129226, 9129227, 9129228, 9129229, 9129230, 9129231, 9129232, 9129234, 9129235, 9129236, 9129238, 9129239, 9129240, 9129241, 9129242, 9129243;                 
 
5) Units: 9175025;
    
6) Units: 9175025 Part 2, 9175025 Part 3, 9175026, 9175027 Part 1, 9175027 Part 2, 9175028 Part 1, 9175028 Part 2, 9175030, 9175032 Part 2;
   
7) 2107577, 2107578, 2107579, 2107581, 2107582, 2107583, 2107586, 2107587, 2107886, 2107887, 2107888, 2107889, 2107890, 2107891, 2107892, 2107894, 2107895, 2107896, 2107897, 2107898, 2107899, 2107900, 2107901, 2107902, 2107903, 2107904, 2107906, 2107907, 2107909, 2107910, 2107911, 2107912, 2107913, 2107914, 2107915, 2107916, 6803363, 6803364, 6803365, 6803366, 6803367, 6803368, 6803369, 6803370, 6803371, 6803372, 6803373, 6803374, 6804625, 6804626, 6804627, 6804628, 6804631, 6804632, 6804634, 6804635, 6804636, 6804637, 6804638, 6804639, 6804640, 6804641, 6804642, 6808875, 6808876, 6808877, 6808878, 6808879, 6808880, 6808881, 6808882, 6808883, 6808884, 6808885, 6808886, 6808887, 6808889, 6808890, 6808891, 6808892, 6808893, 6808895, 6808896, 6808897, 6808898, 6808899, 6808900, 6809414, 6809416, 6809417, 6809418, 6809419, 6809420, 6809421, 6809422, 6809423, 6809424, 6809425, 6809426, 6809427, 6809428, 6809429, 6809431, 6812202, 6812203, 6812204, 6812205, 6812206, 6812207, 6812208, 6812210, 6812211, 6812212, 9129202, 9129203, 9129204, 9129205, 9129206, 9129207, 9129208, 9129209, 9129210, 9129211, 9129212, 9129213, 9129214, 9129215, 9129216, 9129217, 9129218, 9129219, 9129220, 9129221, 9129222, 9129223, 9129225, 9129226, 9129227, 9129228, 9129229, 9129230, 9129231, 9129232, 9129233, 9129234, 9129235, 9129236, 9129238, 9129239, 9129240, 9129241, 9129242, 9129243, 9129322, 94149035
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on March 21, 2007. Firm initiated recall is complete.
REASON
Blood products, tested for anti-HBc and HCV using expired reagents, were distributed.
VOLUME OF PRODUCT IN COMMERCE
165 units       
DISTRIBUTION
AK, CA, CO, FL, KS, IL, MO, NJ, NY, TN, and Switzerland
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0911-12;
2) Cryoprecipitated AHF. Recall # B-0912-12;
3) Recovered Plasma. Recall # B-0913-12
CODE
1), 2), 3) Unit: 5201676
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood Center, Inc., New York, NY, by letter on November 13, 2006.
Manufacturer: New York Blood Center, Inc., Westbury, NY. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NY, Switzerland
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Recall # B-0918-12
CODE
Units: 6507720 Unit A; 6507720 Unit B
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood Center, Inc. New York, NY, by letter on October 17, 2006 and facsimile on November 1, 2006.
Manufacturer: New York Blood Center, Inc., Elmsford, NY. 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
NY
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0919-12
CODE
Units: 6415283 (BAG2); 6415283 (BAG1)
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood Center, Inc., New York, NY, by telephone on March 18, 2007 and by facsimile on March 23, 2007.
Manufacturer: New York Blood Center, Inc., Westbury, NY. Firm initiated recall is complete.
REASON
Blood products, which were possibly contaminated with bacillus species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY
___________________________________
PRODUCT
Source Plasma. Recall # B-0923-12
CODE
Units: 391057127, 391055830, 391055410, 391054960, 391054517, 391054094, 391053700, 391053301, 391052940, 391052622, 391051878, 391051851, 391051016, 391050866, 391047374, 391047273, 391058441, 391057961, 391046657, 391046438, 391045712, 391045475, 391044805, 391044540, 391042652, 391042491, 391041312, 391039791, 391039321, 391038720, 391028908, 391028863
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., N Las Vegas, NV, by facsimile on June 2, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for a history of intravenous drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
32 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0933-12
CODE
Units: 106684462 (2 units)
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone on November 2, 2005. Firm initiated recall is complete.
REASON
Blood products, for which quality control testing was not performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AZ
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0437-12
CODE
Units: W038111350525; W038111350526 Part 1; W038111350526 Part 2; W038111350526 Part 3
RECALLING FIRM/MANUFACTURER
Recalling Firm: Florida's Blood Centers, Inc., Orlando, FL, by letter on January 25, 2012 and January 31, 2012.
Manufacturer: Florida's Blood Centers, Inc., Leesburg, FL. Firm initiated recall is complete.
REASON
Blood products, for which storage condition was outside the acceptable range, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
FL
___________________________________
PRODUCT
1) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0860-12;
2) Platelets Pheresis Leukocytes Reduced. Recall # B-0861-12
CODE
1) Unit: W067111706751;
2) Units: W067111706753; W067111706752; W067111703556
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on October 4, 2011 and letter on October 26, 2011. Firm initiated recall is complete.
REASON
Blood products, which were labeled with the wrong product volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
MS, LA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0864-12
CODE
Unit: 011KY56348
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Saint Louis, MO, by fax on November 19, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Plasma Frozen. Recall # B-0872-12
CODE
Unit: W053311701819
RECALLING FIRM/MANUFACTURER
Community Blood Center, Inc., Appleton, WI, by letter dated January 13, 2012. Firm initiated recall is complete.
REASON
Blood Product, collected from a donor whose donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Wisconsin; Switzerland
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0873-12
CODE
Unit: W038111376175
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by telephone on January 24, 2012. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose vital signs were not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0897-12;
2) Plasma Frozen within 24 hours (FP24). Recall # B-0899-12
CODE
1) Units: 29KL65328; 29GFL99595; 29GK81826; 29GY85608; 29KE88471; 29KE88805; 29FL99618; 29KL65331; 29KL65334; 29KL65338; 29KL65339; 29KL65449;
 
2) Units: 29KJ44194; 29KJ45360; 29KL63276; 29KL63280; 29KJ45367; 29KL63290; 29KL65331; 29KS17556; 29KS18565
RECALLING FIRM/MANUFACTURER
American National Red Cross Mid Atlantic Region, Norfolk, VA, by telephone on December 8, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from donors who were not appropriately questioned regarding CJD risk, were distributed.
VOLUME OF PRODUCT IN COMMERCE
21 units
DISTRIBUTION
NC, VA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0909-12
CODE
Units: 2107577, 2107578, 2107579, 2107581, 2107582, 2107583, 2107586, 2107587, 2107886, 2107887, 2107888, 2107889, 2107890, 2107891, 2107892, 2107894, 2107895, 2107896, 2107897, 2107898, 2107899, 2107900, 2107901, 2107902, 2107903, 2107904, 2107906, 2107907, 2107909, 2107910, 2107911, 2107912, 2107913, 2107914, 2107915, 2107916, 6803363, 6803364, 6803365, 6803366, 6803367, 6803368, 6803369, 6803370, 6803371, 6803372, 6803373, 6803374, 6804625, 6804626, 6804627, 6804628, 6804631, 6804632, 6804634, 6804635, 6804636, 6804637, 6804638, 6804639, 6804640, 6804641, 6804642, 6808875, 6808876, 6808877, 6808878, 6808879, 6808880, 6808881, 6808882, 6808883, 6808884, 6808885, 6808886, 6808887, 6808889, 6808890, 6808891, 6808892, 6808893, 6808895, 6808896, 6808897, 6808898, 6808899, 6808900, 6809414, 6809416, 6809417, 6809418, 6809419, 6809420, 6809421, 6809422, 6809423, 6809424, 6809425, 6809426, 6809427, 6809428, 6809429, 6809431, 6812202, 6812203, 6812204, 6812205, 6812206, 6812207, 6812208, 6812210, 6812211, 6812212, 9129202, 9129203, 9129204, 9129205, 9129206, 9129207, 9129208, 9129209, 9129210, 9129211, 9129212, 9129213, 9129214, 9129215, 9129216, 9129217, 9129218, 9129219, 9129220, 9129221, 9129222, 9129223, 9129225, 9129226, 9129227, 9129228, 9129229, 9129230, 9129231, 9129232, 9129233, 9129234, 9129235, 9129236, 9129238, 9129239, 9129240, 9129241, 9129242, 9129243, 9129322, 94149035
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on March 21, 2007. Firm initiated recall is complete.
REASON
Blood products, tested for anti-HBc and HCV using expired reagents, were distributed.
VOLUME OF PRODUCT IN COMMERCE
155 units                                
DISTRIBUTION
AK, CA, CO, FL, KS, IL, MO, NJ, NY, TN, and Switzerland ___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0920-12
CODE
Unit: 84W94042
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Oakland, CA, by telephone on February 27, 2008 and by facsimile on March 4, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose health history screening was inadequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0925-12;
2) Recovered Plasma. Recall # B-0926-12
CODE
1) and 2) Unit: 6273061
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by letter dated September 23, 2008 or by e-mail on September 23, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking the medication Enbrel, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL, Austria
 
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS I
___________________________________
PRODUCT
1) NicoletOne Software v 5.60.2-5.71.4 with Cortical Stimulator License, Catalog/Part Number: 828-056600 Product Usage: The SSU Amplifier is used with the Cortical Stimulator Control unit which is used for functional brain mapping procedures during treatment of patients with seizure disorder and brain tumors, providing stimulation via electrode pairs or a hand held bipolar probe. Recall # Z-0799-2012;
 
2) Nicolet Cortical Stimulator Control Unit, Catalog/Part Number: 982A0558 Product Usage: The SSU Amplifier is used with the Cortical Stimulator Control unit which is used for functional brain mapping procedures during treatment of patients with seizure disorder and brain tumors, providing stimulation via electrode pairs or a hand held bipolar probe. Recall # Z-0800-2012;
 
3) Nicolet C64 Stimulus Switching Unit (SSU Amplifier), Catalog/ Part Numbers: 382-610800, 688-624200, 688-624300, 842-687900, 672-610800F. Product Usage: The SSU Amplifier is used with the Cortical Stimulator Control unit which is used for functional brain mapping procedures during treatment of patients with seizure disorder and brain tumors, providing stimulation via electrode pairs or a hand held bipolar probe. Recall # Z-0801-2012
CODE
1) Software v 5.60.2-5.71.4;
 
2) Units: CS09350168 CS-09140115 CS-09140135 CS-09140114 CS09160139 CS-09160155 CS-09070102R CS-09350179 CS-09350177 CS-09160147 CS-09160113 CS09140119 CS0916148 CS09350165 CS09140132 CS-09140122 Unknown Unknown CS-09350173 CS-09160136 CS-09160153 CS09350181 CS09350183 CS-09070109 RA090266M CS-09350171 C64SSU100081-0 CS-09350172 CS09140128 CS-09350174 CS-09350170 CS-09140111 Unknown CS-09160152 Unknown Unknown CS-09160141 CS-09160144 Unknown Unknown CS-09140117 CS09140112 CS-09160158 CS-09160123 CS-09160137 CS-09160126 CS-09140127 CS09350164 CS09140125;
 
3) Units: C64SSU090058 C64SSUS100002-0 C64SSU090040 C64SSU090015 C64SSU090027 C64SSU090025 C64SSU090029 C64SSU100096-0 C64SSU090068 C64SSU090058 C64SSUS100001-0 C65SSU100074 C64SSU090053 C64SSU090011 C64SSU100086-0 C65SU090054 C64SSU100098-0 C64SSU090028-1 C64SSU090028 C64SSU090030 C64SSU090031 C64SSU090067-1 C64SSU100088-0 C64SSU100079 C54SSU090035 C64SSU090044 C64SSU100091-0 CS64SSU090049 C64SSU090064 C64SSU090045 C64SSU100076 C64SSU090062 C64SSU100099-0 & C64SSU100104-0 C64SSU100069 C64SSU090033 C64SSU100073 C64SSU100101-0 C64SSU100093-1 C64SSU100082-0 C64SSU090036 C64SSU090022 C64SSU090051-1 CS64SSU090049 C64SSU090038 C64SSU100097-1, C64SSU100105-0, C64SSU100110-0 C64SSU090048 C64SSU090055-1 C64SSU090066 C64SSU100100-0 C64SSU100081-0 C64SSU100084-0 C564SSU090061-1 C64SSU100107-0 C64SSU090057-1 C54SSU100087-0 CS09160157 CS-09350163 C64SSU100096-0
RECALLING FIRM/MANUFACTURER
CareFusion 209 Inc., Middleton, WI, by letter dated October 5, 2011. Firm initiated recall is ongoing.
REASON
It is possible that during cortical stimulation the electrode annotation label may be incorrect on the screen and in the report when the current is correctly delivered through the selected electrodes. Also, it has been determined that the stimulus cable connection in the Cortical Stimulator Control Unit and C64 SSU Amplifier have the potential to develop a short circuit.
VOLUME OF PRODUCT IN COMMERCE
167 units
DISTRIBUTION
Nationwide and Internationally
 
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS II ___________________________________
PRODUCT
1) Medtronic DLP, DLP Single Stage Venous Cannula w/Right Angle Metal Tip. Rx Only, Sterile EO, Nonpyrogenic. Model number #'s: 67312, 67314, 67316, 67318, 67320, 69312, 69314, 69316, 69318, 68320, 69322, 69324, 69328, 69331, 69424, 69428, 69431, 69528, 69531. These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less. Recall # Z-0807-2012;
 
2) Medtronic DLP, DLP Single Stage Venous Cannulae. Rx Only, Sterile EO, Nonpyrogenic. Model #'s 66112, 66114, 66116, 66118, 66120, 66122, 66124, 66126, 66128, 66130, 66132, 66134, 66236, 66238, 66240, 66136, 66140. These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less. Recall # Z-0808-2012;
 
3) Medtronic, DLP, DLP Right Angle Single Stage Venous Cannulae. Rx Only, Sterile EO, Non-pyrogenic. Model #'s 67512, 67514, 67516, 67518, 67520, 67522, 67524, 67526, 67528, 67530, 67532, 67534, 67636.67638, 67640, 67536, 67540. These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less. Recall # Z-0809-2012;
 
4) Medtronic, DLP, DLP Malleable Single Stage Venous Cannulae. Rx Only, Sterilized Using Ethylene Oxide, Nonpyrogenic. Model #'s 68112, 68114, 68116, 68118, 68120, 68122, 68124, 68126, 68128, 68130, 68132, 68134, 68136, 68138, 68140. These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less. Recall # Z-0810-2012;
 
5) Medtronic, DLP, DLP Malleable Single Stage Venous Cannulae. Rx Only, Sterilized Using Ethylene Oxide, Nonpyrogenic. Model # 91037. These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less. Recall # Z-0811-2012;
 
6) Medtronic, Single Stage Venous Cannula, Carmeda Bio-Active Surface Venous Cannula, Sterilized Using Ethylene Oxide, Rx Only, Nonpyrogenic. Model # 's CB66112, CB66114, CB66116, CB66118, CB66120, CB66122, CB66124, CB66128, CB66130, CB66132, CB66134, CB66136, CB66140, CB66236, CB66240, CB67312, CB67314, CB67316, CB67318, CB67320, CB67512, CB67514, CB67516, CB67518, CB67520, CB67522, CB67524, CB67528, CB67530, CB67532, CB67534, CB67536, CB67540, CB67636, CB67640, CB68112, CB68114, CB68116, CB68118, CB68120, CB68122, CB68124, CB68126, CB68128, CB68130, CB68132, CB68134, CB68136, CB68138, CB68140, CB69312, CB69316, CB69320,CB69322, CB69324, CB69328, CB69331, CB69428. These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less. Recall # Z-0812-2012;
 
7) Custom Packs/Mexico, Medtronic Cardio-Kit, Sterilized Using Ethylene Oxide, Nonpyrogenic, Rx Only. Model # DLP6N48R3 & DLP6N48R4. Medtronic Intercept Custom Tubing Pack with Trillium Biosurface, Sterilized Using Ethylene Oxide, , Model # TL4F71R1. These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less. Recall # Z-0813-2012;
 
8) Custom Packs/ Kerkrade. Contain Medtronic Venous Cannula, Sterile EO. Model #'s C330201C, C330201D, C330201E, C330206B, C342603A, C350106A, C390101D, C390203D, C390406C, C390409B, C390601C, C390601D, C390702A, C390802A, C390903A, C391001B, C391102F, C391104F, C391203A, C391203B, C392502A, C392503A, C410201D, C410407A, C410407B, C431601A, C391104B, C391104D, C390601E, C350103B, C490901B, S342603B. These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less. Recall # Z-0814-2012
CODE
1) Model # / Lot # 69431 67312 67314 67316 2009010377 2008110555 2008101197 200808C074 2009010733 2008110584 2008101198 2008110082 2009011144 2008110593 2008101199 2008110085 2009030545 2008110627 200810C087 2008110088 200903C053 2008110628 2008110326 2008110227 2009050720 2008110769 2008111018 2008110238 2009051020 2008110932 2008111019 2008110456 2009060260 2008111015 200811C088 2008110457 2009060955 2008111016 2008120221 2008110471 2009070017 2008111017 2008120393 2008111020 2009081561 2008111148 2008120655 2008111270 2009090939 2008111269 2008120946 2008120222 2009101695 2008120219 2008121120 2008120223 2009110293 2008120220 200812C091 2008120656 2010011405 2008120651 200812C235 2008120947 2010012934 2008120652 2009010204 2008121121 2010022294 2008120653 2009010205 2009010334 2010030396 2008120654 2009010332 2009011377 2010031095 2008120945 2009010333 2009020247 2010032967 200812C034 2009011124 2009020248 2010032968 2009010331 2009011375 2009020249 201003C057 2009010878 2009011376 2009030485 2010062163 2009011123 2009020648 2009030776 201007C041 2009011374 2009020834 2009031075 2010081967 2009020246 2009021163 2009031076 2010090957 2009020638 2009030192 2009031077 2010100006 2009021162 2009030193 2009040064 201010C069 2009030250 2009030194 2009040675 2010111455 2009030772 2009030195 2009050705 2010120043 2009030773 2009030251 2009050941 2011020616 2009030774 2009030775 2009050942 2011021651 200903C057 2009040063 2009050998 2011041265 200903R025 2009041173 2009051344 2011051033 200903R030 2009050995 2009060918 2011051682 200903R035 2009050996 2009061499 2011101554 200903R040 2009050997 200906R208 200903R045 2009051342 2009070274 2009040062 2009051343 2009081544 2009040672 2009060245 2009081945 2009040673 2009060246 2009090203 2009040674 2009060470 2009091612 2009041172 2009060472 2009100215 200904C030 2009060473 2009100554 200904C123 2009060939 2009101095 200904R050 2009061237 2009101675 200904R055 2009061238 2009101676 200904R060 200906C002 200910C010 2009050079 200906R207 200910C054 2009050082 2009070534 2009112099 2009050083 2009071386 200911C079 2009050084 200907C086 2010012829 2009050085 2009081543 201001C059 2009050309 2009081944 2010020281 2009050648 2009090202 2010020282 2009050994 2009090681 2010022246 200905C081 2009090933 2010022247 200905C096 200909C002 2010022248 2009061236 200909C034 2010022249 2009061498 200909C092 2010030378 200906R202 2009100214 2010031052 2009071385 2009100553 2010031053 200907C042 2009101094 2010032281 200907R005 2009101674 2010032953 200907R006 200910C145 2010040365 200907R007 2009110265 2010050496 200907R008 2009110956 2010062967 2009080482 2009111477 2010070064 2009080490 2009112098 2010071011 200908C078 2009120830 2010071501 2009090201 200912C087 2010080884 2009090680 2010012828 2010081078 2009091611 201001C058 2010081223 2009100213 2010020277 2010090001 2009100552 2010020278 2010090242 2009101093 2010020279 2010090436 200910C005 2010020280 2010090669 200910C147 2010022242 201009C149 2009110264 2010022243 2010100688 2009110955 2010022244 2010100706 2009111476 2010022245 2010100778 2009120016 2010030376 2010101105 2010012827 2010030377 2010101143 201001C008 2010031051 201010C068 2010020273 2010032279 2010111574 2010020274 2010032280 2010121148 2010020275 2010032952 2010121279 2010020276 2010050407 2010122077 2010022238 2010061488 2011010051 2010022239 2010061491 2011011035 2010022240 2010062707 201101C037 2010022241 2010071007 2011020211 2010030375 2010071008 2011021162 2010031048 2010071150 2011022135 2010031049 2010072017 2011030093 2010031050 2010080082 2011030319 2010032278 2010080976 2011031157 2010032951 2010081079 2011031646 201003C171 2010081526 2011031883 2010040454 2010091335 2011040006 2010040455 2010091509 2011040383 2010061932 2010092142 2011040427 2010062962 201009C101 201104C066 2010070065 2010100005 2011050044 2010072135 2010100014 2011050613 2010072137 2010100959 2011051036 2010080002 2010100967 2011051343 2010080497 2010101100 2011051471 2010081227 2010101616 2011051472 2010090002 2010110021 2011051683 2010090080 2010110636 2011061989 2010090672 201011C096 201106C158 2010092265 2010120133 2011070013 201009C176 2010120293 2011070157 2010100583 2010122186 2011070509 2010102078 201012C098 2011070973 2010102080 2011010138 2011071688 2010110032 2011010306 2011080091 2010110529 2011010550 2011080340 2010110532 2011010831 2011080340 2010110779 2011020958 2011080500 2010110781 2011021459 2011081407 2010111576 2011021650 2011081688 201011C207 2011030543 2011090925 2010121149 2011031185 2011091044 2010121281 2011031645 2011091788 2011010377 2011032120 2011100011 2011010496 2011040254 2011100140 2011010559 2011040853 2011100860 2011011477 2011041627 2011102053 2011020618 201104C107 2011102155 2011020887 2011050071 201110R041 2011021163 2011050375 2011021515 2011050614 201102C149 2011050664 2011030026 2011050666 2011030544 2011050983 2011032103 2011051109 2011032121 2011051474 2011032122 2011060837 2011032123 2011061623 2011040007 2011061624 2011040697 2011061828 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2010070159 2011020338 2010110396 2010070568 2011020339 2010110637 2010070729 2011020601 2010110641 2010071048 2011020603 201011C024 2010080607 2011020954 2010120013 2010081687 201102C066 2010120292 2010090238 2011030501 201012C082 2010090763 201107R024 2011010755 2010091807 2011020022 2010092137 2011020023 2010100988 2011020951 2010101095 2011021957 2010101137 2011030056 2010101479 2011031173 2010101610 2011032149 2010110200 2011032524 2010110642 201103C022 2010110645 2010111143 2010112000 2010120620 2010122185 2011010756 2011011089 2011031032 2011032523 201103C073 8*09080415 66132 66134 66136 66140 66236 2008101192 2008101194 2009010875 2008120649 2008101179 2008101193 2008110054 200907R011 2009010329 2008101195 2008110093 2008110425 200909R058 2009010390 2008110325 2008110096 2008110455 2010100002 2009050992 200811C066 2008110414 2008110725 2010100003 200907R013 2008120218 2008110454 2008111013 2010110018 2009090199 2008120650 2008110748 2008111250 2010110395 200909R056 2008120773 2008111009 2008120217 2010121006 2009100211 2009010085 2008111010 2008120648 2010121007 2009110954 2009010330 2008111011 2008120944 2011010047 200912C089 2009010876 2008111012 200812C062 2011010328 2010012823 2009011122 2008120214 2009010328 2011020952 2010020270 2009030771 2008120215 2009010874 201102C050 2010031043 2009031074 2008120216 2009011373 2011030504 2010041078 2009040671 2008120647 2009020833 2010080606 200904R070 2008120942 2009030484 2010101106 2009050647 2008120943 2009030770 2010120623 2009050993 2009010203 2009031073 2010121147 2009051341 2009010327 2009040061 201110R134 2009061235 2009010873 2009040317 2009071056 2009011121 2009040670 2009071384 2009011335 2009041171 200907R033 2009011336 2009050307 2009080480 2009020245 2009050308 2009081942 2009020637 2009050646 2009090678 2009030167 2009050991 2009091610 2009030181 2009051340 200909R043 2009030182 2009060244 2009100212 2009030483 2009060465 2009100551 2009030769 2009060937 2009101090 2009031072 200907R040 2009110262 2009040060 2009080994 2009110263 2009040292 2009081540 2010012824 2009040668 2009081541 2010020271 2009040669 2009081941 2010022234 2009040977 2009090931 2010022235 2009040978 2009090932 2010030374 2009041170 200909R037 2010031044 200904C011 2009100210 2010031045 200904R095 2009101672 2010032276 2009050304 2009110261 2010032950 2009050305 2009112096 201003C170 2009050306 2009120014 2010061605 2009050644 200912C168 2010062291 2009050645 2010012822 2010070158 2009050989 201001C114 2010071047 2009050990 2010020269 2010081684 2009051339 2010022230 2010081820 2009060242 2010022231 201009C072 2009060243 2010022232 2010100686 2009060464 2010022233 2010101382 2009060935 2010030373 2010101395 2009060936 2010031042 2010110198 2009061234 2010032275 2010110644 2009071055 2010032949 2010121562 2009071383 2010040453 2011012069 200907R030 2010050406 201101C084 2009080416 2010050689 2011020885 2009080417 2010051333 201102C069 2009080993 2010060245 2011041302 2009081539 2010060246 2011050254 2009081940 2010070015 2011050454 2009090677 2010070860 2011061103 2009090930 2010071049 2011062712 2009091609 2010071498 2011071488 2009091609 2010090241 2011071705 200909R032 2010091966 2011071706 2009100208 2010092264 2011071792 2009100209 201009C145 2011071875 2009100550 2010102206 201107R008 2009101671 2010102208 201108C070 2009110257 2010102213 2011090564 2009110258 201010C032 2011091136 2009110259 2010110397 2011100264 2009110260 2010110638 2011100534 2009111473 2010110639 2011101478 2009120826 2010120291 2011102136 2009121483 2010120621 201110R007 2010010283 2010120934 2011110012 2010012821 2010121563 201001C016 201012C097 201001C056 2011021513 2010020266 2011021514 2010020267 2011030503 2010020268 2010021559 2010021560 2010021561 2010021562 2010021563 2010021564 2010021565 2010022228 2010022229 2010030372 2010031039 2010031040 2010031041 2010032272 2010032273 2010032274 2010032947 2010032948 201003C120 2010040067 2010041076 2010041077 201004C057 2010050493 2010050962 2010051207 2010051208 2010051267 201005C134 2010062610 2010062697 2010062698 2010062699 2010062930 2010062931 2010070017 2010071412 2010072133 2010081502 2010082112 2010082224 2010082225 2010082226 201008C043 2010090480 2010090764 2010092263 201009C131 2010100377 2010100380 2010102075 2010102392 2010102393 2010110009 2010110012 2010110308 2010110311 2010110527 2010110528 2010110530 2010111905 2010111906 201011C136 2010121146 201012C045 2011010373 2011010374 2011011133 2011011471 201101C083 2011020604 2011020884 2011021160 2011021815 2011030054 2011031175 2011031455 2011031820 2011032525 66238 66240 2008101196 2009010877 2008110768 200907R010 2008111014 2009080161 2008111147 2009090200 200901C057 2009090679 200904R067 200909R014 2009060466 2009101092 2009060938 2010012826 200907R012 2010022237 2009080481 2010031047 2009081542 2010090067 2009081943 2010102211 2009101091 2011010123 2009101673 2011062328 2009111474 2011070232 2009112097 2011072443 200912C047 201107R040 2010012825 2010022236 2010031046 2010041079 2010062731 2010080967 2010081503 2010081688 2010101312 2010102215 2010110196 2010120637 2011051727 2011052057 201107R028 2011090265 201109C157;
 
3) Model # / Lot # 67512 67514 67516 67518 67520 2008120772 2008120764 2009010345 2011051400 2009010363 2009020928 2008120951 2009020657 2011051756 2009011014 200902C083 2009021206 2009030252 2011051991 2009011126 2009060940 2009040678 2009080996 201109C051 200901C098 2009070724 2009050310 2009101098 2011100296 2009030778 2009120921 200906C140 2009120922 2011100296 2009040979 2010012832 200907C100 2010012834 2009081545 2010012832 2009110266 201003C172 2009102294 2010022256 2010012833 2010071569 2009120020 2010081992 2010020287 201008C158 2009121491 2010092162 201003C174 2010092166 2010012907 2011010390 2010080882 2011021006 2010031058 201101C123 2010081016 2011030122 2010051219 2011030269 2010081842 2011040908 2010081240 201103C206 2010082373 2011050610 2010082375 2011051757 2011020786 2011051212 201009C127 2011021764 2011061006 2011010165 201102C150 201106C159 2011011198 2011030477 2011070129 201102C020 201103C062 2011080426 2011040442 2011080425 2011082100 2011050734 2011100955 201108C035 2011080608 2011091007 2011081061 2011091519 2011092182 67522 67524 67526 67528 67530 2008110263 200810C234 200811C068 2008110384 200810C036 2008110458 200810C235 2008120913 2008110459 2008110260 2008121122 2008110113 2009010206 200811C167 2008111129 200812C017 2008110329 2009020253 2008120952 200811C092 2009011127 2008111022 2009020798 2008121004 2008120226 2009020658 2008120542 2009030486 2009010207 2009030253 2009040679 200812C058 2009030780 2009010346 200903C042 2009041174 2009010165 2009041176 2009010356 2009040325 2009060247 2009011128 2009060483 2009011378 2009050313 2009061467 200901C060 2009061239 200901C094 2009050314 2009070536 2009020835 200908C105 200901C110 2009061501 200907C037 2009030779 2009090936 2009020659 2009070275 2009101099 200903C062 2009091614 2009030487 2009071391 2009111480 2009040680 2009100556 2009031078 200907C045 2010011382 2009041175 2009101682 2009040681 200907C083 2010022257 2009050311 2009110267 2009040682 2009101684 201003C173 2009060248 2009110958 2009040980 200911C044 2010061881 2009060482 200911C045 2009041177 2009121493 2010071761 2009071389 200912C167 200904C121 2010010294 2010081242 200907C030 2010012909 200904C134 2010012911 201008C047 2009080492 2010022259 2009050312 201003C101 2010101289 200908C141 2010061880 2009051002 2010040457 2010120667 2009100218 2010080941 200905C029 2010051417 2011012087 2009101680 2010091859 200905C085 2010061065 201103C023 2009101680 2010101802 2009060484 2010062719 2011041066 2009101681 2010121023 2009070537 201006C078 2011051401 200910C073 201101C033 2009071390 2010091185 2011060106 2009112101 2011021007 2009080493 201010C040 2011061594 200911C075 2011030336 200908C143 2010120035 2011062399 2009120163 2011030861 2009091615 2010121022 2011071825 2009121492 2011040909 2009100219 2011010393 2011100295 200912C079 2011041293 2009101683 2011011649 2010012908 2011050126 200910C013 2011030337 2010022258 2011050732 2009110268 2011041287 2010030381 2011061007 2009110959 2011061005 2010031059 2011061595 200911C080 2011070923 2010040456 201106C129 2009120164 2011082711 2010061680 2011070150 2009120923 2011090552 2010071872 2011070326 2009120923 2011100956 2010081353 2011072144 2010012910 2011102229 2010081995 2011072505 2010022260 2010082369 201108C041 2010022261 2010091521 2011092035 2010022262 2010091522 201109C095 2010031060 2010091523 201110R042 2010032956 2010092158 201003C054 201009C179 2010050410 2010120668 2010050857 2010121825 2010070079 2011010391 2010070339 2011011003 2010071510 2011011003 2010072159 201101C122 2010072161 2011031499 2010081993 2011031891 2010082370 2011040476 2010090508 2011041475 2010091183 201104C021 2010101488 2011050125 2010101807 2011051211 201010C034 2011051903 2010120356 201105C109 2010121579 2011060415 2011011387 201106C160 201101C034 2011070324 2011021185 2011070947 2011021533 2011080872 2011031176 2011081996 2011032571 201108C036 201103C024 2011090377 2011041067 2011091382 201104C067 2011100096 2011050127 2011100787 2011050733 2011101612 2011060414 2011061987 2011062117 201106C125 2011071554 2011080030 2011081508 2011082882 201108C096 2011090378 2011091022 2011100515 2011101023 67532 67534 67536 67540 67636 2008110460 2008110707 2008121169 2009011131 2009010358 2008111023 2008111130 2009010742 2009020642 2009011234 2008111255 2008120228 2009050316 2009041180 200901C090 2008120227 2009011130 2009051345 200907C035 2009020255 2008120739 2009020661 2009060942 2009081548 2009030782 2008120953 2009041179 2009061241 2009090685 2009040684 2009010347 200904C010 2009080998 2010010297 2009051005 2009011129 2009051004 2009081547 2010012915 2009060943 200901C059 2009070277 2009091617 201003C058 2009071064 2009020254 2009070539 2009101102 2010040366 2009080495 2009020660 2009080997 200910C008 2011032425 2009100557 2009030781 200908C144 2009120925 2011041473 2009101103 2009040065 2009101101 2009121494 2011070399 200910C150 2009040683 2009101685 2010012914 2011082527 2009110960 2009040981 200910C149 201001C011 2011091131 200912C088 2009041178 2009112102 2010022265 2010012916 2009050315 2010012913 2010031063 2010022266 2009050709 2010022264 2010081038 2010040368 2009051003 2010031062 2010082371 2010061283 2009060485 2010060085 2010090510 2010070377 2009060941 2010070755 2010091343 2010070646 2009061240 2010080653 2010101288 2010071762 2009070276 2010081090 201011C178 2010120860 2009070538 2010081843 2010121577 2010121823 2009071063 201008C048 2011010071 201012C099 200907C036 201008C170 2011011707 2011011005 2009080494 2010101490 2011040907 2011020545 2009081546 2010121824 2011051213 2011020787 200908C077 201101C125 2011061592 2011031498 200908C102 2011021005 2011070325 2011032424 2009090684 2011040439 2011081310 201103C207 2009091616 2011041937 2011082712 2011040149 200909C005 2011061511 2011090551 2011040263 200909C058 201106C130 2011101801 2011040761 2009100220 2011070528 2011041142 2009101100 2011081308 201104C032 2009110269 201108C040 2011051214 2009111481 2011091555 2011061593 2009120194 2011092181 2011070164 2009120195 2011100788 2011072330 200912C045 2011101613 2011080786 200912C165 2011101800 201109C054 2010012912 2011100095 2010020288 2010021566 2010021567 2010022263 2010030382 2010031061 2010032284 201003C099 201003C142 2010050693 2010051221 2010060086 2010062650 2010070648 2010071210 2010080196 2010080198 2010081996 2010090784 2010090976 2010091342 2010091861 2010092160 201010C031 2010120861 2010121158 2011010070 2011010301 2011011004 2011011282 201101C124 2011021377 201102C070 2011031894 201103C063 2011040148 2011040436 2011041065 2011041290 2011050518 2011051907 2011051974 2011060416 201106C198 2011070924 2011071359 2011080877 2011082218 201108C037 2011090231 2011092042 2011101020 2011102039 2011102299 201110R043 67638 67640 2009070278 2009120196 2009110961 2010012918 2010010298 2010070098 2010012643 2010081015 2010012917 2010121578 2010070378 2011062120 2010081017 2011100953 2010091864 201009C028 2010101290 2011011392 2011021186 2011041938 2011051758 2011091132 2011100954 201110R121;
 
4) Model # / Lot # 68112 68114 68116 68118 68120 200810C211 2008101200 2008120907 200811C069 2008120073 2008120225 2008120308 2008121123 2008120196 2009010209 2009010348 2008120660 2009010417 2009010208 2009010850 2009010419 2008120910 2009040066 2009010349 2009011133 200902C029 2009061242 2009040685 2009011132 2009011239 2009041127 2009100221 2009041181 2009041182 2009020717 2009060944 2009110963 2009060249 2009050317 2009050710 2009071392 2010011384 200906C132 2009060486 2009060250 2009091618 2010041080 2009080496 2009081947 2009061502 2009110962 2010060595 2009080497 2009090205 2009080498 2009111482 2010060696 2009081549 2009100558 2009080999 2009120926 201008C106 200908C182 2009101686 200909R028 2009121495 2010091334 2009101104 2009120198 2009102295 2010012899 2010100685 2009120197 2010010299 2009121497 201001C063 2010101102 2009121496 201003C060 2010011385 2010050411 2010110010 2010012054 2010060923 201001C006 2010051060 2010110015 2010071304 2010070386 2010031064 2010070728 201011C075 2010080547 2010071053 2010031065 2010071051 201101C035 2010080679 2010080409 2010062293 2010081686 2011081467 2010090847 201008C148 2010091329 201008C105 2011082277 2010101777 2010092447 2010091675 201009C178 2011100126 2011041866 2010100153 2010092138 2010112026 2011051722 2010101611 2010092658 201101C036 2011070348 2010102218 2010102225 2011021958 2011090565 2010110197 2010111451 2011030171 2011090922 2010111144 2010122184 2011031823 2011100260 201011C205 2011021352 2011050659 2011052056 2011030172 2011061100 2011070537 201103C025 2011070132 2011080662 2011051728 2011080882 2011090020 2011061104 2011081468 2011091285 2011062014 201109C055 2011100261 201107R029 2011100850 2011080375 2011091486 2011092309 201109C056 2011100452 2011100851 68122 68124 68126 68128 68130 2008110235 200810C057 2008120954 200807C104 2008110978 2009010087 2008120299 2009010211 2008101176 2008120871 2009010210 200812C056 2009010351 200810C068 2009010353 2009020813 2009010350 2009011135 2008110472 2009010425 2009040656 2009010729 2009011379 2008120229 2009011448 2009040686 2009011134 2009040067 2008120559 2009020257 2009050318 200901C068 2009051346 2008120955 2009040214 2009051006 2009020712 2009061503 2008121181 2009040689 2009080500 2009030334 2009071065 2009010173 2009050320 2009081000 2009030488 2009071394 2009010352 2009060488 2009091619 2009040687 200907R014 2009010851 2009060947 2009120199 2009040982 2009080502 2009011136 2009070541 2009121498 2009041183 200909R047 2009011388 2009071067 2010070155 200904R094 2009101105 2009020256 2009071397 2010071306 2009050319 2009110964 2009030254 2009080506 2010092448 2009060945 2010010300 2009040688 2009080507 2010100105 2009071393 2010011386 2009051007 2009080508 2010111454 200907C084 2010040369 2009051347 2009081003 2011041035 2009080501 2010070156 2009060251 2009081550 2011051725 2009081001 2010070730 2009060487 2009101106 2011060723 2009100559 2010071500 2009060946 2009120929 2011061217 2009101687 2010092136 2009070540 200912C085 2011070517 2009110270 2010100375 2009071066 2010010302 2011070596 2009120200 2010101399 2009071395 2010010303 2011070597 2010012902 2010101782 2009071396 2010011388 2011070602 2010020289 2010110958 2009080503 2010011389 2011070968 2010022267 2010112027 2009080504 2010012920 201108C240 2010022268 2011010133 2009080505 2010022273 201108C241 2010060695 201101C080 2009081002 2010031070 2011090563 2010061615 2011031457 2009090206 2010032285 2011090580 2010062167 201103C239 2009090686 2010032958 2011092195 2010080387 2011041036 2009100560 2010070909 201109C215 2010091330 2011050612 2009101688 2010080957 2011100820 2010091674 2011050978 2009101689 2010081691 2011101480 2010092139 2011050979 200910C052 2010101138 2010092655 2011051407 2009120928 2010101475 2010100154 2011060722 2009121499 2010101785 2010101287 2011060783 2009121500 2010120012 2010101409 2011060943 2009121718 2010120132 2010101780 2011070970 2010012919 201012C083 201010C036 2011071095 2010022270 2011020052 201010C037 2011100259 2010022271 2011020335 2010110956 2011101779 2010022272 2011021781 2010111147 201110R045 2010030383 2011022032 201011C192 2010031066 2011031036 2011010048 2010031067 2011031822 2011010757 2010031068 2011032526 2011020882 2010031069 2011040192 2011030055 2010050494 2011050903 2011040179 2010060924 2011050975 2011041051 2010070343 2011050976 2011051406 2010070359 2011050977 2011060488 2010070596 2011061105 2011060724 2010080930 201106C131 201107C056 2010080972 2011070133 2011080376 2010090838 2011070347 2011082054 2010091331 201107C099 201108C173 2010091809 2011080659 2011090557 2010092648 201108C133 2011090584 2010101478 2011090960 2011091875 201010C038 2011091283 201109C028 2010110534 2011100535 2011100127 2010111453 2011101078 201011C086 2011101461 2010121564 2011010049 2011010493 2011011472 201101C081 2011021353 201102C151 2011031033 2011031454 2011040180 2011040190 2011040582 2011041598 2011051027 2011060785 2011060941 2011060942 2011070538 2011072227 201107C057 2011080639 201108C132 2011090264 2011091282 2011100987 2011102100 2011102791 68132 68134 68136 68138 68140 200808C112 2008121124 2008120663 2009030873 2009021164 2008110567 2009010028 2008120737 2009070280 2009050711 2008111025 2009010214 200812C088 2009070400 2009070619 2008120230 2009010354 2009011200 2009110968 2009071072 2008120399 2009011016 2009020933 2010080520 2009120931 2008120661 2009011390 2009021128 2010082062 2010031076 2008120662 200901C086 2009060253 2010090955 2010032288 2008121182 2009030489 2009061245 2011020953 2010070157 2009010212 2009040070 2009061504 2011030170 2010101305 2009010213 2009050056 2009071071 201103C142 2010120619 2009011389 2009050321 2009071399 2011090566 2009020662 2009060949 2009101109 2011090585 2009030783 2009061244 2009110276 2009040068 2009070279 2009110967 2009040069 2009071070 2009120213 2009041184 2009071398 2010012904 2009051008 2009080511 2010020291 2009051348 2009081551 2010022278 2009060252 2009090688 2010031075 2009060550 2009100224 2010032960 2009060948 2009101108 2010071547 2009061243 2009110275 2010100119 2009070542 2009120930 2010110957 2009071068 2009121503 2010120011 2009071069 2010010304 2011011474 200907C043 2010012923 2011021897 200907R017 2010022277 2011031013 2009080509 2010031074 2011032013 2009080510 2010032959 2011050980 2009081004 2010071046 2011060633 2009090687 2010081821 2011060899 200909R022 2010101256 2011060900 2009100222 2010101474 2011060901 2009100223 2010102203 2011062330 2009101107 2010110195 2011062331 2009101690 2010120936 2011062332 200910C141 2010122183 2011062498 2009110965 2011010046 201106C035 2009110966 2011010494 2011080975 2009121501 2011011473 201108C222 2010011390 201101C030 2011090562 2010011391 2011020054 2011090950 2010011392 2011030367 2011100817 2010012056 2011032012 2011101452 2010012921 2011032150 2011101951 2010020290 2011032151 2010022274 201103C064 2010022275 2011050626 2010022276 2011050630 2010031071 2011050631 2010031072 2011060107 2010031073 2011061424 201003C015 2011061426 2010050495 2011062015 2010050688 2011062030 2010050805 2011070228 2010062668 2011070969 2010072181 2011071094 2010072183 2011072442 2010080408 201108C221 2010080494 2011090018 2010090239 2011090074 2010091092 2011100117 2010091967 2011100643 2010100152 2011101586 2010101139 2010101140 2010110531 2010111141 2010111142 2010120636 2011010557 2011011652 2011020053 2011021161 2011031034 2011031179 2011031824 2011040181 2011040583 2011040693 2011040807 2011041481 2011050255 2011050455 2011050660 2011060634 2011060902 2011060903 2011061365 2011061421 2011061568 2011061570 2011062017 2011062127 2011062128 2011062497 2011070352 2011070397 2011071356 2011080641 2011080841 2011080843 2011081469 201108C220 2011091331 2011091514 2011092190 2011092191 2011100450 2011100819 2011101479 2011101707 2011102915 201110R046;
 
5) Model # / Lot # 91037 2008120758 2008121114 2009020137 2009040853 2009050547 2009061436 2010051435 2010101499 2011011022 2011030416 2011041113;
 
6) Model # / Lot # CB66112 CB66114 CB66116 CB66118 CB66120 CB66122 11813252 11843724 11827750 11843725 11813258 11584816 11799778 11827756 11785647 11813251 11799807 11561410 11785661 11785648 11760072 11799779 11754233 11538323 11760079 11773439 11749844 11785671 11734973 11502622 11734945 11710255 11710254 11734970 11710271 11452595 11691759 11691748 11691757 11572754 11669004 11254883 11613172 11681293 11681289 11561406 11655514 11182280 11610933 11669018 11641156 11508900 11641162 11150759 11599805 11599798 11584819 11493477 11627324 11091693 11572780 11561382 11561388 11434967 11599813 10919617 11561378 11538310 11502627 11264460 11528295 10856277 11538313 11528250 11385846 11182276 11490554 10843209 11411017 11452576 11276282 11173236 11315471 10820591 11370812 11373266 11182290 11150770 11278706 10792650 11361018 11370804 11091678 11137730 11241600 10773248 11326455 11361014 11137732 11123865 11206047 10751519 11264468 11326456 11123882 11103220 11193432 10721043 11241591 11254866 11114391 11091684 11173268 10699666 11231073 11182289 11080537 11069185 11137743 10691424 11218584 11150779 11069195 11058824 11103236 10613562 11193453 11137720 11058842 11050709 11108109 10514225 11137754 11123863 11041173 11041174 11080547 10503899 11123841 11114398 11028717 11016744 11069202 10487793 11080539 11069197 10992835 10960981 11041175 10318730 11058851 11050712 10980889 10923636 10992836 10278866 11028715 11041172 10832387 10919615 10970848 10269102 11016742 11028716 10820589 10856275 10960982 10980899 11016743 10806901 10843148 10945751 10945750 11007099 10792648 10832388 10919616 10923635 10992834 10783528 10820590 10856276 10919613 10980884 10773245 10806902 10832389 10867469 10970847 10699672 10783529 10792649 10843208 10960980 10691455 10773246 10773247 10832386 10919614 10602850 10751518 10738032 10820587 10878783 10569665 10729510 10729497 10783526 10856274 10559130 10699694 10721042 10729534 10820588 10552235 10691463 10699704 10691412 10806900 10542908 10613407 10691464 10683880 10792647 10521730 10593905 10683908 10674111 10783527 10514236 10577104 10664495 10652292 10773244 10503880 10569677 10631770 10631752 10751517 10468804 10552243 10621341 10593945 10699689 10460194 10526627 10593931 10559122 10691469 10443541 10521722 10552234 10542875 10683896 10426841 10494788 10542905 10514256 10593942 10383047 10468812 10526630 10503859 10584281 10380517 10460167 10514222 10479511 10569692 10373509 10443564 10494795 10480197 10543465 10297648 10420852 10487845 10443537 10521726 10278862 10406890 10468799 10297669 10503873 10269077 10403803 10460198 10232697 10494786 10261310 10397632 10443550 10185498 10479551 10395337 10340579 10460193 10318738 10318753 10451347 10297661 10282386 10443531 10289587 10269130 10435584 10278840 10261341 10426824 10215032 10191687 10318754 10189491 10186263 10297653 10289595 10278886 10269114 10261340 10189490 CB66124 CB66128 CB66130 CB66132 CB66134 CB66136 11827767 11627333 11773446 11799799 11827744 11799792 11773419 11599767 11749845 11681291 11710269 11760052 11760049 11326472 11710245 11668999 11681284 11572757 11734956 11218598 11641155 11641159 11627296 11425915 11710265 11182291 11627304 11627300 11452588 11276285 11681302 11173246 11599769 11452587 11370813 11231093 11669022 11154396 11547341 11338577 11315466 11123840 11655492 11150767 11538311 11326447 11295324 11058807 11641165 11058804 11361023 11295323 11241607 11041178 11627311 11055669 11315461 11254872 11206081 10913654 11613167 11050669 11264444 11206086 11154378 10856281 11528290 11028718 11028719 11154399 11150748 10751522 11349220 11007101 10980910 11150747 10945753 10577107 11326462 10992837 10923637 11058847 10820595 10569700 11298131 10945752 10674167 11041177 10631766 10542971 11241610 10901167 10664513 11028720 10613551 10526622 11231080 10832391 10631746 10930780 10602851 10521720 11206066 10820593 10602783 10867470 10577109 10468760 11182272 10806904 10593927 10856280 10552240 10460162 11154406 10792651 10584280 10843149 10521701 10420850 11150755 10783531 10577075 10832392 10318761 10370321 11137740 10762628 10566526 10820594 10289594 10360543 11058849 10751521 10503905 10806905 10278841 10318727 11050668 10674164 10494797 10792652 10269112 10261331 11041176 10631765 10479479 10783532 10261334 10224560 11007100 10621311 10397558 10773250 10199614 10175944 10980906 10593951 10395345 10762629 10176023 10960984 10583515 10383009 10613400 10856278 10569669 10380509 10583513 10843210 10559114 10360542 10577110 10832390 10552204 10330246 10569667 10820592 10521705 10339016 10460147 10806903 10503888 10322855 10390319 10783530 10494753 10271119 10370317 10773249 10487834 10175986 10360551 10762627 10479514 10318749 10729512 10468767 10297689 10593914 10460140 10199613 10569680 10443571 10559134 10408590 10542901 10397633 10514237 10395341 10503891 10380514 10487802 10318809 10468761 10318755 10460163 10297693 10443563 10278837 10408593 10191685 10395325 10390317 10383058 10318747 10310127 10176022 10168504 CB66140 CB66236 CB66240 CB67312 CB67314 CB67316 11710278 10856282 10913655 11843701 11799793 11773402 10792653 11773411 11773405 11721260 11150766 10674109 11710239 11749854 11655484 10659949 11641133 11627306 11613156 11173267 11627298 11315477 11599771 11613144 11182266 11572760 11193423 11397357 11114383 11538319 11315465 11069200 11434981 11231092 11058812 11028721 11278703 11050681 11016745 11193478 11278705 11007102 11007103 11150787 10992838 10992839 11091694 11411012 10960985 10980903 11050688 10878784 10970849 11041180 11538331 10832393 10878785 10992840 10691448 10856283 10970850 11627328 10613414 10832394 10960986 10535617 10820596 10878786 11681310 10503871 10792654 10831678 10487783 10773252 10820597 10176010 10479477 10751523 10820598 10460161 10738034 10773253 10232698 10721063 10751525 10542920 10751524 10243466 10526614 10729536 10514238 10652290 10261358 10494790 10593920 10487818 10569675 10278867 10479491 10514250 10468802 10487846 10318724 10460149 10479485 10448672 10468800 10535599 10189494 10460188 10189492 10435591 10542877 10420843 10403807 10569699 10318697 10310119 10593943 10289588 10278865 10613560 10218174 10215035 10621477 10199619 10631755 10643153 10652271 10721064 10738033 10773251 11749857 CB67318 CB67320 CB67512 CB67514 CB67516 CB67518 11799773 10176018 11855547 10297643 11827753 11502624 11773388 11813261 11681280 11154374 11721247 10525864 11799808 10980872 10980877 11137718 11655500 11785633 10691420 10783533 11627302 10536236 10613365 11655464 10297644 10743959 11599778 10593901 10232496 11502625 10542894 11710275 10175992 11326452 11041181 10613552 10992841 10919618 11099826 10888953 10820599 11108114 10593939 10569674 11114403 10542917 10521697 11721238 10479539 10289593 10278876 10269127 10261354 10255194 10243449 10218173 10218172 10185494 CB67520 CB67522 CB67524 CB67528 CB67530 CB67532 11749837 11773418 11799783 11799806 11760053 11584781 11754236 11543083 11721261 11584783 11627303 11540968 11669021 11610941 11613139 11561387 11572752 11276283 11627308 11538303 11599784 11538306 11530556 11241615 11538328 11373263 11572763 11384694 11370803 11231095 11373280 11298122 11538309 11338703 11349214 11114371 11349227 11241631 11438994 11295305 11069205 11050718 11254894 11193454 11370814 11278698 11016747 11041183 11206075 11123870 11360994 11241635 10970851 11028723 11182292 11050676 11264452 11206071 10960987 11016748 11173224 10843150 11254878 11193448 10945754 10888954 11150784 10820601 11241623 11173262 10514230 10856288 11028722 10806906 11241602 11150788 10479496 10820604 11016746 10751527 11231069 11069177 10468763 10792656 11007104 10613585 11193438 11058846 10435587 10631780 10980905 10514229 11137746 11050660 10232679 10621482 10856285 10503881 11123835 10980916 10189495 10602845 10820600 10494770 11069188 10856287 10577087 10773254 10451323 11041182 10843151 10558734 10751526 10318759 10992842 10832396 10514257 10683867 10297687 10843211 10820603 10494796 10674107 10278853 10820602 10792655 10487821 10664501 10269086 10773255 10783534 10479549 10621269 10261336 10751528 10773256 10426811 10621268 10255180 10535606 10751529 10420866 10613429 10215034 10494779 10729532 10318698 10542895 10194016 10460192 10699713 10312644 10535612 10330244 10683914 10289569 10521703 10322857 10674171 10232684 10460168 10318737 10664499 10194032 10420870 10289548 10652265 10403801 10269093 10621483 10395328 10263877 10593921 10370324 10215033 10569691 10360554 10175994 10552220 10354598 10175985 10521714 10318729 10503897 10261367 10494769 10232492 10460195 10443546 10318688 10318689 10310114 10289597 10269108 10261311 10232712 10176003 CB67534 CB67536 CB67540 CB67636 CB67640 CB68112 11691780 11799776 11384688 11584779 11813262 11154393 11627325 11599804 11538291 11799809 11137721 11584818 11315473 11349219 11785634 11080525 11572761 11193472 11298129 11732169 10992843 11538318 11041185 11123878 10960988 10751531 11425919 10820606 11103223 10203287 11338574 10683900 11080542 11276288 10542972 11069189 11114390 10494789 11058850 11069187 10460144 11041186 11050717 10435537 11028724 11050654 10945756 11041184 10843212 10980901 10683865 11016749 10674110 11007105 10569684 10945755 10542973 10856289 10536238 10843152 10514216 10832397 10496084 10820605 10773257 10751530 10738035 10691438 10683882 10621494 10552233 10542876 10514241 10503889 10487832 10479499 10435543 10420860 10318732 10261372 10224561 10203282 10176011 CB68114 CB68116 CB68118 CB68120 CB68122 CB68124 11508865 11813242 11691746 11254886 11773429 11813248 11484956 11734964 11584789 11080562 11721235 11799766 11091656 11655472 11528294 11058813 11655478 11721234 11050663 11502626 11338711 11050675 11627323 11641138 11041187 11058828 11193474 11007107 11584800 11613154 10751532 11050686 11058845 10992844 11561402 11584803 10691422 11041188 11050699 10960989 11254888 11452597 10664497 11028725 11016750 10621313 11193446 11370808 10232687 10751533 11007106 10613412 11150797 11058802 10683859 10919619 10487841 11091686 11050667 10318690 10820607 10443566 10856290 11016751 10261324 10613410 10426820 10820608 10970852 10243437 10318694 10400250 10792657 10960990 10289565 10397628 10773258 10945757 10175995 10318693 10691475 10820609 10297680 10683869 10792658 10278787 10664494 10773259 10269115 10621308 10569662 10613564 10593937 10569695 10542879 10494757 10479537 10287042 CB68126 CB68128 CB68130 CB68132 CB68134 CB68136 11827739 11827760 11681282 11827757 11785639 11813223 11773407 11749829 11484942 11760046 11773435 11641135 11613138 11773410 11218603 11773447 11710259 11502597 11540970 11721254 11150750 11754238 11655466 11373272 11540971 11681294 11075680 11734949 11641125 11326445 11502612 11613145 10960991 11710244 11411011 10992845 11206082 11254859 10843153 11669002 11114370 10992845 11108136 11254874 10820611 11655473 11103232 10992845 11058827 11231072 10751535 11641126 11028726 10960993 11050687 11206077 10691449 11528261 11007110 10843214 10913656 11114372 10487840 11241589 10970853 10843214 10552215 11058811 10460171 11231067 10843213 10843214 10503882 11050674 10397562 11123833 10832399 10843214 10487839 11007108 10390340 11007109 10806908 10820612 10460143 10856291 10380510 10960992 10751536 10792659 10269111 10820610 10318733 10901168 10558730 10773260 10176024 10806907 10176012 10878787 10542980 10751537 10751534 10856293 10514226 10552239 10503895 10832398 10479478 10526617 10487799 10664505 10452170 10521715 10479543 10652262 10435573 10487833 10460133 10631764 10176013 10435575 10443547 10613578 10420853 10395326 10602844 10339017 10390320 10577111 10318721 10380506 10569697 10278857 10318723 10514228 10224558 10261342 10487801 10175977 10255183 10435535 10186264 10420856 10397560 10380515 10330247 10339020 10322860 10310107 10278881 10269080 10261309 10218186 10218176 10168507 CB68138 CB68140 CB69312 CB69316 CB69320 CB69322 11827728 11547343 No lot Manf No lot Manf 11760075 11528256 11827753 11349213 11691777 11315457 10930779 10867471 11641160 11193464 10487797 10832400 11599810 11150783 10479472 10602831 11561407 10773261 10460369 10558731 11543093 10762630 10380507 10339014 11538321 10738036 10339011 10318691 11502623 10652277 10278783 11373282 10651921 10168502 11326470 10651860 11315462 10651858 11254882 10185497 11182275 11080563 11058844 11041189 10992846 10970854 10960994 10856294 10832401 10820613 10806909 10792661 10699714 10652270 10613409 10602834 10577096 10569655 10542868 CB69324 CB69328 CB69331 CB69428 10820614 11627332 11827735 11827729 11610931 11773404 11114402 10843215 11621107 11584777 11091706 11241603 11547344 10577076 10856298 11231096 11538288 10552201 11193467 11484933 10542861 10901169 11173265 11154376 10535597 11114381 11075678 10514262 10919620 11091671 10970856 11075725 10691434 10923638 11041191 10398312 11007111 10278845 10980890 10980883 10232689 10960995 11028727 10970855 10945758 11041190 10923639 10901170 11050659 10878788 10856296 11069171 10843154 10820615 11114395 10783535 10773263 11150794 10751540 10613550 11182285 10583504 10569681 11206048 10261375 10176027 11241628 11278697 11338690 11349218 11538298 11538300 11543085 11584782 10186265 10261371 10487806 10494775 10503892 10514227 10542903 10683889 10721070 10738037 10751539 10773262 10792662 10806910;
 
7) Model # / Lot # DLP6N48R3 DLP6N48R4 TL4F71R1 11241044 11465359 11799944 11755661 11713167 11669547 11616953 11568176 11509030 11478537 11432935 11414606 11282018 11252748 11239976 11209356 11130765 11110871 11101609 11051824 11015290 10916961 10860025 10816466 10693674 10656545 10588143 10502496 10454472 10426945 10310272 10255607 11669547 11616953 11568176 11509030 11478537 11432935 11414606 11282018 11252748 11239976 11209356 11130765 11110871 11101609 11051824 11015290 10916961 10860025 10816466 10693674 10656545 10588143 10502496 10454472 10426945 10310272 10255607;
 
8) Model #/ Lot # C330201C C330201D C330201E C330206B C342603A C350103B 201778990 201333560 205081295 201308440 204054606 201551424 202046133 205309658 203601818 202303911 202640160 205320345 203954482 202632898 203901734 205382559 204022437 202749853 203988245 205405093 205295088 204702221 204083070 205430380 205341343 204140301 205382558 205009633 C350106A C390101D C390203D C390406C C390409B C390601C 203386584 201756864 201271206 201089120 201333454 201254615 204702226 201905232 201301780 201503223 201467644 201293772 204814118 202008866 201350933 201649278 202740140 201323302 201446358 201762036 202949628 201585473 201567009 202025197 203360831 201699263 201930998 202369699 203745171 201764741 202012666 202561642 204288932 201927157 202165777 203310174 204311077 201983847 202831965 203863206 204311078 202147109 203040326 203974731 204981269 202338794 203176693 204285949 204311100 202607179 203824089 204359270 205191686 203031085 203989352 204772228 204311101 203280877 204083184 204942619 204311102 204140178 205058667 205402352 204524639 205198592 205505532 204878946 205502765 204981273 205090466 205167834 205260796 205284044 205322751 205389438 C390601D C390601E C390702A C390802A C390903A C391001B 201978568 204506615 201514769 201254604 201412703 201424864 203458279 204524638 201669440 201581163 201716502 203721546 204774490 201893277 201777104 203958431 204918792 202102480 202045021 204030513 205135410 202276601 203217589 204186594 205204813 203293858 203435712 204314702 205314074 203722121 203647848 204444206 205327511 203844438 203814643 205397133 203955760 203909330 204133788 203988762 204334538 204080477 204399838 204136158 204437462 204236435 204567894 204319619 204828993 204404301 204952274 204480662 205127283 205050557 205199773 205114489 205284050 205225609 205322756 C391102F C391104B C391104D C391104F C391203A C391203B 201260397 202335015 202648288 203814113 201592267 202335015 201316863 202721406 203912313 201779099 202564471 201328866 202956306 203989351 202031340 202648288 201354079 203435354 204315229 202201301 202629850 201582137 204486509 202721406 201685303 204703505 202956306 201767640 204976133 203212352 201923860 205135962 203457797 202018139 205284041 203703579 202147111 205357458 203829112 202338090 205455476 203958091 202607450 204005429 202832635 204133662 202978994 204339276 203218293 204421636 203420717 204642948 203657578 204796134 203824092 204943321 203966968 205059363 204038746 205113433 204080534 204323903 204424421 204501914 204921866 205014886 205114486 205291411 205459133 205512599 203824093 C392502A C392503A C410201D C410407A C410407B C431601A 204821370 204821369 201249841 201428181 205113428 205357187 205217073 204916548 201278746 201436433 205287910 205217281 201334984 201715753 205397136 201454169 201892654 205470270 201585444 201971522 205507854 201685309 202496001 201767422 202604823 201936374 203142177 202212131 203434662 202596479 203451447 202657601 203800302 202753829 204070146 202942379 204288401 203218561 204399839 203531683 204437258 203784895 204548389 203863203 204695802 203977359 204921862 204039082 204129083 204179722 204368226 204452404 204563923 204942617 205050810 205122774 205244751 205307931 205354349 205407856 202212132 C490901B S342603B 201748829 204426525 202689619 203819553 205086432 205203567
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Inc. Cardiac Rhythm Disease Management, Saint Paul, MN, by letter dated December 2011. 
Manufacturers: Medtronic Cardia Surgery Division Europe, Kerkrade, Netherlands;
Medtronic Mexico, S. De R. L. De C.V., Tijuana, Baja California, Mexico. Firm initiated recall is ongoing.
REASON
Instructions for Use for the DLP Single Stage Venous Cannulae are in the process of being updated. The current precaution statement referencing ventricular assist procedures will be identified as a contraindication in the updated Instructions for Use. DO NOT USE THIS PRODUCT FOR EXTENDED TERMS SUCH AS VENTRICULAR ASSIST PROCEDURES. Medtronic has received two reports of patient deaths due to product failure during use in ventricular assist procedures, which are outside the indications for use.
VOLUME OF PRODUCT IN COMMERCE
1,232,914 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including: Rehab Kidster( Kidster). Product Usage: The purpose of these wheelchairs is to provide mobility to individuals limited to a seating position. They may also be used as attendant propelled transport devices in a health care environment such as a hospital, nursing home or extended care facility. Recall # Z-0863-2012;
 
2) Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including: Rehab Tough and Tilt (TNT). Product Usage: The purpose of these wheelchairs is to provide mobility to individuals limited to a seating position. They may also be used as attendant propelled transport devices in a health care environment such as a hospital, nursing home or extended care facility. Recall # Z-0864-2012;
 
3) Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including: Rehab RAM Product Usage: The purpose of these wheelchairs is to provide mobility to individuals limited to a seating position. They may also be used as attendant propelled transport devices in a health care environment such as a hospital, nursing home or extended care facility. Recall # Z-0865-2012;
 
4) Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including: Bariatric Rehab Tough & Tilt (BTNT) Product Usage: The purpose of these wheelchairs is to provide mobility to individuals limited to a seating position. They may also be used as attendant propelled transport devices in a health care environment such as a hospital, nursing home or extended care facility. Recall # Z-0866-2012;
 
5) Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including: Rehab MAC Platform Chair Product Usage: The purpose of these wheelchairs is to provide mobility to individuals limited to a seating position. They may also be used as attendant propelled transport devices in a health care environment such as a hospital, nursing home or extended care facility. Recall # Z-0867-2012
CODE
1) Serial numbers: 32357-0904, 33303-1205, 33911-1106, 34312-0107, 34769-0807, 35216-0308, 35314-0408, 35337-0508, 35836-0109, 35669-1008, 35716-1108, 35752-1208, 35764-1208, 35908-0209, 35244-0308, 35627-1008, 35832-0109, 36050-0409, 36744-0610, 36805-0710, 36839-0810, 36849-0810;
 
2) Serial numbers: 32071-0304, 32390-0904, 32394-0904, 32420-0904, 32492-1004, 32584-1204, 32777-0305, 32849-0405, 32903-0505, 32956-0705, 32989-0805, 33689-1206,32585-1204, 33139- 0905, 33749-0606, 33750-0606, 33966-0806, 34222-1106, 34187-1206, 34277-1206, 34752-0707, 35390-0508, 35613-0908, 35956-0309, 35980-0309, 36264-0909, 36423-1209, 36460-1209, and 36648-0310;
 
3) Serial number: 35435-0608;
 
4) Serial numbers: 32031-0504, 32280-0704, 34402-0207, 33383-01 06, 33304-1205, 33409-0106, 33436-0206, 33515-0306, 34712-0607, 35899-0209;
 
5) Serial numbers: 32541-1104, 32912-0605, 33018-0805, 33828-0806, 36626-0310, 36665-0310, and 36827-0810
RECALLING FIRM/MANUFACTURER
Gunnell, Inc., Millington, MI, by letters dated November 1, 2011. Firm initiated recall is ongoing.
REASON
Gunnell has received complaints that the gas cylinders used in Gunnell manual wheelchairs with dynamic recline would not hold a firm position, or as described by users, the back support or canes were spongy.
VOLUME OF PRODUCT IN COMMERCE
69 devices
DISTRIBUTION
Nationwide and Australia and Canada
___________________________________
PRODUCT
Model 73X Uni-Vent Product Usage: Intended for use at mass casualty incidents. Recall # Z-0870-2012
CODE
Unit: K051476
RECALLING FIRM/MANUFACTURER
Impact Instrumentation, Inc., West Caldwell, NJ, by letter dated November 3, 2011. Firm initiated recall is ongoing.
REASON
A piece of internal tubing in the 73X portable ventilator is of incorrect specifications for the device.
VOLUME OF PRODUCT IN COMMERCE
57 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
***REF 66800694***Qty 10***RENASYS Port Foam Dressing Kit Port***STERILE***Rx Only.***Made in Mexico for/Fabrique au Mexique pour: Smith & Nephew, Inc., St. Petersburg, FL 33716***Smith & Nephew Medical Limited Hull HU3 2BN England***Lot 123456. Product Usage: The product is a suction device used as an accessory to the foam dressing kits, which is used in conjunction with Smith & Nephew Negative Pressure Wound Therapy (NPWT) systems to deliver negative pressure to a wound. Product Code Number: 66800694. Recall # Z-0875-2012
CODE
Lot numbers: 50512962, 50512969, 50512974, 50513087, 50514672, 50513073, 50513074, 50517647, 50516110, 50539644, 50539645, 50539646, 50539647, 50555348, 50555349, 50555351, 50539648, 50546339, 50546340, 50548244, 50548245, 50548246, 50548247 and 50548248
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smith & Nephew Inc., Saint Petersburg, FL, by letter dated December 14, 2010.
Manufacturer: Availmed S.A. de CV, Tijuana, Mexico. Firm initiated recall is ongoing.
REASON
Recall due to small holes in the primary pouch of some of the packaged units of which constituted a breach of the sterile barrier.
VOLUME OF PRODUCT IN COMMERCE
71,329 units
DISTRIBUTION
Nationwide and Internationally
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PRODUCT
1) Artiste Nano-Hybrid Affected Product. Syringe Part No. Value Pack Part. No Shade N28A N28VA A1 N28B N28VB A2 N28C N28VC A3 N28D N28VD A3.5 N28E N28VE A4 N28F N28VF B1 N28G N28VG B2 N28J N28VJ C1 N28K N28VK C2 N28L N28VL C3 N28N N28VP D2 N28R N28VR Universal Opaque N28XA N28VXA A0 N28XC N28VXC Incisal. The intended use of this device is as a light cured, low viscosity, hybrid composite material which is compatible with a variety of bonding agents and luting materials during the course of dental restorations. Artiste Flowable and Flow Tec (private label of Artiste Flowable) are indicated for restorations of carious lesions, porcelain repairs, small core build-ups, fill-in of surface enamel irregularities, etc. Recall Z-0989-2012;
 
2) Flow Tec Nano-Hybrid Flowable Affected Product Syringe Part No. Value Pack Part. No. Shade BEN3784-514 BEN3786-754 A1 BEN3784-532 BEN3786-763 A2 BEN3784-541 BEN3784-738 A3 BEN3784-550 BEN3784-747 A3.5 BEN3784-569 BEN3784-756 A4 BEN3784-578 BEN3784-765 B1 BEN3784-596 BEN3784-774 B2 BEN3784-603 BEN3784-783 C1 BEN3784-612 BEN3784-792 C2 BEN3784-621 BEN3784-809 C3 BEN3784-649 BEN3784-818 D2 BEN3784-722 BEN3784-818 Universal Opaque BEN3784-685 BEN3784-827 A0 BEN3784-701 BEN3784-836 Incisal. The intended use of this device is as a light cured, low viscosity, hybrid composite material which is compatible with a variety of bonding agents and luting materials during the course of dental restorations. Artiste Flowable and Flow Tec (private label of Artiste Flowable) are indicated for restorations of carious lesions, porcelain repairs, small core build-ups, fill-in of surface enamel irregularities, etc. Recall # Z-0990-2012
CODE
All Lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sybron Dental Specialties, Orange, CA, by letters dated April 20, 2011, November 10, 2011 and December 8, 2011.  
Manufacturer: Kerr Corp., Orange, CA. Firm initiated recall is ongoing.
REASON
The Flow Tec Nano-Hybrid Flowable Composite material has been found to be difficult to extrude.
VOLUME OF PRODUCT IN COMMERCE
77,289 Units
DISTRIBUTION
Nationwide and Internationally
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PRODUCT
Agfa DX-D Imaging Package - (The detector power cables described in the Report of Correction and Removal are connected to portable detector panels used in the DX-D systems) Product Usage: DX-D Imaging Package ha the same intended use as the predicative devices: namely to provide diagnostic quality images to aid the physician with diagnosis. The device uses Agfas fla panel detectors with amorphous silicon scintillators and NX workstations with MUSICA imaeg processing to create radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts. The product is not indicated for use in mammography. Model Numbers DX-D 20G and DX-D 20C; Catalog Numbers ABC. Recall # Z-1062-2012
CODE
Code 5PYTM and 5PYUO
RECALLING FIRM/MANUFACTURER Recalling Firm: AGFA Corp., Greenville, SC, by letter dated January 16, 2012. 
Manufacturer: Agfa-Gevart NV, Mortsel, Belgium. Firm initiated recall is complete.
REASON
The firm received a complaint that when using the DX-D Mobile DR X-Ray unit they noticed the detector cable was hot.
VOLUME OF PRODUCT IN COMMERCE
42 units
DISTRIBUTION
Nationwide
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PRODUCT
GE SENOGRAPHE 2000D Full Field Digital Mammography System (SENO 2000D). The Senographe 2000D system generates digital mammographic images that can be used for screening and in the diagnosis of breast cancer. The Senographe 2000D is intended to be used in the same clinical applications as traditional mammographic film/screen systems. Recall # Z-1063-2012
CODE
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00000553032BU4 00000408812BU6 00000425068BU4 00000461132BU3 00000562580BU1 00000566610BU2 00000572094BU1 00000573527BU9 00000538516BU6 00000553677BU6 00000572614BU6 00000567840BU4 00000380493BU7 00000424254BU1 00000440580BU9 00000548410BU0 00000568729BU8 00000485499BU8 00000369033BU6 00000381271BU6 00000324648BU5 00000313482BU2 00000561581BU0 00000362612BU4 00000361530BU9 00000380494BU5 00000369027BU8 00000338730BU5 00000362613BU2 00000381270BU8 00000371580BU2 00000298661BU0 00000381268BU2 00000410070BU7 00000406718BU7 00000361531BU7 00000361533BU3 00000306913BU5 00000358814BU2 00000366069BU3 00000388402BU0 00000389901BU0 00000391759BU8 00000385191BU2 00000393813BU1 00000426220BU0 00000438681BU9 00000541159BU0 00000560529BU0 00000425064BU3 00000410076BU4 00000362301BU4 00000541161BU6 00000457471BU1 00000424253BU3 00000380492BU9 00000508905BU7 00000343364BU1 00000444049BU1 00000273546BU2 00000512134BU8 00000308625BU3 00000508902BU4 00000512140BU5 00000512137BU1 00000336012BU0 00000357324BU3 00000323411BU9 00000361528BU3 00000380779BU9
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, LLC, Waukesha, WI, by letter dated October 17, 2011.
Manufacturer: GE Medical Systems, SCS, Buc Cedex, France. Firm initiated recall is ongoing.
REASON
GE Healthcare has become aware of inaccurate measurements on GE magnified images provided by Senographe 2000D Mammography systems when reviewed on IHE compliant workstations. This issue may impact patient safety.
VOLUME OF PRODUCT IN COMMERCE
1,060 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Correct VPS Vinyl Polysilocane Impression Material, Product Number Q01B. The intended use of this device is as a dental impression material. Recall # Z-1146-2012
CODE
Lot Number: 3510059
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sybron Dental Specialties, Orange, CA, by letters dated November 17, 2010.
Manufacturer: Kerr Corp., Orange, CA. Firm initiated recall is complete.
REASON
It was discovered that the individual tubes inside the Correct VPS Medium Body Tube boxes are missing the lot/expiration date sticker.
VOLUME OF PRODUCT IN COMMERCE
176 units
DISTRIBUTION
Nationwide, Canada and Pakistan
___________________________________
PRODUCT
Titanium SURFIX ALPHA SCREWS, a component of the Newdeal Hallu Lock Plate System. Surfix Alpha Variable angle locking system exists in different diameters and lengths. The product can be sold as a replenishment part individually packaged sterile, or as one (1) unit which is kitted within an instrumentation tray at which point, the product is non-sterile until the tray in which it is kitted is sterilized a the designated facility. The product is indicated for use in fixation of fractures, osteotomies or arthrodesis of the first metatarso-phalangeal joint. Model #295214S, Part #295214SND. Recall # Z-1147-2012
CODE
Batch #EGH9
RECALLING FIRM/MANUFACTURER
Recalling Firm: Integra LifeSciences Corp., Plainsboro, NJ, by letter on December 21, 2011.
Manufacturer: Newdeal Sas, Saint Priestsaint Priest, France. Firm initiated recall is ongoing.
REASON
Manufacturing error. The part number which corresponds to the length dimension of : 14 mm. was incorrectly etched on to screws with the actual measurement of: 12 mm.
VOLUME OF PRODUCT IN COMMERCE
105 units
DISTRIBUTION
Nationwide, United Kingdom, France, Switzerland, and Austria
___________________________________
PRODUCT
1) Philips MultiDiagnost Eleva II Software Version R4.1.x Model: 708032 This Philips MultiDiagnost Eleva system is intended to be used as a multifunctional I universal system. General R/F. Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications. Recall # Z-1196-2012;
 
2) Philips MultiDiagnost Eleva FD, Software R5.1.x Model: 708034 Philips MultiDiagnost Eleva system is intended to be used as a multifunctional I universal system. General R/F. Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications. Recall # Z-1197-2012
CODE
1) Software Version R4.1.x S/N: 284 290 291 293 294 295 296 297 298 299 303 305 306 307 308 309 310 312 314 315 316 317 318 327 329 338 346 349 350 352 353 354 354 355 358 362 365 366 367;
 
2) Software Version R4.1.x S/N: 3 5 6 8 9 10 12 13 14 15 16 17 18 19 22 23 24 25 26 27 28 29 30 32 33 34 36 37 38 39 40 41 46 47 50 51 52 53 54 55 56 58 60 61 63 64 65 66 67 68 69 70 71 72 73 75 76 77 78 79 80 81 82 83 84 85 88 93 94 95 96 97 98 100 101 103 104 105 106 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 125 126 129 130 131 132 133 134 135 136 137 138 142 143 144 146 147 148 149 151 152 155 157 159 160 161 162 167 168 170 174 175 176 177 179 180 181 182 185 186 187 189 190 191 193 194 195 196 197 201 202 204 205 206 207 208 209 210 211 213 216 217 219 220 221 222 223 224 225 228 233 234 235 237 240 241 242 244 246 247 249 251 253 254 255 257 259 261 262 264 265 266 268 269 272 273 277 278
RECALLING FIRM/MANUFACTURER
Philips Medical Systems Nederlands, Best, Netherlands, by letter dated February 21, 2012. Firm initiated recall is ongoing.
REASON
Displayed skin dose rate is calculated using an incorrect point of reference, resulting in too low displayed values.
VOLUME OF PRODUCT IN COMMERCE
1) 39; 2) 192
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) Nucletron Adapter and Transfer Guide Tube, part number AL 13005000, a component used with the VariSource" IX HDR Afterloader. Product Usage: The adapter is part of the VariSource Afterloader System, a computer controlled remote HDR Afterloader used to place a high activity radioactive source within a needle(s) or applicator(s) which have previously been placed for a specific clinical purpose in a patient. Recall # Z-1199-2012;
 
2) Nucletron Adapter and Transfer Guide Tube Set, part number AL 13005001, set of 3 adapters, components used with the VariSource" IX HDR Afterloader. Product Usage: The adapter is part of the VariSource Afterloader System, a computer controlled remote HDR Afterloader used to place a high activity radioactive source within a needle(s) or applicator(s) which have previously been placed for a specific clinical purpose in a patient. Recall # Z-1200-2012
CODE
1) and 2) All lots of the components are recalled.  Serial numbers: H600097 H600254 H600255 H600268 H600274 H600341 H600345 H600352 H600377 H600381 H600416 H600435 H600437 H600462 H600513 H600524 H600538 H600546 H600548 H600583;
RECALLING FIRM/MANUFACTURER
Recalling Firm: Varian Medical Systems, Inc., Charlottesville, VA, by letter dated January 5, 2012.
Manufacturer: Varian Medical Systems Haan, Haan, Germany.  Firm initiated recall is ongoing.
REASON
Components of medical device used in brachytherapy may be defective and cause a shifted dose distribution to patients.
VOLUME OF PRODUCT IN COMMERCE
122 units
DISTRIBUTION
Nationwide and Canada, Japan and Sweden
___________________________________
PRODUCT
da Vinci S. Surgical System, da Vinci Si and da Vinci Si-e Surgical Systems. The Intuitive Surgical Endoscopic instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. Recall # Z-1202-2012
CODE
IS2000 and IS3000, serial numbers: USG484 USG364 SH1071 SH0569 SH0508 SH0449 SH0412 SH0063 SG489 SG204 SG2013 SG2006 SG804 SG108 SG150 SG734 SH0411 SH0209 SH0329 SH0148 SG326 SG794 SH0511 SH1102 SH0991 SH0882 SH0881 SH0878 SH0758 SH0757 SH0573 SH0570 SH0568 SH0567 SG675 SG176 SH0210 SH0364 USG071 SG498 SG095 SG070 SG735 SG076 SG779 SH0817 SH0461 SG597 SG306 SH0636 SH0190 SG411 SH0475 SH0915 SH0234 USG043 SG2024 SH0564 USG754 SH0841 SG572 SG830 SG812 SG369 SG2018 SG834 SH0653 SH0086 SH0957 SH0659 SH0406 SH0249 SG031 SH0258 SG035 SG608 SH0293 SH0280 SH0334 SG447 SH0430 SH1129 SG448 SH0275 SG280 SH0681 SG302 SG327 SG325 SG086 SG291 SG614 SG129 SG626 SG417 SG104 SH0229 SG106 SH0227 SG105 SH0228 SH1029 SG655 SG653 SH0772 SH0092 SH0750 SG088 SH0594 SH0154 SG235 USG508 SG785 SH0501 SH0079 SH0202 SH0730 SH0977 SH0110 SH0651 SH0942 SH0933 USG026 SH0932 SG188 USG132 SG534 SG595 SG276 SH0180 SG193 SG842 SH1123 SH1003 SG412 SG180 SH0478 SH0513 SH0862 SG318 SH0109 SH0642 SG565 SG197 SH0640 SH0399 SG611 SH0872 SH0175 SG2001 SG211 SH0315 SH0678 SH0993 SG184 SH1086 SG143 USG515 SG662 SH0619 SH0696 SH0768 SH0767 SH1145 SH0247 SH0711 SH0779 SH0536 SH0361 SG883 SG820 SG816 SG757 SG738 SG665 SG467 SG435 SG349 SG290 SG2008 SG159 SG667 SH0285 SG284 SH0663 SG362 SG825 SG776 SG714 SG827 SG875 SG838 SG258 SG740 SH0271 SG308 SG839 SG383 SG465 SH0093 SG259 SG257 SG537 SH1093 SH0423 SH0491 SG781 SH0121 SH0751 SG100 SG588 SG768 SH1124 SG533 SG548 SH0997 SH0897 SG2033 SG706 SG466 SG2041 SG138 SG419 SH0410 SH0884 SG382 SH0811 SG739 SH0497 SH0858 SG674 SH0701 SH0986 SG055 SH0967 SH0670 SH0669 SH0355 SH0610 SG564 SG387 SG632 SH0431 SH1081 SH0493 SH0473 SH0755 SH0729 SH0673 SH0722 SH1018 SH1091 SH0419 SG612 SH1026 SG422 SH0450 SH0089 SG200 SH1068 SH0592 SH0591 SH0141 SH0794 SG2028 SG107 SH0087 SH1103 SG160 SH0213 SG553 SH0452 SH0928 SG222 SH0705 SG621 SH0896 SH0042 SH1143 SG561 SG697 SH0173 SH0291 SG540 SG758 SH0987 SH0072 SH0693 SG766 SG026 SG075 SG682 SG831 SG130 SG809 SG813 SG805 SG671 SH0820 SG335 SG005 SG808 SG252 SG829 SH0965 SG815 SG814 SH0067 SG578 SG423 SH0892 SH0886 SG322 SG303 SG399 SH1097 SH1004 SG087 SG2020 SH1005 SH0522 SG357 SG374 SH0193 SH0372 SG677 SG398 SG716 SG260 SH1036 SH0127 SH0019 SG328 SG320 SG207 SG233 SG232 SH0778 SH0200 SH0199 SH0198 SH0197 SH0196 SG275 SG2022 SG008 SG438 SG368 SG733 SG678 SG708 SH0832 SG795 SH1114 SH0833 SH0680 SG640 SG679 SG347 SG370 SH0296 SG596 SH1070 SH0454 SH1106 SH0801 SH0800 SH0799 SH0297 SH0272 SH0810 SH0345 SG645 SH0585 SG503 SH0308 SG077 SG619 SG270 SG265 SH0177 SH0054 SH0733 SH0665 SH0658 SH0574 SH0534 SH0357 SH0328 SH0251 SH0062 SG823 SG742 SG452 SG425 SH0893 SH0598 SH1069 SG725 SH1017 SG520 SH0332 USG113 SG566 SG835 SH0714 SG762 USG703 SG551 SG2009 SG2015 SG189 SH0962 SG605 SH0474 SG582 SG481 SH0980 SH0088 SH0528 SH0743 SH1031 SH0443 SG2037 SH0654 SG2035 SG2004 USG642 USG332 SH0698 SH0689 SH0690 SH0688 SG661 SG2030 SH0910 SH0909 SG116 SH0218 SG166 SH0921 SH0798 SG255 SG436 SH0555 SH0116 SH0816 SG495 SG652 SH0126 SG434 SG472 SG122 SH0609 SH1013 SG2029 SH0737 SG194 SH0641 SG643 SH0964 SH0309 SH1076 SG636 SH0113 USG213 SH0115 SH0356 SG514 SH1059 SH0704 SH0727 SH0898 SG429 SH0025 SH0048 SG752 SH0869 SG033 SH0927 SH0181 SH1134 SH0349 SG575 SG301 SG523 SG524 SH0516 SG641 SH0256 SG299 SG437 SH0668 USG230 SH1052 SH0279 SH0278 SH0052 SH0051 SG373 SG371 SG2034 SG048 SH0624 SH0499 SH0498 SH0049 SG054 SH0956 SH1149 USG728 SG771 SH0333 SG027 SH0440 SH0165 SH0702 SG500 SH0904 SH0903 SG307 SG078 SG269 SG2025 SH0890 SG492 SH0835 SG672 SG724 SH1148 SH1136 SG623 SH0853 SH0793 SH0224 USG146 SH1132 SH0638 SH0515 SH0417 SH0354 SH0036 SG144 SG660 SH1138 SG822 SH1014 SH0082 SH0547 SG283 SG507 SH0529 SH0445 SH0490 SG112 SH0813 SH0167 SH0565 SG406 SH0740 SG841 SG505 SG689 SG819 SG530 SG664 SG378 SG377 SG366 USG317 SH0103 SH0099 SG177 SH0985 SH0058 SH0885 SG765 SH0868 SH0353 SG456 SG457 SH0390 SG573 SH0527 SH0526 SH0018 SG658 SG162 SG149 SG051 SH0712 SH0432 SH0946 SH0906 SH0721 SG2031 USG727 SH0759 SH0339 SG562 SH0531 SG351 SG169 SG555 SG554 SH1001 SH0463 SH0608 SG584 SG400 SG123 SH0174 SH0976 SG461 SH0796 SH0633 SH1092 SG699 SG271 SG272 SH0560 SH0781 SH0780 SH0521 SG618 SG237 SH0622 SG427 USG201 USG044 SH0035 SH0703 SH0055 SG254 SH0192 SH0556 SH0971 SH0301 SG432 SG073 SH0647 SH0489 SH1041 SH0859 SH0404 SH1057 SG288 SH0352 SH0468 SG755 SG476 SG471 SG300 SG571 SG350 SH1061 SH1108 USG806 SH1073 SH1028 SG199 SH1064 SH1088 SG844 SG828 SH0589 SH1153 SH1083 SH0546 SG267 SH1042 USG800 SH1012 SH1011 USG802 SH0477 SH0045 SH0671 SH0426 SG167 SG360 SH0613 SH0694 SG760 SG2027 SG798 SG710 SH0988 SG544 SG021 SH0948 SG628 SH0723 SH0683 SH0697 SH1023 SH0214 SG485 SG131 SH0551 SH0169 SH0168 SH0171 SG091 USG775 SH0789 SH0170 SG263 SH0085 SH0273 SH0205 SH0398 SG292 SG246 SH0504 SH0123 SG528 SH1090 SH0639 SG480 SH0880 SH1062 SH1113 SG430 SH0350 SH0939 SH0012 SG372 SH0186 SH0655 SH0013 SH0827 SG521 SG068 SH0699 SH0995 SG179 SH1019 SG736 SG482 SH0505 SG415 SH0156 SG450 SG901 SG897 SG878 SG895 SG884 SG888 SG2023 SG899 SG862 SG886 SG896 SG863 SG900 SG850 SG893 SG892 SG874 SG887 SG894 SG877 SG885 SG889 SG898 SG052 SH0805 SH0584 USG748 USG750 SG224 SG223 SH0646 SH0429 SH0139 SH0138 SG003 SG891 SG861 SG860 SG859 SG858 SG857 SG856 SG855 SG854 SG853 SG852 SG851 SG849 SG848 SG558 SG547 SH0996 SH0754 SH0464 SH0307 SG531 SH1152 SH0060 SG281 SH0761 SG676 SH0317 USG726 SH0488 SH0403 SG761 SG591 SH0201 SG024 SG579 SH1079 SG196 SH1047 SH0593 SH0562 SG379 SG081 SG711 SH0028 SG346 SG2039 USG577 SG483 SH0958 SH0561 SH0084 SG753 SG478 SH0828 SH0377 SG666 SG833 SH0870 SG315 SG047 SG2005 SH0422 SH0421 SG173 SG2032 SG638 SH0629 SH0628 SH0774 SG253 SH1051 SH1050 SG426 SG407 SH1060 SH0919 SH0476 SH0096 SH0300 SH0232 SH1115 SH0715 USG788 SH0582 SG464 SH0250 SH0935 SH0864 SH1080 SG083 SH0625 SG746 SH0687 SG096 SH0648 SG312 SH0483 SH1085 SH0618 SG440 SH0905 SH0203 SG049 SH0825 SH0766 SH0819 SG602 USG700 USG631 SH0940 SH0923 SG745 USG147 SG585 SH0635 SH0056 SH0466 SG723 SG140 SG620 SG363 SH0902 SG339 SH0111 SH0691 SG183 SH0360 SG355 SG593 SG185 SG418 SH0220 SG793 SH0216 SH0215 SH0925 SH0912 SH0559 SH0558 SH0575 SH0206 SH0615 SH0614 SH0185 SH0572 USG552 SH0731 SH0535 SG792 SG698 SH0760 SG509 SG310 SG174 SH0874 SG297 SH0321 SH1002 SH0792 SG409 SH0550 SH0397 SH0456 SG198 SH0839 SH0821 SH0782 SH0749 SH0748 SH0129 SG215 SG161 USG770 SH0804 SH0786 SH0685 SH0557 SH0441 SH0344 SH0343 SH0342 SH0207 SG234 SH0934 SH0040 SH1055 SH1054 SH0577 SH0576 SH0152 271326 SH1022 SH0163 SH0374 SH0033 SG783 SH0979 SG333 SG2011 SH0020 SH0963 SH0532 SH1130 SH1032 SH0847 SH0806 SH0732 SG778 SG763 SG615 SG490 SG441 SG244 SG433 SH0617 SG470 SG644 SH0437 USG559 SH0777 SH0385 SH0306 SH0069 SG569 SG293 USG015 SH1151 SG444 SG039 SH0599 SH0140 SH0137 SG341 SG2026 SH0135 SG737 SG148 SH0348 SH1077 SH0643 SH1128 SG413 SH0068 SH0601 SH0204 SG696 SG609 SH0848 SH0717 SH0634 SH0183 SH0189 SH0265 SG486 SG345 253342 SH1104 SH1095 SH0645 SH0370 SH0260 SG570 SG431 SG359 SG268 SG242 SG120 SH0838 USG101 SH0184 SG463 SH1094 SG580 SH0597 SG603 SG182 SH0973 SH0972 SH0974 SH0900 SG060 SH0241 SH0580 SH0029 SH0151 SH0030 USG018 SG380 SH0552 SH0982 SG556 SH1087 SG145 SG549 SG439 SH0837 SH0230 SG497 SH0544 SH0953 SH0325 SH0057 SG473 SH0840 SH0376 SG458 SG334 SH0713 SH0153 SG890 SH0907 SH0736 SG659 SH1139 SG568 SG499 SH1040 SH0644 SH0401 SH0021 SG693 SG396 SH0242 SH0448 SH0286 SG020 SH0563 SG468 SH1027 SH0319 SG451 SG586 SH0438 SH0100 SH0954 SH0073 SH0590 SG2021 SG041 USG136 SG589 SH0632 SH0773 SH0649 SH0851 SG225 SH0253 SH0335 SH0842 SG607 SG195 SG474 SH0951 SH0950 SH0949 SH0166 SH0022 SG538 SG2017 SG191 SH0795 SH0586 SG319 SH0346 SH0439 SH0338 SH0337 SG128 SG289 SH0402 SH0041 SG542 USG642 USG577 USG515 USG136 SH1116 SH1100 SH1099 SH1055 SH1038 SH1001 SH0781 SH0578 SH0239 SG017 SH0814 USG773 USG125 SH1135 SH0428 SG139 SH0427 SH0975 SH0024 SH0108 SG790 SG557 SG036 USG701 SG261 SG2003 SH0442 SH0554 SH1133 SH0899 USG217 SH0631 SH0034 SG192 SH0695 SH0112 SH0026 SH0415 SH0414 SH0457 SH0549 SH0065 SH0420 SG262 SH0785 SH0947 SH0876 SH0510 SH0031 SG629 SG093 SH0368 SH0261 SH1067 SH0150 SH0455 SH0081 SG210 SG2045 SG502 SH0467 SG324 SH0434 SG526 SG212 SG080 SH0238 SG840 SG796 SG581 SG2012 SH0320 SG361 SG744 SG797 SG219 SH0545 SH0095 SG236 SH0465 SG245 SG475 SH0125 SG627 SH0887 SG598 SH0459 SH0413 SH0929 SH0495 SH0791 USG443 SG2040 SH0299 SG278 SH0118 SH0856 SG050 SG868 SH0931 SH0351 SH0124 SH0386 SH0834 SH0494 SH0188 SH1116 SH0187 SH0764 SH0765 SH0753 SG719 SH0131 SG117 SG606 SH0252 SG249 SG550 SH0845 SG408 SH0607 SH1075 SH0692 SG158 SH0990 SH1110 SH0707 SH1084 SH1056 SH0471 SG536 SH0223 USG062 SG401 SG098 SH1101 SH0961 SH0857 SH0742 SH0600 SH0147 SH0146 SH0145 SH0032 SH0268 SH0191 SH0875 SG410 USG053 SH1140 SH0861 SH0257 SG650 SG304 SG206 SH0157 SG683 SG202 SG019 SH0132 SG657 SH1038 SH1072 SH0143 SH1048 SG479 SG152 SH0871 SH0983 SH0739 SG695 SG205 SH0259 SG163 SH0908 SG2014 SH0803 USG721 SH1118 SG712 SG390 SH1066 USG764 SG305 SG803 SG264 SH0627 SG670 SG164 SH0844 SH0496 SH0756 SH0433 SG720 SG709 SH0815 SH1010 SH0506 SH0469 SH0581 SG391 SG691 SG385 SG119 SH0119 SG424 SH0596 SH0425 SH1096 SG477 SH0312 SG759 SG663 SH0679 SG807 SH0676 SH0675 SG178 SH0917 SH0451 SH0588 SH0134 SH0046 SG127 SG040 SG028 SG651 SH0380 SH0650 SH0807 SG510 SG337 SH0097 SG656 SH0133 SH0930 SH0891 SG442 SH0130 SG449 SG099 SH0270 SH0706 SG356 SG030 SG181 SH0866 SH0941 USG718 USG713 USG172 SH0822 SH0039 SH0818 SH0038 SH0852 SG493 SG491 SH0282 SH0064 SG647 SH0708 SH0823 SG625 USG151 SH0194 SH0709 SH0267 SG567 USG769 SH0266 SH0922 SH0149 SG780 SG344 SG336 SH0657 SG238 SH0217 SH0966 SH0383 SH0098 SG529 SH1074 SH0955 SH0393 SG488 SH0362 SH0323 SG216 SG038 SG014 SG157 SG843 SH0926 SH0162 SH0161 SG395 SG381 SH0620 SH0359 SG2038 SH0037 SG376 SH0700 SH0602 SH0503 SH0502 SH0078 SH0076 SH0274 SH0424 SH0936 SH0999 SH0179 SG624 SG496 SG494 SH1111 SG059 SH0776 SH1147 SG348 SH1037 SH1033 SH0240 SG022 SG563 SG799 SH0164 SH0867 SH0616 SH0486 SH0981 SH0292 SH0462 USG029 SH0746 SH0745 SG673 SG688 SH1137 SH0674 SH0409 SH0318 SH0883 SH0212 SH1034 SH0970 SG654 SG250 SG2007 SG2002 SG118 SH0378 SH1009 SH0994 SH0992 SH0863 SH0860 SH0595 SH0053 SG121 SH0288 SH1000 SH0514 SH1030 SH0485 SH0044 SH0518 SH0517 SG782 SH1144 SH1109 SH0763 SG637 SH1065 SH0989 SH0626 SH0612 SH0533 SH0519 SH0363 SG239 SG2010 SG065 SH0830 SH0829 SH0808 SG311 SH1058 SH0379 SH0246 SG574 SG2016 USG342 SH0938 SH0937 SH0790 SH0284 SH0136 SG546 SG404 SG342 SG175 SG013 SH0873 USG622 SH0104 SH0373 SH0290 SH0281 SH0254 SG403 SG397 SH0623 SH0102 SH0101 SG227 SG687 SG393 SH0716 SH0396 SG722 SG705 SG340 SH1127 SH1125 SG460 SG446 SG634 SH0479 SG576 SH0408 SH0233 SH0826 SG587 SG155 SH1053 SG613 SG386 SH1131 SH0762 SH0248 SH0231 USG082 SH1078 SH0400 SH0289 SG511 SG094 SG680 SH0984 SH0879 SG717 SH0741 SH0418 SG285 SG279 SH0901 SH1119 SH0662 SH0276 SG133 SG011 SH0211 SG543 SG535 SG601 SG247 SG142 SH0405 SH0395 SH0283 SG314 SG186 SG539 SG751 SH1043 SG648 SG832 SH1045 SG487 SG811 SH0061 SG743 SG669 SG729 SG298 SG741 SG583 SH0071 SH0195 SG756 SG273 SH1044 SH1105 SG633 SH0245 SG694 SH0725 SG103 SH0783 SG668 SH0330 SH0331 SH0324 SH0172 USG353 SH1008 SH1007 SH1006 SH0775 SH0460 SH0047 SG287 SG218 SH0682 SH0784 SG462 SH0263 SH0262 SG518 SH0849 USG331 SH0831 SG686 SH0630 SG063 SH0484 SG214 SG316 SH0543 SH0160 SG681 SH0298 SG309 SH0611 SH0487 SG367 SG058 SH0583 SH0340 SH0225 SH1039 SG321 SH0416 SG826 SH0894 SH0316 SG616 SH1089 SG707 SH0305 SH0843 SH1120 SH0530 SG012 SG504 SG731 SG324 SH0387 SG685 SH0066 SH0960 SH0391 SH1126 SH0235 SH0525 SH0482 SG208 SG821 SH0369 SG747 SH0458 SG170 SG165 SH0384 SG042 SG453 SH0208 SG241 SH1121 SH1063 SH0738 SH0367 SH0178 SH1035 SH0500 SG090 SH0277 SH1016 SH0945 SH0718 SG545 SH0389 SH0566 SG354 SH0719 SG251 SH0388 SH0809 SG067 SH0553 SH0998 SH0637 SH0155 SH0091 SH0077 SG522 SG454 SG009 SH0221 SH1015 SG594 SH0769 SH0094 SG527 USG517 USG156 USG072 SH1150 SH1142 SH1100 SH1099 SH1082 SH1025 SH0918 SH0914 SH0877 SH0855 SH0672 SH0621 SH0587 SH0571 SH0436 SH0435 SH0407 SH0382 SH0347 SH0311 SH0310 SH0304 SH0303 SH0302 SH0294 SH0255 SH0226 SH0182 SH0159 SH0158 SH0105 SH0080 SH0070 SH0059 SG420 SG329 SG296 SG295 SG294 SG231 SG2042 SG187 SG111 SG110 SG109 SG089 SC0005 SH1107 SG229 SH0735 SH0734 SG630 SH0523 SH0142 SH0392 SH0524 SH0394 SG153 SH0667 SH0090 SH0802 SG824 SG818 SH0117 SH0492 SG789 SH0520 SH0507 SH0381 SH0336 SG749 SG704 SG692 SG323 SG102 SG092 SH0371 SG599 SG532 SH0222 SG639 USG787 SH0606 SH0605 SH0604 SH0144 SG428 SG032 SH0295 SG358 SH1141 SG2019 SH0969 SH0968 SH0812 SG881 SG836 SH0447 SG046 SH0114 SH0664 SG837 SH1122 SH0579 SH1112 SH0375 SG286 SH0846 SH0924 SG455 SG516 SG037 USG786 SH0752 SH0107 SH0836 SG810 SG137 SH0050 SH0472 SG767 SG330 SH0219 SG034 SG784 USG240 SH0824 SH0677 SG061 USG352 SH0128 SG772 SH0512 SH0313 SH0314 SH0176 SH0686 SH1024 SH0889 SH0481 SH0480 SH0865 SH0684 USG702 SH0770 SH0920 SH0548 SG525 SG375 SG590 SG190 SG560 SG392 SG025 SG084 SG506 SG617 SH0747 SH0744 SH0358 SG732 SH1098 SH0656 SH0120 SG282 USG445 SH0453 SH0470 SH0854 SH0895 SH0106 SH0850 SG343 SH0243 SG313 SH0913 SH0726 SH0578 SG057 SH1146 SH0710 SH0509 SG168 SG684 SG801 SH0724 SH0327 SH0326 SG541 SG2036
RECALLING FIRM/MANUFACTURER
Intuitive Surgical, Inc., Sunnyvale, CA, by letter dated February 3, 2012. Firm initiated recall is ongoing.
REASON
The holding brake, a component of the da Vinci S Surgical System, may allow passive uncontrolled motion due to gravity during specific power-off conditions.
VOLUME OF PRODUCT IN COMMERCE
1,996 total units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) Wet PVP-I Small Procedure Preoperative Skin Prep Tray containing 1 - 59 mL bottle Povidone Iodine Cleansing Solution (Scrub) USP 7.5% and 1 - 59 mL bottle Povidone Iodine Topical Solution (Paint) USP 10% with Powder-Free Esteem Gloves; 20 trays per case; a sterile, latex-free, single use only tray, solution not exposed to sterilant; U.S. components packaged in Mexico except as indicated: Gloves and Cotton-Tipped Applicators made in China, Sponge Stick made in Mexico; tray catalog number 4420 The Povidone Iodine patient prep trays are used where chlorhexidine gluconate (CHG) products aren't appropriate or indicated for patient preoperative prep (traditional two-step scrub and paint using cleansing solution and topical solution) on intact skin and mucous membranes, and for washing lacerations and abrasions. Recall # Z-1207-2012;
 
2) Wet PVP-I Preoperative Skin Prep Tray containing 1 - 4 oz. bottle Povidone Iodine Cleansing Solution (Scrub) USP 7.5% and 1 - 4 oz. bottle Povidone Iodine Topical Solution (Paint) USP 10% with Powder-Free Esteem Gloves; 20 trays per case; a sterile, latex-free, single use only tray, solution not exposed to sterilant; U.S. components packaged in Mexico except as indicated: Gloves and Cotton-Tipped Applicators made in China, Sponge Stick made in Mexico; tray catalog number 4468 The Povidone Iodine patient prep trays are used where chlorhexidine gluconate (CHG) products aren't appropriate or indicated for patient preoperative prep (traditional two-step scrub and paint using cleansing solution and topical solution) on intact skin and mucous membranes, and for washing lacerations and abrasions. Recall # Z-1208-2012;
 
3) Wet PVP-I Vaginal Preoperative Skin Prep Tray containing 1 - 4 oz. bottle Povidone Iodine Cleansing Solution (Scrub) USP 7.5% and 1 - 4 oz. bottle Povidone Iodine Topical Solution (Paint) USP 10% with Powder-Free Esteem Gloves; 10 trays per case; a sterile, latex-free, single use only tray, solution not exposed to sterilant; U.S. components packaged in Mexico except as indicated: Gloves and Cotton-Tipped Applicators made in China, Sponge Stick made in Mexico; tray catalog number 4469A The Povidone Iodine patient prep trays are used where chlorhexidine gluconate (CHG) products aren't appropriate or indicated for patient preoperative prep (traditional two-step scrub and paint using cleansing solution and topical solution) on intact skin and mucous membranes, and
CODE
1) Lot numbers: 0000319389, 0000321446, 0000323733, 0000326090, 0000328468, 0000330882, 0000333747, 0000336418, 0000336443, 0000340606, 0000344792, 0000349464, 0000354078, 0000354079, 0000358785, 0000367470, Y11Cl711, Y11C2202, Y11C3733, Y11C3751, Y11D0544;
 
2) Lot numbers: 0000310407, 0000310409, 0000310411, 0000310413, 0000312077, 0000312080, 0000312081, 0000313225, 0000313227, 0000313229, 0000313233, 0000313523, 0000314761, 0000314762, 0000315476, 0000315477, 0000315478, 0000315480, 0000317227, 0000317229, 0000317230, 0000317231, 0000318349, 0000318350, 0000318351, 0000318352, 0000319401, 0000319402, 0000319403, 0000319404, 0000319405, 0000321997, 0000321998, 0000321999, 0000322000, 0000322001, 0000323739, 0000323740, 0000323741, 0000326095, 0000326097, 0000326099, 0000326100, 0000326101, 0000326103, 0000326104, 0000328472, 0000328473, 0000328474, 0000328475, 0000328497, 0000328502, 0000328504, 0000330880, 0000330881, 0000330884, 0000330885, 0000330886, 0000333712, 0000333754, 0000333755, 0000333756, 0000333757, 0000333758, 0000333759, 0000333761, 0000333762, 0000336431, 0000336433, 0000336434, 0000336435, 0000336437, 0000336439, 0000336442, 0000336448, 0000336449, 0000336450, 0000336451, 0000336452, 0000336453, 0000342781, 0000342782, 0000342783, 0000342785, 0000342786, 0000342787, 0000342788, 0000342789, 0000342790, 0000344054, 0000344798, 0000344800, 0000344810, 0000344811, 0000344812, 0000347086, 0000347087, 0000347088, 0000347090, 0000347091, 0000347093, 0000347094, 0000347095, 0000347096, 0000349465, 0000349466, 0000349467, 0000349473, 0000349812, 0000351290, 0000351684, 0000351687, 0000354085, 0000354087, 0000354089, 0000354091, 0000354096, 0000354100, 0000356292, 0000356294, 0000356296, 0000356299, 0000356300, 0000361254, 0000361255, 0000361284, 0000615475, Y1051567, Y10S2362, Y10S2363, Y10S2370, Y10S2371, Y10S2372, Y10S2402, Y10S2436, Y10S2988, Y10S2989, Y10S2990, Y10S3008, Y10S3011, Y1053012, Y10S3118, Y10S3119, Y11A0340, Y11A0341, Y11A0347, Y11A0349, Y11A1125, Y11A1139, Y11A1147, Y11A1148, Y11A1155, Y11A1270, Y11A1980, Y11A1981, Y11A1982, Y11A2013, Y11A2014, Y11A2637, Y11A2638, Y11A2639, Y11A2729, Y11A2733, Y11A2734, Y11A3238, Y11A3239, Y11A3240, Y11B0276, Y11B0279, Y11B0290, Y11B0411, Y11B0603, Y11B0949, Y11B0959, Y11B0960, Y11B0961, Y11B1240, Y11B1241, Y11B1427, Y11B1651, Y11B2564, Y11B2566, Y11B2925, Y11B2927, Y11B2928, Y11B2932, Y11C0274, Y11C0275, Y11C0283, Y11C0284, Y11C0318, Y11C0319, Y11C0320, Y11C1275, Y11C1276, Y11C1277, Y11C1278, Y11C1280, Y11C1976, Y11C1977, Y11C2146, Y11C2147, Y11C2865, Y11C3085, Y11C3086, Y11C3103, Y11C3104, Y11C3105, Y11C3141, Y11C3142, Y11C3744, Y11C3745, Y11C3746, Y11C3752, Y11D0541, Y11D0542, Y11D0777, Y11D0778, Y11D0783, Y11D0784, Y11D0785, Y11D0786, Y11D0787;
 
3) Lot numbers: 0000312078, 0000312079, 0000313237, 0000315474, 0000317224, 0000317225, 0000317226, 0000319388, 0000319398, 0000319399, 0000319400, 0000321995, 0000326091, 0000330888, 0000331259, 0000331933, 0000333748, 0000333749, 0000333750, 0000336430, 0000336454, 0000340623, 0000342778, 0000342779, 0000342780, 0000344796, 0000347085, 0000348120, 0000351690, 0000354083, 0000356290, 0000361072, Y10S1161, Y10S1568, Y10S2006, Y10S2007, Y10S2364, Y10S2993, Y11A1149, Y11A2470, Y11A3023, Y11B0434, Y11B0955, Y11B1613, Y11B2924, Y11C0276, Y11C1279, Y11C1855, Y11C3087, Y11D0543, Y11D0779
RECALLING FIRM/MANUFACTURER
Recalling Firm: Carefusion 2200 Inc., McGaw Park, IL, by e-mail dated February 7, 2012.
Manufacturer: CareFusion Corp dba Productos Urologos De Mexico S.A. De C.V, Mexicali.B.C., Mexico. Firm initiated recall is ongoing.
REASON
for washing lacerations and abrasions. Recall # Z-1209-2012
The povidone-iodine (PVP-I) solution bottles in the trays may have loose caps, allowing leakage and also elevated levels of ethylene oxide (EO) sterilant and/or by-products within the PVP-I solution, which may represent a patient safety hazard.
VOLUME OF PRODUCT IN COMMERCE
1,644,150 trays
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) MPI Rapid Response HUT Table, Model #RRHUT 1217 with Dual 2 Way Drop Section. Designed for multiple uses including a conventional examination table, unexplained syncope, neurocardiogenic syncope, chronic fatigue syndrome, and most noninvasive procedures. With the optional drop section, the use expands to echo/stress echo/Doppler studies, and vascular and carotid echo. Recall # Z-1210-2012;
 
2) MPI Rapid Response HUT Table, Model #RRHUT 1017. Designed for multiple uses including a conventional examination table, unexplained syncope, neurocardiogenic syncope, chronic fatigue syndrome, and most noninvasive procedures. Recall # Z-1211-2012
CODE
1) Serial numbers: 802286, 802303, 802782, and 802722;
2) Serial numbers: 802421, 802780, 802781 802783, and 802784
RECALLING FIRM/MANUFACTURER
Medical Positioning Inc., Kansas City, MO, by letter dated March 5, 2012. Firm initiated recall is ongoing.
REASON
The warning label regarding electrical shock was not placed on the device warning to have the power switch in the "OFF" position prior to connecting the unit to electric power.
VOLUME OF PRODUCT IN COMMERCE
9 tablets
DISTRIBUTION
Nationwide and Thailand
___________________________________
PRODUCT
SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. Intended to be used for palliative treatment of biliary strictures produced by malignant neoplasms. Device Codes: a) S-04-120-120-G3; b) S-04-040-120-G3; c) S-04-060-120-G3; d) S-05-040-120-G3; e) S-05-060-120-G3; f) S-05-080-120-G3; g) S-05-100-120-G3; and h) S-06-080-120-G3. Recall # Z-1213-2012
CODE
a) Lot Number 05180062; b) Lot Numbers 05180031; c) Lot Number 05187032; d) Lot Number 05180034; e) Lot Number 05180035; f) Lot Number 05180036; g) Lot Number 05180037; and h) Lot Number 05180042
RECALLING FIRM/MANUFACTURER
IDEV Technologies, Inc., Webster, TX, by letter dated February 15, 2012. Firm initiated recall is ongoing.
REASON
The firm is taking this action because the device was one of eight that may have been mislabeled with the incorrect size (length).
VOLUME OF PRODUCT IN COMMERCE
7 devices
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Elecsys 2010 Analyzer Software version 06-07 The Elecsys 2010 analyzer is intended for the in vitro quantitative and qualitative analysis of analytes in body fluids. a) Elecsys 2010 Analyzer Rack; b) Elecsys 2010 Analyzer Disk; c) Software version 06-07. Recall # Z-1218-2012
CODE
a) 11804014001; b) 11804014001; c) 06526080001, 06569668001
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Operations, Inc., Indianapolis, IN, by letter dated January 31, 2012.
Manufacturer: Hitachi Ltd., Hitachinaka-Ibaraki, Japan. Firm initiated recall is ongoing.
REASON
Elecsys 2010 customers have reported getting no value and flag 48 results below expected value range after performing automatic dilution for a sample that previously recovered above the measuring range. Incorrect but believable results may occur for the CEA, Rubella IgG or SHBG assays. The other affected assays will generate either no value or a negative result, both of which are not believable since the sample was diluted due to a result that was initially too high.
VOLUME OF PRODUCT IN COMMERCE
13 ACCOUNTS in USA
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Smith & Nephew BIOSURE HA Interference Screw, 7 mm x 25 mm Catalog Number: 72201772. The BIOSURE HA Interference Screw is indicated for fixation of bone-tendon-bone or soft tissue grafts during anterior/posterior cruciate ligament (ACL/PCL) reconstruction procedures. Recall # Z-1225-2012
CODE
Lot Number: 50397157
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smith & Nephew, Inc. Endoscopy Div., Andover, MA, by letter dated February 2012.
Manufacturer: Smith & Nephew, Inc., Endoscopy Div., Mansfield, MA. Firm initiated recall is ongoing.
REASON
Mislabeled: The device was labeled as a standard thread screw (P/N 72201772) on pouch and box, however the device contained in the packaging is a reverse thread screw (P/N 72201773).
VOLUME OF PRODUCT IN COMMERCE
194 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) Access Ostase Calibrators, Part Number: 37305, Subsequent Product Code: JIS. The Access Ostase Calibrators are intended to calibrate the Access Ostase assay for the quantitative determination of bone alkaline phosphatase (BAP) levels in human serum and plasma using the Access Immunoassay Systems. Recall # Z-1238-2012;
 
2) Access Ostase QC, Part Number: 37309. The Access Ostase QC is intended for monitoring system performance of the Access Ostase assay. Recall # Z-1239-2012;
 
3) Access Ostase Reagent, Part Number: 37300, subsequent product code: JIS. The Access Ostase Assay is used for the quantitative measurement of bone alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum and plasma. This device is intended to be used as an aid in the management of postmenopausal osteoporosis and Pagets disease. Recall # Z-1240-2012
CODE
1) Lot Numbers: Expiration dates: 013489 11/30/2010 111530 09/30/2011 013490 01/31/2011 113463 10/31/2011 015210 02/28/2011 114259 10/31/2011 018854 03/31/2011 114260 11/30/2011 020419 05/31/2011 115484 12/31/2011 022834 06/30/2011 116658 01/31/2012 109632 07/31/2011;
 
2) Lot Numbers: Expiration dates: 009091 10/10/2010 109636 09/30/2011 013491 10/31/2010 113465 10/31/2011 013492 11/30/2010 113969 10/31/2011 014488 12/31/2010 114261 11/30/2011 015211 02/28/2011 115485 12/31/2011 018855 03/31/2011 116660 01/31/2012 020420 04/30/2011 118211 02/28/2012 021285 05/31/2011;
 
3) Lot Numbers: Expiration dates: 011167 04/30/2011 017561 09/30/2011 014486 7/31/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter dated November 9, 2011.
Manufacturer: Beckman Coulter, Inc., Chaska, MN. Firm initiated recall is ongoing.
REASON
The Access Ostase Calibrator and QC lots do not meet expiration date claims. The Access Ostase Reagent Kit lots identified were quality control tested and released using Access Ostase Calibrator and QC lots that contain the implicated raw material.
VOLUME OF PRODUCT IN COMMERCE
15,417 units total (2,954 units in US)
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) COULTER LH 780 Analyzer, part number: LH780 System Help 1B1.103272, PN 723585. SW Version: 1B1, 1B2. The COULTER LH 780 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER LH 780 Hematology Analyzer also provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids. Recall # Z-1241-2012;
 
2) COULTER LH 750 Analyzer, part number: LH750 System Help 2D1.103272, PN 6605632, PN 6605632R & PN A85570. SW Version 2D1, 2D2. The COULTER LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER LH 750 Hematology Analyzer provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automatedmethod for enumeration of RBCs and WBCs in body fluids. Recall # Z-1242-2012;
 
3) COULTER LH 500 Series System , part number: LH500 System Help 2A4.103271; LH 500 Series System 100V, PN 178832; LH 500 Series System 120V, PN 178833; LH 500 Series System 240V, PN 178834; LH 500 Series System Remanufactured (115V), PN A91062; LH 500 Series System Remanufactured (220V), PN A90994 SW Version 2A4, 2A5. The COULTER LH 500 Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter For In Vitro Diagnostic Use in clinical laboratories. The LH 500 Analyzer also provides a semi-automated reticulocyte analysis. Recall # Z-1243-2012
CODE
1) SW Version: 1B1, 1B2. Serial Number: all;
2) SW Version 2D1, 2D2. Serial Number: all;
3) SW Version 2A4, 2A5. Serial Number: all.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter dated November 30, 2011.
Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is ongoing.
REASON
The Auto Stop and Auto Transmit features for Quality Control become disabled after scanning assay values from Coulter 5C and Retic-C Cell Controls assay sheets using the 2D Barcode scanner.
VOLUME OF PRODUCT IN COMMERCE
8,922 units total (4073 units in US)
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) IMMULITE/IMMULITE 1000 CK-MB LKMB --- Catalog number: LKMB1 (100 tests), LKMB5 (500 tests) --- Test code: CMB Color: Dark Blue. For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers --- for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in heparinized plasma or serum, as an aid in patient management and the assessment of prognosis of myocardial infarction. Recall # Z-1271-2012;
 
2) IMMULITE/IMMULITE Turbo 1000 CK-MB LSKCP --- Catalog number: LSKCP1 (100 tests), LSKCP5 (500 tests) --- Test code: RCK Color: Orange. For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers --- for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in heparinized plasma or serum, as an aid in patient management and the assessment of prognosis of myocardial infarction. Recall # Z-1272-2012;
 
3) IMMULITE 2000/IMMULITE 2000 XPi CK-MB L2KMB --- Catalog number: L2KMB2 (200 tests), L2KMB6 (600 tests) --- Test code: CMB Color: Dark Blue. For in vitro diagnostic use with the IMMULITE 2000 Analyzers --- for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in heparinized plasma or serum, as an aid in patient management and the assessment of prognosis of myocardial infarction. Recall # Z-1273-2012;
 
4) IMMULITE 2500 CK-MB L5KCP --- Catalog number: L5KCP2 (200 tests), L5KCP6 (600 tests) --- Test code: RCK Color: Orange. For in vitro diagnostic use with the IMMULITE 2500 Analyzer --- for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in heparinized plasma or serum, as an aid in patient management and the assessment of prognosis of myocardial infarction. Recall # Z-1274-2012
CODE
1) Kit lot 312, 313;
2) Kit lot 316, 318;
3) Kit lot 213, 214, 215;
4) Kit lot 136, 137
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Healthcare Diagnostics, Tarrytown, NY, by letter dated January 2012.
Manufacturer: Siemens Healthcare Diagnostics Products Ltd., Caernarfon, UK. Firm initiated recall is ongoing.
REASON
Siemens Healthcare Diagnostics has observed that the median for the reference range with current kit lots of the CK-MB assay differs from the guidelines published in the Instructions for Use (IFU). This difference applies to all IMMULITE platforms.
VOLUME OF PRODUCT IN COMMERCE
1,848 units
DISTRIBUTION
Nationwide and Internationally
 
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS III
___________________________________
PRODUCT
1) Clinitron At Home Bed headboard and foot side rails. The Clinitron At Home Air Fluidized Therapy Unit provides a pressure-relieving sleep surface for patients in the home environment. It helps enable patients with pressure sores to heal their wounds. Recall # Z-1131-2012;
 
2) Clinitron Rite Hite Bed headboard and foot side rails. The Clinitron Rite Hite Air Fluidized Therapy Unit is a patient management system that combines air fluidized therapy and low airloss therapy technologies together on a low-height frame. The lower body section provides air fluidized therapy, and the upper body section provides low airloss therapy. Recall # Z-1132-2012
CODE
The headboard (p/n 6020200003) and siderail (p/n 6020200002) are not serialized. There are no model, catalog or code number identification marks available on the accessories. It is possible to identify these accessories though by a mark stamped into the mounting post that are used to attach these accessories to the bed. May 2011 and October 2011 headboards and siderails were shipped to customers.
RECALLING FIRM/MANUFACTURER
Hill-Rom, Inc., Batesville, IN, by letter dated February 2, 2012. Firm initiated recall is ongoing.
REASON
The Clinitron Rite Hite Bed and Clinitron At Home Bed outer rail, which is extruded Aluminum tubing, is intended to be one piece joined together by a weld at the lower center. The parts received from the supplier were of a two part welded construction. The weld locations of the part did not meet the design requirement, and is unacceptable as it will impact the strength of the rail.
VOLUME OF PRODUCT IN COMMERCE
Foot side rails=70; Headboards=103
DISTRIBUTION
Nationwide and Canada

END OF ENFORCEMENT REPORT FOR MARCH 28, 2012
 
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