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U.S. Department of Health and Human Services

Safety

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Enforcement Report for January 18, 2012

 

January 18, 2012                                                                                              12-03
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
G49967, Garden Vegetable Seasoning, 1200 lb super sack (bulk). Recall # F-0577-2012
CODE
Lot # MS485917
RECALLING FIRM/MANUFACTURER
Newly Weds Foods Inc., Horn Lake, MS, by letter on December 7, 2011. FDA initiated recall is complete.
REASON
Product contained undeclared milk.
VOLUME OF PRODUCT IN COMMERCE
1200 lbs
DISTRIBUTION
Canada
___________________________________
PRODUCT
"***Caribbean Rum Balls***Handmade***" Boxes of 1 oz, 4 oz, 8 oz and 12 oz. Recall # F-0590-2012
CODE
5001117933 (1 oz box), 5001117930 (4 oz box), 5001117931 (8 oz box), 500113428 (12 oz box)
RECALLING FIRM/MANUFACTURER
Barker & Fischer Enterprises Inc. dba Caribbean Rum Balls, St Thomas, Virgin Islands, by press release and letter on November 23, 2011. FDA initiated recall is ongoing.
REASON
Undeclared wheat, whey, soy, eggs and sodium metabisulfite in Rum Balls (confectionary product).
VOLUME OF PRODUCT IN COMMERCE
3,646 units
DISTRIBUTION
St. Thomas, VI, St. John, VI, St. Croix, VI and Puerto Rico
___________________________________
PRODUCT
Old Comiskey(R) Brand Traditional New Orleans Mixers, Bloody Mary Mix, 32 fl oz, (.946 liters). Recall # F-0591-2012
CODE
Units: P090025, P091608, P092845, P101712, P103097, P110785, and P112130
RECALLING FIRM/MANUFACTURER
National Fruit Flavor Company Inc., Harahan, LA, by telephone on December 21-23, 2011 and by letter faxed and mailed on December 23, 2011. FDA initiated recall is ongoing.
REASON
Undeclared soy and wheat in Bloody Mary Cocktail Mix.
VOLUME OF PRODUCT IN COMMERCE
658.08 cases
DISTRIBUTION
LA, TX, TN AR, PA, MS, MO, FL, and Belize
___________________________________
PRODUCT
Gorgonzola cheese vacuum packed in approximate 1.0 lb. wedges. Front label reads in part: "MAURI Gorgonzola Aged 90 days Product of Italy Ingredients: Cow's milk, salt, rennet, milk enzymes and selection moulds. Contains: Milk***" Back label is white stick-on reading in part: "***34449***". Recall # F-0592-2012
CODE
Sell by dates of 01/02/11 through 01/27/11
RECALLING FIRM/MANUFACTURER
DPI Specialty Foods, Tualatin, OR, by telephone and press release on November 10, 2010 and by press release and letter on November 12, 2010. Colorado initiated recall is ongoing.
REASON
Product may be contaminated with E. coli.
VOLUME OF PRODUCT IN COMMERCE
209 cases each containing 18 approximately 1 pound wedges
DISTRIBUTION
CO
___________________________________
PRODUCT
MarieBell New York --- Made in U.S.A. --- The chocolates are packaged in either blue or red boxes in the quantities described below. --- 9 pieces in a blue box, UPC 58289 00011; 9 pieces in a red box, UPC 58285 00086; 16 pieces in a blue box, UPC 58285 00012; 16 pieces in a red box, UPC 58289 00087; 25 pieces in a blue box UPC 58285 00013; 25 pieces in a red box, UPC 58289 00088; 100 pieces in a blue box, UPC 77708 00154; 100 pieces in a red box, UPC 77708 00185. Recall # F-0593-2012
CODE
No codes
RECALLING FIRM/MANUFACTURER
Maribel's Sweets, Inc., Brooklyn, NY, by press release on December 23, 2011 and by letter on January 4, 2012. FDA initiated recall is ongoing.
REASON
Product contains undeclared peanuts and pistachios.
VOLUME OF PRODUCT IN COMMERCE
800 boxes
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
___________________________________
PRODUCT
1) Biscotti-Plain. Biscotti slices bulk packaged in cardboard "donut" type boxes, 12 pieces of biscotti per box. The product is labeled in parts: "***Paximadi Co***Biscotti-Plain***Unbleached Enriched Flour (Wheat Flour, Malted Barley Flour, Niacin, Thiamine, Mononitrate, Riboflavin, Folic Acid), Sugar, Vanilla (Water, Alcohol, Vanilla Bean Extractives), Baking Soda, Salt, Eggs, Butter (Pasteurized Cream and Salt), Olive Oil, Almonds***Net Wt 1oz Each***. Recall # F-0583-2012;
 
2) Biscotti-Almond Top. Biscotti slices bulk packaged in cardboard "donut" type boxes, 12 pieces of biscotti per box. The product is labeled in parts: "***Paximadi Co***Biscotti-Alm. Top***Unbleached Enriched Flour (Wheat Flour, Malted Barley Flour, Niacin, Thiamine, Mononitrate, Riboflavin, Folic Acid), Sugar, Vanilla (Water, Alcohol, Vanilla Bean Extractives), Baking Soda, Salt, Eggs, Butter (Pasteurized Cream and Salt), Olive Oil, Almonds, Semi-Sweet Chocolate (Sugar, Chocolate, Cocoa Butter, Milk Fat, Soy Lecithin, Natural Flavoring***Net Wt 2oz Each***. Recall # F-0584-2012;
 
3) Biscotti-Chocolate Top. Biscotti slices bulk packaged in cardboard "donut" type boxes, 12 pieces of biscotti per box. The product is labeled in parts: "***Paximadi Co***Biscotti-Choc.Top***Unbleached Enriched Flour (Wheat Flour, Malted Barley Flour, Niacin, Thiamine, Mononitrate, Riboflavin, Folic Acid), Sugar, Vanilla (Water, Alcohol, Vanilla Bean Extractives), Baking Soda, Salt, Eggs, Butter (Pasteurized Cream and Salt), Olive Oil, Almonds, Semi-Sweet Chocolate (Sugar, Chocolate, Cocoa Butter, Milk Fat, Soy Lecithin, Natural Flavoring***Net Wt 1.5 Each***. Recall # F-0585-201;
 
4) Baklava. Triangles of Baklava bulk packaged in disposable aluminum containers, 25 pieces per unit. The product is labeled in parts: "***Paximadi Co***Baklava***Fillo (Enriched, Non-Bromine Bleached Wheat Flour, Thiamin Mononitrate, Riboflavin, Niacin, Iron, Folic Acid, Water, Corn Starch, Vegetable Oil (Corn or Canola), Salt, Sodium and/or Calcium Propionate, Potassium Sorbate, Citric Acid), Walnuts, Almonds, Butter (Pasteurized Cream, Salt), Cinnamon, Syrup (Honey, Sugar, Orange, Water)**Net Wt 25-2oz ***. Recall # F-0586-2012;
 
5) Baklava-Whole Wheat. Triangles of Baklava bulk packaged in disposable aluminum containers, 25 pieces per unit. The product is labeled in parts: "***Paximadi Co***Baklava Whole Wheat***Organic Whole Wheat Fillo (Organic Wheat Flour, Organic Whole Wheat Flour, Filtered Water, Organic Wheat Starch, Organic Tapioca Starch, Organic Expeller Pressed Soy Oil, Salt, Organic Malt Extract, Non-GMO Soy Lecithin, Tri-Calcium Phosphate), Walnuts, Almonds, Butter (Pasteurized Cream, Salt), Cinnamon, Syrup (Honey, Sugar, Orange, Water)**Net Wt 25-2oz ***. Recall # F-0587-2012;
 
6) Baklava-Whole Wheat Pistachio. Triangles of Baklava bulk packaged in disposable aluminum containers, 25 pieces per unit. The product is labeled in parts: "***Paximadi Co***Baklava Whole Wheat Pistachio***Organic Whole Wheat Fillo (Organic Wheat Flour, Organic Whole Wheat Flour, Filtered Water, Organic Wheat Starch, Organic Tapioca Starch, Organic Expeller Pressed Soy Oil, Salt, Organic Malt Extract, Non-GMO Soy Lecithin, Tri-Calcium Phosphate), Pistachios, Cashews, Butter (Pasteurized Cream, Salt), Cinnamon, Syrup (Honey, Sugar, Orange, Water). Rose Water (Distilled Rose Water) ***. Recall # F-0588-2012;
 
7) Baklava-Whole Wheat Saragli. Triangles of Baklava bulk packaged in disposable aluminum containers, 25 pieces per unit. The product is labeled in parts: "***Paximadi Co***Baklava Whole Wheat Saragli***Organic Whole Wheat Fillo (Organic Wheat Flour, Organic Whole Wheat Flour, Filtered Water, Organic Wheat Starch, Organic Tapioca Starch, Organic Expeller Pressed Soy Oil, Salt, Organic Malt Extract, Non-GMO Soy Lecithin, Tri-Calcium Phosphate), Crushed Almonds, Butter (Pasteurized Cream, Salt), Semi-Sweet Chocolate (Sugar, Chocolate, Cocoa Butter, Milk Fat, Soy Lecithin, Natural Flavoring), Cinnamon, Syrup (Honey, Sugar, Water, Orange), Orange Water (Distilled Bitter Orange Blossom Water), Rose Water (Distilled Rose Water)***". Recall # F-0589-2012
CODE
Production dates: 12/5-12/15/11
RECALLING FIRM/MANUFACTURER
Paximadi Co. LLC, Seattle, WA, by telephone beginning December 19, 2011. FDA initiated recall is ongoing.
REASON
Butter is declared but milk is not listed as a source.
VOLUME OF PRODUCT IN COMMERCE
796 units
DISTRIBUTION
Western Washington
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III
___________________________________
PRODUCT
Pickled asparagus spears in 1 liter glass jars with a stick-on label. Label reads in part: "Grown in the USA FOSTER'S Pickled ASPARAGUS SPEARS Pointes d'asperges marinees 1L PRODUCT DES E.-U. Ingredients: asparagus, vinegar, water, salt, sugar, spices, garlic***". Recall # F-0579-2012
CODE
Best Before 13 JN 30
RECALLING FIRM/MANUFACTURER
Foster Family Farm, LLC, Pasco, WA, by e-mail and telephone on April 18, 2011. Firm initiated recall is complete.
REASON
The brine on the first day of the run was not mixed thoroughly and resulted in a higher pH in some jars than what their scheduled process requires.
VOLUME OF PRODUCT IN COMMERCE
14,976 1 liter jars
DISTRIBUTION
Canada
 
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 Report17, 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
Medroxyprogesterone Acetate Injectable Suspension, USP 150 mg/mL, 1mL Vials (NDC 0703-6801-01), pkg of 25 single vials (NDC 0703-6801-04) and 1mL Prefilled Syringes (NDC 0703-6811-21)
CODE
1mL single vials (NDC 0703-6801-01) - lot numbers 31310301B, exp 12/2011; 31310788B, exp 1/2012; 31311008B, exp 4/2012; pkg of 25 single vials (NDC 0703-6801-04) lot numbers - 31310787B, exp 1/2012; 31311357B, exp 4/2012 and 1mL prefilled syringe (NDC 0703-6811-21) - lot numbers 31311217B, exp 2/2012; 31311219B, exp 2/2012; 31312156B, exp 4/2012; 31312300B, 4/2012.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA 18960
Manufacturing Firm: Teva Parenteral Medicines Inc, Irvine, CA 92618
REASON FOR RECALL
Presence of Particulate Matter; presence of silicone particles
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I
____________________________________
PRODUCT
1) Cyclafem(TM) 7/7/7, (norethindrone and ethinyl estradiol Tablets USP), 28 Day Regimen, packaged in boxes of 3 cards (NDC 0603-7525-49) and 6 cards (NDC 0603-7525-17, Rx only. Recall # D-1117-2012;
 
2) Cyclafem(TM) 1/35, (norethindrone and ethinyl estradiol tablets USP), 28 Day Regimen, packaged in boxes of 3 cards (NDC 0603-7521-49) and 6 cards (NDC 0603-7521-17, Rx only. Recall # D-1118-2012;
 
3) Emoquette(TM), (desogestrel and ethinyl estradiol tablets USP, 0.15 mg and 0.03 mg USP), 28 Day Regimen, packaged in boxes of 3 cards (NDC 0603-7521-49) and 6 cards (NDC 0603-7540-17), Rx only. Recall # D-1119-2012;
 
4) Gildess(R) FE 1.5/30, (norethindrone acetate and ethinyl estradiol Tablets USP and ferrous fumarate tablets USP), 28 Day Regimen, packaged in boxes of 6 cards (NDC 0603-7608-17), Rx only. Recall # D-1120-2012;
 
5) Gildess(R) FE 1/20, (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate, USP), 28 Day Regimen, packaged in boxes of 6 cards (NDC 0603-7609-17), Rx only. Recall # D-1121-2012;
 
6) Orsythia(TM), (levonorgestrel (0.1 mg) and ethinyl estradiol (0.02 mg) tablets USP), 28 Day Regimen, packaged in boxes of 3 cards (NDC 0603-7634-49) and 6 cards (NDC 0603-7634-17), Rx only. Recall # D-1122-2012;
 
7) Previfem(R), (norgestimate and ethinyl estradiol tablets USP), 28 Day Regimen, packaged in boxes of 6 cards (NDC 0603-7642-17), RX only. Recall # D-1123-2012;
 
8) Tri-Previfem(R), (norgestimate and ethinyl estradiol tablets USP), 28 Day Regimen, packaged in boxes of 6 cards (NDC 0603-7663-17), RX only. Recall # D-1124-2012
CODE
1) All lots within expiry, distributed from 01/20/2010 - 09/30/2011, specifically: NDC NUMBER BOX LOT # CARD LOT # 0603-7525-17 DDC XBM CFCX CBGW FFZH FFZH 0603-7525-49 CPTH CBGX FFZK;
2) All lots within expiry, distributed 01/20/2010 - 09/3/2011, specifically: NDC NUMBER BOX LOT # CARD LOT # 0603-7521-17 DDH CPDK DKGY DMZV DMZY DMZX 0603-7521-49 CPFM ZSH CPFN CBGV DMZS;
3) All codes within expiry, distributed 01/20/2010 - 09/3/2011, specifically: NDC NUMBER BOX LOT # CARD LOT # 0603-7540-49 DGZZ DGZY CPGC 0603-7540-17 CPBS;
4) All lots within expiry, distributed 01/20/2010 - 09/3/2011, specifically: BOX LOT # CARD LOT # MNB MNM MNP ZNP ZNN CNMS DNBG FDGT DNBF;
5) All lots within expiry, distributed 01/20/2010 - 09/3/2011, specifically: BOX LOT # CARD LOT # MNG MNH MNK MWB MVZ MVY ZMY ZMZ CNMT DBSP DMDY DBSS DMPX FDYT DMPY FDGS DMPX FDYP DMPY DNBT FDYS DMPY DNBV;
6) All lots within expiry, distributed 01/20/2010 - 09/3/2011, specifically: NDC NUMBER BOX LOT # CARD LOT # 0603-7634-49 FBNY 0603-7634-17 FBNX FBNW;
7) All lots within expiry, distributed 01/20/2010 - 09/3/2011, specifically: BOX LOT # CARD LOT # DCG DCF DCD CNYG CNYH DBMG DBMF DGGX DGGK DGGH DGGY DMPS DMPT FDGN DMPS;
8) All lots within expiry, distributed 01/20/2010 - 09/3/2011, specifically: BOX LOT # CARD LOT # CSZX DBT CSZW DBT CDYK CNYT DGHH DYZZ DGHK DYZY DGHK DZBB DGHK DVBD DGHH DGHM DGHN FFNX DNBY DBV DNBZ;
RECALLING FIRM/MANUFACTURER
Recalling Firm: Vintage Pharmaceuticals LLC, DBA, Qualitest Pharmaceuticals, Huntsville, AL, by press release on September 15, 2011, and by letter on September 16, 2011.
Manufacturer: Patheon, Inc., Toronto Region Operations, Mississauga Ontario, Canada. Firm initiated recall is ongoing.
REASON
Contraceptive Tablets Out of Sequence; blister cards were rotated 180 degrees, reversing
the weekly tablet orientation.
VOLUME OF PRODUCT IN COMMERCE
3,220,845 cards
DISTRIBUTION
Nationwide and Puerto Rico
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
Fluoxetine Capsules USP, 20 mg, 100-count capsules per bottle, Rx only, NDC 0781-2822-01. Recall # D-1170-2012
CODE
Lot BU9661, Exp 06/14
RECALLING FIRM/MANUFACTURER
Sandoz Inc., Broomfield, CO, by letter on January 6, 2012. Firm initiated recall is ongoing.
REASON
CGMP Deviations: The batch was not manufactured utilizing Good Manufacturing Processes.
VOLUME OF PRODUCT IN COMMERCE
37,971 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Excedrin Extra Strength (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) caplets, 100-count caplets per bottle, NDC 0067-2000-91, UPC 3 0067-2000-91 0. Recall # D-1173-2012;
 
2) Excedrin Migraine (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) caplets, 250-count caplets per bottle, NDC 0067-2039-07, UPC 3 0067-2039-07 1. Recall # D-1174-2012
CODE
1) Lot 10068948, Exp 03/12;
2) Lot 10084053, Exp 12/12
RECALLING FIRM/MANUFACTURER
Novartis Consumer Health, Lincoln, NE, by letters dated September 6, 2011 via overnight mail, e-mail, Rapid Recall Exchange, or hand-delivered. FDA initiated recall is ongoing.
REASON
Adulterated Presence of Foreign Tablets: Foreign tablets contained in bottles.
VOLUME OF PRODUCT IN COMMERCE
120,360 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Ramipril Capsules 1.25 mg, 100-count bottles, Rx only, Code No. GO/DRUGS/654. Recall # D-1175-2012
CODE
Batch 3904946, Exp 10/11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Lupin Pharmaceuticals Inc., Baltimore, MD, by letter and telephone on August 17, 2011.
Manufacturer: Lupin Limited, Goa, India. Firm initiated recall is ongoing.  
REASON
Subpotent; 24 month stability timepoint.
VOLUME OF PRODUCT IN COMMERCE
4,560 bottles
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
1) Proactiv, Rodan & Fields, proactiv SOLUTION, Renewing Cleanser, benzyl peroxide acne treatment 8 Fl. oz 240 mL. Recall # D-1167-2012;
 
2) Rodan & Fields proactiv SOLUTION, Repairing Treatment, benzyl peroxide acne treatment 3 Fl. oz 89 mL. Recall # D-1168-2012;
 
3) Rodan & Fields proactiv SOLUTION CONCEALER PLUS non-comedogenic sulfur acne treatment .25 Fl. oz. 7.5 mL, Active ingredient Sulfur 8%. Recall # D-1169-2012
CODE
1) and 2) All Lots Proactiv Renewing Cleanser manufactured from April 15, 2009 forward that are labeled with 2 year expiration dating;
 
2) All Lots Proactiv Repairing Treatment manufactured from April 15, 2009 forward that are labeled with 2 year expiration dating;
 
3) Units: T8305A0F T8309A0J T8315A T8315A1A T8315A1K T9044A T9062A T9107A T9110A T9175A T9196A T9197A T9218A T9254A T9257A T0048A T0049A T0078A T0119A T0198A T0342A T0343A T1089A T1129A T1130A T1200A T1230A
RECALLING FIRM/MANUFACTURER
Recalling Firm: Guthy-Renker Corp., Santa Monica, CA, by email and letters on November 22, 2011.  
Manufacturer: Thibiant International, Inc., Chatsworth. CA. Firm initiated recall is ongoing.
REASON
1) and 2) Stability Data does not Support Expiration Date;
3) Superpotent; sulfur
VOLUME OF PRODUCT IN COMMERCE
2,546,689 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
1) Nifedipine Extended Release Tablets, 60 mg, 100 Tablets, NDC: 63739-452-10, Rx only. Recall # D-1171-2012;
 
2) Nifedipine Extended Release Tablets, 30 mg, 100 tablets, Rx only, NDC 63739-451-10. Recall # D-1172-2012
CODE
1) Lot number: 00074901;
2) Lot number: 00074888
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mckesson Packaging Services, Concord, NC, by letter on/about December 15, 2011.
Manufacturer: Aptalis Pharma Inc., Vandalia, OH. Firm initiated recall is ongoing.
REASON
Failed USP Dissolution Test Requirements (below specification).
VOLUME OF PRODUCT IN COMMERCE
1,531 unit dose boxes (1,531,000 tablets)
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS I
___________________________________
PRODUCT
1) Tendon, Human tissue for transplantation, labeled in part ***Anterior Tibial Tendon***Posterior Tibial Tendon***Semi-Tendinosus Tendon***Peroneus Longus Tendon***and ***Pre-Shaped Achilles.Ten 10***. Recall # B-0403-12;
 
2) Cardiac Tissue, Non-valved. Recall # B-0404-12;
 
3) Ligament, Human Tissue for Transplantation, labeled in part ***Bisected Pat.Ligament***. Recall # B-0405-12;
 
4) Bone, Human Tissue for Transplantation, labeled in part ***Cerv 4 Deg W/Plug 7***Cancellous 20 (1-4 mm)***Cancellous (1-4 mm)***Tricort Can Wedge***and ***Fibular Segment 100***. Recall # B-0406-12;
CODE
1) Lot/Serial number: 11116610007, 11116610008, 11116610009, 11116610010, 11116610011, 11116610012, 11116610016;
 
2) Lot/Serial number: 11116610001;
 
3) Lot/ Serial Number: 11116610014, 11116610015;
 
4) Lot/Serial numbers:, 11116610018, 11116610019, 11116610020, 11116610021, 11116610022, 11116610023, 11116610024, 11116610025, 11116610026, 11116610027, 11116610028, 11116610029, 11116610030, 11116610031, 11116610032, 11116610033, 11116610035, 11116610036, 11116610037, 11116610038, 11116610039, 11116610040, 11116610041, 11116610042, 11116610043, 11116610044, 11116610045, 11116610046, 11116610047, 11116610048, 11116610049, 11116610050, 11116610051, 11116610052
RECALLING FIRM/MANUFACTURER
LifeNet Health, Virginia Beach, VA, by an advisory on September 30, 2011 and a second advisory on October 6, 2011. Firm initiated recall is ongoing.
REASON
Human tissue allografts, recovered from a donor where infections disease testing was incorrectly performed and recipients are at increased risk for disease transmission, were distributed.
VOLUME OF PRODUCT IN COMMERCE
44 tissues
DISTRIBUTION
VA, AZ, TX, PA, SC, MA, NC, IN and NM
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
Source Plasma. Recall # B-0232-12
CODE
Unit: 11YARB7188
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services LP, Fayetteville, AR, electronically on September 19, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not respond to questions regarding increased risk for vCJD, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Source Plasma Recall # B-0233-12
CODE
Unit: 11MOHC3278
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services LP, Lima, OH, electronically on August 31, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not respond to questions regarding increased risk for vCJD, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-0263-12;
2) Recovered Plasma. Recall # B-0264-12
CODE
1) and 2) Unit: W141608614712
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by electronic mail and letter on November 7, 2008.
Manufacturer: Puget Sound Blood Center and Program, Bellevue, WA. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WA, Austria
___________________________________
PRODUCT
Platelets Pooled Leukocytes Reduced. Recall # B-0265-12
CODE
Unit: W141608436796
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center, Seattle, WA, by letter on October 29, 2008.
Manufacturer: Puget Sound Blood Center and Program, Lynnwood, WA. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported a history of hepatitis after age 11, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA
___________________________________
PRODUCT
1) Platelets Pooled Irradiated. Recall # B-0314-12;
2) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0315-12
CODE
1) Unit: W141608002990;
2) Units: W141608010161AO; W141608010161BO; W141608006054; W141608002990
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center, Seattle, WA, by letter dated October 8, 2008.
Manufacturer: Puget Sound Blood Center and Program, Bellevue, WA. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
WA
___________________________________
PRODUCT
Red Blood Cells. Recall # B-316-12
CODE
Unit: W141608593923
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center and Program, Seattle, WA, by facsimile on September 28, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to a high risk area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA
___________________________________
PRODUCT
1) Platelets Pooled Leukocytes Reduced Irradiated. Recall # B-0317-12;
2) Red Blood Cells. Recall # B-0318-12;
3) Fresh Frozen Plasma. Recall # B-0319-12 
CODE
1), 2), and 3) Unit: W141608472927
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by letter on November 21, 2008.
Manufacturer: Puget Sound Blood Center and Program, Everett, WA. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a piercing within 12 months of donation, were distributed.  
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
WA
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0320-12
CODE
Unit: 8034913 (part 1), 8034913 (part 2)
RECALLING FIRM/MANUFACTURER
Houchin Blood Services, Bakersfield, CA, by telephone on April 1, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0343-12
CODE
Units: 8708665, 6633367
RECALLING FIRM/MANUFACTURER
Houchin Blood Services, Bakersfield, CA, by telephone on March 27, 2008. Firm initiated recall is complete.
REASON
Blood products, which should have been quarantined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0344-12;
2) Red Blood Cells. Recall # B-0345-12;
3) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0347-12
CODE
1) Units: W141608214622; W141607217576;
2) Unit: W141607219445;
3) Unit: W141608210450
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by letter dated October 15, 2008.
Manufacturer: Puget Sound Blood Center and Program, Lynnwood, WA. Firm initiated recall is complete.
REASON
Blood products, collected from a donor taking the medication Finasteride, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
WA, CA, Austria
___________________________________
PRODUCT
Source Plasma. Recall # B-0349-12
CODE
Units: 3300179094, 3300178621, 3300177344, 3300176839, 3300173636, 3300172778, 3300172269, 3300171536, 3300170743, 3300170508, 3300169615, 3300169080, 3300168184, 3300167741, 3300162100, 3300161679, 3300160919, 3300160185, 3300159547, 3300158681, 3300158229, 3300155643, 3300155312, 3300153947, 3300153110, 3300152205, 3300151111, 3300150391, 3300149710, 3300149168, 3300148642, 3300148046, 3300147458, 3300143851, 3300143465, 3300142803, 3300142037, 3300141615, 3300140544, 3300139883, 3300139413, 3300138486, 3300137748, 3300137101, 3300135913, 3300134920, 3300131704, 3300130865, 3300130239, 3300125878, 3300125614, 3300124352, 3300123945, 3300122776, 3300121197, 3300120816, 3300119359
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Saginaw, MI, by facsimile on April 23, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a piercing within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
57 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Source Plasma. Recall # B-0407-12
CODE
Unit: 0370724689  
RECALLING FIRM/MANUFACTURER
CSL Plasma, Inc., Medford, OR, by letter on January 9, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Germany
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0409-12
CODE
Unit: W141607378009
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center and Program, Seattle, WA, by telephone on December 18, 2007. Firm initiated recall is complete.
REASON
Blood product, that lacked assurance of being stored at proper temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0410-12
CODE
Unit: 0935330B0
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Center, Spokane, WA, by telephone on January 8, 2008. Firm initiated recall is complete.
REASON
Blood product, which was labeled with an incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0411-12
CODE
Unit: W141607534462
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by letter on April 9, 2008.
Manufacturer: Puget Sound Blood Center and Program, Tukwila, WA. Firm initiated recall is complete.
REASON
Blood products, which was collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0415-12;
2) Recovered Plasma. Recall # B-0416-12
CODE
1) and 2) Unit: Unit: W137511110369
RECALLING FIRM/MANUFACTURER
Lane Memorial Blood Bank, Eugene, OR, by fax and letter on November 11, 2011 and fax on November 17, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OR, KY
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0417-12
CODE
Unit: 01GH50379
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, West Henrietta, NY, by telephone, fax and the LOGIC system on October 11, 2011. 
Manufacturer: The American National Red Cross, Albany, NY. 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, NY
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0421-12
CODE
Unit: 12KP02192
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Carolinas Region, Charlotte, NC, by fax and letter on October 26, 2011.   
Manufacturer: American Red Cross Blood Services, Asheville, NC. 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
GA
___________________________________
PRODUCT
Source Plasma. Recall # B-0423-12
CODE
Units: 11GINA9495; 11GINA9496; 11GINA9497; 11GINA9498; 11GINA9499; 11GINA9500; 11GINA9501; 11GINA9502; 11GINA9503
RECALLING FIRM/MANUFACTURER
Bio-Blood Components, Inc., Gary, IN, by e-mail on October 7, 2011 and fax on October 31, 2011. Firm initiated recall is complete.
REASON
Blood products, which were untested for viral markers, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced Irradiated. Recall #B-0425-12;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0426-12
CODE
1) Unit: W141607020399;
2) Unit: W141608002859
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by letter dated May 28, 2008.
Manufacturer: Puget Sound Blood Center, Bellevue, WA. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WA
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0230-12
CODE
Unit: W036311013516
RECALLING FIRM/MANUFACTURER
BloodCenter of Wisconsin, Inc., Milwaukee, WI, by fax on September 23, 2011. Firm initiated recall is complete.
REASON
Blood product, which contained antibodies but was not labeled as positive for unexpected antibodies, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0231-12
CODE
Unit: 041LG95907
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Birmingham, AL, via the LOGIC system on September 15, 2011.
Manufacturer: American Red Cross Blood Services, Alabama Region, Huntsville, AL. 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
CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0346-12
CODE
Units: W141608214622; W141607217576
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by letter dated October 15, 2008.
Manufacturer: Puget Sound Blood Center and Program, Lynnwood, WA. Firm initiated recall is complete.
REASON
Blood products, collected from a donor taking the medication Finasteride, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WA, CA, Austria
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0348-12
CODE
Unit: W224308305444
RECALLING FIRM/MANUFACTURER
Houchin Blood Services, Bakersfield, CA, by telephone on September 8, 2008. Firm initiated recall is complete.
REASON
Blood product, which did not meet shipping time frame, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0412-12
CODE
Unit: 021KT33298
RECALLING FIRM/MANUFACTURER
Recalling Firm: American National Red Cross, Lewis and Clark Region, Salt Lake City, UT, by telephone on November 26, 2007 followed by letter dated November 28, 2007.
Manufacturer: American National Red Cross, Boise, ID. Firm initiated recall is complete.
REASON
Blood product, which may have reached an unacceptable temperature during shipment, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
ID
___________________________________
PRODUCT
Plasma Frozen within 24 hours (FP24). Recall # B-0413-12
CODE
Unit: 35FV26135
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake & Potomac Region, Baltimore, MD, by fax on September 8, 2011. Firm initiated recall is complete.
REASON
Blood product, documented as being out of controlled storage for more than 30 minutes, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0418-12
CODE
Unit: 01GH50379
RECALLING FIRM/MANUFACTURER
Recalling Firm: American National Red Cross, West Henrietta, NY, by telephone, fax and the LOGIC system on October 11, 2011. 
Manufacturer: The American National Red Cross, Albany, NY. 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, NY
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0424-12
CODE
Units: 53GN95753PT1; 53GN95753PT2
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake & Potomac Region, Baltimore, MD, by fax on September 1, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose hemoglobin was determined using a Hemocue that failed daily QC, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MD, KY
 
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS II
___________________________________
PRODUCT
Varian Clinac, Trilogy, Trilogy Tx and Novalis linear accelerators. Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated. Model numbers: H14, H18, H27 and H29. Recall # Z-0181-2012
CODE
Code numbers: H140001 H140061 H140121 H140225 H140743 H140801 H140859 H140919 H180082 H180209 H180310 H180463 H180536 H140002 H140062 H140122 H140226 H140744 H140802 H140860 H140920 H180083 H180210 H180311 H180466 H180538 H140003 H140063 H140123 H140227 H140745 H140803 H140861 H140921 H180087 H180214 H180312 H180467 H180539 H140004 H140064 H140124 H140228 H140746 H140804 H140862 H140923 H180088 H180215 H180314 H180468 H180540 H140005 H140065 H140125 H140229 H140747 H140805 H140863 H140924 H180093 H180217 H180318 H180469 H180541 H140006 H140066 H140126 H140230 H140748 H140806 H140864 H140925 H180098 H180218 H180319 H180470 H180542 H140007 H140067 H140127 H140231 H140749 H140807 H140865 H140926 H180099 H180220 H180321 H180471 H180543 H140008 H140068 H140128 H140232 H140750 H140808 H140866 H140927 H180102 H180221 H180322 H180472 H180544 H140009 H140069 H140129 H140233 H140751 H140809 H140867 H140929 H180103 H180222 H180323 H180473 H180545 H140010 H140070 H140130 H140234 H140752 H140810 H140868 H140930 H180104 H180225 H180324 H180474 H180548 H140011 H140071 H140131 H140235 H140753 H140811 H140869 H140931 H180107 H180226 H180325 H180475 H180549 H140012 H140072 H140132 H140236 H140754 H140812 H140870 H140932 H180108 H180228 H180326 H180476 H180550 H140014 H140073 H140133 H140237 H140755 H140813 H140871 H140933 H180115 H180229 H180327 H180477 H180551 H140015 H140074 H140134 H140238 H140756 H140814 H140872 H140934 H180116 H180233 H180328 H180478 H180552 H140016 H140075 H140135 H140239 H140757 H140815 H140873 H140935 H180117 H180235 H180329 H180479 H180553 H140017 H140076 H140136 H140240 H140758 H140816 H140874 H140936 H180119 H180236 H180402 H180480 H180554 H140018 H140077 H140137 H140700 H140759 H140817 H140875 H140937 H180122 H180237 H180404 H180482 H180555 H140019 H140078 H140138 H140701 H140760 H140818 H140876 H140938 H180124 H180238 H180405 H180484 H180556 H140021 H140079 H140139 H140702 H140761 H140819 H140877 H140939 H180128 H180240 H180406 H180485 H180557 H140022 H140080 H140140 H140703 H140762 H140820 H140878 H140940 H180129 H180242 H180407 H180486 H180559 H140023 H140082 H140141 H140704 H140763 H140821 H140879 H140941 H180131 H180243 H180409 H180487 H180560 H140024 H140083 H140142 H140705 H140764 H140822 H140881 H140943 H180132 H180245 H180411 H180489 H180561 H140025 H140084 H140143 H140706 H140765 H140823 H140882 H140944 H180133 H180249 H180412 H180490 H180562 H140026 H140085 H140144 H140707 H140766 H140824 H140883 H140945 H180135 H180250 H180414 H180491 H180563 H140027 H140086 H140145 H140708 H140767 H140825 H140884 H140947 H180143 H180251 H180417 H180492 H180564 H140028 H140087 H140146 H140709 H140768 H140826 H140885 H140948 H180144 H180254 H180419 H180493 H180565 H140029 H140088 H140147 H140710 H140769 H140827 H140886 H140950 H180147 H180255 H180420 H180494 H180566 H140030 H140089 H140148 H140711 H140770 H140828 H140887 H140951 H180148 H180256 H180422 H180495 H180567 H140031 H140090 H140149 H140712 H140771 H140829 H140888 H140952 H180151 H180257 H180424 H180496 H180568 H140032 H140091 H140150 H140713 H140772 H140830 H140889 H140953 H180154 H180258 H180425 H180498 H180569 H140033 H140092 H140151 H140714 H140773 H140831 H140890 H180003 H180157 H180260 H180426 H180499 H180570 H140034 H140093 H140152 H140715 H140774 H140832 H140891 H180004 H180159 H180262 H180427 H180501 H180571 H140035 H140094 H140153 H140716 H140775 H140833 H140892 H180007 H180161 H180264 H180432 H180505 H180572 H140036 H140095 H140154 H140717 H140776 H140834 H140893 H180008 H180164 H180267 H180433 H180507 H180573 H140037 H140096 H140201 H140718 H140777 H140835 H140895 H180016 H180166 H180268 H180434 H180508 H180574 H140038 H140097 H140202 H140719 H140778 H140836 H140896 H180017 H180167 H180271 H180436 H180509 H180575 H140039 H140098 H140203 H140720 H140779 H140837 H140897 H180019 H180168 H180272 H180437 H180510 H180576 H140040 H140099 H140204 H140721 H140780 H140838 H140898 H180025 H180170 H180273 H180440 H180511 H180577 H140041 H140100 H140205 H140722 H140781 H140839 H140899 H180026 H180171 H180275 H180441 H180513 H180578 H140042 H140101 H140206 H140723 H140782 H140840 H140900 H180028 H180173 H180283 H180442 H180514 H180579 H140043 H140102 H140207 H140724 H140783 H140841 H140901 H180040 H180175 H180284 H180443 H180515 H180580 H140044 H140103 H140208 H140725 H140784 H140842 H140902 H180043 H180178 H180285 H180444 H180517 H180581 H140045 H140105 H140209 H140726 H140785 H140843 H140903 H180044 H180179 H180287 H180445 H180518 H180582 H140046 H140106 H140210 H140727 H140786 H140844 H140904 H180045 H180181 H180289 H180446 H180519 H180583 H140047 H140107 H140211 H140728 H140787 H140845 H140905 H180048 H180182 H180290 H180447 H180520 H180584 H140048 H140108 H140212 H140729 H140788 H140846 H140906 H180049 H180185 H180291 H180449 H180521 H180585 H140049 H140109 H140213 H140730 H140789 H140847 H140907 H180050 H180186 H180292 H180450 H180522 H180586 H140050 H140110 H140214 H140731 H140790 H140848 H140908 H180052 H180188 H180293 H180451 H180524 H180587 H140051 H140111 H140215 H140732 H140791 H140849 H140909 H180053 H180192 H180294 H180452 H180525 H180588 H140052 H140112 H140216 H140733 H140792 H140850 H140910 H180056 H180193 H180295 H180453 H180527 H180589 H140053 H140113 H140217 H140734 H140793 H140851 H140911 H180058 H180195 H180296 H180454 H180528 H180590 H140054 H140114 H140218 H140735 H140794 H140852 H140912 H180059 H180197 H180298 H180455 H180529 H180591 H140055 H140115 H140219 H140736 H140795 H140853 H140913 H180065 H180199 H180299 H180456 H180530 H180592 H140056 H140116 H140220 H140737 H140796 H140854 H140914 H180066 H180201 H180303 H180457 H180531 H180593 H140057 H140117 H140221 H140738 H140797 H140855 H140915 H180073 H180203 H180304 H180459 H180532 H180594 H140058 H140118 H140222 H140739 H140798 H140856 H140916 H180075 H180204 H180305 H180460 H180533 H180595 H140059 H140119 H140223 H140740 H140799 H140857 H140917 H180079 H180206 H180307 H180461 H180534 H180596 H140060 H140120 H140224 H140742 H140800 H140858 H140918 H180080 H180208 H180309 H180462 H180535 H180597 H180598 H180661 H180725 H180788 H180852 H181012 H181073 H181135 H181199 H270118 H270353 H270482 H270645 H180599 H180662 H180726 H180789 H180853 H181013 H181074 H181136 H181200 H270126 H270355 H270483 H270646 H180600 H180663 H180727 H180791 H180854 H181014 H181075 H181137 H181201 H270128 H270356 H270486 H270647 H180601 H180664 H180729 H180792 H180855 H181015 H181076 H181138 H181202 H270134 H270360 H270487 H270648 H180602 H180665 H180730 H180793 H180856 H181016 H181077 H181139 H181203 H270136 H270364 H270489 H270649 H180603 H180667 H180731 H180794 H180857 H181017 H181078 H181140 H181204 H270138 H270365 H270490 H270651 H180604 H180668 H180733 H180796 H180858 H181018 H181079 H181141 H181205 H270144 H270370 H270491 H270652 H180605 H180669 H180734 H180798 H180859 H181019 H181080 H181142 H181206 H270201 H270371 H270495 H270653 H180606 H180670 H180735 H180799 H180860 H181020 H181081 H181143 H181207 H270209 H270373 H270498 H270654 H180607 H180671 H180736 H180800 H180861 H181021 H181082 H181145 H181208 H270211 H270378 H270499 H270656 H180608 H180672 H180737 H180801 H180862 H181022 H181083 H181146 H181209 H270215 H270383 H270500 H270660 H180610 H180673 H180738 H180802 H180863 H181023 H181084 H181147 H181210 H270216 H270384 H270501 H270661 H180611 H180674 H180739 H180803 H180864 H181024 H181085 H181148 H181211 H270219 H270385 H270502 H270662 H180612 H180675 H180740 H180804 H180865 H181025 H181086 H181149 H181212 H270227 H270386 H270503 H270664 H180614 H180676 H180741 H180805 H180866 H181026 H181087 H181150 H181214 H270228 H270391 H270504 H270665 H180615 H180678 H180742 H180806 H180867 H181027 H181088 H181151 H181215 H270229 H270392 H270505 H270667 H180616 H180679 H180743 H180807 H180868 H181028 H181089 H181152 H181220 H270230 H270395 H270506 H270669 H180617 H180680 H180744 H180808 H180869 H181029 H181090 H181153 H181223 H270232 H270398 H270508 H270670 H180618 H180681 H180745 H180809 H180870 H181030 H181091 H181154 H182000 H270235 H270399 H270511 H270671 H180619 H180682 H180746 H180810 H180871 H181031 H181092 H181155 H182001 H270240 H270400 H270512 H270675 H180620 H180683 H180747 H180811 H180872 H181032 H181093 H181156 H182002 H270244 H270401 H270513 H270680 H180621 H180684 H180748 H180812 H180873 H181033 H181094 H181157 H182003 H270245 H270404 H270516 H270681 H180622 H180685 H180749 H180813 H180874 H181034 H181095 H181158 H182005 H270251 H270409 H270518 H270682 H180623 H180686 H180750 H180814 H180875 H181035 H181096 H181159 H182006 H270252 H270410 H270520 H270684 H180624 H180687 H180751 H180815 H180876 H181036 H181097 H181160 H182007 H270254 H270412 H270522 H270685 H180625 H180688 H180752 H180816 H180877 H181037 H181098 H181161 H182008 H270255 H270416 H270525 H270686 H180626 H180689 H180753 H180817 H180878 H181038 H181099 H181162 H182009 H270256 H270418 H270526 H270690 H180627 H180690 H180754 H180818 H180879 H181039 H181100 H181163 H182010 H270260 H270419 H270529 H270692 H180628 H180691 H180755 H180819 H180880 H181040 H181101 H181164 H182012 H270261 H270421 H270532 H270693 H180629 H180692 H180756 H180820 H180881 H181041 H181102 H181165 H182013 H270264 H270425 H270534 H270697 H180630 H180694 H180757 H180821 H180882 H181042 H181103 H181166 H182016 H270267 H270426 H270535 H270698 H180631 H180695 H180758 H180822 H180883 H181043 H181104 H181167 H182017 H270271 H270427 H270539 H270699 H180632 H180696 H180759 H180823 H180884 H181044 H181105 H181168 H182018 H270273 H270428 H270540 H270700 H180633 H180697 H180760 H180824 H180885 H181045 H181106 H181170 H182019 H270277 H270430 H270542 H270705 H180634 H180698 H180761 H180825 H180886 H181046 H181107 H181171 H182020 H270280 H270431 H270544 H270708 H180635 H180699 H180762 H180826 H180887 H181047 H181108 H181172 H182021 H270281 H270435 H270547 H270709 H180636 H180700 H180763 H180827 H180888 H181048 H181109 H181173 H182022 H270282 H270436 H270550 H270710 H180637 H180701 H180764 H180828 H180890 H181049 H181110 H181174 H182023 H270285 H270437 H270601 H270711 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H273106 H273173 H290130 H290217 H290284 H290348 H290411 H290547 H291047 H291108 H272919 H272980 H273043 H273107 H273174 H290132 H290219 H290285 H290349 H290412 H290548 H291048 H291109 H272920 H272981 H273044 H273108 H273175 H290135 H290220 H290286 H290350 H290413 H290549 H291049 H291111 H272921 H272982 H273045 H273109 H273176 H290137 H290221 H290287 H290351 H290414 H290550 H291050 H291112 H272922 H272983 H273046 H273110 H273177 H290138 H290222 H290288 H290352 H290415 H290551 H291051 H291113 H272923 H272984 H273047 H273111 H273178 H290139 H290223 H290289 H290353 H290416 H290552 H291052 H291114 H272924 H272985 H273048 H273112 H273179 H290141 H290224 H290290 H290354 H290417 H290553 H291053 H291115 H272925 H272986 H273049 H273113 H273180 H290143 H290225 H290291 H290355 H290422 H290554 H291054 H291116 H272926 H272988 H273050 H273114 H273181 H290144 H290226 H290292 H290356 H290423 H290555 H291055 H291117 H272927 H272989 H273051 H273115 H273182 H290145 H290227 H290293 H290357 H290424 H290556 H291056 H291118 H272928 H272990 H273052 H273116 H273183 H290146 H290229 H290295 H290358 H290425 H290557 H291057 H291119 H272929 H272991 H273053 H273117 H273184 H290151 H290230 H290296 H290359 H290426 H290558 H291058 H291120 H272930 H272992 H273054 H273118 H273185 H290152 H290231 H290297 H290360 H290427 H290559 H291059 H291121 H272931 H272993 H273055 H273119 H273186 H290154 H290232 H290299 H290362 H290500 H290560 H291060 H291122 H272932 H272994 H273056 H273120 H273187 H290155 H290233 H290301 H290363 H290501 H290561 H291061 H291123 H272933 H272995 H273057 H273121 H273189 H290156 H290234 H290302 H290364 H290502 H290600 H291062 H291124 H272934 H272996 H273058 H273122 H273190 H290157 H290235 H290304 H290365 H290503 H291001 H291063 H291125 H272935 H272997 H273059 H273123 H273191 H290158 H290236 H290305 H290366 H290504 H291003 H291064 H291126 H272936 H272998 H273060 H273124 H273193 H290159 H290237 H290306 H290367 H290505 H291004 H291065 H291127 H272937 H272999 H273061 H273125 H273194 H290160 H290239 H290307 H290368 H290506 H291005 H291066 H291128 H272938 H273000 H273062 H273126 H273195 H290161 H290240 H290308 H290369 H290507 H291006 H291067 H291129 H272939 H273001 H273063 H273127 H273196 H290162 H290241 H290309 H290370 H290508 H291007 H291068 H291130 H272940 H273002 H273065 H273128 H273197 H290164 H290242 H290310 H290371 H290509 H291008 H291069 H291131 H272941 H273003 H273066 H273130 H273198 H290165 H290243 H290311 H290372 H290510 H291009 H291070 H291132 H272942 H273004 H273067 H273131 H273199 H290166 H290244 H290312 H290373 H290511 H291010 H291071 H291133 H272943 H273005 H273068 H273132 H273200 H290168 H290246 H290313 H290374 H290512 H291011 H291072 H291134 H272944 H273006 H273069 H273133 H273201 H290171 H290247 H290314 H290375 H290513 H291012 H291073 H291135 H272946 H273007 H273070 H273134 H273202 H290173 H290248 H290315 H290376 H290514 H291013 H291074 H291136 H272947 H273008 H273071 H273135 H273203 H290175 H290249 H290316 H290377 H290515 H291014 H291075 H291137 H272948 H273010 H273072 H273136 H273204 H290176 H290250 H290317 H290378 H290516 H291015 H291076 H291138 H272949 H273011 H273074 H273137 H273206 H290180 H290253 H290318 H290379 H290517 H291016 H291077 H291139 H272950 H273012 H273075 H273138 H273208 H290181 H290254 H290319 H290380 H290518 H291017 H291078 H291140 H272951 H273013 H273077 H273140 H273209 H290182 H290255 H290320 H290381 H290519 H291018 H291079 H291141 H272952 H273014 H273078 H273141 H273210 H290183 H290256 H290321 H290382 H290520 H291019 H291080 H291142 H272953 H273016 H273079 H273142 H290001 H290185 H290257 H290322 H290383 H290521 H291020 H291081 H291143 H272954 H273017 H273080 H273143 H290003 H290186 H290258 H290323 H290384 H290522 H291021 H291082 H291144 H272955 H273018 H273081 H273144 H290021 H290187 H290259 H290324 H290385 H290523 H291022 H291083 H291145 H272956 H273019 H273082 H273145 H290026 H290189 H290260 H290325 H290386 H290524 H291023 H291084 H291146 H272957 H273020 H273083 H273147 H290027 H290191 H290261 H290326 H290387 H290525 H291024 H291085 H291147 H272958 H273021 H273084 H273148 H290030 H290192 H290262 H290327 H290388 H290526 H291025 H291086 H291148 H272959 H273022 H273085 H273149 H290031 H290193 H290263 H290328 H290389 H290527 H291026 H291087 H291149 H272960 H273023 H273086 H273150 H290032 H290194 H290264 H290329 H290390 H290528 H291027 H291088 H291150 H272961 H273024 H273087 H273151 H290033 H290195 H290265 H290330 H290392 H290529 H291028 H291089 H291151 H272962 H273025 H273088 H273152 H290034 H290196 H290266 H290331 H290393 H290530 H291029 H291090 H291152 H272963 H273026 H273089 H273153 H290103 H290197 H290267 H290332 H290394 H290531 H291030 H291091 H291153 H272964 H273027 H273090 H273155 H290104 H290198 H290268 H290333 H290395 H290532 H291031 H291092 H291154 H272965 H273028 H273091 H273156 H290105 H290201 H290269 H290334 H290396 H290533 H291032 H291093 H291155 H272966 H273029 H273092 H273157 H290108 H290202 H290271 H290335 H290397 H290534 H291034 H291094 H291156 H272967 H273030 H273093 H273158 H290109 H290203 H290272 H290336 H290398 H290535 H291035 H291095 H291157 H272968 H273031 H273094 H273159 H290110 H290205 H290273 H290337 H290399 H290536 H291036 H291096 H291158 H272969 H273032 H273095 H273160 H290111 H290206 H290274 H290338 H290400 H290537 H291037 H291097 H291159 H272970 H273033 H273097 H273162 H290113 H290208 H290275 H290339 H290401 H290538 H291038 H291098 H291160 H272971 H273034 H273098 H273163 H290114 H290209 H290276 H290340 H290402 H290539 H291039 H291099 H291161 H272972 H273035 H273099 H273164 H290116 H290210 H290277 H290341 H290403 H290540 H291040 H291101 H291162 H272973 H273036 H273100 H273165 H290118 H290211 H290278 H290342 H290404 H290541 H291041 H291102 H291163 H272974 H273037 H273101 H273166 H290121 H290212 H290279 H290343 H290405 H290542 H291042 H291103 H291164 H272975 H273038 H273102 H273167 H290122 H290213 H290280 H290344 H290406 H290543 H291043 H291104 H291165 H272976 H273039 H273103 H273170 H290123 H290214 H290281 H290345 H290408 H290544 H291044 H291105 H291166 H291167 H291227 H293310 H293370 H293432 H293492 H293554 H293616 H293677 H293739 H293800 H293861 H293921 H291168 H291228 H293311 H293371 H293433 H293493 H293555 H293617 H293678 H293740 H293801 H293862 H293922 H291169 H291229 H293312 H293372 H293434 H293494 H293556 H293618 H293679 H293741 H293802 H293863 H293923 H291170 H291230 H293313 H293373 H293435 H293495 H293557 H293619 H293681 H293742 H293803 H293864 H293924 H291171 H291231 H293314 H293374 H293436 H293496 H293558 H293620 H293682 H293743 H293804 H293865 H293925 H291172 H291232 H293315 H293375 H293437 H293497 H293559 H293621 H293683 H293744 H293805 H293866 H293926 H291173 H291233 H293316 H293376 H293438 H293498 H293560 H293622 H293684 H293745 H293806 H293867 H293927 H291174 H291234 H293317 H293377 H293439 H293499 H293561 H293623 H293685 H293746 H293807 H293868 H293928 H291175 H291235 H293318 H293378 H293440 H293500 H293562 H293624 H293686 H293747 H293808 H293869 H293929 H291176 H291236 H293319 H293379 H293441 H293501 H293563 H293625 H293687 H293748 H293809 H293870 H293930 H291177 H291237 H293320 H293380 H293442 H293502 H293564 H293626 H293688 H293749 H293810 H293871 H293931 H291178 H291238 H293321 H293381 H293443 H293503 H293565 H293627 H293689 H293750 H293811 H293872 H293932 H291179 H291239 H293322 H293382 H293444 H293504 H293566 H293628 H293690 H293751 H293812 H293873 H293933 H291180 H291240 H293323 H293383 H293445 H293505 H293567 H293629 H293691 H293752 H293813 H293874 H293934 H291181 H291241 H293324 H293384 H293446 H293506 H293568 H293630 H293692 H293753 H293814 H293875 H293935 H291182 H291242 H293325 H293385 H293447 H293507 H293569 H293631 H293693 H293754 H293815 H293876 H293936 H291183 H291243 H293326 H293386 H293448 H293508 H293570 H293632 H293694 H293755 H293816 H293877 H293938 H291184 H291244 H293327 H293387 H293449 H293509 H293571 H293633 H293695 H293756 H293817 H293878 H293940 H291185 H291245 H293328 H293388 H293450 H293510 H293572 H293634 H293696 H293758 H293818 H293879 H293941 H291186 H291246 H293329 H293389 H293451 H293511 H293573 H293635 H293697 H293759 H293819 H293880 H293942 H291187 H291247 H293330 H293390 H293452 H293512 H293574 H293636 H293698 H293760 H293820 H293881 H293943 H291188 H291248 H293331 H293391 H293453 H293513 H293575 H293637 H293699 H293761 H293821 H293882 H293944 H291189 H291249 H293332 H293393 H293454 H293514 H293576 H293638 H293700 H293762 H293822 H293883 H293945 H291190 H291250 H293333 H293394 H293455 H293515 H293577 H293639 H293701 H293763 H293823 H293884 H293946 H291191 H291251 H293334 H293395 H293456 H293516 H293578 H293640 H293702 H293764 H293824 H293885 H293947 H291192 H291252 H293335 H293396 H293457 H293517 H293579 H293641 H293703 H293765 H293825 H293886 H293948 H291193 H291253 H293336 H293397 H293458 H293518 H293581 H293642 H293704 H293766 H293826 H293887 H293949 H291194 H291254 H293337 H293398 H293459 H293519 H293583 H293643 H293705 H293767 H293827 H293888 H293950 H291195 H291255 H293338 H293399 H293460 H293520 H293584 H293644 H293706 H293768 H293828 H293889 H293951 H291196 H291256 H293339 H293401 H293461 H293521 H293585 H293645 H293707 H293769 H293829 H293890 H293952 H291197 H291257 H293340 H293402 H293462 H293522 H293586 H293646 H293708 H293770 H293830 H293891 H293953 H291198 H291258 H293341 H293403 H293463 H293523 H293587 H293648 H293709 H293771 H293831 H293892 H293954 H291199 H291259 H293342 H293404 H293464 H293524 H293588 H293649 H293710 H293772 H293832 H293893 H293955 H291200 H291260 H293343 H293405 H293465 H293525 H293589 H293650 H293712 H293773 H293833 H293894 H293956 H291201 H291261 H293344 H293406 H293466 H293527 H293590 H293651 H293713 H293774 H293834 H293895 H293957 H291202 H291262 H293345 H293407 H293467 H293528 H293591 H293652 H293714 H293775 H293835 H293896 H293958 H291203 H291263 H293346 H293408 H293468 H293529 H293592 H293653 H293715 H293776 H293836 H293897 H293959 H291204 H291264 H293347 H293409 H293469 H293530 H293593 H293654 H293716 H293777 H293837 H293898 H293960 H291205 H291265 H293348 H293410 H293470 H293531 H293594 H293655 H293717 H293778 H293838 H293899 H293961 H291206 H291266 H293349 H293411 H293471 H293532 H293595 H293656 H293718 H293779 H293839 H293900 H293962 H291207 H291267 H293350 H293412 H293472 H293533 H293596 H293657 H293719 H293780 H293840 H293901 H293963 H291208 H291268 H293351 H293413 H293473 H293534 H293597 H293658 H293720 H293781 H293841 H293902 H293964 H291209 H291269 H293352 H293414 H293474 H293535 H293598 H293659 H293721 H293782 H293842 H293903 H293965 H291210 H291270 H293353 H293415 H293475 H293536 H293599 H293660 H293722 H293783 H293843 H293904 H293966 H291211 H291271 H293354 H293416 H293476 H293537 H293600 H293661 H293723 H293784 H293844 H293905 H293967 H291212 H291272 H293355 H293417 H293477 H293538 H293601 H293662 H293724 H293785 H293845 H293906 H293968 H291213 H291273 H293356 H293418 H293478 H293539 H293602 H293663 H293725 H293786 H293846 H293907 H293969 H291214 H292832 H293357 H293419 H293479 H293540 H293603 H293664 H293726 H293787 H293847 H293908 H293970 H291215 H293009 H293358 H293420 H293480 H293541 H293604 H293665 H293727 H293788 H293848 H293909 H293971 H291216 H293207 H293359 H293421 H293481 H293542 H293605 H293666 H293728 H293789 H293849 H293910 H293972 H291217 H293300 H293360 H293422 H293482 H293543 H293606 H293667 H293729 H293790 H293850 H293911 H293974 H291218 H293301 H293361 H293423 H293483 H293544 H293607 H293668 H293730 H293791 H293851 H293912 H293975 H291219 H293302 H293362 H293424 H293484 H293545 H293608 H293669 H293731 H293792 H293852 H293913 H293976 H291220 H293303 H293363 H293425 H293485 H293546 H293609 H293670 H293732 H293793 H293854 H293914 H293977 H291221 H293304 H293364 H293426 H293486 H293548 H293610 H293671 H293733 H293794 H293855 H293915 H293978 H291222 H293305 H293365 H293427 H293487 H293549 H293611 H293672 H293734 H293795 H293856 H293916 H293979 H291223 H293306 H293366 H293428 H293488 H293550 H293612 H293673 H293735 H293796 H293857 H293917 H293980 H291224 H293307 H293367 H293429 H293489 H293551 H293613 H293674 H293736 H293797 H293858 H293918 H293981 H291225 H293308 H293368 H293430 H293490 H293552 H293614 H293675 H293737 H293798 H293859 H293919 H293982 H291226 H293309 H293369 H293431 H293491 H293553 H293615 H293676 H293738 H293799 H293860 H293920 H293983 H293984 H294045 H294107 H294169 H294229 H294291 H294352 H294413 H294477 H294537 H294604 H294666 H294730 H293985 H294046 H294108 H294170 H294230 H294292 H294353 H294414 H294478 H294538 H294605 H294667 H294731 H293986 H294047 H294109 H294171 H294231 H294293 H294354 H294415 H294479 H294539 H294606 H294668 H294732 H293987 H294048 H294110 H294172 H294232 H294294 H294355 H294416 H294480 H294540 H294607 H294669 H294733 H293988 H294049 H294111 H294173 H294233 H294295 H294356 H294417 H294481 H294541 H294608 H294670 H294734 H293989 H294050 H294112 H294174 H294234 H294296 H294357 H294418 H294482 H294542 H294610 H294671 H294735 H293990 H294051 H294113 H294175 H294235 H294297 H294358 H294419 H294483 H294543 H294611 H294672 H294736 H293991 H294052 H294114 H294176 H294236 H294298 H294359 H294420 H294484 H294544 H294612 H294673 H294737 H293992 H294053 H294116 H294177 H294237 H294299 H294360 H294421 H294485 H294545 H294613 H294674 H294738 H293993 H294054 H294117 H294178 H294238 H294300 H294361 H294422 H294486 H294546 H294614 H294675 H294739 H293994 H294055 H294118 H294179 H294239 H294301 H294362 H294423 H294487 H294547 H294615 H294676 H294740 H293995 H294056 H294119 H294180 H294240 H294302 H294363 H294424 H294488 H294548 H294616 H294677 H294741 H293996 H294057 H294120 H294181 H294241 H294303 H294364 H294425 H294489 H294549 H294617 H294678 H294742 H293997 H294058 H294121 H294182 H294242 H294304 H294365 H294426 H294490 H294550 H294618 H294679 H294743 H293998 H294059 H294122 H294183 H294243 H294305 H294366 H294427 H294491 H294551 H294619 H294680 H294744 H293999 H294060 H294123 H294184 H294244 H294306 H294367 H294428 H294492 H294552 H294620 H294681 H294745 H294000 H294061 H294124 H294185 H294245 H294307 H294368 H294429 H294493 H294553 H294621 H294682 H294746 H294001 H294062 H294125 H294186 H294246 H294308 H294369 H294430 H294494 H294554 H294622 H294683 H294747 H294002 H294063 H294126 H294187 H294247 H294309 H294370 H294431 H294495 H294555 H294623 H294684 H294748 H294003 H294064 H294127 H294188 H294248 H294310 H294371 H294432 H294496 H294556 H294624 H294685 H294749 H294004 H294065 H294128 H294189 H294249 H294311 H294372 H294433 H294497 H294557 H294625 H294686 H294750 H294005 H294066 H294129 H294190 H294250 H294312 H294373 H294434 H294498 H294564 H294626 H294687 H294751 H294006 H294067 H294130 H294191 H294252 H294313 H294374 H294435 H294499 H294565 H294627 H294688 H294752 H294007 H294068 H294131 H294192 H294253 H294314 H294375 H294436 H294500 H294567 H294628 H294689 H294753 H294008 H294069 H294132 H294193 H294254 H294315 H294376 H294437 H294501 H294568 H294629 H294690 H294754 H294009 H294070 H294133 H294194 H294255 H294316 H294377 H294438 H294502 H294569 H294630 H294691 H294755 H294010 H294071 H294134 H294195 H294256 H294317 H294378 H294439 H294503 H294570 H294631 H294692 H294756 H294011 H294072 H294135 H294196 H294257 H294318 H294379 H294440 H294504 H294571 H294632 H294693 H294757 H294012 H294073 H294136 H294197 H294258 H294319 H294380 H294442 H294505 H294572 H294633 H294694 H294758 H294013 H294074 H294137 H294198 H294259 H294320 H294381 H294443 H294506 H294573 H294634 H294695 H294759 H294014 H294075 H294139 H294199 H294260 H294321 H294382 H294444 H294507 H294574 H294635 H294696 H294760 H294015 H294076 H294140 H294200 H294261 H294322 H294383 H294445 H294508 H294575 H294636 H294697 H294761 H294016 H294077 H294141 H294201 H294262 H294323 H294384 H294446 H294509 H294576 H294637 H294698 H294762 H294017 H294078 H294142 H294202 H294263 H294324 H294385 H294447 H294510 H294577 H294638 H294700 H294763 H294018 H294079 H294143 H294203 H294264 H294325 H294386 H294448 H294511 H294578 H294639 H294701 H294764 H294020 H294080 H294144 H294204 H294265 H294326 H294387 H294449 H294512 H294579 H294640 H294702 H294765 H294021 H294081 H294145 H294205 H294266 H294327 H294388 H294450 H294513 H294580 H294641 H294704 H294766 H294022 H294083 H294146 H294206 H294267 H294328 H294389 H294451 H294514 H294581 H294642 H294705 H294767 H294023 H294084 H294147 H294207 H294268 H294329 H294390 H294452 H294515 H294582 H294643 H294706 H294768 H294024 H294085 H294148 H294208 H294269 H294330 H294391 H294454 H294516 H294583 H294644 H294707 H294769 H294025 H294086 H294149 H294209 H294270 H294331 H294392 H294457 H294517 H294584 H294645 H294708 H294770 H294026 H294087 H294150 H294210 H294271 H294332 H294393 H294458 H294518 H294585 H294646 H294709 H294771 H294027 H294088 H294151 H294211 H294272 H294333 H294394 H294459 H294519 H294586 H294647 H294710 H294772 H294028 H294089 H294152 H294212 H294273 H294334 H294395 H294460 H294520 H294587 H294648 H294711 H294773 H294029 H294090 H294153 H294213 H294274 H294335 H294396 H294461 H294521 H294588 H294649 H294712 H294774 H294030 H294091 H294154 H294214 H294275 H294336 H294397 H294462 H294522 H294589 H294650 H294713 H294775 H294031 H294092 H294155 H294215 H294276 H294337 H294398 H294463 H294523 H294590 H294651 H294714 H294776 H294032 H294093 H294156 H294216 H294277 H294338 H294399 H294464 H294524 H294591 H294652 H294715 H294777 H294033 H294094 H294157 H294217 H294278 H294339 H294401 H294465 H294525 H294592 H294653 H294716 H294778 H294034 H294095 H294158 H294218 H294279 H294340 H294402 H294466 H294526 H294593 H294654 H294717 H294779 H294035 H294097 H294159 H294219 H294280 H294341 H294403 H294467 H294527 H294594 H294655 H294718 H294780 H294036 H294098 H294160 H294220 H294281 H294342 H294404 H294468 H294528 H294595 H294656 H294719 H294781 H294037 H294099 H294161 H294221 H294283 H294343 H294405 H294469 H294529 H294596 H294657 H294720 H294782 H294038 H294100 H294162 H294222 H294284 H294345 H294406 H294470 H294530 H294597 H294658 H294721 H294783 H294039 H294101 H294163 H294223 H294285 H294346 H294407 H294471 H294531 H294598 H294659 H294723 H294784 H294040 H294102 H294164 H294224 H294286 H294347 H294408 H294472 H294532 H294599 H294660 H294724 H294785 H294041 H294103 H294165 H294225 H294287 H294348 H294409 H294473 H294533 H294600 H294661 H294726 H294786 H294042 H294104 H294166 H294226 H294288 H294349 H294410 H294474 H294534 H294601 H294663 H294727 H294787 H294043 H294105 H294167 H294227 H294289 H294350 H294411 H294475 H294535 H294602 H294664 H294728 H294788 H294044 H294106 H294168 H294228 H294290 H294351 H294412 H294476 H294536 H294603 H294665 H294729 H294789 H294790 H294854 H294917 H294984 H295049 H295120 H295203 H294791 H294855 H294918 H294986 H295050 H295121 H295206 H294792 H294856 H294919 H294987 H295051 H295122 H295207 H294793 H294857 H294920 H294988 H295053 H295125 H295209 H294794 H294858 H294921 H294989 H295054 H295126 H295211 H294795 H294859 H294922 H294990 H295056 H295127 H295212 H294796 H294860 H294923 H294991 H295057 H295128 H295213 H294797 H294861 H294924 H294992 H295058 H295129 H295216 H294798 H294862 H294925 H294993 H295059 H295130 H295217 H294799 H294863 H294926 H294995 H295060 H295131 H295224 H294800 H294864 H294927 H294996 H295061 H295132 H295225 H294801 H294865 H294928 H294997 H295062 H295133 H295226 H294802 H294866 H294929 H294998 H295063 H295134 H295227 H294803 H294867 H294930 H294999 H295064 H295135 H295231 H294804 H294868 H294931 H295000 H295065 H295136 Hcx3582 H294806 H294869 H294932 H295001 H295066 H295138 Hcx4019 H294807 H294870 H294933 H295002 H295067 H295139 Hcx4138 H294808 H294871 H294934 H295003 H295068 H295140 Hcx4344 H294809 H294872 H294935 H295004 H295069 H295141 Hcx4400 H294810 H294874 H294936 H295006 H295070 H295142 Hcx4566 H294811 H294875 H294937 H295008 H295071 H295143 Hcx4662 H294812 H294876 H294938 H295009 H295072 H295144 Hcx4703 H294813 H294877 H294940 H295010 H295073 H295145 Hcx4849 H294814 H294878 H294941 H295011 H295074 H295146 Hcx4852 H294815 H294879 H294942 H295012 H295075 H295147 Hcx4973 H294816 H294880 H294943 H295013 H295076 H295148 Hcx4994 H294817 H294881 H294945 H295014 H295077 H295149 Hcx5055 H294818 H294882 H294946 H295015 H295078 H295150 Hcx5088 H294820 H294883 H294947 H295016 H295080 H295151 Hcx5113 H294821 H294884 H294949 H295017 H295081 H295152 H294822 H294885 H294950 H295018 H295082 H295155 H294823 H294886 H294951 H295019 H295083 H295156 H294824 H294887 H294952 H295020 H295084 H295157 H294825 H294888 H294953 H295021 H295085 H295158 H294826 H294889 H294954 H295022 H295087 H295159 H294827 H294890 H294955 H295023 H295089 H295160 H294828 H294891 H294956 H295024 H295090 H295161 H294829 H294892 H294957 H295025 H295093 H295162 H294830 H294893 H294958 H295026 H295094 H295169 H294831 H294894 H294959 H295027 H295095 H295170 H294832 H294895 H294960 H295028 H295096 H295171 H294833 H294896 H294961 H295029 H295097 H295172 H294834 H294897 H294962 H295030 H295099 H295173 H294835 H294898 H294963 H295031 H295100 H295174 H294836 H294899 H294965 H295032 H295101 H295176 H294837 H294900 H294966 H295033 H295102 H295177 H294838 H294901 H294967 H295034 H295103 H295178 H294839 H294902 H294969 H295035 H295105 H295179 H294840 H294903 H294970 H295036 H295106 H295182 H294841 H294904 H294971 H295037 H295107 H295183 H294842 H294905 H294972 H295038 H295108 H295184 H294843 H294906 H294974 H295039 H295109 H295185 H294844 H294907 H294975 H295040 H295110 H295186 H294845 H294908 H294976 H295041 H295111 H295188 H294846 H294910 H294977 H295042 H295112 H295193 H294847 H294911 H294978 H295044 H295114 H295195 H294848 H294912 H294979 H295045 H295116 H295196 H294850 H294914 H294980 H295046 H295117 H295199 H294851 H294915 H294981 H295047 H295118 H295201 H294853 H294916 H294982 H295048 H295119 H295202
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter dated September 9, 2011. Firm initiated recall is ongoing. 
REASON
Varian has received reports in which a user has remotely rotated the gantry into contact with the couch or with the patient, in both the manual mode and the automate mode.
VOLUME OF PRODUCT IN COMMERCE
5823 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) Stryker Modular Dual Mobility (MDM) Liner and X3 Acetabular Insert; The MDM Liner and X3 Acetabular Inserts is a sterile single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. This device is intended to be used only with any currently available Howmedica Osteonics 22.2 mm and 28 mm diameter femoral heads. Catalog No. 626-00-XXY (XXY= 36C, 38D, 42E, 46F, 48G, 52H, 54I, 58J). Recall # Z-0192-2012;
 
2) Stryker Restoration ADM System X3 Acetabular Insert. The Restoration ADM System X# Acetabular Insert is a sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. This device is intended to be used only with any currently available Howmedica Osteonics 28mm diameter femoral heads. Catalog No.: 1236-2-8XX (XX=46, 48, 50, 52, 54, 56, 58, 60, 62, 64). Recall # Z-0193-2012;
 
3) Stryker Restoration ADM System; The Restoration ADM is a sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. This device is intended to be used only with any currently available Howmedica Osteonics 22.2 mm and 28 mm diameter femoral heads. Catalog No: 1235-2-8XX (XX+48, 50, 52, 54, 56, 58, 60, 63, 64). Recall # Z-0194-2012
CODE
1) All Lots K103233;
2) All Lots K093644;
3) All Lots K0272020
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letter dated June 3, 2011.
Manufacturer: Stryker Ireland, Ltd., Orthopaedics, Carrigtohill, County Cork, Ireland. Firm initiated recall is ongoing.
REASON
There is the potential for interpretation of the product labeling which may lead to an incorrect implant being used.
VOLUME OF PRODUCT IN COMMERCE
16,891 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) SUPER TORQUE MB Angiographic Catheter product is labeled in part: "***5F (1.65 mm)***110 cm .038" (0.97 mm)***PIG***Max. 1200 psi (8274 kPa)***Markers***Open End 6 Sideholes***Angiographic Catheter*** REF Cat No.***Lot***Use By***Assembled in Mexico, USA***EC***REP*** Cordis Cashel, ***Cordis***a Johnson&Johnson company***" UPN H739532598A3, Cat No 532-598A, No. MB 10, French Size 5, Shape (PIG), Length cm 110, Flow Rate, ml/sec, 18, Sideholes 6. UPN H739532598B3, Cat No 532-598B, No. MB 20, French Size 5, Shape (PIG), Length cm 110, Flow Rate, ml/sec, 18, Sideholes 6. UPN H73953298C3, Cat No 532-598C, No MB 20 French Size 5, Shape (PIG), Length, cm 65, Flow Rate, ml/sec, 30, Side Holes 6. UPN H73953298D3, Cat No 532-598D, No MB 2 French Size 5, Shape (PIG), Length , cm 70, Flow Rate, ml/sec, 30, Side Holes 10. Cordis SUPER TORQUE MB angiographic catheters with Market Bands are designed to provide angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to selected sites in the vascular system. Catalog No. 532-598A and 532-598B. Recall # Z-0204-2012;
 
2) SUPER TORQUE MB Angiographic Catheter product is labeled in part: "***5F (1.65 mm)***110 cm .038" (0.97 mm)***MULTIPURPOSE A SUPER TORQUE MB***Max. 1200 psi (8274 kPa)***Markers***OPEN end***Sideholes***SPECIAL***Angiographic Catheter*** REF Cat No.***Lot***Use By***STERIAL EO***Assembled in Mexico***EC***REP*** Cordis Cashel, Cahir Road Cashel, Co Tipperary, Ireland***Cordis***a Johnson&Johnson company***" UPN SRD5724MB, No MB 2, Length, cm 100, Sideholes 2. UPN SRD5727MB, No MB 4, Length, cm 80, Sideholes 4. Cordis SUPER TORQUE MB angiographic catheters with Market Bands are designed to provide angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to selected sites in the vascular system. Catalog No. 532-598A and 532-598B. Recall # Z-0205-2012
CODE
Not Lot Specific.
RECALLING FIRM/MANUFACTURER
Cordis Corp., Miami Lakes. FL, by letter dated November 2011. Firm initiated recall is ongoing.
REASON
Marker bands dislodged during a procedure.
VOLUME OF PRODUCT IN COMMERCE
119,000 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Varian brand Eclipse Release 10 with RT Chart Release 10 (Client Build 10.0.28 or Build 10.0.34), An Eclipse Treatment Planning System used with ARIA Radiation Oncology (RT Chart module), Reference/FSCA Identifier: CP-05277, Model Number: H48. The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye. Recall # Z-0370-2012
CODE
All codes from H480005 through H48C896.
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter dated October 31, 2011. Firm initiated recall is ongoing.
REASON
An anomaly has been identified with Varian Eclipse and RT Chart where adding a reference point in RT Chart and editing the field dose contributions may change the Prescribed Dose Per Fraction in Eclipse.
VOLUME OF PRODUCT IN COMMERCE
2472 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Synthes Oscillating Saw Attachment/Large w/Key for Small Battery Drive. This surgical instrument motor and accessories are AC-powered, battery-powered or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver and saw blade. Catalog number: 532.026. Recall # Z-0348-2012
CODE
All lots
RECALLING FIRM/MANUFACTURER
Synthes USA (HQ), Inc., West Chester, PA, by letter dated October 17, 2011. Firm initiated recall is ongoing.
REASON
The potential exists for the Large Oscillating Saw Attachment to disengage from the Small Battery Drive handpiece. If the attachment disengages from the handpiece, there is a potential for injury to the patient and/or user.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Crystalens Accommodating Posterior Chamber Intraocular Lens, AT-50AO. Crystalens Accommodating Posterior Chamber Intraocular Lens PMA No.: P030002. The Crystalens is intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients with and without presbyopia. Recall # Z-0445-2012
CODE
Serial No.: Expiration Date: 11-699865 to 11-699951 01/14/2016 11-699952 to 11-700027 01/14/2016
RECALLING FIRM/MANUFACTURER
Bausch and Lomb, Inc., Aliso Viejo. CA, by letter dated November 14, 2011. Firm initiated recall is ongoing.
REASON
Bausch + Lomb voluntary initiated the recall due to a physician complaint of haze on the Crystalens AO which was visualized using an angled beam from a slit lamp during the post-operative examination.
VOLUME OF PRODUCT IN COMMERCE
62 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Microcyn Solution with Preservatives (Rx), a) Part number: 84798, 16.9 fl oz (500 mL) and b) Part number: 84781; 33.5 fl oz. (990 mL) Ingredients: Electrolyzed Water (99.97%) Sodium Chloride (NaCl) (230 mg/L) and preservatives: Sodium Hypochlorite (Na0Cl) (40 mg/L), Hypochlorous acid (H0CL) (30 mg/L) -Non Foaming -Does not contain antibiotics - Does not facilitate resistance - No known drug/treatment interactions or contraindications -laboratory proven in solution inactivation of bacteria, viruses, fungi and spores. Performance testing: Microcyn Solution with Preservatives has been evaluated by the USP <51> antimicrobial Effectiveness Test and in Time-Kill studies. It has demonstrated effectiveness by reducing the microorganisms listed below and passed the USP antimicrobial Effectiveness test for a category 1 product. Intended to be used by health care professionals in the management in wounds. Recall # Z-0448-2012;
 
2) Puracyn OTC; Wound & Skin Care Solution with Preservatives; a) Part number: 6000; 80003 (8 oz trigger spray); b) Part number: 6002; 80001, (8 oz finger pump); c) Part number: 6004; 80005, (16 fl oz pump with insert). Kills 99.99% of Staph, MRSA, Strep and other Infectious Germs in 30 seconds in solution. Does not contain Antibiotics, Steroids or Alcohol. -Cleans infected wounds in one step - Safe to use around eyes, nose, m mouth and open wounds - Accelerated healing of minor wounds by keeping the wound clean -Non-toxic and non-irritating. Made in USA. Intended for OTC use for the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin. Recall # Z-0449-2012;
 
3) Microcyn Dermatology Spray with germ killing Preservatives (Rx); Part number: 84866 - 8 fl oz spray bottle. 99.999% Reduction In-solution in 30 seconds. MRSA - Staphylococcus aureus VFR - Enterococcus faecalis Acinetobacter baumannii Pseudomonas aeruginosa. Microcyn Dermatology Spray has been evaluated by the USP <51> Antimicrobial Effectiveness Test and in Time Kill studies. It has demonstrated effectiveness by reducing the microorganisms listed below and passed the USP antimicrobial Effectiveness test for a Category 1 product. Safe to use around eyes, nose and mouth. Oculus Innovative Sciences . Petaluma, CA 94954. Intended for use by health care professionals in management via debridement of wounds. Recall # Z-0450-2012;
 
4) Microcyn Dermatology HydroGel, Spray, a) Part number: 84811 - 1.76 oz. and b) Part number 84828, 4 oz. Provided Pain Relief, Relieve Itch, Reduces symptoms of inflammation due to irritation, Provide a protective shield against contamination. Antibiotic-free, steroid-free and biodegradable. Intended for use by health care professionals in management of wounds including itch and pain relief associated with dermal irritation, sore, injuries and ulcers or dermal tissue. Microcyn Skin and Wound hydrogel is intended for use on first and second degree burns, excluding wounds such as leg ulcers, pressure ulcers, diabetic ulcers, and for the management of mechanically or surgically debrided wounds. Recall # Z-0451-2012
CODE
1) a) Lot numbers: OIS00011-01, exp 1/12; OIS00011-02, exp 1/12; 10l0119, exp 8/12; 10J0145, exp 8/12; 10K0158, exp 8/12; 10K0159, exp 8/12; 10K0160, exp 8/12; 1C0130, exp 2/13; b) lot numbers: OIS00012-01, exp 1/12; OIS00012-02, exp 1/12; 10E0086-01, exp 5/12; 10l0120, exp 8/12; 10J0145, exp 8/12; 11A0042, exp 1/13; 11B0056, exp 2/13; 11B0081-01, exp 2/13; 11B0082-02, exp 2/13; 11E0192, exp 6/13; 11F0197, exp 6/13;
 
2) a) Lot numbers: 10E0084-01, exp 11/11; 10F0099, exp 12/11; 10F0105, exp 12/11; 041311-01, exp 5/12; b) lot number s: 041311-01, exp 5/12; 081710-01, exp.9/11; 120810-01, exp 2/2012; 073010-02, exp 11/11; c) lot number: 061511-02, exp 12/12;
 
3) Lot numbers: 11G0108, exp 1/12; 10H0113-01, exp 2/12; 10H0118-01, exp 8/12; 10l0122-03, exp 3/12; 10l0125-01, exp 3/12; 10J0137-03, exp 4/12; 10K0164, exp 5/12; 11B0068-01, exp 8/12;
 
4) a) Lot numbers: 10C0030-03, exp 3/12; 10C0034-03, exp 3/12; 10D0051-01, exp 4/12; 10D0059-02, exp 4/12; 10E0076-01, exp 5/12; 10H0112-03, exp 8/12; 10H0116-03, exp 8/12; 10J0143-02, exp 10/12; 11B0051-01, exp 2/13; b) lot number: 10C0032, exp 3/12
RECALLING FIRM/MANUFACTURER
Oculus Innovative Sciences Inc., Petaluma, CA, by letter dated November 15, 2011. FDA initiated recall is ongoing.
REASON
Unapproved drug claims and those not approved under 510K clearance.
VOLUME OF PRODUCT IN COMMERCE
18397 total units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Urine Reagent Strips (URS) 10 Parameters URS-l0-1OOW 510(K) number: K970250 Devise Listing number: D072377. Each device consists of 100 strips of Urine Reagent Strips 10 parameters packed with a desiccant pouch inside a gray bottle with Teco Diagnostics Label on the bottle and the bottle placed inside a Teco Diagnostics Box. For the semi-quantitative and qualitative detection of Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocytes in urine. Recall # Z-0511-2012;
 
2) Urine Reagent Strips (URS) 10 Parameters URS-l0-1OOW 510(K) number: K970250 Devise Listing number: D072377 Each device consists of 100 strips of Urine Reagent Strips 10 parameters packed with a desiccant pouch inside a gray bottle with Teco Diagnostics Label on the bottle and the bottle placed inside a Teco Diagnostics Box. For the semi-quantitative and qualitative detection of Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocytes in urine. URS-II-I00G-00I i. 3. Recall # Z-0512-2012
CODE
1) Lot Number: 35264 ii. Expiration Date: 0112014;
2) Lot Number: 35224 ii. Expiration Date: 08/2013
RECALLING FIRM/MANUFACTURER
Teco Diagnostics, Anaheim, CA, by letter dated October 14, 2011. Firm initiated recall is ongoing.
REASON
This recall was initiated in response to findings during a FDA inspection of the firm. The firm's recall has been initiated due to improper manufacture of sub-component nitrite paper Lot 35134, Expiration Date: 01/2014. Discrepancies were found on the information recorded on formulation sheet and manufacturing log sheets (Refer to next paragraph). Sampling size submitted for QC testing was insufficient based upon number of rolls manufactured.
VOLUME OF PRODUCT IN COMMERCE
1) 550 kits; 2) 200 kits
DISTRIBUTION
CA, Poland
___________________________________
PRODUCT
The IS Can Disposable CO2 absorber x 6 --- Carbon Dioxide absorbent for use on GE rebreathing systems. Intended use: GE Healthcare anesthetic machines: S5 Aespire, S5 Avance, Aisys. The Intersurgical IS Can is for use with air, oxygen, nitrous oxide, halothane, enflurane, isoflurane, desflurane and sevoflurane. Recall # Z-0518-2012
CODE
Lot # Expiration Date 2194 1101240 2013-04 2194 1101425 2013-05 2194 1101426 2013-05 2194 1101902 2013-06 2195 1102927 2013-08 2195 1102596 2013-07 2195 1101423 2013-05 2195 1102596 2013-07 2196 1100392 2013-02 2196 1101241 2013-04 2196 1101426 2013-05 2196 1103379 2016-01 2197 1101281 2013-05 2197 1102597 2013-08 2198 1101107 2013-04 2198 1101427 2013-05 2198 1101428 2013-05
RECALLING FIRM/MANUFACTURER
Recalling Firm: Intersurgical Inc., Liverpool, NY, by letter dated February 8, 2011,
Manufacturer: Intersurgical Ltd. – Guernsey, Guernsey, UK. Firm initiated recall is complete. 
REASON
Intersurgical Incorporated has issued a voluntary recall of the IS Cans Carbon Dioxide Absorber due to a possibility that loose granules may enter the inspiratory path of the breathing system.
VOLUME OF PRODUCT IN COMMERCE
2216 cans
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Smith & Nephew, SPIDER2 Limb Positioner, including accessories Battery, foot pedal and charger Catalog Number: 72203299. Table, Operating-room, Pneumatic. Recall # Z-0519-2012
CODE
Serial Numbers: VAL07, VAL08,VAL11,VAL15, VAL16, VAL19, VAL20, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 58, 59, 60, 61, 62, 63, 66, 71, 73, 76, 77, 79, 80, 81, 82, 88, 90, 92, 93, 94, 95, 97, 98, 99, 100, 101, 102, 103, 104, 106, 107, 110
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smith & Nephew, Inc. Endoscopy Division, Andover, MA, by letter dated July 26, 2011.
Manufacturer: Tenet Medical Engineering, Calgary, Canada. Firm initiated recall is complete.
REASON
SPIDER2 may unlock (loss of traction) resulting in potential movement of the patient when the device is within close proximity to an RF source. Loss of traction can potentially result in the unintended repositioning of the extremity and potential for tissue or cartilage damage.
VOLUME OF PRODUCT IN COMMERCE
52 units
DISTRIBUTION
Nationwide, Canada and France
___________________________________
PRODUCT
Agfa Computed Radiography Systems with DX-G Digitizer. DX-G Digitizers have the same intended use as the predicate devices. They are intended to use in providing diagnostic images to aid the physician with diagnosis. DX-G Digitizers provide the ability to use both standard needle phosphor image plates and can be used with either Musica or Musica 2. In the US, Agfa's Computed Radiography Systems with DX-G Digitizers are not intended for use in mammography. Model No. 5170/100. Recall # Z-0591-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm:AGFA Corp., Greenville, SC, by letter dated December 6, 2011.
Manufacturer: Agfa-Gevart NV, Mortsel, Belgium. Firm initiated recall is ongoing.
REASON
Occasionally images can be lost or sent to an incorrect folder or the digitizer may stop either during startup or during a cassette scan cycle.
VOLUME OF PRODUCT IN COMMERCE
124 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
0.9% Sodium Chloride Injection, USP, pre-filled flush solution, for IV Flush only, sterile fluid path; 10 mL Single-Use Syringe with Male Luer Lock, 100 syringes per pack, 4 packs per case; list no. 1978-20 lock flush solution. Recall # Z-0596-2012
CODE
Lots: 91-100-5E, 91-102-5E, 91-106-5E, 91-114-5E, 91-116-5E and 91-118-5E
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira Inc., Lake Forest, IL, by letter dated November 18, 2011.
Manufacturer: Hospira Holdings de, Costa Rica Ltd., La Aurora de Heredia, Costa Rica. Firm initiated recall is ongoing.
REASON
There is particulate matter in the fluid pathway, which has been identified as the same material as the rubber tip of the syringe plunger.
VOLUME OF PRODUCT IN COMMERCE
1,277,600 syringes
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
ETCO2 Divided Sampling Cannula with Simultaneous Oxygen Delivery, Model number 4707 7-7-24. Salter Labs Nasal Cannula (Adult), Salter Style with modified nasal prongs. w/7' O2 line and 7' CO2 line with male luer lock connector. Recall # Z-0605-2012
CODE
Lot: 090610
RECALLING FIRM/MANUFACTURER
Salter Labs, Arvin, CA, by telephone on December 7, 2011. Firm initiated recall is ongoing.
REASON
Mis-labeling: report of cases labeled as 4707 (cannulas with male luer lock connector) actually contained 4707F (with female luer lock connectors).
VOLUME OF PRODUCT IN COMMERCE
240 cases, 24 to be part of the recall
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Eius Unicompartmental Knee System. Intended for use in Unicompartmental Knee Arthroplasty (UKA). Surgeon users have identified the following potential advantages of UKA procedures versus Total Knee Arthroplasty procedures generally: conservation of the opposite compartment, preservation of ligaments and patellofemoral articulation, reduced loss of bone stock and lower implant cost. The EIUS UKA is a Resurfacing device that requires the removal of a thin condylar cross-section intended to replace the diseased cartilage only. This allows the surgeon to conserve good quality subchondral bone. Recall # Z-0606-2012
CODE
K052917, K9922887 6636-2-001 002,003, 004, 005, 011, 012, 013, 014, 015, 308, 309, 310, 312, 318, 319, 320, 322, 408, 409, 410, 412, 418, 419, 420, 422, 508, 509, 510, 512, 518, 519, 520, 522, 608, 609, 610, 612, 618, 619, 620, 622, 708, 709, 710, 712, 718, 719, 720, and 722 - ALL LOTS  
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters dated August 17and 25, 2011. Firm initiated recall is ongoing.
REASON
Two National Joint Registries suggest that the EIUS Unicompartmental System is associated with a higher revision rate then the unicompartmental devices.
VOLUME OF PRODUCT IN COMMERCE
26,348 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
SKYLight Imaging Systems, Model 882050; Intended to produce images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. Recall # Z-0607-2012
CODE
Code numbers: K01110023 K02040041, K02050049 K03050121 K02030032 K01070004 K02080079 K02100095 K02030033 K02030034 K01070003 K02070068 K02080075, K02080082 K01090015 K01080005 K02080077 K01080009 K01100016 K02050058 K02070065 K02080078 K02030035 K02070070 K01100019 K01110027 K01110021 K02100092 K02090087 K02060061 K03060124 K02040040 K02030037 K02100094 K02070063 K01100017 K01110025 K02050052 K03080132 K02040043 K01090012 K03030112 K01100020, K02070064 K03070128 K03040115 K01080008 K02090084, K03030108 K02100098 K01110022 K01110024 K02050048 K02090088 K03050119 K03030107 K02050055 K01090011 K03060122 K02070062 K02040047 K01090010 K02050059 K03040116 K02050054 K03030109 K03080134 K02030038 K03080133 K02070072, K02080081 K02100091 K02060050 K02020029 K03030114 K02100096 K02070071 K03040117 K03060123 K01080006 K03030135 K03080135 K01080007 K02020030, K02040045 K02070067 K02020031 K03070125 K02030036 K02070066 K02090083 K02100090 K02090089 K02110097 K02120104 K02120106 K03070129 K03070130 K02080074 K02120105 K02040042 K03040118 K02110101 K02120103 K03050120 K02110102 K02110001 K03070131 K02050053 K03070126 K02040044 K03030113 K03030110 K03030111 K02070073 K02050056 K02110100 K02050050 K02040046 K01090013 K03070127 K01110028 K02050051 K02030039 K02080076 K02050057 K02090085
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems, San Jose, CA, by letter dated December 08, 2011.
Manufacturer: Philips Medical Systems (Cleveland) Inc., Cleveland, OH. Firm initiated recall is ongoing.
REASON
During preventative maintenance, a crack was discovered in the lower portion of the old style, non-common arm for the detector assembly, which could result in the detector dropping in an uncontrolled manner.
VOLUME OF PRODUCT IN COMMERCE
129 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) STAT 2 I.V. Controller, Catalog/REF No. S2, ASSEMBLED IN MEXICO. This is a disposable device with a sterile, nonpyrogenic fluid path. For controlling the infusion of Intravenous fluids into the human body. Recall # Z-0629-2012;
 
2) STAT 2 Extension Set Gravity Flow Controller, 12" length, Catalog/REF No. S2-12, STERILE, ASSEMBLED IN MEXICO. This is a disposable device with a sterile, nonpyrogenic fluid path. The STAT 2 Extension sets are for use in conjunction with commonly available I.V. administration sets for controlling the infusion of I.V. fluids into the human body. Recall # Z-0630-2012;
 
3) STAT 2 Extension Set Gravity Flow Controller (Needle-Free), 12" length, Catalog/REF No. S2-12N, STERILE, ASSEMBLED IN MEXICO. This is a disposable device with a sterile, nonpyrogenic fluid path. The STAT 2 Extension sets are for use in conjunction with commonly available I.V. administration sets for controlling the infusion of I.V. fluids into the human body. Recall # Z-0631-2012;
 
4) STAT 2 Primary Administration Set Gravity Flow Controller, 20 Drops/cc, 84" length, Catalog/REF No. S2V-20, STERILE, ASSEMBLED IN MEXICO. This is a disposable device with a sterile, nonpyrogenic fluid path. The STAT 2 Secondary and Primary Administration Sets are for use in attachment to an I.V. bag and patient catheter inserted into a vein to control the infusion of intravenous fluids into the human body. Recall # Z-0632-2012;
 
5) STAT 2 Primary Administration Set Gravity Flow Controller (Needle-Free), 20 Drops/cc, 84" length, Catalog/REF No. S2V-20 N, STERILE, ASSEMBLED IN MEXICO. This is a disposable device with a sterile, nonpyrogenic fluid path. The STAT 2 Secondary and Primary Administration Sets are for use in attachment to an I.V. bag and patient catheter inserted into a vein to control the infusion of intravenous fluids into the human body. Recall # Z-0633-2012;
 
6) STAT 2 Secondary Set Gravity Flow Controller, 20 Drops/cc, 13" length, Catalog/REF No. S2-20 MD, STERILE, ASSEMBLED IN MEXICO. This is a disposable device with a sterile, nonpyrogenic fluid path. The STAT 2 Secondary and Primary Administration Sets are for use in attachment to an I.V. bag and patient catheter inserted into a vein to control the infusion of intravenous fluids into the human body. Recall # Z-0634-2012;
 
7) STAT 2 Primary Administration Set Gravity Flow Controller, 60 Drops/cc, 84" length, Catalog/REF No. S2V-60, STERILE, ASSEMBLED IN MEXICO. This is a disposable device with a sterile, nonpyrogenic fluid path. The STAT 2 Secondary and Primary Administration Sets are for use in attachment to an I.V. bag and patient catheter inserted into a vein to control the infusion of intravenous fluids into the human body. Recall # Z-0635-2012;
 
8) STAT 2 Primary Administration Set Gravity Flow Controller (Needle-Free), 60 Drops/cc, 84" length, Catalog/REF No. S2V-60 N, STERILE, ASSEMBLED IN MEXICO. This is a disposable device with a sterile, nonpyrogenic fluid path. The STAT 2 Secondary and Primary Administration Sets are for use in attachment to an I.V. bag and patient catheter inserted into a vein to control the infusion of intravenous fluids into the human body. Recall # Z-0636-2012
CODE
1) Beginning Lot Code 1007195, Ending Lot Code 1010085;
2) Beginning Lot Code 1006214, Ending Lot Code 1103304;
3) Beginning Lot Code 1006284, Ending Lot Code 1103294;
4) Beginning Lot Code 1006094, Ending Lot Code 1103214;
5) Beginning Lot Code 1006304, Ending Lot Code 1103284;
6) Beginning Lot Code 1006304, Ending Lot Code 1103114;
7) Beginning Lot Code 1006284, Ending Lot Code 1103104;
8) Beginning Lot Code 1007054, Ending Lot Code 1011104
RECALLING FIRM/MANUFACTURER
Recalling Firm: ConMed Corp., Utica, NY, by letters dated April 14, 2011, April 22, 2011 and May 10, 2011.  
Manufacturer: Consolidated Medical Equipment Co., Chihuahua, Mexico. Firm Initiated recall is ongoing.
REASON
Certain units were assembled with an incorrect component which could result in the devices exhibiting a different flow rate and might reduce the ability of the user to regulate the device at low flow rates.
VOLUME OF PRODUCT IN COMMERCE
265,540 sets: Nationwide - 225,192; Internationally - 40,348
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) Zee Clear Vinyl Medical Examination Gloves, Powder Free, Medium, Non-Sterile; 100 gloves per box, 10 boxes per case; Made in China; Zee Part No.: 3061 Single Use, medical exam glove worn on the hand to provide a barrier against potentially infectious materials and other contaminants. Recall # Z-0679-2012;
 
2) Zee Clear Vinyl Medical Examination Gloves, Powder Free, Large, Non-Sterile; 100 gloves per box, 10 boxes per case; Made in China; Zee Part No.: 3062 Single Use, medical exam glove worn on the hand to provide a barrier against potentially infectious materials and other contaminants. Recall # Z-0680-2012;
 
3) Zee Clear Vinyl Medical Examination Gloves, Powder Free, X-Large, Non-Sterile; 100 gloves per box, 10 boxes per case; Made in China; Zee Part No.: 3063 Single Use, medical exam glove worn on the hand to provide a barrier against potentially infectious materials and other contaminants Recall # Z-0681-2012
CODE
Lot number CZA04-22
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cypress Medical Products LLC, McHenry, IL, by telephone and letters dated November 14, 2011.  
Manufacturer: QINGDAO LANGHUI Import and Export Co, LTD, Qingdao, China. FDA initiated recall is ongoing.
REASON
The gloves fail to meet the performance requirements of 21 CFR 800.20 for leakage defects.
VOLUME OF PRODUCT IN COMMERCE
680 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Biomet Series A Thin Patella size 25mm, three pegs, Part 184780, Sterile. For use with Vanguard, Maxim, Ascent & AGC Knee Systems. Knee joint patellofemorotibial, cemented, polymer /metal/polymer, semi-constrained. Knee joint replacement prosthesis, intended for patella replacement of the knee joint in conjunction with a femoral and tibial component. Recall # Z-0695-2012;
 
2) Biomet Series A Standard Patella size 25mm, one peg, Part 184700, Sterile. Knee joint patellofemorotibial, cemented, polymer/metal/polymer, semi-constrained. For use with Vanguard, Maxim, Ascent & ACG knee system. Knee joint replacement prosthesis, intended for patella replacement of the knee joint in conjunction with a femoral and tibial component. Recall # Z-0696-2012;
 
3) Biomet Series A Standard Patella size 28mm, one peg – 184702. For use with Vanguard, Maxim, Ascent & ACG Knee system. Knee joint patellofemorotibial, cemented, polymer/metal/polymer, semi-constrained. Knee joint replacement prosthesis, intended for patella replacement of the knee joint in conjunction with a femoral and tibial component. Recall # Z-0697-2012;
 
4) Biomet Series A Thin Patella size 25mm, one peg - 184720 Sterile. For use with Vanguard, Maxim, Ascent & AGC Knee Systems Knee joint patellofemorotibial, cemented, polymer/metal/polymer, semi-constrained. Knee joint replacement prosthesis, intended for patella replacement of the knee joint in conjunction with a femoral and tibial component. Recall # Z-0698-2012;
 
5) Biomet Series A Thin Patella size 25mm, one peg - 184720, Sterile. For use with Vanguard, Maxim, Ascent & AGC Knee Systems Knee joint patellofemorotibial, cemented, polymer/metal/polymer, semi-constrained. Knee joint replacement prosthesis, intended for patella replacement of the knee joint in conjunction with a femoral and tibial component. Recall # Z-0699-2012;
 
6) Biomet Series A Standard Patella size 25mm, three pegs - 184760, Sterile. For use with Vanguard, Maxim, Ascent & AGC Knee Systems Knee joint patellofemorotibial, cemented, polymer/metal/polymer, semi-constrained. Knee joint replacement prosthesis, intended for patella replacement of the knee joint in conjunction with a femoral and tibial component. Recall # Z-0700-2012;
 
7) Biomet Series A Standard Patella size 28mm, three pegs - 184762, Sterile. For use with Vanguard, Maxim, Ascent & AGC Knee Systems Knee joint patellofemorotibial, cemented, polymer/metal/polymer, semi-constrained. Knee joint replacement prosthesis, intended for patella replacement of the knee joint in conjunction with a femoral and tibial component. Recall # Z-0701-2012;
 
8) Biomet Series A Thin Patella size 28mm, three pegs - 184782, Sterile. For use with Vanguard, Maxim, Ascent & AGC Knee Systems Knee joint patellofemorotibial, cemented, polymer/metal/polymer, semi-constrained. Knee joint replacement prosthesis, intended for patella replacement of the knee joint in conjunction with a femoral and tibial component. Recall # Z-0702-2012;
 
9) Biomet Series A Asymmetrical Patella size 25mm, three pegs - 184790, Sterile. For use with Vanguard, Maxim, Ascent & AGC Knee Systems Knee. Joint patellofemorotibial, cemented, polymer/metal/polymer, semi-constrained. Knee joint replacement prosthesis, intended for patella replacement of the knee joint in conjunction with a femoral and tibial component. Recall # Z-0703-2012;
 
10) Biomet Series A Asymmetrical Patella size 28mm, three pegs – Part 184791, Sterile. For use with Vanguard, Maxim, Ascent & AGC Knee Systems Knee. Joint patellofemorotibial, cemented, polymer/metal/polymer, semi-constrained. Knee joint replacement prosthesis, intended for patella replacement of the knee joint in conjunction with a femoral and tibial component. Recall # Z-0704-2012
CODE
1) Lot 357470, 438780, 527760, 633870, 684140, and 710230;
 
2) Lot 079520, 118810, 136470, 190350, 232400, 248190, 332290, 517200, 572130, 732770;
 
3) Lot 107600, 136480, 136490, 190360, 248230, 312420, 312430, 344660, 413600, 413610, 485560, 517210, 517240, 614990, 644400, 678050, and 732780;
 
4) Lot 079520, 136540, 332320, 506170, 678090;
 
5) Lot 079530, 190400, 344670, 423400, 474010, 619850, and 740130;
 
6) Lot 190410, 369920, 423430, 572150, 633870, 721650;
 
7) Lot 107610, 136550, 205940, 205950, 205960, 205970, 248270, 248280, 248290, 344680, 344690, 344700, 369940, 369950, 403040, 423440, 423450, 474020, 184762 474030, 474040, 498270, 527680, 527690, 527700, 527710, 572160, 312080, 572170, 572180, 572190, 572200, 687900, 687910, 687920, and 687930;
 
8) Lot 098970, 144970, 190440, 232540, 274550, 357320, 397810, 397820, 438790, 438800, 498310, 539710, 599220, 644430, 710240;
 
9) Lot 219180, 219190, 219200;
 
10) Lot 098760, 143320, 143480, 247410, 247420, 283590, 311990
RECALLING FIRM/MANUFACTURER
Biomet, Inc., Warsaw, IN, by letter dated October 3, 2011. Firm initiated recall is ongoing.
REASON
Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system.
VOLUME OF PRODUCT IN COMMERCE
1757 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
U-Joint Hex Head Driver 3.5mm, Part Number 228-0016, for the Escalade Acetabular Cup System. Driver is included in Part Number 270-9004-Escalade Acetabular Prep Kit and Part Number 228-9001-Triplus Acetabular Instrument Kit. The Acetabular Cup System is indicated for use in total hip arthroplasty procedures where the means of cup fixation is uncemented, biological fixation. The Hex Head Drive is used to place the screw that affixes the acetabular cup to the hip acetabulum. Recall # Z-0740-2012
CODE
Lot numbers: 1365304, 1365305
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ortho Development Corp., Draper, UT, by letter dated December 19, 2011.
Manufacturer: Symmetry Medical USA, Inc., Warsaw, IN. Firm initiated recall is ongoing.
REASON
Tip of hex-head screwdriver may break off during use in hip replacement procedure.
VOLUME OF PRODUCT IN COMMERCE
37 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Olympus Electrosurgical Unit. The Olympus Electrosurgical Unit (ESG-100) is used in conjunction with cutting and coagulation electrosurgical devices intended for use in electrosurgery procedures during flexible gastrointestinal endoscopy. Recall # Z-0747-2012
CODE
Serial numbers 11053P230001, 11053P230002, 11053P230003, 11053P230004, 11053P230005, 11060P230001, 11160P230002, 11060P230003, 11160P230004, 11160P230005, 11081P230001, 11081P230003, 11081P230004, 11081P230005, 11081P230006, 11081P230007, 11081P230008, 11081P230009, 11081P230010, 11094P230006, 11094P230007, 11094P230008, 11094P230009, 11094P230010, 11096P230007, 11096P230008, 11096P230009, 11096P230010, 11102P230001, 11102P230002, 11102P230003, 11102P230004, 11102P230005, 11109P230002, 11109P230003, 11109P230004, 11109P230005, 11110P230001, 11110P230002, 11110P230003, 11110P230004, 11110P230005, 11116P230001, 11116P230002, 11116P230003, 11116P230004, 11116P230005, 11117P230001, 11117P230002, 11117P230003, 11117P230004, 11117P230005, 11132P230001, 11132P230002, 11132P230003, 11132P230004, 11132P230005, 11133P230001, 11133P230002, 11133P230003, 11138P230002, 11138P230003, 11138P230004, 11139P230001, 11139P230002, 11139P230005, 11167P230001, 11167P230004, 11180P230003, 11180P230005, 11201P230005, 11201P230010, 11202P230001, 11202P230005, 25456W23-101, 25456W23-102, 25456W23-107, 25456W23-108, 25456W23-109, 25522W23-101, 25522W23-102, 25522W23-103, 25522W23-104, 25522W23-105, 25553W23-105, 25553W23-107, 25553W23-108, 25553W23-109, 25553W23-110, 25565W23-102, 25565W23-103, 25565W23-105, 25565W23-106, 25565W23-108, 25565W23-109, 25565W23-110, 25593W23-101, 25593W23-102, 25593W23-103, 25593W23-104, 25593W23-105, 25593W23-107, 25593W23-109, 25593W23-110, 25607W23-101, 25607W23-102, 25607W23-103, 25607W23-104, 25607W23-105, 25607W23-106, 25607W23-107, 25607W23-108, 25607W23-110, 25613W23-101, 25613W23-102, 25613W23-103, 25613W23-104, 25613W23-105, 25613W23-106, 25613W23-107, 25613W23-108, 25613W23-109, 25613W23-110, 25686W23-102, 25719W23-105, 25719W23-106, 25736W23-101, 25736W23-102, 25736W23-103, 25736W23-104, 25736W23-105, 25736W23-106, 25736W23-107, 25736W23-108, 25736W23-109, 25752W23-101, 25752W23-102, 25752W23-103, 25752W23-104, 25752W23-105, 25752W23-106, 25752W23-107, 25776W23-101, 25776W23-102, 25776W23-103, 25776W23-105, 25776W23-106, 25776W23-107, 25776W23-108, 25776W23-109, 25776W23-110, 25869W23-101, 25869W23-102, 25869W23-103, 25869W23-104, 25869W23-105, 25869W23-106, 25869W23-107, 25869W23-108, 25869W23-109, 25869W23-110, 25978W23-104, 25978W23-105, 25978W23-106, 25978W23-107, 26052W23-109, 26052W23-110, 26085W23-101, 26085W23-102, 26085W23-103, 26085W23-104, 26085W23-105, 26085W23-106, 26085W23-107, 26085W23-108, 26085W23-109, 26136W23-101, 26136W23-103, 26136W23-104, 26136W23-105, 26136W23-107, 26136W23-108, 26136W23-109, 26136W23-110, 26162W23-108, 26162W23-109, 26162W23-110, 26227W23-102, 26227W23-103, 26227W23-104, 26227W23-105, 26227W23-106, 26227W23-107, 26227W23-108, 26227W23-109, 26227W23-110, 26456W23-101, 26456W23-102, 26456W23-103, 26456W23-104, 26456W23-105, 26456W23-106, 26456W23-107, 26456W23-108, 26456W23-109, 26456W23-110, 26559W23-101, 26559W23-103, 26559W23-104, 26559W23-105, 26559W23-108, 26559W23-109, 26559W23-110, 26710W23-108, 26710W23-109, 26770W23-101, 26770W23-102, 26770W23-103, 26770W23-104, 26770W23-105, 26770W23-106, 26770W23-107, 26770W23-108, 26770W23-109, 26770W23-110, 26878W23-101, 26878W23-102, 26878W23-103, 26878W23-104, 26878W23-105, 26879W23-102, 26879W23-103, 26879W23-104, 26879W23-105, 26917W23-101, 26917W23-102, 26917W23-103, 26917W23-105, 26917W23-106, 26917W23-107, 26917W23-108, 26917W23-109, 26917W23-110, and 26992W23-110
RECALLING FIRM/MANUFACTURER
Recalling Firm: Olympus America Inc., Center Valley, PA, by letter dated November 28, 2011.
Manufacturer: Celon AG Medical Instruments, Teltow, Germany. Firm initiated recall is ongoing.
REASON
Investigations of customer complaints revealed a counterfeit capacitor was used in the manufacture of some lots of the ESG-100
VOLUME OF PRODUCT IN COMMERCE
245 units
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS III
___________________________________
PRODUCT
MORPHEUS CT PICC with STYLET, 5F Dual Lumen 65 cm Insertion Kit, Catalog No./REF 1200923, STERILE, COMMON/USUAL NAME: Percutaneous, implanted, long-term intravascular catheter; CLASSIFICATION NAME: Percutaneous, implanted, long-term intravascular catheter; Device Listing # D095274. PICC Catheters are utilized for Short or Long Term peripheral access to the Central Venous system for intravenous therapy and power injections of contrast media. Recall # Z-0467-2012
CODE
Lot Number 974842; exp. 10/2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Angiodynamics Worldwide Headquarters, Latham, NY, by letter dated December 2, 2011.
Manufacturer: Angiodynamics, Inc., Queensbury, NY. Firm initiated recall is ongoing.
REASON
AngioDynamics distributed the affected PICC catheters that were beyond their expiration date.
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
MAQUET QUADROX iD PEDIATRIC -OXYGENATOR: BEQ-HMOD 3000; Made In Germany The diffusion membrane oxygenator Quadrox iD pediatric is intended for use in an extracorporeal perfusion system. The oxygenator is designed for a blood flow rate of 0.2 -2.8 I/min and is intended for the treatment of pediatric patients. Within the specified flow rate range, the device oxygenates the blood, removes carbon dioxide and regulates the blood temperature.The utilization period for this device is restricted to six hours. Recall # Z-0689-2012
CODE
510(k) numbers: 1<100278 (Bioline coated) Device Listing No. 0098004 BEQ-HMOD 30000 70064002-28 units 70064004-140 units
RECALLING FIRM/MANUFACTURER
Maquet Cardiovascular Us Sales, LLC, Wayne, NJ, by letter dated September 22, 2011. Firm initiated recall is ongoing.
REASON
There are reports of leakage in the Leuer connector of the blood outflow connector of the Quadrox-iD pediatric oygenator.
VOLUME OF PRODUCT IN COMMERCE
168 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
GE LOGIQ E9 Diagnostic Ultrasound Systems running software versions R3.1.0 and R3.1.1. The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular and neurosurgical). Recall # Z-0705-2012
CODE
Serial Number 103674US8 105837US9 104914US7 104936US0 105527US6 104692US9 102751US5 104924US6 103932US0 100901US8 100461US3 104253US0 104257US1 105521US9 104943US6 104252US2 104941US0 98527US5 106276US9 106324US7 104669US7 104217US5 106966US5 105488US1 96282US9 106381US7 105373US5 100021US5 106341US1 105068US1 104909US7 104956US8 104933US7 106512US7 103928US8 106450US0 106380US9 105704US1 106571US3 106570US5 106574US7 105222US4 106378US3 100434US0 100443US1 102760US6 105827US0 105519US3 106379US1 103908US0 102853US9 103458US6 94284US7 102454US6 97788US4 105740US5 105128US3 103810US8 100304US5 103395US0 96382US7 95471US9 105744US7 99804US7 104366US0 106563US0 103820US7 105329US7 105350US3 105339US6 95985US8 95965US0 95961US9 105461US8 107078US8 107154US7 103741US5 104776US0 107075US4 107079US6 106180US3 105608US4 106958US2 106843US6 106954US1 106977US2 105469US1 106846US9 107026US7 107110US9 107137US2 102952US9 96866US9 99107US5 99104US2 96812US3 106946US7 106472US4 105278US6 107044US0 107086US1 106829US5 107061US4 107035US8 107152US1 107196US8 107030US9 107096US0 107133US1 96791US9 107124US0 107010US1 106908US7 104889US1 107192US7 107117US4 100084US3 106405US4 94348US0 103772US0 106730US5 96232US4 96173US0 102281US3 105948US4 105940US1 104938US6 102276US3 106771US9 99287US5 103768US8 100297US1 97785US0 106302US3 105691US0 106294US2 104086US4 106776US8 104797US6 105362US8 106535US8 104198US7 104877US6 105721US5 105850US2 104278US7 104616US8 104831US3 106839US4 104875US0 105760US3 105122US6 106853US5 106851US9 104817US2 97344US6 98846US9 94943US8 98739US6 103697US9 105124US2 106815US4 105736US3 105931US0 106810US5 106629US9 105670US4 103028US7 94125US2 105076US4 102183US1 99937US5 98975US6 102918US0 103923US9 105231US5 105223US2 104828US9 106484US9 105150US7 106090US4 106956US6 106168US8 106803US0 100984US4 105617US5 95409US9 103086US5 105123US4 106035US9 106715US6 106757US8 100362US3 100369US8 102728US3 103895US9 105415US4 97263US8 106568US9 102591US5 106824US6 96607US7 106669US5 106818US8 95665US6 105393US3 105490US7 97209US1 100946US3 105282US8 104307US4 106667US9 105680US3 105976US5 105116US8 105141US6 105576US3 105565US6 104282US9 105573US0 105432US9 106799US0 105382US6 106627US3 101665US8 106666US1 103093US1 105385US9 100452US2 103662US3 99060US6 103792US8 105616US7 95197US0 95131US9 104426US2 104203US5 103971US8 105860US1 106982US2 106968US1 103668US0 103637US5 103642US5 106234US8 105614US2 100897US8 107004US4 105719US9 105672US0 106980US6 99159US6 101537US9 101530US4 105874US2 105902US1 105623US3 105889US0 104091US4 103633US4 100490US2 104354US6 105893US2 99284US2 106494US8 105682US9 99663US7 104564US0 102013US0 99007US7 97914US6 106903US8 107051US5 105601US9 99080US4 103854US6 107206US5 104854US5 104486US6 105730US6 103146US7 103875US1 101171US7 97917US9 103935US3 105830US4 105795US9 95729US0 99062US2 100829US1 98804US8 99641US3 104285US2 106872US5 106893US1 102799US4 101909US0 104858US6 104876US8 103016US2 105143US2 97740US5 96113US6 95696US1 103825US6 102125US2 103230US9 100836US6 103259US8 103252US3 104027US8 103247US3 102718US4 103142US6 104638US2 104762US0 103909US8 105592US0 105556US5 104713US3 104712US5 104191US2 102218US5 106489US8 106509US3 103821US5 106479US9 106990US5 107202US4 105118US4 103437US0 105066US5 97779US3 107153US9 103663US1 106481US5 101542US9 105534US2 98089US6 106671US1 106772US7 102707US7 105655US5 106960US8 106959US0 106421US1 104085US6 106634US9 106636US4 106637US2 106857US6 106699US2 106847US7 106700US8 106845US1 106712US3 106858US4 107073US9 94783US8 106227US2 106835US2 106782US6 106773US5 106882US4 106350US2 106351US0 106096US1 106953US3 101305US1 100925US7 99993US8 107000US2 107034US1 107002US8 107007US7 105553US2 107006US9 107015US0 107021US8 107020US0 106888US1 98980US6 102415US7 103801US7 98709US9 104552US5 106686US9 102927US1 103831US4 104661US4 95507US0 100466US2 97243US0 105681US1 107005US1 106364US3 106354US4 106462US5 106340US3 104107US8 103109US5 101408US3 101410US9 99175US2 100958US8 105495US6 96963US4 105661US3 106569US7 106445US0 104765US3 104766US1 104691US1 105751US2 106848US5 103191US3 98449US2 105675US3 102978US4 98814US7 97329US7 98516US8 106382US5 105866US8 105676US1 105852US8 106399US9 106392US4 105854US4 97720US7 97722US3 105737US1 106511US9 106844US4 105858US5 104458US5 104456US9 104451US0 106501US0 107062US2 106646US3 107163US8 107071US3 106766US9 107159US6 107170US3 107105US9 107103US4 103856US1 106989US7 106995US4 107143US0 106961US6 106969US9 106658US8 99561US3 107055US6 106614US1 106623US2 106935US0 106861US8 106880US8 104326US4 104622US6 104518US6 104502US0 100888US7 105658US9 106203US3 104799US2 104880US0 103944US5 106920US2 106926US9 106933US5 106900US4 106918US6 106929US3 101454US7 106923US6 102057US7 104927US9 106558US0 106157US1 99206US5 99208US1 105938US5 105896US5 105839US5 104586US3 101928US0 106019US3 105752US0 105805US6 100932US3 101026US3 102197US1 105294US3 104019US5 105500US3 105496US4 105514US4 96050US0 104076US5 106204US1 98952US5 98478US1 102447US0 102419US9 105975US7 105862US7 105980US7 105952US6 105692US8 105937US7 105817US1 105782US7 105811US4 105820US5 105792US6 105939US3 105930US2 104025US2 101929US8 103988US2 106029US2 106545US7 106179US5 105784US3 105808US0 105798US3 105814US8 105801US5 105602US7 105605US0 105599US5 93694US8 93697US1 104214US2 105569US8 105869US2 105707US4 105711US6 104213US4 104866US9 106914US5 106306US4 106564US8 104689US5 102529US5 103979US1 106652US1 106645US5 104808US1 106552US3 104834US7 102037US9 105733US0 102461US1 104919US6 104920US4 104911US3 105129US1 104978US2 104890US9 104929US5 104917US0 105659US7 99309US7 105526US8 104688US7 105112US7 104497US3 105923US7 105911US2 106553US1 104505US3 106377US5 106677US8 106673US7 105261US2 104979US0 106554US9 105105US1 106741US2 106746US1 105579US7 104678US8 105643US1 105879US1 106383US3 103681US3 104925US3 104908US9 104975US8 106655US4 105422US0 106608US3 105701US7 106122US5 104980US8 102460US3 106451US8 106292US6 104028US6 105987US2 106151US4 106154US8 106690US1 106477US3 106463US3 106460US9 106474US0 106469US0 106468US2 106457US5 106466US6 106455US9 105584US7 105686US0 105325US5 106701US6 106704US0 106135US7 106448US4 96796US8 96723US2 106644US8 105957US5 105804US9 106118US3 106146US4 106141US5 106109US2 105158US0 105954US2 106243US9 105265US3 106365US0 104942US8 106372US6 106370US0 104954US3 106246US2 104823US0 99381US6 99380US8 95340US6 95338US0 95343US0 105789US2 103238US2 106160US5 102458US7 106510US1 99487US1 106796US6 99621US5 98695US0 102022US1 105632US4 105660US5 106447US6 106152US2 106156US3 106898US0 106892US3 105436US0 101887US8 106042US5 100136US1 100139US5 104215US9 104874US3 104928US7 104156US5 104865US1 105108US5 105645US6 106347US8 106073US0 106081US3 106140US7 105109US3 105103US6 105125US9 106488US0 106601US8 104477US5 104607US7 105160US6 106312US2 105183US8 105136US6 106974US9 104030US2 106208US2 106193US6 106075US5 106213US2 106209US0 106590US3 106588US7 104910US5 106507US7 104913US9 102426US4 104873US5 105304US0 105567US2 106155US5 104912US1 104867US7 105286US9 106565US5 106585US3 106162US1 106161US3 107001US0 102501US4 104885US9 104926US1 106374US2 102506US3 101393US7 106215US7 106219US9 104020US3 105280US2 105316US4 105634US0 105709US0 106651US3 106631US5 105291US9 106201US7 106060US7 105115US0 106181US1 105741US3 105753US8 106593US7 102505US5 105107US7 105003US8 105001US2 106176US1 106139US9 95304US2 95905US6 106304US9 104221US7 102117US9 102383US7 102090US8 104218US3 104029US4 106153US0 106163US9 99630US6 105964US1 105219US0 104633US3 104962US6 105145US7 106045US8 94579US0 94580US8 106779US2 101880US3 102526US1 103392US7 104666US3 104181US3 106299US1 104907US1 105005US3 106527US5 106842US8 100988US5 105582US1 106326US2 104684US6 104682US0 102391US0 103946US0 106513US5 105450US1 105218US2 104959US2 104887US5 105625US8 105004US6 104918US8 104921US2 105857US7 99351US9 104811US5 104861US0 106376US7 102364US7 104538US4 103203US6 102457US9 106483US1 106482US3 107072US1 105300US8 104888US3 103631US8 104598US8 104805US7 101381US2 105668US8 104273US8 106938US4 103587US2 104558US2 104862US8 104510US3 106859US2 106790US9 96396US7 96559US0 96565US7 104977US4 104026US0 104998US0 105945US0 105000US4 100636US0 105283US6 106692US7 106171US2 106125US8 106108US4 104018US7 104868US5 102311US8 104711US7 104976US6 104903US0 106534US1 106082US1 106277US7 106720US6 106777US6 106647US1 106616US6 106600US0 106732US1 106769US3 106597US8 106520US0 106642US2 106638US0 106530US9 106595US2 106602US6 106598US6 106538US2 106544US0 106780US0 104999US8 104660US6 105377US6 104690US3 102673US1 106710US7 104966US7 102049US4 102102US1 102528US7 102358US9 104667US1 105114US3 104021US1 105633US2 105665US4 106128US2 106210US8 103945US2 104778US6 104881US8 104968US3 105268US7 106279US3 106127US4 106435US1 106426US0 106278US5 106438US5 102041US1 103752US2
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, LLC, Waukesha, WI, by letter dated December 20, 2011.  
Manufacturer: GE Medical Systems Information Tecnology, Wauwatosa, WI. Firm initiated recall is ongoing.  
REASON
GE Healthcare has recently become aware of a potential safety issue associated with the data of your LOGIQ E9 system that may impact patient safety. 1 User may notice an image from a different patient, or an image from the current patient with title information from a different patient. 2 Incorrect measurements/calculations on images, when viewed on the off-line review station. As a result imaging may need to be repeated due to the confusion in the image information.
VOLUME OF PRODUCT IN COMMERCE
894 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Outer Carton labeled in part: "1-DAY ACUVUE MOIST BRAND CONTACT LENSES WITH LACREON FOR ASTIGMATISM***Contact Lenses for Daily Wear***D -1.50***-1.25 100***2016/07***BC 8.5***DIA 14.5***Made in USA***" Individual Lenses labeled in part: "***1-DAY ACUVUE MOIST FOR ASTIGMATISM WITH LACREON***BC 8.5***DIA 14.5***AXIS -1.75 -0.75***080***2016/06***" It is intended for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with not diseased eyes who may have 1.00D or less of astigmatism. Recall # Z-0734-2012
CODE
External carton Lot Number B00BVTN -1.50 -1.25cyl. 100 (30 primary packages per secondary carton Internal package Lot Number B00BSBH -1.75 -0.75cyl. 80 (30 primary packages per secondary carton)
RECALLING FIRM/MANUFACTURER
Johnson & Johnson Vision Care, Inc., Jacksonville, FL, by letter dated December 1, 2011. Firm initiated recall is ongoing.
REASON
Johnson & Johnson Vision Care, Inc. recalled their 1-DAY ACUVUE MOIST Brand Contact Lenses for ASTIGMATISM due to a lot being mixed. The secondary carton lot number and power are not the same as on the primary package inside the carton.
VOLUME OF PRODUCT IN COMMERCE
152 cartons
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) Varian brand 4D Integrated Treatment Console (4DITC) v10.2.3, Reference/FSCA Identifier: CP-06873, Model Number: H51. The 4D Integrated Treatment Console [4DITC] is designed to interface to the Varian Clinac Treatment Control System [TCS] for the purpose of providing verification of treatment parameters, imaging and providing a record of treatment. The general function of the 4D Integrated Treatment Console is to allow treatment plans and images to be retrieved from the Oncology Information System [OIS] and sent to the TCS, planned treatment plan parameters to be verified against the TCS delivery parameters for accuracy and treatment history to be recorded in the OIS for use and display. The Barcode Conical Collimator Verification [BCCV] device assists operators of radiation therapy devices by preventing irradiation until the conical collimator required by the treatment plan is in place. Recall # Z-0715-2012;
 
2) Varian brand Barcode Conical Collimator Verification (BCCV) v1.0, Reference/FSCA Identifier: CP-06873, Model Number: HB. The 4D Integrated Treatment Console [4DITC] is designed to interface to the Varian Clinac Treatment Control System [TCS] for the purpose of providing verification of treatment parameters, imaging and providing a record of treatment. The general function of the 4D Integrated Treatment Console is to allow treatment plans and images to be retrieved from the Oncology Information System [OIS] and sent to the TCS, planned treatment plan parameters to be verified against the TCS delivery parameters for accuracy and treatment history to be recorded in the OIS for use and display. The Barcode Conical Collimator Verification [BCCV] device assists operators of radiation therapy devices by preventing irradiation until the conical collimator required by the treatment plan is in place. Recall # Z-0716-2012
CODE
1) Units: HBC0001 H512022 H511551 H511275 HBC0004 H512993 H513292 H515900 HBC0007 H512781 H513115 H511691 HBC0018 H512241 H515092 H513533 HBC0021 H513561 H514438 H515524 HBC0024 H510889 H512278 H513927 HBC0028 H515461 H515076 H514202 HBC0048 H510126 H513080 H515780 HBC0069 H515541 H512967 H515068 HBC0070 H511840 H513262 H510732 HBC0075 H514160 H513701 H511593 HBC0079 H513117 H513551 H514018 HBC0083 H511663 H511565 H512454 HBC0090 H513989 H515570 H515064 HBC0097 H512618 H512464 H515737 HBC0106 H514439 H515943 H515696 HBC0111 H515691 H511821 H515523 HBC0115 H515998 H514402 H514521 HBC0174 H515387 H514403 H513548 HBC0210 H513769 H514080 HBC0211 H515262 H513002 HBC0348 H514488 H512998
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter dated December 12, 2011. Firm initiated recall is ongoing.
REASON
When multiple conical collimator treatment plans are scheduled to be treated in a session, the Plan Label should be displayed on the BCCV dialog box should match the Plan Label on the 4DITC. However, the name of the plan is not being updated correctly
VOLUME OF PRODUCT IN COMMERCE
64 units
DISTRIBUTION
Nationwide, Canada, Germany, Japan and Qatar
 
RECALLS AND FIELD CORRECTIONS: VETERINARY – CLASS II
___________________________________
PRODUCT
1) Bovine Eye Wash, Item #1030, Size 16 oz., Applicator: Trigger, 6 case, $35. UPC: 852009002086. Recall # V-021-2012;
 
2) Bovine Eye Wash, Item #1031, Size: 8 oz., Applicator: Trigger & Pump, 6 case, $28, UPC: 852009002055. Recall # V-022-2012;
 
3) Canine Eye Wash, Item #1033, Size 4 oz., Applicator: Drops, 6 case, $24, UPC: 852009002161. Recall # V-023-2012;
 
4) Feline Eye Wash, Item #1034, Size 4 oz., Applicator: Drops, 6 case, $24, UPC: 852009002178. Recall # V-024-2012;
 
5) Canine Ear Rinse, Item #1024, Size 4 oz., Applicator: Drops, 6 case, $24, UPC: 852009002321. Recall # V-025-2012;
 
6) Feline Ear Rinse, Item #1025, Size 4 oz., Applicator: Drops, 6 case, $24, UPC: 852009002338. Recall # V-026-2012
CODE
1) Lot # Expiration Date 070710-01 01/2012 082310-02 02/2012 083110-01 02/2012 012411-02 06/2012 032911-02 09/2012 062211-01 11/2012 081611-01 01/2013;
 
2) Lot # Expiration Date 101810-02 03/2012, 021611-02 08/2012;
 
3) Lot # Expiration Date 062410-02D 12/2011, 080910-01B 01/2012, 090210-02C 02/2012, 102510-02B 04/2012, 012511-02B 06/2012, 020811-01C 07/2012, 080811-02 01/2013;
 
4) Lot # Expiration Date 062410-02B 12/2011, 062910-05 12/2011, 090210-02D 02/2012, 111610-05 04/2012, 011111-04B 06/2012;
 
5) Lot # Expiration Date 062410-02C 12/2011, 070810-02 12/2011, 080910-01A 01/2012, 090210-02A 02/2012, 102510-02A 04/2012, 121610-02A 05/2012, 012511-02A 06/2012. 020811-01A 07/2012, 061611-02A 11/2012, 072011-03B 12/2012;
 
6) Lot # Expiration Date 062410-02A 12/2011, 071310-02 01/2012, 090210-02B 02/2012, 121610-02B 05/2012
RECALLING FIRM/MANUFACTURER
Innovacyn Inc., Rialto, CA, by letter on December 9, 2011.  Firm initiated recall is ongoing.
REASON
Innovacyn is voluntarily recalling certain Vetericyn eye and ear care products due to the product being mislabeled as "sterile." There is a concern that the term "sterile" misbrands the product.
VOLUME OF PRODUCT IN COMMERCE
49,697 units
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: VETERINARY – CLASS III
___________________________________
PRODUCT
1) Priority Care 1 Kaolin Pectin Suspension; an OTC oral anti-diarrheal liquid; Packaged in gallon containers, 4 gallons per case; Each fluid ounce (2 tablespoonfuls) contains Kaolin 90 gr. (5.8 g) and Pectin 4 gr. (0.268 g), in a palatable vehicle with flavorings and color added; for animal use only, Keep Out of Reach of Children; reorder number MS170PC, NDC #58829-233-01 The product was also sold under the following labels: a) Kao-Pec, UPC 3 57561 00176 3; b) Kaolin Pectin Suspension, UPC 0 99355 00165 7; c) KaoPectolin, reorder no. 002524, NDC 11695-2173-1; d) Cooper's Best Kaolin Pectin Suspension, 1 gallon - UPC 0 99355 00111 4, 1 quart - UPC 0 99355 00081 0; e) Kaolin Pectin Suspension, 1 gallon - UPC 7 26087 79219 4, 1 quart - UPC 7 26087 79205 7; f) Kao-Pect-Aid, IBA Stock No. 524253; g) Partnar Kaolin Pectin Suspension; h) Kaolin Pectin Suspension, NDC 50989-182-29, UPC 3 50989 18229 8; i) Kao-Pectin. Recall # V-019-2012;
 
2) Priority Care 1 Bismusol Suspension; an OTC oral anti-diarrheal liquid; Packaged in gallon containers, 4 gallons per case; Ingredients: Bismuth Subsalicylate 1.75% in a palatable vehicle with flavorings and color added; for animal use only, Keep Out of Reach of Children; reorder number MS120PC, NDC #58829-221-01 The product was also sold under the following labels: a) Bismusal Suspension, UPC 7 54629 39061 4; b) Bismusol Suspension, UPC 0 99355 00017 9; c) Gastro-Cote, reorder no. 002518, NDC 11695-2169-1; d) Durvet Bismusal Suspension, NDC 30798-931-35, UPC 7 45801 10019 0; e) Bismu-Kote, NDC 50989-501-29, UPC 3 50989 50129 7. Recall # V-020-2012
CODE
1) Lot: G29D;
2) Lot: G22D and G24D
RECALLING FIRM/MANUFACTURER
First Priority, Inc., Elgin, IL, by letters on November 22, 2011. Firm initiated recall is ongoing.
REASON
The products were manufactured with a lot of an excipient which tested above specification of Aerobic Plate Count and Yeast.
VOLUME OF PRODUCT IN COMMERCE
10,498 gallons
DISTRIBUTION
Nationwide
 
END OF ENFORCEMENT REPORT FOR JANUARY 18, 2012.
 
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