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U.S. Department of Health and Human Services

Safety

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Enforcement Report for July 13, 2011

 

 
July 13, 2011                                                                                        11-28
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
Publix brand Caesar Salad Dressing 16 oz plastic bottle. Recall # F-1506-2011
CODE
Expiration code 31MAR12 A
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ken's Foods. Inc., Marlborough, MA, by telephone on June 16, 2011 and by press release on June 17, 2011.
Manufacturer: Ken's Foods, Inc., McDonough, GA. Firm initiated recall is ongoing.
REASON
Product contains undeclared allergens: Fish, Soy, Gluten.
VOLUME OF PRODUCT IN COMMERCE
33,024 bottles
DISTRIBUTION
FL, GA, TN, AL, SC
___________________________________
PRODUCT
Chewable Multi Formula high in vitamins A, D, E & K (chocolate Mint Truffle); a)60 tablet bottles; b)180 tablet bottles; c) Individual sample packets. Recall # F-1507-2011
CODE
a) Lot number 411499D; b) lot number 411499B; c) lot number 411499
RECALLING FIRM/MANUFACTURER
Recalling Firm: Catalina Lifesciences Inc., Irvine, CA, by letter/e-mail beginning June 9, 2011.
Manufacturer: VitaTech International Inc AKA Vita Tech, Tustin, CA. Firm initiated recall is ongoing.
REASON
Product contains undeclared milk allergen.
VOLUME OF PRODUCT IN COMMERCE
4751 bottles and 19,260 individual sample packs
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
___________________________________
PRODUCT
1) Kashi, Mediterranean Thin Crust Pizza, 12.7 oz, a) UPC 1862732902 2 at Customer Warehouse 8 count corrugated case. At consumer selling unit retail carton has b) UPC 1862732905 3. Recall # F-1492-2011;
 
2) Kashi, Roasted Vegetable Thin Crust Pizza, 12.7 oz, a) UPC 1862737340 7 at Customer Warehouse, 8 count corrugated case. At consumer selling unit retail carton has b) UPC 1862737342 1. Recall # F-1493-2011;
 
3) Kashi, Mushroom Trio and Spinach Thin Crust Pizza, 12.7 oz, a) UPC 1862737343 8 at Customer Warehouse, 8 count corrugated case. At consumer selling unit retail carton has b) UPC 1862737344 5. Recall # F-1494-2011
CODE
1) a) Better if Used Before Date on case: May 10 2012NU, May 18 2012NU, May 19 2012NU; b) Better if Used Before Date on carton May10 12 NU, May18 12 NU, May19 12 NU;
 
2) a) Better if Used Before Date on case: May 09 2012NU, May 14 2012NU; b) Better if Used Before Date on carton: May 09 12 NU, May14 12 NU;
 
3) a) Better if Used Before Date on case: May 17 2012NU; b) Better if Used Before Date on carton: May17 12NU
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kellogg Co., Battle Creek, MI, by email, telephone, an urgent recall alert on June 2, 2011 and by press release on June 6, 2011.
Manufacturer: Little Lady Foods Inc., Elk Grove Village, IL. Firm initiated recall is ongoing.
REASON
Products may contain a foreign material.
VOLUME OF PRODUCT IN COMMERCE
11,203 cases of 8 pizzas each case
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Delphi Greek Pepperoncini, 1 gallon container Peppers, Water, Salt, Vinegar. Recall # F-1508-2011
CODE
Lot # 2401
RECALLING FIRM/MANUFACTURER
Constantine Poulos and Co., Williston, VT, by email and fax between June 19/20, 2011. FDA initiated recall is ongoing.
REASON
Product label fails to declare Sulfites and Yellow #5.
VOLUME OF PRODUCT IN COMMERCE
816 cases
DISTRIBUTION
OH, TX
___________________________________
PRODUCT
1) Creme Curls (6 oz) - packaged in white colored foam tray and wrapped with clear plastic film. Sticker label with brand name "BOTTEMA BAKERY" is applied on front of package. Recall # F-1510-2011;
 
2) Creme Horns (6 oz) - packaged in white colored foam tray and wrapped with clear plastic film. Sticker label with brand name "NATURALLY YOURS" is applied on front of package. Recall # F-1511-2011
CODE
1) and 2) Best by dates from 35-45 days from May 1-June 22, 2011.
RECALLING FIRM/MANUFACTURER
Bottema Bakery, Inc., Grand Rapids, MI, by letter on June 27, 2011. Firm initiated recall is ongoing.
REASON
Product contains undeclared colors - FD&C Yellow # 6 and FD&C Red # 40.
VOLUME OF PRODUCT IN COMMERCE
5,288
DISTRIBUTION
IN, MI
___________________________________
PRODUCT
Pan Mexicano is a variety (randomly selected from the non-filled pastries) of Mexican pastry products and sold under brand name Chavita's Food. It is packaged into clear plastic bags, 6 counts to a bag. The retail plastic bag has an orange adhesive stick-on label to declare expiration date. The UPC is 7 10638 40196 3. The products are also produced and bagged in bulk as needed for delivery or for retail customers. The 6 ct. bag is labeled in part: "Pan mexicano Chavita's Foods***6 Count*** Ingredients: Enriched Unbleached Wheat Flour, (Niacin, Iron, Thiamine Mononitrate, Riboflavin), Water, Non Fat Powdered Milk, Vegetable Shortening Containing One or More of the Following: Cottonseed Oil, Soybean Oil, or Palm Oil, Sugar, Eggs, Yeast, May Contain Baking Powder in Place of Yeast, Artificial Color (F D & C Red #40, F D & C Yellow #6), May Contain Coconut Flakes, or artificial Flavor". Recall # F-1512-2011
CODE
Codes: 6 06; 6 07; 6 10; and 6 13. These code dates signify the Expiration Dates for the products.
RECALLING FIRM/MANUFACTURER
Chavita's Foods, Woodburn, OR, by telephone, visit and letter beginning June 8, 2011. FDA initiated recall is ongoing.
REASON
Product contains undeclared colors - FD&C Yellow # 5 and FD&C Red # 3.
VOLUME OF PRODUCT IN COMMERCE
78/6 ct. bags and undetermined bulk amount
DISTRIBUTION
OR
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III
___________________________________
PRODUCT
Country Life brand Liquid VITAMIN D3 5,000 I.U., Dietary Supplement, Delicious Cherry Flavor, of 16 fl. oz and 1 fl. oz samples packed in 12 units, packaged in plastic bottles; a) Product No. 5809: 16 fl oz. (473.1 mL), UPC 0 15794 05809 0, and b) Product No. 95809: 1 fl. oz. (29.5 mL), UPC 0 15794 95809 3. Recall # F-1509-2011
CODE
a) Lots K5199, K5198, J5130, J5131, J4713, J4714, J4715, I4622, I4623, I4585, I4584, I4541, I4504, I4319; b) Lot I4507
RECALLING FIRM/MANUFACTURER
Recalling Firm: Country Life Dba Consac Ind., Hauppauge, NY, by letter dated April 27, 2011.
Manufacturer: Nutritional Engineering Inc., Vista, CA. Firm initiated recall is ongoing.
REASON
The dietary supplement contains undeclared FD&C Red 40 color from a sub-ingredient.
VOLUME OF PRODUCT IN COMMERCE
Product Code 5809: 73,641 bottles; Product Code 95809: 994 bottles
DISTRIBUTION
Nationwide, Puerto Rico, Bermuda, St. Maarten, Cayman Islands, and Jamaica
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
1) Hydralazine HCl Tablets, USP 10 mg; packaged in cartons of 10 blister cards containing 10 tablets each (100 tablets), Rx only, NDC 51079-074-20. Recall # D-616-2011;
 
2) Hydralazine HCl Tablets, USP 50 mg; packaged in cartons of 10 blister cards containing 10 tablets each (100 tablets), Rx only, NDC 51079-076-20. Recall # D-617-2011
CODE
1) Lot 0P643, expiration date 01/12; lot 9V346, expiration date 06/11; lot 0J293, expiration date 12/11;
 
2) Lot 0S788, expiration date 05/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: UDL Laboratories, Inc., Rockford, IL, by letter on March 7, 2011, April 8, 2011 and on April 28, 2011.
Manufacturer: Pliva Krakow S.A., Krakow, Poland. Firm initiated recall is ongoing.
REASON
Tablet Thickness: Some tablets may not conform to weight requirements/specifications.
VOLUME OF PRODUCT IN COMMERCE
12,734 unit dose cartons
DISTRIBUTION
Nationwide, and Guam
___________________________________
PRODUCT
1) RE-PB Hyos Elixir, a) 5 mL Oral Syringe containing (Phenobarbital 16.2 mg, Hyoscyamine SO4 0.1037 mg, Atropine SO4 0.0194 mg, Scopolamine HBr 0.0065 mg), Alcohol not more than 23.8%, barcode 6803239505; b) 10 mL Oral Syringe containing (Phenobarbital 32.4 mg, Hyoscyamine SO4 0.2074 mg, Atropine SO4 0.0388 mg, Scopolamine HBr 0.013 mg), Alcohol not more than 23.8%; River's Edge; Rx only. Recall # D-618-2011;
 
2) Donnatal Elixir, a) 5 mL Oral Syringe containing (Phenobarbital 16.2 mg, Hyoscyamine SO4 0.1037 mg, Atropine SO4 0.0194 mg, and Scopolamine HB4 0.0065 mg), Alcohol not more than 24.3%, Grape, PBM, barcode 6621342305; b) 10ml Oral Syringe containing (Phenobarbital 32.4 mg, Hyoscyamine SO4 0.2074 mg, Atropine SO4 0.0388 mg, and Scopolamine HBr 0.0013 mg), Alcohol not more than 23.8%, Grape, PBM, barcode 6621342310, Rx only. Recall # D-619-2011;
 
3) Levetiracetam Oral Solution, a) 5 mL Oral Syringe containing levetiractem 500 mg (100 mg/mL), barcode 0781614105, Sandoz; b) 10 mL Oral Syringe delivers 7.5 mL containing levetiracetam 750 mg , barcode 0054022475, Roxane; c) 20 mL Oral Syringe delivers 15 mL containing levetiracetam 1500 mg (1.5 grams), barcode 0054022415; Roxane; Rx only. Recall # D-620-2011;
 
4) Methadone HCl Oral Solution, a) 3 mL Oral Syringe delivers 1 mL containing methadone HCl 2 mg, barcode 0054355601; b) 10 mL Oral Syringe containing methadone HCl 20 mg, barcode 0054355610; Roxane; Rx only. Recall # D-621-2011;
 
5) Keppra (levetiracetam) Oral Solution, a) 1 mL Oral Syringe containing levetiracetam 100 mg, barcode 5047400101; b) 5 mL Oral Syringe containing levetiracetam 500 mg, barcode 5047400105; UCB; Rx only. Recall # D-622-2011;
 
6) Methadone HCl Oral Solution, 5 mL Oral Syringe containing methadone HCl 5 mg, Alcohol 8%, barcode 0054355505; Roxane; Rx only. Recall # D-623-2011
CODE
1) a) Lot 304551, Exp 03/05/11; b) Lot 306566, Exp 03/19/11; 310627, Exp 04/13/11; 316690, Exp 05/21/11;
 
2) a) Lot 316582, Exp 05/18/11; 316198, 05/14/11; b) 312411, Exp 04/23/11; 313461, Exp 04/30/11; 318378, 318380, Exp 05/28/11; 318731, 318732, Exp 06/01/11;
 
3) a) 306772, 310806, Exp 03/18/11; 310874, Exp 04/16/11; 311862, Exp 04/21/11; 314150, Exp 05/04/11; b) Lot 311863, 311859, Exp 04/21/11; 314151, Exp 05/04/11; 317839, 317841, Exp 05/26/11; c) 311864, 311865, Exp 04/21/11; 315177, Exp 05/11/11; 315380, 315379, Exp 05/12/11; 317840, 05/26/11;
 
4) a) Lot 308264, Exp 04/01/11; b) Lot 308263, Exp 04/01/11;
 
5) a) Lot # 312322, Exp 04/23/11; b) Lot # 316942, Exp 05/21/11; 319218, Exp 06/04/11;
 
6) Lot # 318365, Exp Exp 06/03/11
RECALLING FIRM/MANUFACTURER
Safecor Health, LLC, Woburn MA, by letter on March 2, 2011. Firm initiated recall is ongoing.
REASON
Container Leakage: Drug product may not contain the labeled volume/dose due to evaporation or leakage.
VOLUME OF PRODUCT IN COMMERCE
6,646 syringes
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Sinalar Decongestant and Nostrils Lubricant, Dropper with 0.50 oz., UPC 619114001006. Recall # D-624-2011;
 
2) Sinalar Inflammation and Infection of Ear, Dropper with 0.5 fl. oz., UPC 619114010036. Recall # D-625-2011;
 
3) Sinalar Inflammation and Eye Infection, Dropper with 0.5 fl. oz., UPC 619114010029.  Recall # D-626-2011
CODE
1) Lot #SINNA 1209;
2) Lot #SINOT02-11;
3) Lot #SINOF02-11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Multimex, Tucker, GA, by press release on May 9, 2011 and by letter on May 11, 2011.
Manufacturer: Goper's International LLC, San Diego, CA;
Multimex, Tucker, GA. Firm initiated recall is ongoing.
REASON
The products are misbranded and unapproved new drugs.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
TRIAD Plus, Three Benzalkonium Chloride Swabsticks, NDC 50730-5150-8, Active Ingredient, Benzalkonium Chloride, Three BZK Swabsticks, 0.13%. Recall # D-627-2011 
CODE
Unit: 1A21
RECALLING FIRM/MANUFACTURER
H & P Industries, Inc., Hartland, WI, by letter dated June 21, 2011. FDA initiated recall is ongoing.
REASON
Microbial contamination of non-sterile products.
VOLUME OF PRODUCT IN COMMERCE
396 cases (500/case)
DISTRIBUTION
Ireland
___________________________________
PRODUCT
Retavase (Reteplase) recombinant kit, containing 2 x 10 Unit vials (10.4 Unit/18.1 mg) sterile lyophilized Retavase powder for reconstitution, 2 x 10 mL vials Sterile Water for Injection, USP, 2 x 10 mL sterile syringes, 2 sterile dispensing pins, 4 sterile injection needles, 2 alcohol swabs, Rx only, a) NDC 67286-0040-01; b) NDC 24477-041-02. Recall # D-628-2011
CODE
a) Lot # 522203F-04, 522203F-05, 522253F-07, Exp 04/11; b) Lot #522253F-09, Exp 04/11
RECALLING FIRM/MANUFACTURER
EKR Therapeutics, Inc., Bedminster, NJ, by letters on January 28, 2011. Firm initiated recall is ongoing.
REASON
Lack of Assurance of Sterility: Retavase full kits are being recalled since it contains Triad sterile alcohol pads which were recalled under the Triad Group recall.
VOLUME OF PRODUCT IN COMMERCE
10,247 kits
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Lansoprazole Delayed-Release Capsules USP, 30 mg, 30-count capsules, Rx Only, NDC 0093-7351-56. Recall # D-629-2011
CODE
Lot #'s: 44L031, 44L032, Exp 01/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on May 31, 2011.
Manufacturer: Teva Pharmaceutical Industries, Jerusalem, Israel. Firm initiated recall is ongoing.
REASON
Discoloration: Some capsules may not meet the appearance specifications; Pellet color varies from white to pink (pellet color spec is off-white to beige).
VOLUME OF PRODUCT IN COMMERCE
155,636 bottles
DISTRIBUTION
Nationwide and PR
___________________________________
PRODUCT
1) Aripiprazole 10 mg per half-tab (1/2 Abilify 20 mg tab) per blister, Rx only, -Otsuka-, barcode 5914801050. Recall # D-630-2011;
 
2) Allopurinol 50 mg per half-tab (1/2 Allopurinol 100 mg tab) per blister, Rx only, -Qualitest-, Pkg By: Safecor Health, Woburn, MA 01801, barcode 0603211550. Recall # D-631-2011;
 
3) Amiodarone HCL 100 mg per half-tab (1/2 Amiodarone HCl 200 mg tab) per blister, Rx only, -Taro-, NDC 51672402562. Recall # D-632-2011; 
 
4) Donepezil HCL 5 mg half-tablet (1/2 Aricept 10 mg tablet) per blister, Rx only, -Esai-, barcode 6285624650. Recall # D-633-2011;
 
5) Aripiprazole 5 mg per half-tab (1/2 Abilify 10 mg tablet) per blister, Rx only, -Otsuka-, barcode 5914800850. Recall # D-634-2011;
 
6) Aspirin For Children 40.5 mg per half-tab, chewable, (1/2 Children's Aspirin 81 mg tablet) per blister, -Rugby-, barcode 0536329750. Recall # D-635-2011;
 
7) Aspirin For Children 20.25 mg per quarter-tab (1/4 aspirin 81 mg) per blister, chewable, -Rugby-, barcode 0536329725. Recall # D-636-2011;
 
8) Candesartan Cilexetil 2 mg per half-tab (1/2 Atacand 4 mg tablet) per blister, Rx only, -A/Zeneca-, NDC 00186000462. Recall # D-637-2011;
 
9) Atenolol 12.5 mg per half-tablet (1/2 Atenolol 25 mg tablet) per blister, Rx only, a) -Cadila-, barcode 6838202250; b) -Ranbaxy-, (Tenormin Equivalent), barcode 0000-0002-60; c) -Sandoz-, NDC 00781107862. Recall # D-638-2011;
 
10) Baclofen 5 mg per half-tab (1/2 Baclofen 10 mg tablet) per blister, Rx only, a) -Qualitest-, barcode 0603240650; b) -Northstar-, barcode 1671407150; c) -Up/Smith-, (Lioresal Equivalent), barcode 0000-0009-86; d) -Teva-, barcode 00000001048; Recall # D-639-2011;
 
11) DiphenhydraAMINE HCL 6.25 mg per half-tab (1/2 Benadryl 12.5 mg dissolving tablet) per blister, -McNeil-, Grape, barcode 5058034850. Recall # D-640-2011;
 
12) Bisoprolol Fumarate 2.5 mg per half-tab (1/2 Bisoprolol Fumarate 5 mg tablet) per blister, Rx only, -Sandoz-, NDC 00185077162. Recall # D-641-2011;
 
13) BusPIRone HCL 2.5 mg per half-tab (1/2 Buspirone HCl 5 mg tablet) per blister, (Buspar Equivalent), Rx only, a) -Watson-, barcode 0000-0003-95; b) -Teva-, barcode 0000-0003-95. D-642-2011;
 
14) Captopril 6.25 mg per half-tab (1/2 Captopril 12.5 mg tablet) per blister, Rx only, a) -Wockhardt-, barcode 6467990250; b) -Westward-, barcode 0143117150; c) -Mylan-, barcode 00378300750. Recall # D-643-2011;
 
15) Carbidopa 12.5 mg & Levodopa 50 mg per half-tablet (1/2 Carbidopa/Levodopa 25/100 mg tablet) per blister, Rx only, a) -Sun-, (anhydrous equivalent), barcode 6275651850; b) -Activis-, (Sinemet Equivalent), barcode 0000-0003-20. Recall # D-644-2011;
 
16) Warfarin Sodium 0.5 mg per half-tab (1/2 Coumadin 1 mg tablet) per blister, Rx only, -B/M/S-, a) barcode 0056016950; b) barcode 000056016770; (Coumadin). D-645-2011;
 
17) Misoprostol 50 mcg per half-tab (Cytotec) (1/2 Cytotec 100 mcg tablet) per blister, Rx only, -Pfizer-; barcode 00047102934. Recall # D-646-2011;
 
18) Digoxin 62.5 mcg per half-tab (1/2 Digoxin .125 mg tablet) per blister, (Lanoxin Equivalent), Rx only, -Westward-, barcode 0000000788. Recall # D-647-2011;
 
19) Phenytoin 25 mg per half-tab (1/2 Dilantin Infatab 50 mg tablet) per blister, chewable, Rx only, -P/D-, barcode 0071000750. Recall # D-648-2011;
 
20) Valsartan 80 mg (1/2 Diovan 160 mg tablet) per blister, Rx only, -Novartis, barcode 0078035950. Recall # D-649-2011;
 
21) Fludrocortisone Acetate 0.05 mg per half-tab (1/2 Fludrocortisone Acetate 0.1 mg tablet) per blister, Rx only, -Barr-, barcode 0555099750. Recall # D-650-2011;
 
22) Glimepiride 0.5 mg per half-tab (1/2 Glimepiride 1 mg tablet) per blister, Rx only, (Amaryl Equivalent), -Reddy-; barcode 0000-0004-02. Recall # D-651-2011;
 
23) glipiZIDE 2.5 mg per half-tab (1/2 Glipizide 5 mg tablet) per blister, Rx only, a) -Sandoz-, barcode 0781145250; b) -Watson-, (Glucotrol Equivalent), barcode 0000000403. Recall # D-652-2011;
 
24) hydrALAZINE HCL 12.5 mg per half-tablet (1/2 Hydralazine HCl 25 mg tablet) per blister, Rx only, -Barr-; NDC 50111032762. Recall # D-653-2011;
 
25) Hydrochlorothiazide 6.25 mg per half-tablet (1/2 Hydrochlorothiazide 12.5 mg tablet) per blister, Rx only, -Actavis-; barcode 0228282050. Recall # D-654-2011;
 
26) Isosorbide Mononitrate 15 mg per half-tab Extended Release (1/2 Isosorbide Mononitrate ER 30 mg tablet) per blister, Rx only, -K/U-, barcode 6217512850. Recall # D-655-2011;
 
27) Warfarin Sodium (Crystalline Warfarin Sodium Isopropanol Clathrate) 0.5 mg per half-tab (1/2 Jantoven 1 mg tablet) per blister, Rx only, -Up/Smith-; barcode 000832121000. Recall # D-656-2011;
 
28) Labetalol 50 mg per half-tab (1/2 Labetalol 100 mg tablet) per blister, Rx only, (Trandate Equivalent), -Sandoz-; barcode 0000000405. Recall # D-657-2011;
 
29) Levothyroxine Sodium 12.5 mcg per half-tab (1/2 Levothyroxine Sodium 25 mcg tablet) per blister, Rx only, a) -Sandoz-, (0.0125 mg per half-tab), barcode 0781518050; b) -Mylan-, (0.0125 mg), barcode 0378180050. Recall # D-658-2011;
 
30) Escitalopram Oxalate Equivalent to Escitalopram 5 mg per half-tab (1/2 Lexapro 10 mg tablet) per blister, Rx only, -Forest-, barcode 0456201050. Recall # D-659-2011;
 
31) Atorvastatin 5 mg per half-tablet (1/2 Lipitor 10 mg tablet) per blister, Rx only, -P/PD-; NDC: 00071015562. Recall # D-660-2011;
 
32) Loratadine 5 mg per half-tab (1/2 Loratadine 10 mg tablet) per blister, a) -Perrigo-, (Claritin Equivalent), barcode 0000000406; b) -UDL-, NDC: 51079053862. Recall # D-661-2011;
 
33) Mercaptopurine 25 mg per half-tab (1/2 Mercaptopurine 50 mg tablet) per blister, Rx only, -Roxane-, barcode 0054458150. Recall # D-662-2011;
 
34) metFORMIN HCL 250 mg per half-tab (1/2 Metformin HCl 500 mg tablet) per blister, Rx only, a) -Mutual-, NDC 53489046762; b) -Caraco-, barcode 5766439750; c) -Cadila-, (Glucophage Equivalent), barcode 0000-0004-08. Recall # D-663-2011;
 
35) Methocarbamol 250 mg per half-tab (1/2 Methocarbamol 500 mg tablet) per blister, Rx only, -Westward-; barcode 0143129050. Recall # D-664-2011;
 
36) a) Metoprolol Succinate ER 12.5 mg per half-tab (1/2 Metoprolol Succinate ER 25 mg tablet) per blister (Toprol-XR Equivalent), -Par-, barcode 0000-0004-07; b) Metoprolol XL (succinate) 12.5 mg per half-tab (1/2 Metoprolol Succinate ER 25 mg tablet) per blister, -Par-, barcode 1010108001. Recall # D-665-2011;
 
37) Metoprolol Tartrate 12.5 mg per half-tab (1/2 Metoprolol Tartrate 25 mg tablet) per blister, Rx only, a) -Caraco-, barcode 5766450650; b) -Caraco-, barcode 57664050662; c) -Ranbaxy-, barcode 6330457950; d) -Aurobindo-, barcode 6586206250; e) -Mylan-, barcode 3101010170120512; f) -Mylan-, barcode 0378001850; g) -Mylan-, barcode 0378-0018-50; h) -Greenstone-, barcode 5976213050. Recall # D-666-2011;
 
38) Mirtazapine 7.5 mg per half-tablet (1/2 Mirtazapine 15 mg tablet) per blister, Rx only, a) -Teva-, NDC 00093720662; b) -Watson-, barcode 0591111750; c) -Aurobindo-, (Remeron Equivalent), barcode 0000-0003-92. Recall # D-667-2011;
 
39) Misoprostol 25 mcg per quarter-tab (1/4 Misoprostol 100 mcg tablet) per blister, Rx only, a) -Ivax-, barcode 0172443025; b) -Teva-, barcode 0172443025 and 0172203801; c) -Greenstone-, barcode 5976250025; d) -Teva-, barcode 0172443025; e) -Ivax-, barcode 0172443025; f) -Pfizer-, (Cytotec), barcode 00047102942. Recall # D-668-2011;
 
40) Nabumetone 250 mg per half-tab (1/2 Nabumetone 500 mg tablet) per blister, Rx only, -Sandoz-, (Relafen Equivalent); barcode 0000000409. Recall # D-669-2011;
 
41) Oxybutynin 2.5 mg per half-tab (1/2 Oxybutynin Chloride 5 mg tablet) per blister, Rx only, -Qualitest-; barcode 0000000259.  Recall # D-670-2011;
 
42) Propafenone HCL 75 mg per half-tab (1/2 Propafenone HCl 150 mg tablet) per blister, Rx only, -Barr-; barcode 5011170850. Recall # D-671-2011;
 
43) Pyrazinamide 250 mg per half-tab (1/2 Pyrazinamide 500 mg tablet) per blister, Rx only, a) -Versapharm-, barcode 61748001250; b) -Dava-, NDC 67253066062. Recall # D-672-2011;
 
44) QUEtiapine FUMARATE 12.5 mg per half-tab (1/2 SEROquel 25 mg tablet) per blister, Rx only, -A/Zeneca-; barcode 0310027550.  Recall # D-673-2011;
 
45) Metaxalone 400 mg per half-tab (1/2 Skelaxin 800 mg tablet) per blister, Rx only, -King-; barcode 6079313650. Recall # D-674-2011;
 
46) Sotalol HCL 40 mg per half-tab (1/2 Sotalol HCl 80 mg tablet) per blister, Rx only, a) -Teva-, NDC 00093106162; b) -Mylan-, barcode 0378030550; c) -Sandoz-, (Betapace Equivalent), barcode 0000-0004-14. Recall # D-675-2011;
 
47) Spironolactone 12.5 mg per half-tab (1/2 Spironolactone 25 mg tablet) per blister, Rx only, a) -Mutual-, barcode 5348914350; b) -Sandoz-, NDC: 00781159962; c) -Qualitest-, barcode 0603576350; d) -Greenstone-, (Aldactone Equivalent), barcode 0000-0004-13. Recall # D-676-2011;
 
48) Levothyroxine Sodium 12.5 mcg per half-tab (1/2 Synthorid 0.025 mg tablet) per blister, Rx only, (0.0125 mg per half-tab), -Abbott-; barcode 0000-0006-59. Recall # D-677-2011;
 
49) Metoprolol Succinate Extended Release 12.5 mg per half-tab (1/2 Toprol XL 25 mg tablet) per blister, Rx only, -A/Zeneca-, Equiv. To Metoprolol Tartrate; barcode 0186108850. Recall # D-678-2011;
 
50) traMADOL HCL 25 mg per half-tab (1/2 Tramadol HCl 50 mg tablet) per blister, Rx only, -Amneal-, (Ultram Equivalent); barcode 0000-0012-44. Recall # D-679-2011;
 
51) traZODONE HCL 25 mg per half-tab (1/2 Trazodone HCl 50 mg tablet) per blister, Rx only, -Teva-, (Desyrel Equivalent); barcode 0000-0003-02. Recall # D-680-2011;
 
52) Venlafaxine 12.5 mg per half-tab (1/2 Venlafaxine Hydrochloride 25 mg tablet) per blister, Rx only, -Teva-, (Effexor Equivalent); barcode 0000-0004-15. Recall # D-681-2011;
 
53) Warfarin Sodium 0.5 mg per half-tab (1/2 Warfarin Sodium 1 mg tablet) per blister, Rx only, -Taro-; barcode 5167240250. Recall # D-682-2011;
 
54) OLANZapine 5 mg per half-tab (1/2 ZyPREXA 10 mg tablet) per blister, Rx only, -Lilly-; barcode 0002411750. Recall # D-683-2011;
 
55) Quinapril 2.5 mg per half-tab (1/2 Quinapril HCl 5 mg tablet) per blister, Rx only, -Greenstone-, (Accupril Equivalent); barcode 000-0002-43. Recall # D-684-2011;
 
56) Aripiprazole 15 mg per half-tab (1/2 Abilify 30 mg tablet) per blister, Rx only, -Otsuka-; barcode 5914801150. Recall # D-685-2011;
 
57) Aripiprazole 2.5 mg per half-tab (1/2 Abilify 5 mg tablet) per blister, Rx only, -Otsuka-; barcode 5914800750. Recall # D-686-2011;
 
58) Aspirin 40.5 mg per half-tab (1/2 Aspirin Low Dose 81 mg tablet) per blister, -Sunmark-; barcode 4934875750. Recall # D-687-2011;
 
59)  Candesartan Cilexetil 4 mg per half-tab (1/2 Atacand 8 mg tablet) per blister, Rx only, -A/Zeneca-, NDC 00186000862. Recall # D-688-2011;
 
60) azaTHIOprine 25 mg per half-tab (1/2 Azathioprine 50 mg tablet) per blister, Rx only, -Roxane-, (Imuran Equivalent), Pkg By: Safecor Health, Woburn, MA 01801; barcode 0000000917. Recall # D-689-2011;
 
61) Furosemide 10 mg per half-tab (1/2 Furosemide 20 mg tablet) per blister, Rx only, a) -Ivax-, barcode 0172290850; b) -Roxane-, barcode 0054429750. Recall # D-690-2011;
 
62) Escitalopram 10 mg mg per half-tab (1/2 Lexapro 20 mg tablet) per blister, Rx only, -Forest-, barcode 0456202050. Recall # D-691-2011;
 
63) Misoprostol 50 mcg per half-tab (1/2 Misoprostol 100 mcg tablet) per blister, Rx only, -Teva-; barcode 0172443050. Recall # D-692-2011;
 
64) Memantine HCL 5 mg per half-tab (1/2 Namenda 10 mg tablet) per blister, Rx only, -Forest-; barcode 0456321050. Recall # D-693-2011;
 
65) Reispridone 0.125 mg per half-tablet (1/2 Risperidone 0.25 mg tablet) per blister, Rx only, -Patriot-; NDC: 50458059062. Recall # D-694-2011;
 
66) Low Strength Aspirin For Adults 40.5 mg per half-tab (1/2 Aspirin 81 mg tablet) per blister, Chewable, -Gericare-; barcode 5789691150. Recall # D-695-2011
CODE
1) Lot #: 316500, Exp 05/18/11; 318504, Exp 05/28/11; 320818, Exp 06/10/11; 325158, 07/07/11; 336387; 336388, Exp 09/03/11; 342011, Exp 10/04/11; 348819, Exp 11/04/11;
 
2) Lot #: 350207, Exp 11/09/11;
 
3) Lot #: 326177, 07/15/11; 333272, Exp 08/18/11;
 
4) Lot #: 330880, Exp 08/05/11; 335241, Exp 08/30/11; 342508, Exp 10/05/11;
 
5) Lot #: 319696, Exp 06/04/11; 323666, Exp 06/28/11; 325153, Exp 07/07/11; 330866, Exp 08/04/11; 336389, Exp 09/03/11; 342010, Exp 10/04/11; 348818, Exp 11/02/11; 318765, Exp 05/28/11;
 
6) Lot # 309023, Exp 04/05/11; 310461, Exp 04/09/11; 344661, Exp 10/15/11;
 
7) Lot #: 310462, Exp 04/09/11; 317693, Exp 05/24/11;
 
8) Lot #: 343063, Exp 10/07/11;
 
9) Lot #: a) 330139, Exp 08/04/11; 314426, Exp 05/06/11; b) 311200, Exp 04/16/11; 344227, Exp 10/15/11; 318571, Exp 06/01/11; 333280, Exp 08/19/11; c) 340162, Exp 09/24/11;
 
10) Lot #: a) 311201, Exp 04/14/11; b) 340167, Exp 09/24/11; 349149, Exp 11/04/11; 339016, Exp 09/17/11; c) 316646, Exp 05/19/11; 333889, Exp 08/23/11; 334171, Exp 08/23/11; d) 324207, Exp 06/30/11; 331727, Exp 08/10/11; 344707, Exp 10/18/11;
 
11) Lot #: 313695, Exp 04/29/11;
 
12) Lot #: 331501, Exp 08/10/11; 333273, Exp 08/18/11;
 
13) Lot #: a) 349334, Exp 11/04/11; b) 334699, Exp 08/26/11; 335196, Exp 08/27/11;
 
14) Lot #: a) 336345, Exp 09/02/11; b) 339017, Exp 09/17/11; 313211, Exp 04/28/11; 333036, Exp 08/17/11; 324787, Exp 07/02/11; 348700, Exp 11/04/11; c) 328072, Exp 07/02/11; 347476, Exp 11/01/11;
 
15) Lot #: a) 330896, Exp 08/04/11; b) 320980, Exp 06/14/11; 316431, Exp 05/17/11; 327478, Exp 07/16/11;
 
16) Lot #: a) 307389, Exp 03/22/11; b) 343982, Exp 10/15/11; 319328, Exp 06/02/11;
 
17) Lot #: 308760, Exp 03/31/11;
 
18) Lot #: 332404, Exp 08/12/11;
 
19) Lot #: 314428, Exp 05/04/11;
 
20) Lot #: 330890, Exp 08/05/11; 342503, Exp 10/06/11; 348248, Exp 10/29/11;
 
21) Lot #: 314430, Exp 05/06/11; 339753, Exp 09/21/11;
 
22) Lot #: 308619, Exp 03/30/11;
 
23) Lot #: a) 332295, 08/16/11; 339396, 09/22/11; 344839, Exp 10/18/11; 331001, Exp 08/05/11; 314493, Exp 05/06/11; 339754, Exp 09/22/11; b) 321737, Exp 06/16/11; 319319, Exp 06/04/11; 339292, Exp 09/21/11;
 
24) Lot #: 340172, Exp 09/23/11;
 
25) Lot #: 341552, Exp 09/30/11:
 
26) Lot #: 350210, Exp 11/09/11; 325276, Exp 07/07/11;
 
27) Lot #: 328607, Exp 07/22/11;
 
28) Lot #: 332403, Exp 08/12/11;
 
29) Lot #: a) 314495, Exp 05/04/11; b) 339759, Exp 09/21/11;
 
30) Lot #: 314494, Exp 05/04/11;
 
31) Lot #: 347593, Exp 10/27/11;
 
32) Lot #: a) 340249, Exp 06/30/11; b) 325875, Exp 07/08/11;
 
33) Lot #: 322268, Exp 06/18/11;
 
34) Lot #: a) 335842, Exp 08/31/11; b) 350211, Exp 11/09/11; c) 328063, Exp 07/20/11;   
 
35) Lot #: 314496, Exp 05/04/11;
 
36) Lot #: 317880, Exp 05/26/11; 334700, Exp 08/25/11; b) 334726, Exp 08/25/11;
 
37) Lot #: a) 312569, Exp 04/22/11; 312573, Exp 04/23/11; 319003, Exp 06/02/11; 323889, Exp 06/29/11; 324572, Exp 07/06/11; 326309, Exp 07/12/11; 336141, Exp 09/02/11; 342820, 342824, Exp 10/07/11; 350804, 350806, Exp 11/10/11; b) 326179, Exp 07/15/11; 330036, Exp 07/30/11; 344155, Exp 10/15/11; 350603, Exp 11/10/11; c) 315348, Exp 05/10/11; d) 351267, Exp 11/11/11; e) 344217, Exp 10/14/11; f) 311626, Exp 4/20/11; 329572, Exp 07/28/11; 334386, Exp 08/25/11; 342012, 342013, Exp 10/04/11; 349813, Exp 11/05/11; 307582, Exp 03/25/11; 319012, Exp 06/02/11; 325685, Exp 07/07/11; 314497, Exp 05/04/11; 330130, Exp 08/04/11; 327545, Exp 07/16/11; 331500, Exp 08/09/11; 341868, Exp 10/04/11; 307316, Exp 03/25/11; 327106, Exp 07/15/11; 337152, Exp 09/09/11; 339018, Exp 09/24/11; 330151, Exp 08/03/11; 322852, Exp 06/25/11; 338588, Exp 09/20/11; 347088, Exp 11/1/11; 320630, Exp 06/10/11; 332502, Exp 08/17/11; 338700, Exp 09/20/11; 342831, Exp 10/08/11; 307796, Exp 03/29/11; 311364, Exp 04/16/11; 313930, Exp 05/04/11; 315757, Exp 05/12/11; 316430, Exp 05/18/11; 319074, Exp 06/02/11; 323756, Exp 06/28/11; 324378, Exp 06/30/11; 328064, Exp 07/22/11; 331880, Exp 08/13/11; 333640, 334385, Exp 08/25/11; 340812, 09/28/11; 349352, Exp 11/08/11; 327325, Exp 07/16/11; 328067, 328069, 328070, Exp 07/22/11; 346119, 346120, 346121, Exp 10/22/11; 348752, Exp 11/05/11; 349055, 349061, 349089, Exp 11/04/11; 349357, Exp 11/05/11; g) 325888, Exp 07/09/11; 335732, Exp 09/03/11; 343716, Exp 10/12/11; h) 316229, Exp 05/17/11; 321623, Exp 04/30/11;
 
38) Lot #: a) 340173, Exp 09/24/11; 342523, Exp 10/05/11; b) 307315, Exp 03/25/11; 316743, Exp 05/18/11; c) 308337, Exp 03/30/11; 319713, Exp 06/07/11; 328377, Exp 07/21/11;
 
39) Lot #: a) 346165, Exp 10/22/11; b) 341350, Exp 09/30/11; 313350, Exp 04/29/11; 331371, Exp 08/06/11; 335493, Exp 08/30/11; 309605, Exp 04/05/11; 341994, Exp 10/01/11; c) 339038, Exp 09/17/11; 313965, Exp 05/05/11; d) 321597, Exp 01/05/12; e) 312246, Exp 04/22/11; 317909, Exp 06/02/11; 327306, Exp 07/15/11; f) 308761 Exp 03/31/11;
 
40) Lot #: 321867, Exp 06/16/11
 
41) Lot #: 333040, Exp 08/17/11;
 
42) Lot #: 350214, Exp 11/09/11;
 
43) Lot #: a) 325879, Exp 07/08/11; b) 330998, Exp 08/04/11;
 
44) Lot #: 350215, Exp 11/09/11; 333297, Exp 08/19/11; 321869, Exp 06/18/11; 334701, Exp 08/26/11; 346381, Exp 10/25/11;
 
45) Lot #: 334219, Exp 08/25/11;
 
46) Lot #: a) 330133, Exp 08/04/11; 365339, Exp 01/19/12; 330999, Exp 08/05/11; 337196, Exp 09/09/11; b) 316250, Exp 08/17/11; c) 327052, Exp 07/15/11;
 
47) Lot #: a) 332296, Exp 08/11/11; b) 330095, Exp 07/30/11; c) 350217, Exp 11/09/11; d) 326490, Exp 07/12/11;
 
48) Lot #: 330360, Exp 04/29/11;
 
49) Lot #: 311202, Exp 04/14/11; 328073, Exp 07/22/11; 334455, Exp 08/25/11; 339086, Exp 09/17/11;
 
50) Lot #: 313333, Exp 04/29/11; 321868, Exp 06/18/11; 324512, Exp 06/30/11; 340174, Exp 09/24/11; 350602, Exp 11/02/11;
 
51) Lot #: 343064, Exp 10/08/11; 308933, Exp 04/05/11; 319356, Exp 06/07/11; 321332, Exp 06/16/11; 321749, Exp 06/18/11; 322745, Exp 06/23/11; 326113, Exp 07/12/11; 328378, 328379, Exp 07/23/11; 330363, Exp 08/04/11; 331882, Exp 08/13/11; 346545, Exp 10/16/11; 348742, Exp 11/04/11; 349328, Exp 11/08/11; 351544, Exp 11/15/11;
 
52) Lot #: 349318, Exp 11/04/11;
 
53) Lot #: 337321, Exp 09/09/11; 350219, Exp 11/11; 326239, Exp 07/09/11;
 
54) Lot #: 318505, Exp 05/27/11; 319473, Exp 06/04/11; 320821, Exp 06/10/11;
 
55) Lot #: 308176, Exp 03/29/11; 310856, Exp 04/14/11; 313931, Exp 05/03/11; 317702, Exp 05/25/11; 323755, Exp 06/28/11; 327272, Exp 07/16/11; 328065, Exp 07/22/11; 342285, Exp 10/05/11;
 
56) Lot #: 316498, Exp 05/18/11; 319778, Exp 06/07/11; 323664, Exp 06/28/11; 325156, Exp 07/02/11;
 
57) Lot #: 312651, Exp 04/23/11;
 
58) Lot #: 339015, Exp 09/17/11;
 
59) Lot #: 350957, Exp 11/10/11; 350958; Exp 11/15/11;
 
60) Lot #: 339585, Exp 09/21/11;
 
61) Lot #: a) 311205, Exp 04/14/11; b) 314433, Exp 03/31/11;
 
62) Lot #: 330885, Exp 08/05/11; 342501, Exp 10/05/11;
 
63) Lot #: 315176, Exp 05/10/11; 327243, Exp 07/14/11; 309603, Exp 04/05/11; 346034, 346036, Exp 10/25/11;
 
64) Lot #: 330887, 335243, 338923, 342502, 347644, Exp 10/28/11;
 
65) Lot #: 344154, Exp 10/13/11;
 
66) Lot #: 349335, Exp 11/04/11
RECALLING FIRM/MANUFACTURER
Safecor Health, LLC, Woburn, MA, by letter dated March 21, 2011. Firm initiated recall is ongoing.
REASON
Marketed Without An Approved NDA/ANDA: Split tabs distributed as an unapproved new drug.
VOLUME OF PRODUCT IN COMMERCE
97,148 blisters
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Dantrolene Sodium Capsules, 25 mg, Rx only, 100 count HDPE bottle. Recall # D-696-2011
CODE
Lot #:  H0070141
RECALLING FIRM/MANUFACTURER
Impax Laboratories, Inc., Hayward, CA, by letters on June 22, 2011. Firm initiated recall is ongoing.
REASON
Subpotent; empty capsules found in one lot of Dantrolene Sodium Capsules, 25 mg.
VOLUME OF PRODUCT IN COMMERCE
5,367 bottles of 100
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
HydrALAZINE Hydrochloride Tablets USP, 50 mg, UD 100 Tablets, Rx only; NDC 63739-127-10. Recall # D-697-2011
CODE
Lot number: 000073105, Exp. date: 04/12 and Lot number: 000074634, Exp. date: 08/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mckesson Packaging Services, Concord, NC, by letter on April 6, 2011. 
Manufacturer: Pliva Krakow S.A., Krakow, Poland. Firm initiated recall is ongoing.
REASON
CGMP Deviations: There is the potential that some tablets do not conform to weight specifications.
VOLUME OF PRODUCT IN COMMERCE
4,786 unit dose boxes
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Hydrocodone Bitartrate and Acetaminophen Tablets, USP, C-III, 7.5 mg/500 mg, 1000-count, Rx only, May be habit forming. NDC 0603-3882-32. Recall # D-698-2011;
 
2) Butalbital, Acetaminophen, and Caffeine Tablets, USP, 50 mg/325 mg/ 40 mg, 500-count, Rx Only, NDC 0603-2544-28. Recall # D-699-2011
CODE
1) and 2) Lot #s: C0390909A; C0400909A; C0410909A; C0590909B, Exp. 03/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals, Huntsville, AL, by press release on June 24, 2011 and by letters on June 27, 2011.
Manufacturer: Qualitest Pharmaceuticals, Charlotte, NC. Firm initiated recall is ongoing.
REASON
Labeling: Ingredient mix-up due to mislabeling; Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg may be mislabeled as Hydrocodone Bitartrate/Acetaminophen, 7.5 mg/500 mg Tablets.
VOLUME OF PRODUCT IN COMMERCE
21,560 units
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1492-11
CODE
Units: 8030359; 8030577
RECALLING FIRM/MANUFACTURER
Houchin Blood Services, Bakersfield, CA, by telephone on December 20, 2006 and December 21, 2006. Firm initiated recall is complete.
REASON
Blood products, mislabeled for antigen phenotype, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1552-11;
2) Platelets Leukocytes Reduced. Recall # B-1553-11;
3) Plasma Frozen. Recall # B-1554-11
CODE
1) Unit: 17GS19203;
2) Unit: 17GS19203;
3) Unit: 17GS19203
RECALLING FIRM/MANUFACTURER
The American National Red Cross - North Central Region, Saint Paul, MN, by telephone on September 20, 2007 and/or fax and letter dated September 21, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
WI, MN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1555-11
CODE
Unit: 3697395
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by letter dated August 28, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells. Recall # B-1559-11
CODE
Unit: G52136
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, facsimile and telephone dated May 30, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells. Recall # B-1560-11
CODE
Unit: R22764
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by facsimile and telephone dated February 26, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1568-11
CODE
Unit: 9129890
RECALLING FIRM/MANUFACTURER
Recalling Firm: Community Blood Bank of Lancaster County Medical Society, Lincoln, NE, by e-mail on April 6, 2011.
Manufacturer: Nebraska Community Blood Bank, Lincoln, NE. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1569-11
CODE
Unit: W068510383010
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Center, Spokane, WA, by fax on May 2, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AZ
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1570-11
CODE
Unit: W054811001469
RECALLING FIRM/MANUFACTURER
Regional West Medical Center, Scottsbluff, NE, by telephone on May ll, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to an area possibly endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NE
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1573-11
CODE
Units: 11631176767100; 11631176767100
RECALLING FIRM/MANUFACTURER
Florida Blood Services, Inc., Pensacola, FL, by telephone and fax on May 11, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
1) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1574-11;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1575-11
CODE
1) Units: W087909313187; W087909313187;
2) Units: W087909202618; W087911801262; W087910805587; W087910805682; 6553228
RECALLING FIRM/MANUFACTURER
Community Blood Bank of Lancaster County Medical Society, Lincoln, NE, by fax on April 29, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
NY; NE; FL; Austria
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1579-11
CODE
Unit: W088411506046
RECALLING FIRM/MANUFACTURER
Blood Bank Of Hawaii, Honolulu, HI, by e-mail on May 13, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1580-11;
2) Plasma Frozen within 24 hours (FP24). Recall # B-1581-11;
3) Platelets Leukocytes Reduced. Recall # B-1582-11
CODE
1), 2) and 3) Unit: W038111014461
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by telephone on April 6, 2011 and follow up letter dated April 12, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a body piercing within 12 months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1583-11
CODE
Unit: W137510112525
RECALLING FIRM/MANUFACTURER
Lane Memorial Blood Bank, Eugene, OR, by fax on April 21, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KY
___________________________________
PRODUCT
1) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1584-11;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1585-11;
3) Plasma Frozen within 24 hours (FP24). Recall # B-1586-11
CODE
1) Units: 026KJ563491; 026KJ563492;
2) and 3) Unit: 026KN79197
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Birmingham, AL, by telephone on April 12, 2011 and fax on April 14, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had previously tested reactive for hepatitis C (HCV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
AL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1611-11
CODE
Unit: W128709016143
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by telephone on September 10, 2009 and by letter dated October 9, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1614-11
CODE
Unit: W115908053325
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by e-mail on August 6, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Source Plasma. Recall # B-1622-11
CODE
Units: 4280004918, 4280004786, 4280004401, 4280004122, 4280003890
RECALLING FIRM/MANUFACTURER
Octapharma Plasma Inc., Council Bluffs, IA, by e-mail on May 18, 2011. 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
5 units
DISTRIBUTION
Austria
___________________________________
PRODUCT
Platelets Pheresis. Recall # B-1623-11
CODE
Unit: W120611003304
RECALLING FIRM/MANUFACTURER
Michigan Blood, Grand Rapids, MI, by facsimile on April 20, 2011. Firm initiated recall is complete.
REASON
Blood product, which was labeled as leukoreduced, but was not tested to verify white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1624-11;
2) Fresh Frozen Plasma. Recall # B-1625-11;
3) Platelets Pooled Leukocytes Reduced. Recall # B-1626-11
CODE
1) and 2) Unit # W051709652012;  3) Unit # W051709807280
RECALLING FIRM/MANUFACTURER
Rhode Island Blood Center, Providence, RI, by e-mail on April 21, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking Finasteride, were distributed
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NY, CT
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1627-11;
2) Recovered Plasma. Recall # B-1628-11
CODE
1) and 2) Unit: 40KC46256
RECALLING FIRM/MANUFACTURER
American National Red Cross Heart of America Region, Peoria, IL, by telephone on April 14, 2011 and by e-mail on April 15, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA, IL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1630-11
CODE
Unit: 12FQ01086
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Carolinas Region, Charlotte, NC, by letter dated April 22, 2011.
Manufacturer: American Red Cross Blood Services, Durham, NC. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1687-11;
2) Fresh Frozen Plasma. Recall # B-1688-11
CODE
1) Units: 084FT79593, 084FT79817;
2) Units: 084FT79431, 084FT79432, 084FT79735
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Oakland, CA, by letter dated May 3, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1691-11;
2) Recovered Plasma. Recall # B-1692-11
CODE
1) and 2) Units: 8243224, 8246236
RECALLING FIRM/MANUFACTURER
Houchin Blood Services, Bakersfield, CA, by facsimile on September 2, 2005 and by letter dated September 27, 2005. Firm initiated recall is complete.
REASON
Blood products, which tested negative for anti-HIV-1/2, but were collected from a donor who previously tested repeatedly reactive for anti-HIV-1/2 and was not properly re-entered, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA, Austria
___________________________________
PRODUCT
1) Recovered Plasma. Recall # B-1694-11;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1695-11;
3) Red Blood Cells. Recall # B-1696-11
CODE
1) Units: W128709301431, W128709300623, W128709300238, W128708300969, W128708300615;
2) Unit: W128708300615;
3) Unit: W128709301431
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by facsimile and e-mail on November 12, 2009 and by letter dated December 18, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
CA, Austria
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1719-11
CODE
Unit: KR84869
RECALLING FIRM/MANUFACTURER
Blood Bank of the Redwoods, Santa Rosa, CA, by facsimile and letter dated November 14, 2007. Firm initiated recall is complete.
REASON
Blood product, which was not quarantined after receiving information concerning a post donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1571-11
CODE
Units: W071210086015; W071210086467
RECALLING FIRM/MANUFACTURER
Medic Inc., Knoxville, TN, by telephone on January 11 and follow up letter on January 14, 2011. Firm initiated recall is complete.
REASON
Blood products, erroneously labeled as negative for unexpected antibodies, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN
___________________________________
PRODUCT
Platelets Pooled Leukocytes Reduced Irradiated. Recall # B-1572-11
CODE
Unit: W037911888377
RECALLING FIRM/MANUFACTURER
LifeServe Blood Center, Des Moines, IA, by telephone on May 9, 2011. Firm initiated recall is complete.
REASON
Blood Product, collected from a donor whose health history screening was not adequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1576-11
CODE
Units: W087909202618; W087911801262; W087910805587; W087910805682; 6553228
RECALLING FIRM/MANUFACTURER
Community Blood Bank of Lancaster County Medical Society, Lincoln, NE, by fax on April 29, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
NY, NE, FL, Austria
___________________________________
PRODUCT
Red Blood Cells. Recall # B-1597-11
CODE
Units: W087610044930; W087610051001
RECALLING FIRM/MANUFACTURER
Virginia Blood Service Inc., Richmond, VA, by telephone on April 15, 2011 and follow up letter dated May 16, 2011. Firm initiated recall is complete.
REASON
Blood products, labeled with extended expiration dates, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NJ, VA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1615-11
CODE
Recall # 8265256
RECALLING FIRM/MANUFACTURER
Houchin Blood Services, Bakersfield, CA, by telephone on April 20, 2006. Firm initiated recall is complete.
REASON
Blood product, which did not meet the minimum requirement for red cell recovery, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1631-11
CODE
Unit: 12FQ01086
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Carolinas Region, Charlotte, NC, by letter dated April 22, 2011.
Manufacturer: American Red Cross Blood Services, Durham, NC. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1632-11
CODE
Unit: W0352100493566
RECALLING FIRM/MANUFACTURER
Carter BloodCare/ WE & Lela I Stewart Blood Center, Inc., Tyler, TX, by letter dated May 12, 2011. Firm initiated recall is complete.
REASON
Blood product, labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1633-11
CODE
Unit: 18GY20545
RECALLING FIRM/MANUFACTURER
American National Red Cross Great Lakes Region, Lansing, MI, via the LOGIC system on April 29, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
_______________________________________
PRODUCT
Recovered Plasma. Recall # B-1634-11
CODE
Unit: 06LF15953
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, via the LOGIC system on April 24, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1635-11
CODE
Unit: W067111004308
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on May 4, 2011. Firm initiated recall is complete.
REASON
Blood product, leukoreduced after the specified post collection time limit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1689-11
CODE
Units: 17FE23823 (2 units), 17FE23826 (2 units), 17FE23824 (2 units)
RECALLING FIRM/MANUFACTURER
The American National Red Cross - North Central Region, Saint Paul, MN, by telephone on August 31, 2007 and by facsimile on September 19, 2007. Firm initiated recall is complete.
REASON
Blood products, which were not tested for the antibody to hepatitis B core antigen (anti-HBc), were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
MN, WI
___________________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-1690-11
CODE
Units: 8250765, 8250770, 8022018, 8250756
RECALLING FIRM/MANUFACTURER
Houchin Blood Services, Bakersfield, CA, by telephone on July 21, 2005. Firm initiated recall is complete.
REASON
Blood products, labeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1720-11
CODE
Unit: 3520854
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by telephone on October 17, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from donor who exceeded the donor with an elevated body temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
DrugCheck, Model numbers: a) 70801-4 (NxScan OnSite, AMP500-COC-MDMA-MET500-MTD-OP1300-TCH-BUP-pH,SG-NI,CR, Export Only); b) 65500-4A (AMP-COC--OP1-TCH-MET-ALC-pH,SG-NI,CR, For forensic use only); c) 30705 ( DIP DRUG TEST, AMP500/COC/MDMA/MET500/MTD/OP1300/TCH); d) 60702-6A AUS (AMP300-COC300-OP1300-OP12000-MET300-TCH50-BZ0200-ALC-pH,SG,OX-NI,CR-GL, Export Only); e) 60600-A (AMP-COC--OP1-TCH-MET-BZO-ALC, For forensic use only); f) 61205 (AMP-BAR-BZO-COC-MDMA-MET-MTD-OPI-OXY-PCP-TCA-THC); g) 70701-4 (NxScan OnSite, AMP500-COC-MDMA-MET500-MTD-OP1300-TCH-pH, SG-NI,CR, Export Only); h) 31012-6 (DIP DRUG TEST, AMP/BAR/BZO/COC/MDMA/MTD/OPI/OXY/ PCP/THC/pH SG, OX/NI, CR, GL); i) 31003 (AMP/COC/OP10300/THC/MET/BZO/BAR/PCP/MTD/TCA/MET); Intended use: The DrugCheck Dip Drug Test is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine. Recall # Z-2387-2011
CODE
a)Lot 4-801 102910, Exp APR 2012, & Lot 4-801 112210, Exp MAY 2012; b) Lot 4A-500 110310, Exp MAY 2012; c) Lot 705 112210, Exp MAY 2012; d) Lot 6A-702 113010 & 6A-702 112910, Exp MAY 2012; e) Lot A600 110310, Exp MAY 2012; f) Lot 205 110410, Exp MAY 2012; g) Lot 4-701 102910, Exp APR 2012; h) Lot 6-012 110310, Exp MAY 2012; i) Lot 003 102510, Exp APR 2012
RECALLING FIRM/MANUFACTURER
Express Diagnostics Int'l., Inc., Blue Earth, MN, by letter dated April 19, 2011. Firm initiated recall is ongoing.
REASON
This recall was due to incorrect product expiration dating after findings from an FDA inspection. Use of expired product may not work properly, and may give incorrect screening results.
VOLUME OF PRODUCT IN COMMERCE
6,925 devices
DISTRIBUTION
Nationwide, Australia and Italy
___________________________________
PRODUCT
1) URI-DRAIN Medium Male External Catheter With Two-Sided Adhesive Strap and Skin Protective Wipe Product ID: 8884732000 Intended use: Collector urine from male patients (and accessories) for indwelling catheter. Recall # Z-2392-2011;
 
2) URI-DRAIN Standard Male External Catheter with Two-Sided Adhesive Strap and Skin Protective Wipe Product ID: 8884732500 Intended use: Collector urine from male patients (and accessories) for indwelling catheter. Recall # Z-2393-2011;
 
3) URI-DRAIN Male Urinary Control Device - Large Product ID: 8884732598 (sold in Canada only) Intended use: Collector urine from male patients (and accessories) for indwelling catheter. Recall # Z-2394-2011
CODE
1) Lot Numbers: 030772764 109555264;
 
2) Lot Numbers: 016671464 019371364 022372464 023072264 027272564 032972964 034172164 100370964 103170664 106855364;
 
3) Lot Numbers: 020272164 100370664
RECALLING FIRM/MANUFACTURER
Recalling Firm: Covidien LP, Mansfield, MA, by letter dated April 29, 2011.
Manufacturer: H & P Industries, Inc., Hartland, WI. Firm initiated recall is ongoing.
REASON
A component of the Uri-Drain device recalled the Skin-Prep, a protective wipe due to bacterial contamination.
VOLUME OF PRODUCT IN COMMERCE
62,352 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Monaco Radiation Treatment Planning Workstation. Monaco Release 2.03.00 and above. The Monaco RTP system is used to create treatment plans for any cancer patient for whom external beam intensity modulated radiation therapy (IMRT) has been prescribed. Recall # Z-2561-2011
CODE
Release 2.03.00 and above
RECALLING FIRM/MANUFACTURER
Computerized Medical Systems Inc., Maryland Heights, MO, by letter on January 13, 2011. Firm initiated recall is ongoing.
REASON
Monaco: For VMAT plans, the measured dose of radiation delivered is lower than the software calculated dose by about 5% in Monaco Release 2.03.00 and 2.04.00.
VOLUME OF PRODUCT IN COMMERCE
94 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Integra CUSA NXT Ultrasonic Tissue Ablation System Service Module The CUSA NXT Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation. emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable. including Neurosurgery. Gastrointestinal and affiliated organ surgery. Urological surgery. Plastic and Reconstructive surgery. General surgery, Orthopedic surgery. Gynecological surgery, Thoracic surgery. laparoscopic surgery and Thoracoscopic surgery. Recall # Z-2585-2011
CODE
Serial Numbers: NBF1001601IE NBA1000501IE NBA1100901IE NBA1101001IE NBA1102701IE NBA1102801IE NBC1001501IE NBC1002001IE NBC1002301IE NBC1002901IE NBD1000101IE NBE1001301IE NBF1000701IE NBF1001101IE NBG1001001IE NBG1001201IE NBJ1002401IE NBL0901901IE NBL0902101IE NBL0902501IE NCE1001901IE NCF1002201IE NCG1000201IE NCG1001401IE NCG1001501IE NXT1001 NXT1002 NXT1003 NXT1004 NXT1005 NXT1006 NXT1007 NXT1008 NXT1009 NXT1010 NXT1011 NXT1012 NXT1013 NXT1014 NXT1015 NXT1016 NXT1017 NXT1018 NXT1019 NXT1020P NXT1021 NXT1022 NXT1023 NXT1024 NXT1025 NXT1026 NXT1027 NXT1028 NXT1029 NXT1030 NXT1031 NXT1032 NXT1033 NXT1034 NXT1035 NXT1036 NXT1037 NXT1038 NXT1039 NXT1040 NXT1041 NXT1042 NXT1043 NXT1044 NXT1045 NXT1046 NXT1047 NXT1048 NXT1049 NXT1050 NXT1051 NXT1052 NXT1053 NXT1054 NXT1055 NXT1056 NXT1057 NXT1058 NXT1059 NXT1060 NXT1061 NXT1062 NXT1063 NXT1064 NXT1065 NXT1066 NXT1067 NXT1068 NXT1069 NXT1070 NXT1071 NXT1072 NXT1073 (Asia) NXT1074 NXT1075 NXT1076 NXT1077 NXT1078 NXT1079 NXT1080
RECALLING FIRM/MANUFACTURER
Recalling Firm: Integra Limited, Plainsboro, NJ, by letter dated May 2, 2011.
Manufacturer: Integra Lifesciences (Ireland) Limited, Sragh, Tullamore, CO, Ireland;
Integra Radionics Inc., Burlington, MA. Firm initiated recall is ongoing.
REASON
The insulated covering of a wire cable that powers the vacuum pump in the CUSA NXT Service Module can become abraded over time resulting in the exposure of bare wire. If this bare wire were to come in contact with the metal surface of the pump, it could result in a short circuit and a loss of aspiration.
VOLUME OF PRODUCT IN COMMERCE
105 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Silicone CTS (Close to Shaft) Cuff Adjustable Neck Flange Tracheostomy Tube (Wire Reinforced), Arcadia Medical Silicone Air Cuff Adjustable Tracheostomy Tube, Sterile, Latex-Free, Provides direct tracheal access for airway management, a) Catalog # 180-060, and b) Catalog # 180-080. Recall # Z-2657-2011
CODE
a) Lots 00911114, and b) Lot 00911116
RECALLING FIRM/MANUFACTURER
Arcadia Medical Corp., Crown Point, IN, by email on May 8, 2011 and by letter on May 9, 2011. Firm initiated recall is ongoing.
REASON
The product does not contain a punched hole above the cuff access port (a lumen that enables suctioning of secretions proximal to the inflated cuff) as intended by the devices design. This eliminates the user's ability to suction secretions through this suction port, necessitating that the user revert to standard of care methods for suctioning secretions from around the cuffed trach tube shaft.
VOLUME OF PRODUCT IN COMMERCE
118 units
DISTRIBUTION
Nationwide and Inaternationally
___________________________________
PRODUCT
Triad Alcohol Prep Pads, 0200086, 100 box 0200432, Alcohol Prep Pads, packaged in the Alere INRatio 2 PT/INR Home Monitoring Kit; or Hemosense INRatio 2 Prothrombin Time/lNR Testing Kit, Self-Test System; 0100007, Alcohol Prep Pads, packaged in the Hemosense INRatio Prothrombinme/lNR Testing Kit, Self- Test System; 0100072, Alcohol Prep Pads, packaged in the INRatio Starter Kit. Recall # Z-2661-2011
CODE
Lot/Unit Codes: Applicable to all INRatio kit lots packaged Triad Alcohol prep pads from 4/19/09 through 2/7/11, including the following: 218494, 220447, 223941, 223943, 224250, 224251, 224770, 224771, 224772, 225544, 229364, 229365, 229366, 229367, 229368, 229369, 229370, 229371, 235188, 235189, 236334, 236335, 236336, 238868, 238869, 239283, 239418, 239419, 239595, 243020, 243021, 243413, 243414, 243415, 243416, 243417, 243418, 243855, 243856, 243857, 243858, 243859, 243860, 243861, 243862, 243863, 243864, 243865, 244432, 245759, 245760, 245761, 245762, 245763, 245764
RECALLING FIRM/MANUFACTURER
Alere San Diego, San Diego, CA, by letter on February 28, 2011. Firm initiated recall is ongoing.
REASON
The recall of the Triad Group alcohol prep products is due to potential contamination of these products with the bacteria Bacillus cereus, which could lead to life-threatening infections.
VOLUME OF PRODUCT IN COMMERCE
4,829 Total units
DISTRIBUTION
Nationwide and Canada, Australia, Japan and PR
___________________________________
PRODUCT
Infusable and InfusaScan Single Patient Use Pressure Infusors. A pressure infusor for an IV bag is a device consisting of an inflatable cuff which is placed around and IV bag. When the device is inflated, it increases the pressure on the IV bag to assist the infusion of the fluid. IN800012; IN80048; IN80020; IN900012; IN900048; IN900020; IN950006; IN950012. Recall # Z-2663-2011
CODE
Lot numbers: For the year 2009- Lot Number 2449 to Lot number 3659 F0r the year 2010 - Lot Number 0010 to Lot number 3250
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, LLC, Waukesha, WI, by letter dated February 25, 2011.
Manufacturer: Vital Signs Inc., Totowa, NJ. Firm initiated recall is ongoing.
REASON
Infusable and InfusaScan Pressure Infusors may leak and not apply desired pressure to their IV solution bag and subsequently the rate of infusion may be inadequate.
VOLUME OF PRODUCT IN COMMERCE
954,888 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) AMS Acticon Neosphincter Pump, Product Number 72402287, Sterilization Method Steam. The Acticon Neosphincter is an implantable device used to treat severe fecal incontinence in males and females eighteen years and older who have failed, or are not candidates for less invasive forms of restorative therapy. Recall # Z-2668-2011;
 
2) AMS 800 Urinary Control System Control Pump, REF 72400098, (720172-01 Japan only ), Sterilization Method Steam, InhibiZone Antibiotic Surface Treatment, AMS 800 Urinary Control Pump with InhibiZone, REF 72404127, Sterilization Method ETO. The AMS Urinary Control System (of which the pump is a component) is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery. Recall # Z-2669-2011
CODE
1) Lot Serial Number 479415015 484404007 484404008 479415001 441676011 456698011 588991014 599446004 599446008 618008001 618008009 656990003 688922003 690865009 416939013 459455017 660672019 451253005 546586004 546586005 546586006 601217007 601217008 660672005 434294009 416939002 430867008 430867010 430867015 434294015 441676009 441676017 459455019 522254014 430867011 430867016 441676003 479415006 484404005 681287002 434294008 434294013 430867006 433642013 434294011 537230009 588991002 618008010 632486010 690865001 690865005 554713002 681287001 635096008 477323017 484404001 546586009 580744007 587820013 587820018 529636010 450543002 415852010 656990009 434294006 491165014 491165015 528183002 544786016 571919013 610099003 493958005 635096006 660672020 508855001 587820020 451253004 533769015 580744004 459455009 484404016 493960002 571919001 593567017 601217001 601217002 601925008 618008008 631132003 441676006 508855008 528182003 528182016 631132004 462074004 462074005 462074006 462074007 462074008 593567001 433642010 434294017 587820001 450543007 450543008 451253006 451253007 451253008 456698005 456698008 456698010 456698019 467865015 416345004 462074002 529636003 546586002 580744019 587820007 632486006 635096009 688923007 528182006 546586001 522254011 528183006 533769007 537229002 544786007 546586003 571919011 580744014 610099008 647233007 414139011 484404011 522254018 451253010 424978004 450543018 467865020 539183003 554713003 580744016 610099010 533769003 533769008 529636004 588991008 660672016 395455007 529636006 631132010 554713016 462074012 462074013 493958008 493960006 512032004 528182002 528183008 533769006 537229001 539183005 554713005 571919004 587820009 588991005 406656002 456698004 681287008 451253002 479415010 528183012 462074001 462074003 479415002 593567002 544786008 414139014 593567013 601217003 647233005 681287003 358210006 571919019 477323018 528182011 539183008 533769001 580744018 544786001 580744002 673762006 522254007 651976004 430867013 434294010 651976010 462074010 433642005 467865012 433642008 508855004 660672010 462074015 467865017 467865018 467865019 477323020 529636011 456698003 528182019 647233009 384884002 408478005 477323010 508895006 554713014 528183004 554713012 580744003 632486007 651976006 681287004;
 
2) Lot Serial Number Model 72400098 331544008 364861014 378181008 379515015 379515016 381584018 383424011 384677004 387975018 390279019 391689015 392472008 392802016 394617015 397986004 398690003 399152019 399886014 401696018 401698014 403662016 403773004 404506011 405093015 406168014 408796016 409096007 410461012 410463012 411503008 412906004 412913009 413757006 413757008 413860005 413860006 414275001 414757005 414757006 414760017 415271016 415274002 415275003 415276011 415846005 416339019 416340016 416340019 416342013 416932019 416933018 417674002 417776008 418275016 418277017 418773010 418915006 418916015 419374018 419832017 420062013 420063011 420133008 420656014 420658010 421033012 421602010 421603012 421603017 421680018 422720006 422720009 422729014 422802010 423278001 423278009 423797018 424126016 424182002 424234012 424234018 424743014 424810010 425289018 425403005 426068017 426071017 426282003 426376012 426377008 426782010 427219003 427428007 427428014 427825003 427827005 427827018 427828004 427828010 428257008 428278007 428278008 428278009 428278015 428279015 428495001 428495010 428720008 429139012 429580019 429750008 429750010 429750012 429750018 429751012 429856008 429856011 430013010 430180006 430375008 430376005 430376007 430376008 430376010 430592005 430592015 430592016 430748019 430749020 430855005 430855010 430857008 431130002 431130006 431130011 431263011 431263015 431263019 431264003 431264009 431264012 431264014 431264017 431548001 431902008 432044012 432045013 432045016 432045020 432174004 432174009 432174017 432175007 432175010 432175015 432175017 432177008 432177010 432202011 432202014 432203006 432450004 432450007 432748009 432748015 432829005 432830007 432831001 432831007 433031001 433031005 433031009 433031010 433031017 433070006 433070008 433070010 433070019 433071005 433071009 433071011 433071013 433071019 433139001 433139006 433139007 433139008 433139010 433139011 433139012 433438008 433438009 433438011 433438012 433438017 433489002 433489006 433489009 433505001 433505002 433505004 433505005 433505010 433505015 433505017 433567006 433567008 433567009 433567015 433568001 433568002 433568012 433568017 433568018 433643002 433643007 433643015 433643018 433721002 433721005 433721006 433721012 433920001 433920005 433920006 433920010 433920011 433920016 433920019 433920020 434103006 434103007 434103014 434103019 434103020 434191007 434191016 434295017 434613002 434613004 434614001 434614002 434614005 434614013 434942001 434942003 434942009 434943005 434943017 435297004 435297010 435298002 435298003 435298005 435298011 435298014 435298016 435524004 435524005 435524015 435549006 435549007 435549008 435549009 435549012 435549015 435549017 435549018 435759003 435759004 435759007 435759010 435760002 435760009 435760010 435760013 435769009 435769010 435769012 435770003 435770014 435770015 435939011 435939012 435980007 435980008 435980010 435980012 435980013 435980014 435980015 435980016 435980017 435980018 436001019 436177004 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707607010 707607015 707607020 707608018 Lot Serial Number Model number 720172-01 610651001 610651002 610651003 610651004 610651005 610651006 610651007 610651008 610651009 610651010 610651011 610651012 622966001 622966002 622966003 622966004 622966005 628617001 628617002 634914001 634914002 634914003 634914004 634914005 634914006 634914007 634914008 634914009 634914010 649686001 649686002 649686003 649686004 649686005 652568001 664382001 664382002 664382003 664382004 664382005 674801001 674801002 674801003 678805001 678805002 678805003 678805004 678805005 678805006 678805007 678805008 678806001 688224001 688224002 688224003 688224004 688224005 688224006 688224007 688224008 693882001 693882002 693882003 693882004 693882005 693882006 703145001 703145002 703145003 703145004
RECALLING FIRM/MANUFACTURER
American Medical Systems, Inc., Minnetonka, MN, by letter dated May 9, 2011. Firm initiated recall is ongoing.
REASON
American Medical Systems is recalling all unexpired AMS 800 and AMS Acticon Neosphincter Control Pumps. Based upon a review of our product test procedures, we are unable to confirm that all Control Pumps have met our requirements. Test errors could potentially result in a failure to identify a malfunction in the Control Pump activation mechanism. This malfunction may lead to inadvertent activation of the control pump which could lead to a health consequence.
VOLUME OF PRODUCT IN COMMERCE
15,691 (15,466 AMS 800, & 225 ACTICON
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) Jet-Ventilator Catheter for Adults, 14G, Sterile, No Latex, REF 30-02-914-1. Allows a safe and atraumatic transtracheal access for oxygenation/ventilation with a manual jet ventilator or an automatic high frequency jet ventilator. Article number ACU 1060.2. Recall # Z-2675-2011;
 
2) Jet-Ventilator Catheter for Adults, 14G, Sterile, No Latex, REF 30-02-918-1. Allows a safe and atraumatic transtracheal access for oxygenation/ventilation with a manual jet ventilator or an automatic high frequency jet ventilator. Recall # Z-2676-2011
CODE
1) Lot numbers: 28327, 30067, 31065, 32642;
2) Lot number: 28326
RECALLING FIRM/MANUFACTURER
Recalling Firm: VBM Medical Inc., Noblesville, IN, by letter dated May 9, 2011.
Manufacturer: VBM Medizintechnik GmbH, Sulz Am Neckar, Germany. Firm initiated recall is ongoing.
REASON
Product labeled with incorrectly as being appropriate for use in adults when the intended population for use of the product is children and infants.
VOLUME OF PRODUCT IN COMMERCE
417 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Oxford Femoral Knee System REF 154600, WARNING DO NOT RESTERILIZE, Sterile Unless Pack Damaged, (510K# K011138). This device is used in partial knee replacement surgery as a result of patients who are experiencing degenerative arthritis. Recall # Z-2698-2011
CODE
Lot number: 2272736
RECALLING FIRM/MANUFACTURER
Biomet U.K., Ltd. Bridgend, South Wales, United Kingdom, by letter dated April 21, 2011. Firm initiated recall is ongoing.
REASON
This recall was initiated due to a customer complaint which reported that while peeling off the Tyvek lid on the blister pack, very little effort was required to remove it and this could lead to contamination of the device.
VOLUME OF PRODUCT IN COMMERCE
12 devices
DISTRIBUTION
Austria, Belgium, and Germany
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PRODUCT
Codman Enterprise Vascular Reconstruction Device and Delivery System 4.5mm x 28mm Product code: ENF452812. Recall # Z-2701-2011
CODE
Lot Numbers: 01420432, 01420851, 01421192, 01421315, 01421338, 01421601, 01421949, 01422123, 01422396, 01422401, 02420432, VV1419796
RECALLING FIRM/MANUFACTURER
Codman & Shurtleff, Inc., Raynham, MA, by letters on March 21, 2011. Firm initiated recall is ongoing.
REASON
Mislabeled: One of the stick on stickers on the sterile pouch inside of the product box indicates the stent size to be 22mm in length, when in fact the product is 28mm in length.
VOLUME OF PRODUCT IN COMMERCE
380 units
DISTRIBUTION
Nationwide, Canada and Korea
_______________________________________
PRODUCT
Eclipse Radiation Treatment Planning System, model H48. Recall # Z-2702-2011
CODE
Units: H480004 H480090 H480215 H480355 H480469 H480614 H480711 H480863 H480989 H481203 H481293 H480005 H480091 H480216 H480356 H480473 H480619 H480718 H480869 H480992 H481204 H481296 H480006 H480095 H480221 H480357 H480474 H480621 H480729 H480870 H480994 H481213 H481298 H480007 H480096 H480222 H480365 H480475 H480626 H480732 H480881 H480996 H481214 H481300 H480009 H480105 H480223 H480369 H480476 H480627 H480733 H480883 H480997 H481220 H481301 H480010 H480106 H480224 H480370 H480481 H480628 H480739 H480884 H480998 H481221 H481308 H480011 H480112 H480236 H480371 H480482 H480629 H480740 H480886 H480999 H481223 H481311 H480012 H480113 H480237 H480372 H480485 H480630 H480746 H480887 H481000 H481224 H481315 H480013 H480115 H480245 H480373 H480486 H480631 H480747 H480890 H481002 H481225 H481316 H480014 H480118 H480246 H480374 H480487 H480632 H480748 H480892 H481005 H481226 H481317 H480023 H480119 H480247 H480375 H480488 H480633 H480749 H480898 H481006 H481227 H481318 H480024 H480121 H480248 H480376 H480489 H480634 H480750 H480899 H481007 H481228 H481328 H480025 H480122 H480249 H480377 H480490 H480635 H480751 H480901 H481008 H481229 H481329 H480026 H480123 H480256 H480382 H480491 H480636 H480755 H480902 H481009 H481230 H481334 H480027 H480124 H480257 H480383 H480492 H480637 H480756 H480903 H481010 H481231 H481335 H480028 H480125 H480265 H480384 H480494 H480638 H480757 H480913 H481038 H481236 H481341 H480031 H480126 H480277 H480403 H480495 H480640 H480758 H480915 H481054 H481237 H481342 H480034 H480127 H480281 H480404 H480496 H480641 H480759 H480927 H481055 H481256 H481343 H480035 H480131 H480282 H480405 H480497 H480642 H480761 H480936 H481062 H481257 H481345 H480036 H480138 H480286 H480406 H480498 H480643 H480772 H480939 H481070 H481262 H481346 H480037 H480139 H480294 H480408 H480513 H480644 H480774 H480940 H481077 H481263 H481347 H480038 H480141 H480297 H480409 H480514 H480646 H480781 H480941 H481078 H481264 H481348 H480039 H480143 H480298 H480410 H480518 H480647 H480789 H480942 H481092 H481265 H481349 H480042 H480147 H480300 H480411 H480519 H480651 H480790 H480943 H481093 H481266 H481358 H480046 H480148 H480305 H480412 H480529 H480653 H480791 H480944 H481094 H481267 H481359 H480047 H480149 H480306 H480413 H480536 H480654 H480792 H480947 H481095 H481268 H481360 H480048 H480150 H480307 H480414 H480539 H480655 H480796 H480948 H481096 H481269 H481361 H480056 H480152 H480308 H480415 H480541 H480657 H480797 H480949 H481097 H481270 H481362 H480057 H480153 H480311 H480416 H480549 H480658 H480802 H480950 H481108 H481271 H481363 H480058 H480154 H480312 H480417 H480570 H480660 H480808 H480952 H481114 H481272 H481366 H480059 H480155 H480313 H480418 H480571 H480661 H480809 H480953 H481115 H481273 H481367 H480060 H480156 H480314 H480419 H480572 H480663 H480810 H480954 H481133 H481274 H481381 H480061 H480157 H480315 H480420 H480573 H480665 H480811 H480955 H481134 H481275 H481382 H480062 H480158 H480318 H480421 H480574 H480667 H480812 H480956 H481136 H481276 H481383 H480063 H480180 H480321 H480423 H480575 H480672 H480813 H480957 H481143 H481277 H481397 H480064 H480181 H480322 H480424 H480576 H480673 H480815 H480958 H481144 H481278 H481398 H480065 H480187 H480323 H480433 H480583 H480674 H480827 H480959 H481153 H481279 H481399 H480066 H480188 H480324 H480434 H480585 H480675 H480828 H480960 H481154 H481280 H481401 H480078 H480189 H480325 H480435 H480586 H480679 H480829 H480962 H481155 H481281 H481402 H480079 H480190 H480326 H480436 H480587 H480682 H480830 H480965 H481156 H481282 H481405 H480080 H480201 H480327 H480437 H480592 H480683 H480831 H480966 H481157 H481283 H481419 H480081 H480202 H480328 H480438 H480593 H480684 H480832 H480968 H481158 H481284 H481428 H480082 H480203 H480329 H480439 H480599 H480699 H480855 H480980 H481159 H481285 H481434 H480083 H480204 H480330 H480440 H480600 H480700 H480856 H480982 H481160 H481286 H481435 H480084 H480205 H480331 H480441 H480604 H480701 H480857 H480983 H481169 H481287 H481442 H480085 H480206 H480332 H480461 H480605 H480705 H480858 H480984 H481184 H481288 H481445 H480086 H480211 H480333 H480462 H480610 H480707 H480859 H480985 H481188 H481289 H481465 H480087 H480212 H480334 H480463 H480611 H480708 H480860 H480986 H481193 H481290 H481466 H480088 H480213 H480335 H480467 H480612 H480709 H480861 H480987 H481194 H481291 H481476 H480089 H480214 H480339 H480468 H480613 H480710 H480862 H480988 H481195 H481292 H481494 H481499 H481662 H481798 H481926 H481995 H482045 H482095 H482228 H482347 H482534 H482662 H481502 H481663 H481799 H481927 H481996 H482046 H482096 H482229 H482348 H482539 H482663 H481515 H481664 H481800 H481928 H481997 H482047 H482097 H482242 H482349 H482550 H482671 H481517 H481665 H481801 H481929 H481998 H482048 H482098 H482243 H482350 H482551 H482678 H481518 H481666 H481810 H481930 H481999 H482049 H482099 H482250 H482351 H482552 H482679 H481519 H481678 H481812 H481931 H482000 H482050 H482100 H482251 H482352 H482555 H482680 H481520 H481679 H481813 H481932 H482001 H482051 H482101 H482252 H482353 H482557 H482681 H481521 H481680 H481814 H481933 H482002 H482052 H482102 H482253 H482354 H482559 H482682 H481525 H481681 H481818 H481934 H482003 H482053 H482103 H482254 H482355 H482560 H482683 H481530 H481682 H481820 H481936 H482004 H482054 H482104 H482258 H482356 H482561 H482684 H481531 H481683 H481828 H481953 H482005 H482055 H482105 H482259 H482357 H482566 H482685 H481540 H481684 H481829 H481956 H482006 H482056 H482106 H482260 H482358 H482567 H482686 H481547 H481685 H481830 H481957 H482007 H482057 H482107 H482261 H482359 H482568 H482687 H481558 H481689 H481831 H481958 H482008 H482058 H482108 H482262 H482360 H482569 H482688 H481562 H481690 H481832 H481959 H482009 H482059 H482109 H482263 H482361 H482579 H482689 H481563 H481707 H481833 H481960 H482010 H482060 H482110 H482264 H482362 H482580 H482699 H481564 H481716 H481837 H481961 H482011 H482061 H482111 H482265 H482367 H482581 H482700 H481565 H481717 H481838 H481962 H482012 H482062 H482112 H482272 H482369 H482587 H482701 H481585 H481718 H481845 H481963 H482013 H482063 H482113 H482274 H482389 H482588 H482702 H481586 H481719 H481857 H481964 H482014 H482064 H482114 H482275 H482390 H482589 H482703 H481587 H481720 H481864 H481965 H482015 H482065 H482115 H482276 H482391 H482592 H482705 H481588 H481727 H481865 H481966 H482016 H482066 H482156 H482277 H482396 H482594 H482706 H481589 H481728 H481870 H481967 H482017 H482067 H482157 H482278 H482397 H482595 H482709 H481606 H481729 H481871 H481968 H482018 H482068 H482160 H482279 H482398 H482596 H482710 H481610 H481732 H481872 H481969 H482019 H482069 H482161 H482281 H482399 H482597 H482711 H481611 H481733 H481873 H481970 H482020 H482070 H482164 H482284 H482407 H482598 H482712 H481612 H481734 H481874 H481971 H482021 H482071 H482165 H482296 H482408 H482599 H482713 H481621 H481735 H481875 H481972 H482022 H482072 H482172 H482309 H482409 H482601 H482715 H481622 H481736 H481876 H481973 H482023 H482073 H482178 H482310 H482410 H482602 H482716 H481626 H481737 H481879 H481974 H482024 H482074 H482181 H482323 H482440 H482603 H482717 H481627 H481738 H481884 H481975 H482025 H482075 H482182 H482327 H482441 H482604 H482725 H481631 H481739 H481885 H481976 H482026 H482076 H482183 H482328 H482457 H482605 H482758 H481638 H481740 H481886 H481977 H482027 H482077 H482185 H482329 H482462 H482613 H482761 H481640 H481741 H481889 H481978 H482028 H482078 H482186 H482330 H482463 H482619 H482762 H481644 H481742 H481890 H481979 H482029 H482079 H482187 H482331 H482476 H482620 H482764 H481645 H481743 H481891 H481980 H482030 H482080 H482188 H482332 H482481 H482621 H482765 H481646 H481750 H481893 H481981 H482031 H482081 H482194 H482333 H482484 H482624 H482766 H481647 H481757 H481894 H481982 H482032 H482082 H482195 H482334 H482491 H482628 H482767 H481648 H481758 H481896 H481983 H482033 H482083 H482198 H482335 H482500 H482629 H482768 H481649 H481759 H481897 H481984 H482034 H482084 H482201 H482336 H482501 H482646 H482773 H481650 H481760 H481898 H481985 H482035 H482085 H482203 H482337 H482502 H482647 H482774 H481651 H481771 H481899 H481986 H482036 H482086 H482209 H482338 H482503 H482648 H482792 H481652 H481777 H481909 H481987 H482037 H482087 H482210 H482339 H482504 H482649 H482794 H481653 H481778 H481916 H481988 H482038 H482088 H482211 H482340 H482505 H482650 H482795 H481654 H481779 H481918 H481989 H482039 H482089 H482212 H482341 H482506 H482651 H482796 H481655 H481780 H481919 H481990 H482040 H482090 H482213 H482342 H482508 H482652 H482797 H481656 H481781 H481920 H481991 H482041 H482091 H482214 H482343 H482509 H482653 H482799 H481657 H481787 H481923 H481992 H482042 H482092 H482215 H482344 H482519 H482654 H482801 H481658 H481788 H481924 H481993 H482043 H482093 H482225 H482345 H482522 H482658 H482802 H481659 H481794 H481925 H481994 H482044 H482094 H482226 H482346 H482527 H482661 H482812 H482813 H482985 H483130 H483248 H483336 H483436 H483625 H483775 H483939 H484104 H484268 H482817 H482986 H483131 H483249 H483337 H483437 H483626 H483776 H483940 H484113 H484269 H482821 H482987 H483133 H483250 H483338 H483438 H483627 H483777 H483941 H484114 H484270 H482822 H482988 H483134 H483254 H483339 H483439 H483628 H483778 H483964 H484116 H484271 H482823 H482989 H483135 H483257 H483341 H483440 H483632 H483779 H483970 H484117 H484283 H482839 H482990 H483136 H483265 H483342 H483441 H483633 H483780 H483973 H484118 H484286 H482840 H482991 H483137 H483266 H483343 H483444 H483634 H483797 H483977 H484119 H484294 H482841 H482992 H483138 H483267 H483344 H483445 H483635 H483799 H483978 H484120 H484295 H482846 H483010 H483139 H483273 H483345 H483446 H483636 H483800 H483979 H484135 H484296 H482847 H483011 H483140 H483274 H483354 H483447 H483651 H483801 H483986 H484151 H484297 H482852 H483014 H483141 H483277 H483355 H483452 H483652 H483802 H483994 H484166 H484298 H482854 H483015 H483142 H483278 H483359 H483455 H483653 H483809 H483995 H484174 H484299 H482855 H483016 H483143 H483279 H483360 H483459 H483662 H483810 H483996 H484186 H484300 H482856 H483017 H483144 H483280 H483361 H483460 H483663 H483811 H483997 H484190 H484301 H482857 H483024 H483145 H483281 H483362 H483462 H483664 H483812 H483998 H484191 H484302 H482858 H483025 H483146 H483282 H483363 H483470 H483665 H483813 H483999 H484192 H484303 H482859 H483026 H483147 H483283 H483364 H483488 H483666 H483817 H484000 H484193 H484304 H482860 H483027 H483151 H483286 H483365 H483494 H483667 H483824 H484001 H484194 H484305 H482861 H483042 H483152 H483287 H483366 H483501 H483668 H483825 H484008 H484198 H484306 H482862 H483043 H483153 H483288 H483367 H483506 H483674 H483826 H484009 H484199 H484307 H482863 H483044 H483157 H483289 H483369 H483522 H483675 H483831 H484014 H484213 H484308 H482866 H483051 H483161 H483290 H483373 H483532 H483676 H483844 H484015 H484214 H484309 H482867 H483052 H483162 H483291 H483374 H483533 H483677 H483847 H484016 H484215 H484310 H482868 H483059 H483163 H483292 H483375 H483534 H483682 H483848 H484017 H484216 H484320 H482869 H483070 H483164 H483294 H483376 H483537 H483683 H483849 H484031 H484217 H484321 H482870 H483071 H483165 H483295 H483378 H483546 H483684 H483850 H484032 H484218 H484322 H482876 H483072 H483176 H483296 H483379 H483554 H483694 H483851 H484033 H484219 H484332 H482877 H483073 H483182 H483297 H483380 H483556 H483695 H483856 H484034 H484220 H484334 H482878 H483084 H483183 H483298 H483382 H483558 H483696 H483860 H484035 H484222 H484335 H482879 H483088 H483184 H483299 H483383 H483559 H483705 H483862 H484036 H484224 H484336 H482880 H483089 H483185 H483300 H483384 H483560 H483712 H483868 H484039 H484225 H484346 H482888 H483097 H483186 H483301 H483385 H483566 H483713 H483874 H484040 H484226 H484354 H482889 H483099 H483194 H483302 H483386 H483567 H483715 H483914 H484041 H484227 H484362 H482892 H483100 H483197 H483303 H483388 H483568 H483716 H483915 H484042 H484233 H484363 H482893 H483101 H483200 H483306 H483389 H483569 H483721 H483916 H484043 H484234 H484368 H482894 H483102 H483203 H483309 H483403 H483586 H483722 H483917 H484044 H484235 H484369 H482920 H483106 H483204 H483311 H483404 H483589 H483726 H483921 H484045 H484236 H484370 H482925 H483109 H483206 H483315 H483405 H483590 H483727 H483922 H484051 H484237 H484371 H482935 H483110 H483207 H483317 H483407 H483599 H483728 H483923 H484062 H484238 H484372 H482936 H483117 H483208 H483318 H483416 H483600 H483731 H483924 H484063 H484239 H484374 H482938 H483118 H483209 H483319 H483417 H483602 H483732 H483925 H484079 H484240 H484381 H482939 H483119 H483215 H483321 H483418 H483606 H483733 H483926 H484085 H484241 H484382 H482940 H483121 H483223 H483327 H483419 H483609 H483754 H483927 H484090 H484242 H484383 H482941 H483123 H483224 H483328 H483420 H483611 H483756 H483928 H484091 H484243 H484384 H482942 H483124 H483225 H483330 H483421 H483616 H483766 H483929 H484092 H484244 H484385 H482943 H483125 H483242 H483331 H483422 H483620 H483769 H483930 H484093 H484245 H484388 H482970 H483126 H483243 H483332 H483427 H483621 H483771 H483932 H484094 H484246 H484389 H482982 H483127 H483244 H483333 H483431 H483622 H483772 H483933 H484095 H484247 H484390 H482983 H483128 H483245 H483334 H483433 H483623 H483773 H483937 H484096 H484248 H484391 H482984 H483129 H483246 H483335 H483435 H483624 H483774 H483938 H484103 H484258 H484392 H484403 H484528 H484622 H484735 H484819 H484971 H485097 H485216 H485314 H485446 H485569 H484404 H484529 H484625 H484736 H484820 H484972 H485099 H485217 H485319 H485447 H485570 H484408 H484530 H484626 H484737 H484822 H484973 H485102 H485218 H485320 H485448 H485571 H484409 H484531 H484627 H484738 H484823 H484975 H485103 H485222 H485335 H485451 H485572 H484410 H484532 H484628 H484739 H484824 H484976 H485104 H485223 H485337 H485452 H485576 H484411 H484533 H484629 H484740 H484825 H484977 H485105 H485224 H485338 H485454 H485577 H484412 H484534 H484630 H484741 H484826 H484978 H485106 H485225 H485339 H485455 H485578 H484413 H484535 H484631 H484742 H484827 H484987 H485107 H485226 H485340 H485457 H485579 H484414 H484536 H484632 H484752 H484837 H484988 H485108 H485227 H485341 H485458 H485580 H484415 H484537 H484634 H484753 H484839 H484989 H485112 H485231 H485342 H485460 H485581 H484416 H484538 H484641 H484754 H484846 H484990 H485118 H485234 H485344 H485461 H485582 H484419 H484541 H484659 H484755 H484847 H484992 H485119 H485240 H485345 H485463 H485583 H484421 H484542 H484661 H484756 H484858 H484993 H485120 H485241 H485346 H485465 H485586 H484422 H484543 H484662 H484761 H484862 H484994 H485121 H485243 H485352 H485466 H485587 H484423 H484544 H484663 H484762 H484863 H484995 H485122 H485250 H485353 H485468 H485592 H484424 H484545 H484665 H484763 H484865 H484996 H485129 H485251 H485354 H485469 H485593 H484425 H484549 H484670 H484764 H484866 H484997 H485130 H485253 H485355 H485470 H485594 H484426 H484550 H484671 H484765 H484872 H484998 H485131 H485254 H485356 H485472 H485595 H484427 H484551 H484672 H484766 H484873 H484999 H485132 H485255 H485362 H485473 H485597 H484431 H484552 H484682 H484767 H484874 H485000 H485133 H485256 H485366 H485475 H485599 H484436 H484554 H484691 H484768 H484895 H485001 H485134 H485257 H485370 H485476 H485602 H484439 H484556 H484692 H484781 H484896 H485002 H485136 H485258 H485374 H485477 H485603 H484440 H484557 H484693 H484782 H484897 H485003 H485148 H485262 H485375 H485478 H485612 H484441 H484558 H484694 H484787 H484898 H485004 H485152 H485264 H485376 H485485 H485613 H484442 H484559 H484708 H484791 H484899 H485005 H485161 H485265 H485377 H485486 H485614 H484443 H484560 H484709 H484792 H484900 H485006 H485188 H485266 H485378 H485487 H485615 H484444 H484561 H484710 H484793 H484901 H485007 H485189 H485268 H485379 H485488 H485620 H484445 H484562 H484711 H484794 H484903 H485012 H485190 H485269 H485380 H485489 H485621 H484446 H484563 H484712 H484795 H484910 H485013 H485191 H485270 H485382 H485490 H485622 H484447 H484564 H484714 H484798 H484911 H485020 H485194 H485271 H485383 H485491 H485629 H484448 H484593 H484715 H484799 H484912 H485021 H485195 H485272 H485388 H485492 H485630 H484449 H484594 H484716 H484800 H484916 H485024 H485196 H485273 H485393 H485516 H485642 H484464 H484598 H484717 H484801 H484917 H485025 H485197 H485274 H485396 H485526 H485644 H484465 H484599 H484718 H484802 H484923 H485026 H485198 H485275 H485397 H485527 H485645 H484481 H484600 H484719 H484803 H484925 H485027 H485199 H485283 H485398 H485533 H485648 H484482 H484601 H484720 H484804 H484926 H485028 H485200 H485284 H485400 H485534 H485653 H484483 H484602 H484721 H484805 H484932 H485029 H485201 H485286 H485401 H485541 H485654 H484485 H484603 H484722 H484806 H484933 H485030 H485202 H485288 H485413 H485542 H485662 H484494 H484604 H484723 H484807 H484934 H485033 H485203 H485289 H485418 H485543 H485663 H484496 H484605 H484724 H484808 H484939 H485035 H485204 H485290 H485419 H485545 H485667 H484501 H484606 H484725 H484809 H484941 H485036 H485205 H485292 H485420 H485546 H485668 H484502 H484607 H484726 H484810 H484943 H485038 H485206 H485293 H485421 H485547 H485669 H484503 H484608 H484727 H484811 H484948 H485039 H485207 H485294 H485437 H485548 H485672 H484504 H484612 H484728 H484812 H484950 H485043 H485209 H485295 H485438 H485549 H485678 H484509 H484613 H484729 H484813 H484951 H485044 H485210 H485296 H485439 H485550 H485679 H484510 H484616 H484730 H484814 H484952 H485051 H485211 H485307 H485440 H485551 H485682 H484511 H484617 H484731 H484815 H484953 H485079 H485212 H485309 H485442 H485552 H485683 H484512 H484619 H484732 H484816 H484966 H485087 H485213 H485310 H485443 H485553 H485694 H484526 H484620 H484733 H484817 H484968 H485088 H485214 H485312 H485444 H485554 H485699 H484527 H484621 H484734 H484818 H484970 H485092 H485215 H485313 H485445 H485555 H485700 H485701 H485775 H485912 H486065 H486134 H486286 H486380 H486481 H486594 H486698 H486829 H485702 H485789 H485917 H486067 H486136 H486287 H486381 H486482 H486597 H486699 H486830 H485703 H485798 H485918 H486069 H486143 H486288 H486382 H486487 H486598 H486700 H486831 H485704 H485799 H485919 H486070 H486144 H486289 H486383 H486492 H486599 H486701 H486832 H485705 H485804 H485920 H486071 H486187 H486290 H486384 H486493 H486600 H486702 H486833 H485709 H485805 H485921 H486072 H486188 H486292 H486386 H486494 H486603 H486703 H486834 H485710 H485806 H485922 H486073 H486189 H486293 H486387 H486495 H486604 H486704 H486835 H485711 H485807 H485923 H486074 H486190 H486294 H486399 H486496 H486605 H486705 H486836 H485715 H485808 H485924 H486075 H486191 H486298 H486405 H486497 H486613 H486706 H486837 H485719 H485809 H485925 H486076 H486198 H486299 H486411 H486500 H486614 H486707 H486838 H485720 H485810 H485926 H486079 H486199 H486306 H486418 H486506 H486617 H486708 H486839 H485722 H485811 H485929 H486080 H486200 H486309 H486419 H486507 H486618 H486715 H486842 H485723 H485827 H485933 H486082 H486201 H486310 H486420 H486508 H486619 H486721 H486843 H485724 H485831 H485934 H486088 H486205 H486322 H486421 H486511 H486620 H486722 H486844 H485725 H485832 H485935 H486089 H486206 H486323 H486434 H486520 H486621 H486723 H486845 H485726 H485833 H485936 H486091 H486207 H486324 H486436 H486522 H486624 H486724 H486846 H485727 H485844 H485937 H486092 H486208 H486325 H486439 H486523 H486626 H486731 H486849 H485728 H485845 H485938 H486093 H486213 H486326 H486441 H486524 H486628 H486735 H486850 H485732 H485848 H485939 H486094 H486218 H486327 H486442 H486535 H486638 H486736 H486851 H485733 H485849 H485940 H486095 H486219 H486328 H486443 H486536 H486639 H486737 H486852 H485734 H485850 H485942 H486097 H486220 H486329 H486444 H486537 H486642 H486738 H486853 H485736 H485851 H485946 H486098 H486223 H486330 H486445 H486538 H486643 H486739 H486854 H485737 H485852 H485949 H486099 H486226 H486333 H486451 H486539 H486644 H486740 H486855 H485739 H485853 H485964 H486100 H486227 H486335 H486452 H486540 H486645 H486757 H486856 H485740 H485854 H485966 H486101 H486230 H486336 H486453 H486541 H486646 H486758 H486857 H485741 H485855 H485971 H486102 H486231 H486339 H486454 H486542 H486653 H486759 H486866 H485742 H485857 H485972 H486103 H486233 H486340 H486455 H486547 H486654 H486760 H486867 H485751 H485858 H485973 H486104 H486234 H486341 H486456 H486549 H486655 H486769 H486868 H485752 H485859 H485982 H486105 H486235 H486343 H486457 H486553 H486656 H486781 H486869 H485753 H485860 H485983 H486108 H486245 H486346 H486458 H486554 H486660 H486782 H486870 H485754 H485862 H485984 H486109 H486246 H486347 H486459 H486555 H486661 H486784 H486871 H485756 H485863 H485985 H486113 H486253 H486348 H486460 H486556 H486662 H486785 H486872 H485757 H485867 H485989 H486116 H486254 H486349 H486461 H486557 H486663 H486786 H486873 H485758 H485868 H485991 H486117 H486255 H486350 H486462 H486558 H486664 H486797 H486874 H485759 H485869 H485992 H486118 H486256 H486351 H486464 H486559 H486666 H486798 H486875 H485760 H485870 H485994 H486119 H486257 H486352 H486465 H486560 H486667 H486799 H486876 H485761 H485871 H485995 H486120 H486258 H486353 H486466 H486565 H486668 H486803 H486878 H485762 H485872 H485996 H486121 H486259 H486355 H486467 H486566 H486670 H486804 H486879 H485763 H485873 H486003 H486122 H486260 H486368 H486468 H486567 H486683 H486806 H486880 H485764 H485875 H486004 H486123 H486261 H486369 H486469 H486568 H486685 H486807 H486881 H485765 H485876 H486005 H486124 H486262 H486370 H486470 H486570 H486686 H486808 H486882 H485766 H485886 H486007 H486125 H486263 H486371 H486471 H486571 H486687 H486816 H486883 H485767 H485887 H486009 H486126 H486264 H486372 H486473 H486572 H486688 H486817 H486884 H485768 H485888 H486022 H486127 H486273 H486373 H486474 H486583 H486689 H486818 H486888 H485769 H485889 H486023 H486128 H486274 H486374 H486475 H486584 H486690 H486820 H486889 H485770 H485907 H486026 H486129 H486275 H486375 H486476 H486589 H486691 H486821 H486890 H485771 H485908 H486038 H486130 H486276 H486376 H486477 H486590 H486693 H486823 H486891 H485772 H485909 H486062 H486131 H486277 H486377 H486478 H486591 H486695 H486824 H486892 H485773 H485910 H486063 H486132 H486284 H486378 H486479 H486592 H486696 H486825 H486893 H485774 H485911 H486064 H486133 H486285 H486379 H486480 H486593 H486697 H486828 H486897 H486907 H487002 H487138 H487210 H487323 H487432 H487540 H487636 H487794 H487861 H487940 H486914 H487003 H487139 H487211 H487324 H487434 H487549 H487643 H487795 H487862 H487941 H486918 H487004 H487140 H487215 H487325 H487435 H487550 H487644 H487801 H487863 H487942 H486919 H487005 H487141 H487216 H487326 H487438 H487552 H487645 H487802 H487864 H487943 H486921 H487006 H487142 H487217 H487327 H487440 H487553 H487646 H487803 H487866 H487944 H486922 H487007 H487143 H487218 H487328 H487441 H487554 H487647 H487804 H487867 H487945 H486923 H487008 H487144 H487219 H487331 H487442 H487555 H487676 H487805 H487868 H487946 H486924 H487009 H487145 H487220 H487332 H487446 H487556 H487677 H487806 H487871 H487948 H486930 H487010 H487146 H487223 H487333 H487447 H487557 H487678 H487807 H487873 H487949 H486931 H487019 H487147 H487224 H487335 H487448 H487564 H487679 H487808 H487874 H487950 H486932 H487020 H487148 H487226 H487336 H487449 H487565 H487695 H487809 H487876 H487951 H486933 H487021 H487149 H487227 H487337 H487450 H487566 H487696 H487810 H487882 H487952 H486934 H487022 H487150 H487228 H487338 H487452 H487567 H487697 H487811 H487883 H487953 H486935 H487023 H487151 H487232 H487339 H487453 H487568 H487708 H487812 H487884 H487961 H486938 H487024 H487152 H487241 H487343 H487458 H487569 H487709 H487817 H487886 H487962 H486939 H487025 H487153 H487243 H487344 H487460 H487570 H487720 H487818 H487890 H487963 H486940 H487026 H487154 H487244 H487345 H487461 H487573 H487721 H487819 H487891 H487964 H486942 H487027 H487155 H487261 H487346 H487470 H487574 H487723 H487820 H487892 H487965 H486943 H487028 H487156 H487262 H487347 H487493 H487577 H487724 H487821 H487893 H487966 H486945 H487031 H487157 H487263 H487352 H487494 H487579 H487725 H487822 H487894 H487967 H486949 H487032 H487158 H487264 H487381 H487495 H487581 H487729 H487823 H487897 H487968 H486950 H487038 H487159 H487265 H487382 H487496 H487582 H487730 H487824 H487898 H487969 H486951 H487039 H487160 H487280 H487383 H487500 H487583 H487731 H487828 H487899 H487970 H486962 H487066 H487161 H487281 H487384 H487501 H487584 H487732 H487829 H487900 H487971 H486963 H487067 H487162 H487286 H487386 H487502 H487587 H487735 H487830 H487902 H487972 H486964 H487068 H487174 H487287 H487387 H487503 H487588 H487737 H487831 H487903 H487973 H486965 H487069 H487175 H487288 H487392 H487504 H487590 H487739 H487832 H487904 H487977 H486967 H487070 H487176 H487289 H487393 H487505 H487591 H487740 H487834 H487905 H487980 H486968 H487071 H487182 H487290 H487394 H487506 H487592 H487755 H487835 H487909 H487981 H486969 H487072 H487183 H487293 H487395 H487507 H487593 H487759 H487836 H487910 H487982 H486970 H487073 H487184 H487294 H487396 H487508 H487594 H487761 H487837 H487911 H487983 H486971 H487074 H487185 H487295 H487397 H487509 H487603 H487762 H487838 H487912 H487984 H486972 H487075 H487186 H487296 H487398 H487510 H487604 H487763 H487839 H487913 H487991 H486978 H487078 H487187 H487298 H487399 H487511 H487605 H487766 H487840 H487919 H487992 H486979 H487079 H487190 H487299 H487400 H487512 H487606 H487769 H487841 H487920 H487993 H486980 H487080 H487191 H487300 H487403 H487513 H487607 H487771 H487842 H487921 H487998 H486981 H487081 H487192 H487301 H487407 H487518 H487612 H487772 H487843 H487922 H488000 H486982 H487082 H487193 H487302 H487408 H487519 H487613 H487773 H487844 H487923 H488006 H486990 H487083 H487195 H487303 H487410 H487520 H487614 H487774 H487845 H487924 H488007 H486991 H487084 H487196 H487304 H487411 H487526 H487615 H487775 H487846 H487927 H488008 H486992 H487085 H487197 H487305 H487412 H487527 H487619 H487776 H487848 H487928 H488009 H486993 H487089 H487198 H487306 H487413 H487528 H487622 H487777 H487849 H487929 H488010 H486994 H487130 H487199 H487307 H487415 H487532 H487624 H487778 H487850 H487930 H488011 H486995 H487131 H487200 H487308 H487416 H487533 H487625 H487779 H487851 H487933 H488012 H486996 H487132 H487201 H487309 H487417 H487534 H487626 H487780 H487852 H487934 H488013 H486997 H487133 H487202 H487313 H487418 H487535 H487627 H487781 H487853 H487935 H488014 H486998 H487134 H487203 H487314 H487423 H487536 H487630 H487785 H487854 H487936 H488015 H486999 H487135 H487204 H487315 H487426 H487537 H487633 H487786 H487855 H487937 H488016 H487000 H487136 H487205 H487321 H487427 H487538 H487634 H487788 H487859 H487938 H488017 H487001 H487137 H487206 H487322 H487431 H487539 H487635 H487789 H487860 H487939 H488018 H488019 H488126 H488214 H488298 H488375 H488455 H488539 H488627 H488686 H488770 H488862 H488020 H488127 H488215 H488299 H488376 H488456 H488541 H488628 H488687 H488771 H488863 H488021 H488128 H488216 H488300 H488377 H488459 H488542 H488629 H488688 H488772 H488864 H488026 H488129 H488218 H488301 H488378 H488460 H488543 H488630 H488689 H488773 H488865 H488027 H488130 H488219 H488302 H488379 H488461 H488544 H488631 H488690 H488779 H488866 H488028 H488131 H488220 H488303 H488380 H488465 H488545 H488633 H488691 H488780 H488867 H488033 H488132 H488221 H488304 H488381 H488466 H488546 H488635 H488692 H488782 H488868 H488042 H488134 H488225 H488305 H488382 H488467 H488549 H488636 H488693 H488783 H488869 H488047 H488135 H488227 H488306 H488383 H488468 H488550 H488637 H488694 H488784 H488872 H488048 H488136 H488228 H488307 H488384 H488469 H488551 H488638 H488695 H488785 H488873 H488049 H488137 H488230 H488308 H488385 H488470 H488552 H488639 H488696 H488786 H488874 H488050 H488144 H488232 H488309 H488387 H488471 H488553 H488640 H488698 H488787 H488875 H488051 H488163 H488233 H488310 H488388 H488472 H488558 H488641 H488699 H488788 H488876 H488054 H488164 H488235 H488311 H488389 H488473 H488559 H488642 H488701 H488792 H488877 H488055 H488169 H488240 H488312 H488390 H488474 H488560 H488643 H488702 H488793 H488878 H488056 H488170 H488241 H488313 H488391 H488475 H488561 H488649 H488703 H488798 H488879 H488057 H488171 H488242 H488320 H488397 H488476 H488564 H488650 H488706 H488799 H488880 H488058 H488172 H488245 H488321 H488399 H488477 H488565 H488651 H488707 H488801 H488881 H488059 H488173 H488250 H488322 H488401 H488478 H488569 H488652 H488708 H488804 H488882 H488061 H488174 H488251 H488323 H488403 H488481 H488570 H488653 H488709 H488805 H488883 H488062 H488175 H488253 H488324 H488404 H488482 H488573 H488654 H488710 H488809 H488884 H488063 H488176 H488255 H488325 H488405 H488483 H488574 H488655 H488711 H488817 H488885 H488064 H488177 H488256 H488326 H488408 H488488 H488575 H488656 H488713 H488818 H488886 H488072 H488178 H488257 H488327 H488409 H488489 H488576 H488657 H488714 H488820 H488889 H488073 H488179 H488258 H488328 H488411 H488490 H488577 H488658 H488715 H488826 H488890 H488075 H488182 H488259 H488329 H488412 H488491 H488578 H488659 H488720 H488827 H488891 H488076 H488183 H488260 H488330 H488413 H488492 H488579 H488660 H488722 H488828 H488892 H488077 H488184 H488263 H488331 H488414 H488493 H488585 H488661 H488724 H488830 H488893 H488079 H488185 H488264 H488332 H488415 H488494 H488586 H488662 H488729 H488831 H488894 H488080 H488188 H488265 H488336 H488416 H488495 H488587 H488663 H488730 H488832 H488895 H488081 H488189 H488266 H488350 H488417 H488496 H488588 H488664 H488731 H488833 H488896 H488089 H488190 H488267 H488351 H488418 H488497 H488589 H488665 H488732 H488834 H488897 H488090 H488191 H488268 H488352 H488419 H488498 H488590 H488666 H488736 H488835 H488899 H488091 H488192 H488269 H488353 H488420 H488499 H488591 H488667 H488738 H488836 H488900 H488092 H488193 H488270 H488354 H488421 H488507 H488592 H488668 H488739 H488837 H488901 H488093 H488194 H488271 H488355 H488422 H488508 H488593 H488669 H488740 H488838 H488902 H488094 H488196 H488272 H488356 H488424 H488512 H488596 H488672 H488741 H488839 H488903 H488096 H488197 H488273 H488357 H488425 H488513 H488597 H488673 H488742 H488840 H488906 H488101 H488198 H488274 H488358 H488426 H488514 H488598 H488674 H488743 H488850 H488907 H488107 H488199 H488281 H488359 H488427 H488515 H488599 H488675 H488744 H488851 H488910 H488109 H488200 H488282 H488360 H488429 H488519 H488600 H488676 H488746 H488852 H488912 H488114 H488201 H488283 H488361 H488431 H488520 H488601 H488677 H488747 H488853 H488920 H488115 H488202 H488286 H488362 H488438 H488521 H488602 H488678 H488749 H488854 H488921 H488116 H488203 H488287 H488363 H488439 H488525 H488603 H488679 H488756 H488855 H488922 H488117 H488204 H488288 H488364 H488440 H488526 H488612 H488680 H488757 H488856 H488923 H488118 H488205 H488290 H488365 H488441 H488527 H488613 H488681 H488758 H488857 H488924 H488119 H488206 H488291 H488366 H488442 H488528 H488614 H488682 H488759 H488858 H488925 H488120 H488207 H488295 H488367 H488452 H488529 H488624 H488683 H488762 H488859 H488926 H488124 H488208 H488296 H488373 H488453 H488530 H488625 H488684 H488766 H488860 H488927 H488125 H488212 H488297 H488374 H488454 H488538 H488626 H488685 H488769 H488861 H488929 H488930 H489004 H489089 H489182 H489300 H489354 H489437 H489493 H489570 H489662 H489732 H488931 H489005 H489090 H489184 H489301 H489356 H489438 H489494 H489571 H489664 H489733 H488932 H489006 H489091 H489185 H489302 H489357 H489439 H489495 H489573 H489665 H489734 H488933 H489009 H489092 H489187 H489303 H489358 H489440 H489496 H489574 H489666 H489735 H488934 H489014 H489093 H489188 H489304 H489362 H489441 H489497 H489575 H489667 H489736 H488935 H489017 H489094 H489191 H489305 H489363 H489442 H489498 H489576 H489668 H489737 H488937 H489018 H489098 H489192 H489306 H489364 H489443 H489499 H489579 H489669 H489741 H488938 H489019 H489100 H489193 H489307 H489365 H489444 H489506 H489580 H489670 H489742 H488940 H489020 H489101 H489195 H489308 H489366 H489445 H489507 H489581 H489671 H489744 H488941 H489021 H489102 H489199 H489309 H489367 H489446 H489508 H489582 H489672 H489745 H488943 H489024 H489103 H489203 H489310 H489368 H489447 H489510 H489583 H489673 H489746 H488944 H489025 H489104 H489211 H489311 H489369 H489452 H489511 H489584 H489674 H489747 H488945 H489026 H489105 H489212 H489312 H489370 H489453 H489516 H489585 H489675 H489754 H488947 H489028 H489106 H489213 H489313 H489371 H489454 H489517 H489586 H489676 H489755 H488948 H489029 H489109 H489214 H489314 H489373 H489455 H489518 H489587 H489677 H489756 H488949 H489030 H489111 H489215 H489315 H489374 H489456 H489519 H489588 H489678 H489757 H488951 H489031 H489112 H489216 H489316 H489375 H489457 H489520 H489589 H489679 H489758 H488953 H489032 H489113 H489217 H489317 H489376 H489458 H489521 H489590 H489681 H489760 H488955 H489033 H489114 H489219 H489318 H489377 H489459 H489522 H489591 H489682 H489767 H488956 H489034 H489121 H489220 H489319 H489382 H489460 H489523 H489592 H489683 H489768 H488957 H489037 H489124 H489221 H489320 H489383 H489461 H489524 H489593 H489684 H489780 H488958 H489040 H489125 H489222 H489321 H489384 H489462 H489525 H489594 H489685 H489781 H488959 H489041 H489126 H489228 H489322 H489385 H489463 H489532 H489595 H489686 H489782 H488960 H489042 H489127 H489230 H489323 H489386 H489464 H489533 H489598 H489687 H489783 H488961 H489043 H489128 H489231 H489324 H489387 H489465 H489534 H489600 H489688 H489784 H488962 H489045 H489130 H489232 H489325 H489389 H489466 H489535 H489601 H489689 H489785 H488963 H489046 H489131 H489243 H489326 H489390 H489467 H489536 H489602 H489691 H489792 H488964 H489047 H489132 H489244 H489327 H489391 H489468 H489537 H489603 H489692 H489798 H488965 H489053 H489133 H489245 H489328 H489392 H489469 H489538 H489604 H489696 H489799 H488966 H489054 H489134 H489246 H489329 H489393 H489470 H489539 H489605 H489697 H489800 H488967 H489055 H489136 H489251 H489330 H489394 H489471 H489540 H489616 H489698 H489801 H488969 H489060 H489137 H489252 H489331 H489395 H489472 H489541 H489617 H489699 H489802 H488972 H489064 H489138 H489253 H489332 H489396 H489473 H489542 H489619 H489700 H489803 H488973 H489065 H489139 H489254 H489333 H489397 H489474 H489543 H489620 H489701 H489804 H488981 H489066 H489149 H489255 H489334 H489399 H489475 H489544 H489621 H489702 H489807 H488982 H489069 H489150 H489256 H489337 H489400 H489476 H489545 H489632 H489703 H489808 H488983 H489070 H489151 H489260 H489338 H489410 H489478 H489546 H489633 H489704 H489809 H488985 H489071 H489152 H489261 H489340 H489411 H489479 H489552 H489634 H489706 H489810 H488986 H489072 H489153 H489262 H489341 H489412 H489480 H489553 H489635 H489707 H489815 H488987 H489073 H489154 H489263 H489342 H489413 H489482 H489554 H489636 H489708 H489818 H488988 H489075 H489155 H489269 H489343 H489414 H489483 H489555 H489637 H489709 H489819 H488991 H489076 H489162 H489270 H489344 H489418 H489484 H489556 H489638 H489710 H489820 H488992 H489077 H489163 H489290 H489346 H489420 H489485 H489557 H489646 H489719 H489825 H488993 H489078 H489164 H489291 H489347 H489421 H489486 H489558 H489647 H489720 H489826 H488994 H489080 H489166 H489292 H489348 H489422 H489487 H489559 H489648 H489724 H489831 H488995 H489082 H489167 H489293 H489349 H489423 H489488 H489560 H489657 H489725 H489834 H489000 H489084 H489168 H489296 H489350 H489424 H489489 H489563 H489658 H489726 H489835 H489001 H489085 H489169 H489297 H489351 H489434 H489490 H489565 H489659 H489729 H489836 H489002 H489086 H489170 H489298 H489352 H489435 H489491 H489568 H489660 H489730 H489844 H489003 H489087 H489181 H489299 H489353 H489436 H489492 H489569 H489661 H489731 H489845 H489846 H489936 H48A050 H48A140 H48A270 H48A448 H48A601 H48A749 H48A904 H48B093 H48B285 H489847 H489937 H48A051 H48A141 H48A287 H48A454 H48A606 H48A750 H48A911 H48B094 H48B286 H489848 H489938 H48A054 H48A142 H48A288 H48A455 H48A607 H48A751 H48A912 H48B097 H48B288 H489849 H489939 H48A055 H48A143 H48A291 H48A456 H48A616 H48A752 H48A913 H48B122 H48B298 H489850 H489940 H48A057 H48A144 H48A292 H48A457 H48A617 H48A753 H48A914 H48B123 H48B299 H489851 H489941 H48A058 H48A145 H48A293 H48A478 H48A624 H48A754 H48A915 H48B130 H48B300 H489854 H489942 H48A059 H48A146 H48A294 H48A479 H48A625 H48A755 H48A916 H48B131 H48B310 H489856 H489948 H48A060 H48A160 H48A298 H48A480 H48A626 H48A756 H48A917 H48B138 H48B311 H489857 H489949 H48A061 H48A164 H48A299 H48A491 H48A627 H48A757 H48A934 H48B152 H48B313 H489858 H489952 H48A062 H48A165 H48A300 H48A492 H48A628 H48A758 H48A936 H48B155 H48B314 H489859 H489956 H48A063 H48A166 H48A301 H48A493 H48A629 H48A760 H48A941 H48B157 H48B346 H489860 H489957 H48A064 H48A167 H48A305 H48A494 H48A640 H48A761 H48A960 H48B158 H48B347 H489861 H489958 H48A065 H48A168 H48A306 H48A501 H48A641 H48A762 H48A961 H48B169 H48B348 H489862 H489959 H48A066 H48A169 H48A316 H48A502 H48A642 H48A775 H48A962 H48B170 H48B353 H489864 H489961 H48A070 H48A177 H48A317 H48A515 H48A643 H48A776 H48A964 H48B171 H48B354 H489865 H489962 H48A073 H48A178 H48A321 H48A516 H48A644 H48A777 H48A965 H48B178 H48B365 H489866 H489963 H48A074 H48A179 H48A322 H48A517 H48A648 H48A778 H48A972 H48B179 H48B366 H489867 H489964 H48A075 H48A180 H48A323 H48A518 H48A649 H48A792 H48A988 H48B180 H48B368 H489868 H489965 H48A076 H48A181 H48A324 H48A519 H48A650 H48A793 H48A994 H48B181 H48B376 H489869 H489966 H48A077 H48A185 H48A327 H48A520 H48A651 H48A794 H48A995 H48B182 H48B389 H489870 H489970 H48A078 H48A189 H48A335 H48A521 H48A655 H48A811 H48A996 H48B183 H48B390 H489871 H489971 H48A079 H48A190 H48A336 H48A522 H48A656 H48A812 H48B002 H48B184 H48B391 H489872 H489972 H48A080 H48A191 H48A350 H48A523 H48A657 H48A813 H48B003 H48B185 H48B392 H489873 H489973 H48A081 H48A192 H48A351 H48A524 H48A669 H48A815 H48B004 H48B186 H48B399 H489874 H489974 H48A082 H48A193 H48A354 H48A525 H48A670 H48A819 H48B005 H48B191 H48B409 H489875 H489975 H48A086 H48A194 H48A356 H48A526 H48A671 H48A820 H48B006 H48B192 H48B416 H489876 H489976 H48A087 H48A195 H48A357 H48A527 H48A680 H48A821 H48B007 H48B193 H48B417 H489877 H489977 H48A096 H48A203 H48A358 H48A528 H48A682 H48A822 H48B008 H48B206 H48B418 H489878 H489981 H48A100 H48A204 H48A359 H48A529 H48A685 H48A823 H48B009 H48B208 H48B423 H489879 H489982 H48A106 H48A205 H48A360 H48A530 H48A686 H48A824 H48B010 H48B210 H48B425 H489880 H489990 H48A107 H48A209 H48A361 H48A531 H48A687 H48A825 H48B011 H48B217 H48B426 H489881 H48A000 H48A108 H48A210 H48A362 H48A532 H48A688 H48A830 H48B023 H48B218 H48B428 H489883 H48A024 H48A109 H48A211 H48A363 H48A533 H48A689 H48A831 H48B028 H48B221 H48B430 H489884 H48A025 H48A111 H48A213 H48A364 H48A535 H48A693 H48A832 H48B029 H48B222 H48B473 H489886 H48A026 H48A112 H48A214 H48A365 H48A542 H48A696 H48A833 H48B030 H48B224 H48B481 H489890 H48A027 H48A113 H48A215 H48A366 H48A543 H48A697 H48A838 H48B031 H48B248 H48B482 H489891 H48A028 H48A114 H48A217 H48A367 H48A544 H48A703 H48A842 H48B032 H48B249 H48B494 H489892 H48A032 H48A115 H48A231 H48A374 H48A554 H48A704 H48A843 H48B033 H48B250 H48B495 H489898 H48A033 H48A116 H48A236 H48A386 H48A557 H48A705 H48A844 H48B034 H48B251 H48B496 H489899 H48A034 H48A117 H48A237 H48A387 H48A560 H48A706 H48A846 H48B043 H48B252 H48B497 H489900 H48A035 H48A118 H48A238 H48A389 H48A561 H48A707 H48A847 H48B044 H48B257 H48B498 H489903 H48A036 H48A119 H48A239 H48A391 H48A578 H48A708 H48A863 H48B049 H48B258 H48B508 H489911 H48A037 H48A120 H48A242 H48A392 H48A587 H48A709 H48A864 H48B050 H48B259 H48B523 H489912 H48A039 H48A125 H48A243 H48A393 H48A590 H48A710 H48A865 H48B063 H48B260 H48B524 H489913 H48A041 H48A126 H48A244 H48A422 H48A591 H48A711 H48A866 H48B070 H48B261 H48B525 H489916 H48A042 H48A127 H48A245 H48A426 H48A592 H48A713 H48A867 H48B071 H48B264 H48B526 H489917 H48A043 H48A128 H48A246 H48A437 H48A593 H48A714 H48A888 H48B073 H48B281 H48B527 H489926 H48A047 H48A132 H48A258 H48A438 H48A598 H48A715 H48A890 H48B088 H48B282 H48B528 H489927 H48A048 H48A136 H48A268 H48A442 H48A599 H48A747 H48A891 H48B091 H48B283 H48B538 H489935 H48A049 H48A139 H48A269 H48A443 H48A600 H48A748 H48A896 H48B092 H48B284 H48B539 H48B549 H48B677 H48B806 H48B917 H48C044 H48C238 H48B552 H48B678 H48B807 H48B918 H48C047 H48B553 H48B679 H48B808 H48B919 H48C048 H48B554 H48B680 H48B809 H48B927 H48C049 H48B555 H48B681 H48B810 H48B928 H48C050 H48B556 H48B682 H48B820 H48B929 H48C054 H48B559 H48B683 H48B822 H48B930 H48C062 H48B560 H48B684 H48B828 H48B931 H48C063 H48B561 H48B685 H48B829 H48B937 H48C069 H48B570 H48B686 H48B830 H48B938 H48C070 H48B571 H48B687 H48B831 H48B939 H48C082 H48B572 H48B688 H48B832 H48B941 H48C087 H48B575 H48B689 H48B833 H48B942 H48C088 H48B576 H48B690 H48B839 H48B943 H48C095 H48B577 H48B691 H48B840 H48B944 H48C096 H48B578 H48B692 H48B841 H48B945 H48C097 H48B584 H48B693 H48B843 H48B946 H48C098 H48B585 H48B694 H48B845 H48B947 H48C099 H48B599 H48B702 H48B846 H48B948 H48C100 H48B600 H48B703 H48B847 H48B949 H48C101 H48B602 H48B704 H48B848 H48B950 H48C102 H48B605 H48B705 H48B849 H48B951 H48C103 H48B616 H48B728 H48B850 H48B952 H48C104 H48B617 H48B729 H48B851 H48B960 H48C105 H48B619 H48B730 H48B856 H48B963 H48C128 H48B633 H48B731 H48B859 H48B964 H48C129 H48B634 H48B735 H48B860 H48B965 H48C130 H48B635 H48B736 H48B861 H48B966 H48C131 H48B636 H48B738 H48B862 H48B968 H48C145 H48B637 H48B747 H48B864 H48B971 H48C163 H48B638 H48B748 H48B865 H48B972 H48C168 H48B639 H48B749 H48B868 H48C010 H48C171 H48B641 H48B751 H48B869 H48C011 H48C177 H48B647 H48B752 H48B870 H48C012 H48C178 H48B651 H48B753 H48B877 H48C014 H48C179 H48B652 H48B762 H48B886 H48C015 H48C181 H48B653 H48B763 H48B892 H48C016 H48C182 H48B657 H48B764 H48B893 H48C017 H48C183 H48B658 H48B765 H48B894 H48C018 H48C196 H48B664 H48B787 H48B895 H48C022 H48C201 H48B666 H48B796 H48B896 H48C024 H48C203 H48B668 H48B797 H48B907 H48C029 H48C210 H48B669 H48B798 H48B908 H48C030 H48C213 H48B670 H48B799 H48B909 H48C031 H48C214 H48B671 H48B800 H48B910 H48C032 H48C215 H48B672 H48B801 H48B912 H48C033 H48C220 H48B673 H48B802 H48B913 H48C034 H48C232 H48B674 H48B803 H48B914 H48C035 H48C235 H48B675 H48B804 H48B915 H48C036 H48C236 H48B676 H48B805 H48B916 H48C037 H48C237
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letters on May 3, 2011. Firm initiated recall is ongoing.
REASON
In affected Analytical Anisotropy Algorithm versions when modeling the second source, the collimator jaw positions are read from the first control point of the field. This can cause the delivered dose to be higher than planned locally by up to 10%.
VOLUME OF PRODUCT IN COMMERCE
5201 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Broselow/Hinkle Pediatric Emergency System. The kit contains oxygen masks and blood pressure cuffs use on pediatric patients. Expiration for kit is four years. Oz Masks #D075986 Class I Exempt Device If you have purchased directly from Vital Signs, the product codes affected are: 7700BAW2, 7700GAW2, 7700OAW2, 7700PAW2, 7700RAW2, 7700WAW2, 7700YAW2, Kits with masks included: 7730ALS, 7730BLU5, 7730FLY, 7730GRN5, 7730IALS, 7730MOD, 7730ORG5, 7730PUR5, 7730RED5, 7730WHI5, 7730YEL5. If you have purchased directly from Armstrong Medical, the Product Codes affected are: a) AE-4700, , AE-4712, AE-4701, 7730RED, 7730PUR, 7730YEL, 7730WHI, 7730BLU, 7730ORG, 7730GRN, 7700RAW, 7700PAW, 7700YAW, 7700WAW, 7700BAW, 7700OAW, 7700GAW. Medical Device Listing Blood Pressure Cuffs If you have purchased directly from Vital Signs, the product codes affected are: BP4030BR, BP4530BR, 7730POCH, 7730IALS If you have purchased directly from Armstrong Medical, the product codes affected are: b) AE-4703, AE- 4700, AE-4706, AE-4707. Recall # Z-2704-2011
CODE
a) Lot numbers: For the year 2009 K109 through K365, year 2010 P001 through P149510 (k) : K781055; b) Lot numbers: For the year 2009 Lot Number 2689 through Lot Number 3659; For the year 2010 Lot Number 0010 through Lot Number 2530. Any lot number that ends in the number 1 is NOT affected by the recall.
RECALLING FIRM/MANUFACTURER
Vital Signs Devices, a GE Healthcare Co., Totowa, NJ, by letter dated April 26, 2011. Firm initiated recall is ongoing.
REASON
Broselow Pediatric Emergency System Kit may contain oxygen masks that may contain a potentially sticky substance on the inside and/or outside of the mask.
VOLUME OF PRODUCT IN COMMERCE
33,002 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Brand Name STAAR Surgical Collamer Ultraviolet-Absorbing Posterior Chamber Single Piece Foldable Intraocular Lens Common Names Collamer single piece IOL Collamer plate haptic IOL. The Device is intended to correct aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction. The Device is to be implanted in the posterior chamber and in the capsular bag through a tear-free capsulorhexis (circular tear anterior capsulotomy). Recall # Z-2706-2011
CODE
CC4204BF and CC4204A
RECALLING FIRM/MANUFACTURER
Staar Surgical Co., Monrovia, CA, by letter on May 20, 2011. Firm initiated recall is ongoing.
REASON
The recall was initiated by Staar Surgical due to an error in the Directions for Use (DFU) for Staar Surgical's Collamer Ultraviolet Absorbing Posterior Chamber Single Piece Foldable Intraocular Lens (Collamer IP IOL), also known as the nanoFLEX IOL. The Device Description erroneously indicates that the lens could be implanted in the ciliary sulcus.
VOLUME OF PRODUCT IN COMMERCE
16,750 devices
DISTRIBUTION
Nationwide, South Africa, Slovakia, Mexico, Hong Kong, and Sri Lanka
___________________________________
PRODUCT
Baxter Solution Set for Epidural Use, 110" (2.8 m), Male Luer Lock Adapter; a sterile, single use, nonpyrogenic fluid pathway for use with 6200 and 6300 series Flo-Gard Volumetric Infusion Pumps; product code 2C7554s The tubing set is intended for use with Flo-Gard Infusion Pumps to provide epidural delivery of anesthetic or analgesic drugs for periods up to 96 hours. Recall # Z-2708-2011
CODE
Lot GR293209
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated May 31, 2011.
Manufacturer: Baxter Healthcare Corp., Cleveland, MS. Firm initiated recall is ongoing.
REASON
Product is being recalled because the position of the slide clamp and roller clamp may have been reversed during assembly. The reversed orientation of the slide clamp and roller clamp will cause the set to be incorrectly loaded into an infusion pump, resulting in fluid flow from the patient to the pump, rather than from the pump to the patient.
VOLUME OF PRODUCT IN COMMERCE
3,216 units
DISTRIBUTION
Nationwide and Canada and South Africa
___________________________________
PRODUCT
1) Comprehensive Shoulder Instruments Primary Shoulder Stem Inserter, REF 407398.  Instrument used to introduce the stem into the canal. The instrument is used to insert the shoulder implant into the shoulder. Recall # Z-2712-2011;
 
2) Comprehensive Shoulder Instruments Fracture Stem Inserter w/Version Control, REF 31-406901. Instrument used to introduce the stem into the canal. The instrument is used to insert the shoulder implant into the shoulder. Recall # Z-2713-2011
CODE
1) Unit numbers: 043190, 176120, 176130, 176140, 176150, 176870, 176900, 281960, 296760, 296770, 296780, 599260, 678800, 775960, 775980, 806060, 832070, 859290 and 884850;
 
2) Unit numbers: 064320, 189990, 293840, 299010, 299020, 401800, 401810, 406610, 444560, 444600, 517880, 517960, 525360, 534260, 657870, 723150 and 727030
RECALLING FIRM/MANUFACTURER
Recalling Firm: Biomet, Inc., Warsaw, IN, by letters dated April 7, 2011 and April 12, 2011.
Manufacturer: B & M Instruments, Inc., Warsaw, IN. Firm initiated recall is ongoing.
REASON
When the surgeon attempts to remove the inserter from the stem, the inserter may become stuck not allowing it to disengage from the stem. The stem may have to be removed from the patient in order to disengage the inserter from the stem. If the stem is removed from the patient, it could potentially cause a significant delay in the procedure or damage/fracture of the humerus which may require intervention.
VOLUME OF PRODUCT IN COMMERCE
469 (279 domestic; 190 foreign)
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) ECMO Heater Model 333, Cardiopulmonary bypass temperature controller. Part Number: 86130. This device is intended to provide temperature-controlled warm water flow to a blood heat exchanger in order to maintain a patient's blood temperature. It can be used during extracorporeal circulation procedures. It is intended to use with commercially available heat exchangers. Recall # Z-2720-2011;
 
2) ECMO Heater Model: 333W, Cardiopulmonary bypass temperature controllers. Part Number: 86135 (115V), 86136 (230V) and 86138 (240V).This device is intended to provide temperature-controlled warm water flow to a blood heat exchanger in order to maintain a patient's blood temperature. It can be used during extracorporeal circulation procedures. It is intended to use with commercially available heat exchangers. Recall # Z-2721-2011
CODE
1) Serial number: 864-E1180 through 924-E2528;
2) Serial Number: 942-E2979 through 031-E5150
RECALLING FIRM/MANUFACTURER
Cincinnati Sub-Zero Products Inc., Cincinnati, OH, letter on May 2, 2011. Firm initiated recall is ongoing.
REASON
The probe jack contacts (terminals) on certain of the firm's ECMO Heater devices are located too close to the solid state relay contacts (terminals) which can lead to the terminals coming into contact with each other. If this situation occurs, the service technician, user, and/or patient could be exposed to electric shock during servicing and/or use.
VOLUME OF PRODUCT IN COMMERCE
369 units
DISTRIBUTION
Nationwide and Internationally
_______________________________________
PRODUCT
SJM Confirm, Implantable Cardiac Monitor (ICM) Models: DM2100, DM2102 (IDE). This product is a lead less non-therapeutic implantable cardiac monitor and is implanted to aid clinicians in diagnosing intermittent symptoms which may be due to arrhythmia. Recall # Z-2733-2011
CODE
Software Version 10.1.1.2
RECALLING FIRM/MANUFACTURER
St Jude Medical CRMD, Sylmar, CA, by letter on March 25, 2011. Firm initiated recall is ongoing.
REASON
The recall was initiated because St. Jude Medical made new software available for the SJM Confirm DM2100 implantable cardiac monitor (ICM) that incorporates enhancements to the devices sensing algorithm. These enhancements are intended to provide improved sensitivity and specificity for diagnosing arrhythmias. The user is presented with the option to upgrade new software into the SJM Confirm ICM after the device is interrogated by a Mertin programmer with 10.1.1.2 software.
VOLUME OF PRODUCT IN COMMERCE
83 units
DISTRIBUTION
Nationwide and Germany
___________________________________
PRODUCT
Foundation Knee System Instrumentation, Tibial Broach Assembly. Used in conjunction with the Tibial Sizing Template and Tibial Broach Guide to prepare the resected tibial plateau for acceptance of a keeled tibial baseplate stem. P/N 801-01-013. Recall # Z-2734-2011
CODE
Lot number: 37641L01
RECALLING FIRM/MANUFACTURER
Encore Medical, LP., Austin, TX, by letter dated April 20, 2011. Firm initiated recall is ongoing.
REASON
Strike plate may dislodge from the broach stem handle during impaction of the device.
VOLUME OF PRODUCT IN COMMERCE
15 units
DISTRIBUTION
Nationwide, Germany, Italy, United Kingdom and Japan
 
RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS III
___________________________________
PRODUCT
ANIMAX OINTMENT, nystatin-neomycin sulfate-thiostrepton-triamcinolone acetonide ointment, Net Contents 30 mL, ANADA #140-847, NDC 17033-122-30. Recall # V-369-2011
CODE
Lot # 572C, exp. 9/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nycomed US, Inc., Melville, NY, by letter dated February 17, 2011.
Manufacturer: Nycomed US, Inc., Hicksville, NY. Firm initiated recall is ongoing.
REASON
Super-potent; out-of-specification (OOS) assay result for neomycin sulfate during stability testing of Animax Ointment.
VOLUME OF PRODUCT IN COMMERCE
25,860 units
DISTRIBUTION
KS
 
END OF ENFORCEMENT REPORT FOR JULY 13, 2011
 
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