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U.S. Department of Health and Human Services

Safety

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Enforcement Report for September 21, 2011

 

 
September 21, 2011                                                                                        11-38
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
________________________________________
PRODUCT
Sliced Kimchi Cut Napa, in one gallon (8 lb) and five gallon clear plastic containers. Recall # F-1735-2011
CODE
Lot number: 56090959
RECALLING FIRM/MANUFACTURER
Atlanta Oriental Food Wholesale Co., Atlanta, GA, by press release and telephone on August 11, 2011. Georgia initiated recall is ongoing.
REASON
The product is contaminated with Listeria monocytogenes based on the Georgia Department of Agriculture's laboratory analysis.
VOLUME OF PRODUCT IN COMMERCE
27 total (9/5 gallon and 18/1 gallon)
DISTRIBUTION
AL, GA and TN
________________________________________
PRODUCT
Pure Encapsulations PreNatal Nutrients, hypo-allergenic dietary supplement, packaged in plastic bottles of 60 count (Product Code PRE6) and 120 count (Product code PRE12). Recall # F-1741-2011   
CODE
Lot codes: 3560111A or 3560111B and best by date 01/13
RECALLING FIRM/MANUFACTURER
Pure Encapsulations, Inc., Sudbury, MA, by telephone on August 30, 2011 and by letter and press on August 31, 2011. Firm initiated recall is ongoing.
REASON
The product contains undeclared eggs.
VOLUME OF PRODUCT IN COMMERCE
4,600 bottles
DISTRIBUTION
Nationwide and Finland
________________________________________
PRODUCT
Ice cream in paper carton labeled in part: "Western Family***1.75 quarts (1.66L)***Ingredients: Milkfat, Nonfat Milk, Sugar, Corm Sweeteners, English Walnuts, Whey, Tapioca Starch, Guar Gum, Mono and Diglycerides, Tara Gum, Cellulose Gum, ***Contains: Milk, Walnuts. UPC code: 15400 22824. Recall # F-1742-2011 
CODE
"Best By 07-23-11 Plant 41-48" followed by a four digit time code.
RECALLING FIRM/MANUFACTURER
The Matterhorn Group, Inc., Salem, OR, by e-mail on September 21, 2010 and press release on September 22, 2010. Firm initiated recall is ongoing.
REASON
Some cartons labeled as Western Family Maple Nut Ice Cream actually contain a different product, Wolf Tracks Ice Cream, which has peanuts. The label for Maple Nut does not list peanuts as an ingredient.
VOLUME OF PRODUCT IN COMMERCE
739 cases each containing 6 56oz cartons. (Total=4434 cartons)
DISTRIBUTION
OR, WA, ID, MT, CA, AK, and GUAM
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
________________________________________
PRODUCT
Valu Time Creamy Milk Chocolate Frosting, 16 oz. (1 lb) 453 g white plastic tub, 12 tubs per case; UPC 0 11225 02510 5. Recall # F-1736-2011
CODE
Tub lot number JUN 20 12 WW, case lot number 061512WMC16N184
RECALLING FIRM/MANUFACTURER
Recalling Firm: Gilster-Mary Lee Corp., Chester, IL. by letter and emails on August 30, 2011.
Manufacturer: Gilster-Mary Lee Corp., Mc Bride, MO. Firm initiated recall is ongoing.
REASON
Some of the tubs labeled as Valu Time Creamy Milk Chocolate Frosting actually contain creamy vanilla frosting which contains FD&C Yellow #5 and #6 which are not declared in the ingredients statement on the label.
VOLUME OF PRODUCT IN COMMERCE
300 cases
DISTRIBUTION
CA, MA, OH, WA
________________________________________
PRODUCT
Coconut-Pineapple bars. Recall # F-1737-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Fabrica De Dulces La Fe, Caguas, PR, by telephone and visit on July 7, 2011. FDA initiated recall is complete. 
REASON
Undeclared Yellow #5 and other color additives.
VOLUME OF PRODUCT IN COMMERCE
Not known
DISTRIBUTION
PR, Fl and MA
________________________________________
PRODUCT
1) An Tai Chinese Noodles Japanese Ramen. Recall # F-1738-2011;
2) An Tai Chinese Noodles Stir Fry Noodles. Recall # F-1739-2011;
3) An Tai Chinese Noodles Taiwanese Oily Noodles.  Recall # F-1740-2011 
CODE
1) LOT#20110830, DATE MADE AUG/30/11
2) and 3) No code information present.
RECALLING FIRM/MANUFACTURER
An Tai Chinese Noodle Corp., S El Monte, CA, by letters, fax and telephone on September 2, 2011. FDA initiated recall is ongoing.
REASON
The product contains wheat and fails to declare the wheat allergen on the finished product labeling.
VOLUME OF PRODUCT IN COMMERCE
Taiwanese Oily Noodles: 53,978 packages; Stir Fry: 1,331 packages; Japanese Ramen: 6,950 packages
DISTRIBUTION
AZ, CA, FL, MN, NV, TX
________________________________________
PRODUCT
1) Morey's Wild Alaskan Salmon Burgers, Rosemary & Feta, product #179Q2294. Recall # F-1743-2011;
 
2) Morey's Wild Alaskan Salmon Burgers, Red Pepper & Cilantro, product #179Q2293. Recall # F-1744-2011;
 
3) Morey's Wild Alaskan Salmon Burgers, Honey & Tarragon, product #179Q2292. Recall # F-1745-2011;
 
4) Morey's Wild Alaskan Salmon Burgers, Citrus & Dill, product #179Q2291. Recall # F-1746-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Morey's Seafood International, LLC, Golden Valley, MN, by telephone and/or e-mail, letters and visit on August 17, 2011. FDA initiated recall is complete.
REASON FOR RECALL
Refrigerated Salmon Burgers have been mislabeled in that the ingredient listing is missing the ingredient Tofu, which contains soy, a known allergen.
VOLUME OF PRODUCT IN COMMERCE
42 cases (126 pounds)
DISTRIBUTION
MN, WI
 
The FDA begins a pilot program seeking to expedite notifications of human drug product recalls to the public. The agency will modify the drug product section of the Enforcement Report17, published every Wednesday, to include actions that have been determined to be recalls, but that remain in the process of being classified as a Class I, II, or III action. Such recalls will be listed under the heading, “Recalls Pending Classification: DRUGS.” They will be reposted with their classification once that determination has been made. Send comments or suggestions to CDERRecallPilot@fda.hhs.gov.
 
RECALLS PENDING CLASSIFICATION: DRUGS
________________________________________
PRODUCT
Pediatric Atropine Sulfate Injection, USP, 0.05 mg/mL, 5mL single dose vials, NDC 0409-9630-05
CODE
82-397-EV, Exp. Date: 10/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira Inc. 375 N Field Drive, Lake Forest IL 60045-2513
REASON FOR RECALL
Impurities/Degradation Product: 18-month stability testing
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II 
________________________________________
PRODUCT
1) Pro-Mex ***Ampitrexyl Suspension***PARA NINOS ***4 oz (120 mL) *** DIETARY SUPPLEMENT***Propiedades Anitibotico Natural***Sabor a Cereza***Ingredients: Andrographitis Extract 450 mg ***Corydails Yanhusuo 4: 150 mg * Burdock Root * Garlic extract * Spleen * Echineacea Extract * Flavor" UPC 1 84125 00063 0. Recall # D-922-2011;
 
2) "***Pro-Max***AMOXIMIEL***Suspension***DIETARY SUPPLEMENT***PARA NINOS***4 oz (120 mL)***Propiedades Antibioticas Antibacterianas Naturales*** HONEY Flavor***Ingredients: Special blend of Bee Honey Propolis Ext,Oregano Oil, Green Tea, Elderberry Ext, Olive leaf Ext., Citric acid, Turmeric Ext, Potassium Sorbate, Purified water, Sodium Benzoate, Alcohol" UPC 18412500066. Recall # D-923-2011;
 
3) "***Para Las Anginas***Cur Agin***En Liquido Para Ninos***Dietary Supplement***PRO-MEX***4 oz (120 mL) ***Other Ingredients:Sodium Benzoate, Potassium, Flavor, Color, Xantham Gum, Citric Acid, RO Water***" UPC 1 84125 00157 6. Recall # D-924-2011;
 
4) "***Para Las Anginas***Cur Agin***En Liquido Para Adulto***Dietary Supplement***PRO-MEX***4 oz ***Other Ingredients: Sodium Benzoate, Potassium Sorbate, Flavor, Color, Xantham Gum, Citric Acid, RO Water***" UPC 1 84125 00156 9. Recall # D-925-2011;
 
5) Product labeling read in part "***Pro-Mex***AMOXIMIEL***Suspension***500 mg***PARA ADULTO***4 oz (120 mL) DIETARY SUPPLEMENT***HONEY Flavor***Proprietary Blend: Sweetener, wild marjoram, bee pollen powder, hydrastis canadensis, Alliumsaivum L, balsamodendron kua, echinacea purpureus herba, taraxacum of cinale powder.***" UPC 84125 00101. Recall D-926-2011;
 
6) Product labeling reads in part ***ProMex***Ampitrexyl***Supension***ADULTO***500 mg***4 oz (120 mL)***Combate las infecciones en forma natural y sin resgos***Sabor a Fresa***Special Blend of: Andrographis, Propohis, Burdock Root, Garlic Extact, Echinacea, RO Water, Citrus Acid, Sodium Benzoate, Potassium Sorbate, Xantham Gum, Color, HFCS, Flavor. UPC 1 84125 00165 1. Recall # D-927-2011;
 
7) Product labeling read in part "***B Doce***Ampolleta***ProMex***Ampolleta Tomable Reforzada***B1, B2, B3, B5, B6, B7, B8, B9 y B12***Maxima absorcion dirigida al Torente Sanguineo Comparable con el efecto de una Inyeccion***Dietary Supplement***5 vials (18 mL each)***Amount per Serving Vitamin B-1 100 mg***Vitamin B-2 100 mg***Vitamin B-3 100 mg***Vitamin B-5 100 mg***Vitamin B-6 5 mg***Vitamin B-7 25 mcg***Vitamin B-8 100 mcg***Vitamin B-9 400 mcg*** Vitamin B-12 100 mcg***Other ingredients: Methyl & prophyl parabens, corn syrup, guar gum, potassium sorbate, sodium benzoate, propylene glycol & citric acid. UPC 1 84125 00163 7.” Recall # D-928-2011;
 
8) Product labeling read in part "***Ampitrexyl***Drinkable Vials***PRO-MEX***Dietary Supplement***5 Vials (18 mL)***Amount per Serving***Bovine Colostrum Phospholipids 6000 mg***UPC 1 84125 00137 8." Recall # D-929-2011;
 
9) Product labeling read in part "***KNEZTENG" VAGINAL***CLOTRIMAZOLE***Effective treatment for vaginal infections Fast Relief for vaginal odor and itch***NDC 68532-210-45***Net Wt. 1.59 oz (45 g)***Drug Facts***Active Ingredients (100 mg in each application)***Purpose***Clotrimazole 2%***vaginal antifungal***Uses***treats repeat vaginal yeast infections***Relieves external itching and irritation due to a repeat vaginal yeast infection***WARNINGS For vaginal use only***Inactive ingredients benzoic acid, butylated hydroxyaisole, glyceryl stearate, mineral oil, peglicol 5 oleate, pegxol 7 sterate, purified water, perfume***090827***08/12***
UPC 1 84125 00023 4. Recall # D-930-2011;
 
10) Product labeling read in part "******KNEZTENG®***40 g / 1.38 oz***CREAM***ProMex®***-For Athletes Foot***-Relieves Itching, Cracking, Burning and Scaling***EXCELLENT FOR ATHLETES FOOT & SKIN FUNGI***Drug Facts***Active Ingredients***Purpose***Miconazole Nitrate (2%)***Anti-fungal***Uses: Cures athletes foot, burning. Soothes Itching, Cracking and Scaling.***Indications: Proven clinically effective in the treatment of athletes foot (tinea pedis) and ringworm (tinea corporis) relieves the itching, scaling, burning and discomfort that can accompany athletes foot.***For external use only***Inactive ingredients: Stearic Acid, Cetyl Alcohol, Mineral Oil, Methyl Paraben, Propyl Paraben, Triethanolamine, Rheocare ATC, RO Water***UPC 1 84125 00022 7. Recall # D-931-2011
 
11) Product labeling read in part ***Tylex***The Nighttime, Sleep Better***Feel Better Medicine.***Flu***Pro-Mex***30 tablets 525 mg***ACTIVE INGREDIENTS (in each tablet)***Drug Facts***Acetaminophen 500 mg, Dextrometherphan HBr 15 mg***Chlorpheniramine Maleate, 2 mg***Purpose***Strong Pain & Flu Reliever***Inactive Ingredients: Microcrystaline Cellulose, Dicalcium Phosphate, Croscarmellose Sodium, Stearic Acid, Silicon Dioxide, Magnesium Stearate, Hypromellose, Polyethylene Glycol, Propylene Glycol, Mineral Oil, Titanium Dioxide, Talc, FD&C Red # 40, FD&C***UPC 1 84125 00056 2. Recall # D-932-2011;
 
12) Product labeling read in part ***Alivio Rapido Fast Relief Ciklo-Ferol"***Mouth Sore Cream***Ciklo-Ferol"***Crema para Fuegos***tube / tubo 5 g***Pro-Mex®***Miami, FL 33014***DRUG FACTS***Active Ingredients Purpose***Benzocaine (20%)***Oral Anesthetic/Analgesic***Compound Benzoin Tincture***Oral Mucosal Protectant ***Inactive Ingredients: RO Water, White Mineral Oil, Stearic Acid, Cetyl Alcohol, Licorice Root, Trolamine, Stearyl Alcohol, Methyl Paraben, Propyl Paraben, Rheosol AVC. Recall # D-933-2011;
 
13) Product labeling read in part:"***OIDOSANA***Pro-Mex***Fast Relief for***Ears***1 fl oz (30 mL)***DRUG FACTS***Active Ingredients***Purpose***Isopropyl alcohol 95%***Bactericidal***Anhydrous glycerin***Ear drying aid***5% base***UPC 1 84125 00029 6. Recall # D-934-2011;
 
14) Product labeling read in part:"Ampitrexyl Antibiotic***40 g / 1.38 oz***Topical Ointment for External Use Only***ProMex®***DRUG FACTS***Active Ingredient***Purpose***In each g:***Topical Antibiotic***Chlortetracycline HCL, 30 mg in a suitable***First Aid***ointment base***Antibiotic***Inactive Ingredients: Benzocaine USP, Salicylic Acid, Boric Acid, Benzoic Acid, Methyl Salicylate, Sodium Propionate NF, Chlorobutanol Hydrous NF, Thymol NF, RE#22 Pylam, Paraffin NF and White Petrolatum***maximum strength antibiotic ointment approved by the FDA***UPC 84125 00166 8. Recall # D-935-2011;
 
15) Product labeling read in part: ***T-Raojo***Ointment***Ophthalmic***5 g***66% Larger***Pro-Mex***Drug Facts***Active Ingredients***Purpose***Boric Acid 10%***Bacteriostatic & fungistatic properties***Uses***This medication has fungistatic and bacteriostatic properties***For emergency flushing of foreign bodies***Eyes wash loosens foreign matter***Soothes and cleanses eyes**Also relieves redness, refreshes and soothes irritated eyes***Inactive Ingredients: White Petrolatum, mineral oil, lanoli alcohol, purified water. UPC 1 84125 00014 2. Recall # D-936-2011;
 
16) Product labeling read in part: ***Crema***40 g/1.41 oz*** Cuadriderma***Tpica***EXTERNAL USE ONLY***Drug Facts***Active Ingredients: in each gram***Polymyxin B Sulfate 10000 UI***Antibiotic***Neomycin 3.5 mg Antibiotic***Lidocaine HCL***0.5% Pain reliever***Indications: First aid to help prevent infection and provide temporary relief of pain and discomfort in minor***cuts***scrapes***rashes***infections***Inactive Ingredients: RO Water, Mineral Oil, Stearic Acid, Cetyl alcohol, Trolamine, Stearyl Alcohol, Methyl Paraben, Rheosol, Propyl Paraben". UPC 1 84125 00015 9. Recall # D-937-2011;
 
17) Product box label reads in part: â¬S***40 g/1.38 oz***VITAUNG!ENTO***First Aid Antibiotic***Drug Facts***Active Ingredient***Purpose***In each gram:***Neomycin***Antibiotic***Sulfate eq. to 3.5 mg of Neomycin 5 mg***Uses: First aid ointment antibiotic to help prevent infections.***Indications: For the temporary relief of: burns***rashes***itching***minor cuts***scrapes and minor infections***Inactive Ingredients: Bezocaine USP, Salicylic Acid, Boric Acid, Methyl Salicylate, Sodium Propionate NF, Chlorobutanol Hydrous NF, Thymol NF, Red #22 Pylam, Paraffin NF, White Petrolatum***Tarmac®***Products***Miami, FL 33014*** Product tube label reads in part: â¬S***40 g/1.38oz***VITA-UNG!ENTO***Antibi³tico primeros auxilios con Retinol y Neomicina***Drug Facts***Active Ingredients:***Purpose***Neomycin Sulfate eq. to 3.5 mg of Neomycin 5 mg***First Aid Antibiotic***Uses: First aid ointment antibiotic to help prevent infections. For the temporary relief of***burns***rashes***itching***minor cuts***scrapes and minor infections***Indications: First aid Antiseptic, Analgesic & Disinfectant safe and effective to kills bacteria and provides expert protection against germs that cause infection and illness. Fast soothing relief of pain due to: Sunburn, Minor Burns, Cuts, Scrapes & Insect Bites***Inactive Ingredients: Retinol as Vitamin A Palmitate, Lanolin, Petrolatum, Methylparaben, Propylparaben and propylene glycol***Tarmac***Products***33014. UPC 7 26576 00009 0. Recall # D-938-2011;
 
18) Product box label reads in part: "***Para Las Anginas***CurAgin***30***TABLETS***500 mg***Dietary Supplement***PRO-MEX***SUPPLEMENT FACTS:***Serving Size: 1 tablet***Serving Size per Container:***30 tablet s***Amount per serving***RDV%***Acorbic Acid with Rose Hips, 500 mg***100%***Other Ingredients: Rose Hips, Microcrystalline Cellulose, Silicon dioxide, Crosscarmellose Sodium, Stearic Acid, Mineral Oil, Magesium Stearate, Hupromellose, Polyethylene Glycol***" UPC 1 84125 00052 4. Recall # D-939-2011;
 
19) Product box label reads in part: "***Eye Drops***Chamomile***ProMex***Refreshingly***Soothing and***Redness Reliever***15 mL***Drug Facts***Active Ingredients***Purpose***aphazoline HCL 0.012%***Relieves Redness***Use: Uniquely formulated to remove redness and moisturizes, making eyes bright, fresh & clear. Temporarily relieves burning and irritation due to dryness of the eye***Indications: Temporarily relieves redness due to minor eye irritations, for use as a protecting against further irritation or to relieve dryness of the eye due to pollen, ragweed, grass, animal hair and dander.***Inactive Ingredients: Matricaria Chamomiles, (Manzanilla) Virginia Hammelis, Bezalkonium Chloride, Boric Acid, Sodium Borate, Purified Water, Sodium Edetate***UPC 1 84125 00018 0***". Recall # D-940-2011;
 
20) Product box label reads in part: "***Tarmac Products***Sana Piojos Mata los piojos al instante 4 oz (120 mL)***Drug Facts: Active Ingredients: Polydimethysiloxane***Purpose: Eliminates Lice and Eggs***Uses: Pesticide free breakthrough, non-toxic, safe & odorless, helps prevent re-infection 100% effective lice treatment. Take control of Lice outbreaks with SanaPiojos***Indications: Eliminates lice, eggs, and nits from head and body hair****" UPC 7 26576 00023 6. Recall # D-941-2011;
 
21) Product box label reads in part: "***MARAVILLA***ELIMINATES***CORNS***LIQUID CALLUSES REMOVER***Works safely and effectively***For external use only***1 fl oz***NDC 68532-110-01***Drug Facts***Active Ingredient***Purpose***(in each application)***Salicylic Acid (17.6%)***in a flexible collodion base containing Alcohol 24% and Ether 72%***Corns & Calluses Remover***Uses:***For the removal of corns and calluses***Relieves pain by removing corns and calluses, works safely and effectively***Inactive Ingredients: Acetone, Balsam Canada (natural or synthetic), Carotene, Flexible Collodion, Alcohol (from SD alcohol 32), Camphor and Castor Oil***UPC 6 76194 91012 0. Recall # D-942-2011;
 
22) Product box label reads in part: "******STOP***MESQUINOS***REMOVE WART***easy & sure***For external use only***NDC 68532-900-01***1 fl oz***Drug Fast***Active Ingredients***Purpose***(each application)***Salicylic Acid (17%)***Wart Removal***Uses: Podiatrist recommended stop mesquinos liquid for the removal of common warts. Easily recognized by the rough cauliflower-like appearance of the surface***Inactive ingredients: Alcohol, Camphor, Castor Oil, Collodion, Ether, Ethyl Cellulose, Hypophosphorous Acid, Menthol, Polysorbate 80, Croton Lechery And Natural Peppermint Oil.***" "***PARA***MESQUINOS***REMOVE WART***sure & easy***For external use only***1 fl oz***Drug Facts***Active Ingredients***Purpose***(each application)***Salicylic Acid (17%)***Wart Removal***Warnings: Do not use if, You are a diabetic***Or have poor blood circulation***" UPC 6 76194 91013 7. Recall # D-943-2011;
 
23) Product box label reads in part: "***AGRIPEN***ANTIGRIPAL***30 tablets***Flu Pain and Fever Relief***ACTIVE INGREDIENTS (in each tablet)***Acetaminophen, 162.5 mg, Chlorpheniramine Maleate, 2 mg***Purpose***Phenylephrine Hydrochloride, 5 mg***Strong Pain & Flu Reliever***" UPC 1 84125 00057 9. Recall # D-944-2011;
 
24) Product box label reads in part: "***Pro-Mex®***15***Tabletas***Neomeolubryna***Analgesico***Alivio para la Migraña con jaqueca***Migraine and headache relief***NDC # 68532-870-10***Drug Facts***Active Ingredients (per tablet: Acetaminophnen 250 mg )***Purposes***Aspirin 250 mg, Caffeine 65 mg***Treat Migraine and Headaches***Inactive Ingredients: Microcrystalline Cellulose, Providone, Stearic Acid, Crospovidone Pharmaceutical Glaze, Silica, Pregelaticized corn starch, Stearic Acid and and Talc***" UPC 1 84125 00012 8. Recall # D-945-2011;
 
25) Product box label reads in part: "***Fast Soothing Relief***HEMORRODIL***HEMORRHOIDAL OINTMENT***Net Weight: 1 oz (28.35 g)***Made in U.S.A.***Drug Facts***Active Ingredients***Categoria***Zinc Oxide 5%***Astringent***Use: For temporary relief of pain, soreness and burning. Helps relieve the local itching and discomfort. Temporarily shrinks hemorrhoidal tissue & provides a coating for relief of anorectal discomforts. Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful***Other Ingredients: Lanolin, petrolatum, purified H2O, peanut oil, witch hazel, cod liver oil, polysorbate 80, cethyl alcohol, bees wax, glycerin, stearate, menthol, methyl & propyl paraben, blsamo de Per***UPC 7 26576 03254 1. Recall # D-946-2011;
 
26) Product box label reads in part: "***Refresca y alivia***HEMORRODIL***Marca Registrada***(Calamina***Oxido de Zinc***12 SUPOSITORIOS***12 SUPPOSITORIES***Venta Sin Receta Medica***/OTC***Made in USA***Drug Facts***Active Ingredients***Purpose***Calamine 5%***Astringent, Protectant***Zinc Oxide 9%***Astringent, Protectant***Inactive ingredients: lanolin and hydrogenated vegetable oil*** UPC 7 26576 03426 2. Recall # D-947-2011;
 
27) Product box label reads in part: "***Net Weight: 15 g ***HEMORRODIL***Plus***Relieves Pain & Itch***HEMORRHOIDAL OINTMENT***WITH HIDROCORTISONE 1%***Datos del Medicamento***Ingrediente Activo Categoría***Hidrocortisona 1%***Ati-inflamatorio, antipurlitico***Otros Ingredientes: Petrolato, bezocaina, mentol, metal paraben, propel paraben*** Product box label reads in part: "***Hemorrodil Plus***HEMORRHOIDAL OINTMENT WITH HYDROCORTISONE 1%***Active Ingredients: Hydrocortisone (1%)***Uses: Temporary relief of external anal itch & minor skin irritations and rashes.***Inactive Ingredients: Petrolato benzocaine, mentol, metil paraben, propil paraben.*** " UPC 7 26576 14101 4. Recall # D-948-2011;
 
28) Product box label reads in part: "***Alivio al dolor de Anginas***Pro-Mex®***CurAgin***TROSCISCO***24 Lozenges***Relieves Sore Throat Pain***DRUG FACTS***Purpose***Active Ingredients: Each Lozenge***Relieves Sore Throat Pain***Menthol 5 mg***Cough Suppresant/Oral Anesthetic***Uses: Curagin Lozenges Advanced Vapor Action goes to work immediately***Soothing sore throat and help nasal passages feel cool land clearer. Indications: Mentho-Lyptus Menthol, Cough Suppressant / Oral Anesthetic. Fights cough,***Soothes sore throat. Makes nasal passages feel cooler. Advanced vapor action formula***Inactive Ingredients: Acesulfame Potassium, Aspartame, Beta Carotene, Carboxymethylcellulose Sodium, Flavor, Isomalt, RO Water*** UPC 1 84125 00109 5. Recall # D-949-2011;
 
29) Product box label reads in part: "***Cinahalar***Cream***ProMex***NDC 68532-150-30***40 g (1.38 oz.)***Drug Facts***Active ingredient (each application contains)***Purpose***Hydrocortisone (1.0%)***Anti-allergic, Anti-itch***Uses: Cream Helps Heal Rashes for Healthier Skin***Temporarily relieves itching associated with minor skin irritation, inflammation and rashes due to Eczema, Psoriasis, Seborrheic Dermatitis, Insect Bites, Detergents, Poison Ivy/Oak/sumac, Soaps, Cosmetics, Jewelry, External genital and anal itching***Soothing Moisturizers Plus Maximum Strength Relief***Inactive ingredients: Stearic Acid, Cetyl Alcohol, Mineral Oil, Methyl Paraben, Propyl Paraben, Triethaolamine, Rheocare ATC, RO Water***6***49651***" Tube labeling: "***Ciahalar***Cream***40 g/1.38 oz***Drug Facts***Active ingredient (each application contains)***Purpose***Hydrocortisone (1.0%)***Anti-allergic, Anti-itch***Inactive ingredients: Light Mineral Oil, White Petrolatum, Stearic Acid, Isopropyl Myristate, Methyl Paraben, Propyl Paraben, Glyceryn***Matenga la caja para instrucciones en espaol***" UPC 1 84125 00019 7. Recall # D-950-2011;
 
30) Product box label reads in part: "***ESTOMAQUIL***Maximum Strength***ESTOMAQUIL***NDC 68532-130-20***Maximum Strength for:***Upset Stomach***Heartburn***Indigestion***Nausea***Diarrhea***Helps Reduce Gas***20 Packets 3g each Packet***090829***08/12***Drug Facts***ACTIVE INGREDIENT(in each two packets)***Purpose***Bismuth Subsalicylate 525 mg***Antidiarrheal***Uses:***Controls diarrhea***Travelers diarrhea**Reduces number of bowl movements***Helps firm stool***Inactive ingredients: Magnesium Oxide, Calcium Carbonate*** Packet label: ***ESTOMAQUIL***Maximo Alivio para:***Dolor de Estmago***Acidez***Diarrea / Nausea***Reduce Gases Abdominales***Ardor / Malestar en General***3g***Active Ingredients: PURPOSE***Bismuth Subsalicylate: Each pouch contain 3 g***Upset Stomach & Diarrhea Reliever***(262 mg(99 mg of salicylate) Maximum Strength***Inactive Ingredients: Magnesium hidroxido, Calcium carbonate, Microcrystaline Cellulose & silica***UPC 1 84125 00021 0. Recall # D-951-2011;
 
31) Product box label reads in part: "***before***BALSAMO DENTAL***after***Fast Relief for***tooth ache***mouth sores***1 fl oz***NDC 68532-120-01***Drug Facts***Active Ingredients (in each application)***Purpose***Benzocaine (20%)***toothaches***Use:***For night-time toothache pain relief, try maximum strength Balsmo Dental***For mouth and lip sores***For denture pain***For cold sores***For teething pain***Inactive Ingredients: Flavor, Polyethylene Glycol, Sodium Saccharin, Sorbic Acid and Florasone Cardiospermum***" Tube label: "***before***BALSAMO DENTAL***after***Fast Relief for***tooth ache***mouth sores***1 fl oz***Drug Facts***Active Ingredients (in each application)***Purpose***Benzocaine (20%)***relief of pain***due to toothaches***" UPC 1 84125 00005 0. Recall # D-952-2011;
 
32) Product box label reads in part: "***KNEZTENGLIQUID NAILS***Promex***For external use only***1 fl oz***NDC-68532-230-01***Drug Facts***Active Ingredient (in each application)***Purpose***Clotrimazole (1 %)***Nails***Antifungal Liquid)***Uses:***Antifungal, antibacterial. Helps***Eliminate foot odor, clears nails fast,***conditions skin***Effective treatment of***fungus on the skin around and adjacent to***the nails***Inactive Ingredients: Water, Clotrimazole,***Benzalkonium Chloride, Emu Oil, Tea Tree***Oil, Caprylic/Capric Triglyceride,***Polyacrylamide (and) C-13-14 Isoparaffin***Dioxide, Phenoxyethanol, Ethylparaben,***Miconazole Nitrate, Butylparaben, ***Propylparaben, Methylparaben***" UPC 1 84125 00024 1. Recall # D-953-2011;
 
33) Product box label reads in part: "***ProMex***MUKOZOLBAN*** Forte***Suspencin Expect***Rico sabor a naranja***Eficaz Jarabe que alivia la tos ***desde su origen y suaviza la flema***DRUG FACT***Active Ingredients (one teaspoonful (5 mL)contains)***Purpose***Guaifenesin USP (100 mg)***Expectorant***Dextromethorphan Hydrobromide (USP 10 mg)***Coughs Suppressant***Uses: Temporarily relieves coughs due to minor throat and bronchial irritation as may occur with a cold and helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.***Inactive Ingredients: Citric Acid, FD&C Red 40, Flavors, Glucose, Glycerin, High Fructose Corn Syrup, Saccharin Sodium, Sodium Benzoate, Water.***" UPC 1 84125 00003 6. Recall # D-954-2011;
 
34) Product box label reads in part: "***Perlas Eterna***Relief of ***Bloating, Fullness***& Gases***15 Tablets*** DRUG FACTS***Active Ingredients:***PURPOSE***Simethicone 180 mg***Anti-Flatulent***Uses: For relief of bloating, pressure, fullness, stuffed feeling sensation commonly known as gas.***Other ingredients: FD&C Yellow 6, Gelatin, Glycerin, Purified Water***Inactive Ingredients: D&C Yellow10, FD&C Blue 1, Blue 1, FD&C Red 40***Gelatin, Glycerin, Peppermint Oil, Purified Water, Sorbitol, Titanium Dioxide***9***33958*** Includes 15 and 30 ct. UPC 1 84125 00061 6. Recall # D-955-2011;
 
35) Product box label reads in part: "***Ampitrexyl Natural Antibiotic Properties Dietary Supplement***30 Capsules 500 mg***PRO-MEX***Naturally combat microbes without side affects***Indications & Uses: Natural Antimicrobial***Supplement Facts***Andrographitis Extract***450 mg***Corydails Yanhusuo***50 mg***Other Ingredients: Special Blend: Propolis, Burdock Root Garlic extract, Spleen, Echineacea extract***" UPC 1 84125 00043 2. Recall # D-956-2011;
 
36) Product box label reads in part: "***T-RAPIEL***Antibiotic Cream***40 g/ 1.38 oz***free 5 g bigger***Drug Facts***Active Ingredients***(each gram contains) Bacitracin 500 Units***Purpose***First aid Antibiotic***Uses: Antibiotic***Help prevent infection***First Aid Antibiotic Cream help prevent infection in minor cuts***scrapes and burns***Inactive Ingredients: Stearic Acid, Cetyl Alcohol, Mineral Oil, Methyl Paraben, Propyl Paraben, Triethanolamine, Rheocare ATC, RO Water, Aloe Vera***" UPC 1 84125 00031 9. Recall # D-957-2011;
 
37) Product box label reads in part: "***VERMOCKS SUSPENSION***FOR TREATMENT OF PINWORMS***1 oz (30 mL)***Drug Facts***Active Ingredients (in each 1 mL)***Pyrantel Pamoate 144 mg/mL***(50 mg pyrantel base per mL)***Purpose Anthelmintic***Use: for the treatment of pinworm***Inactive Ingredients: Xa tam Gum, Citric Acid, Sodium Benzoate, Potassium Sorbate, Glycerin, Sugar, Flavor and Purified Water***". Recall # D-958-2011;
 
38) Product box label reads in part: "***ProMex®***MUKOZOLBAN***Suspención Expectorante***Forte***Adulto***Rico sabor a limón***Eficaz Jarabe que alivia la tos***desde su origen y suaviza la flema***DRUG FACT***Active Ingredients (2 teaspoons (10 mL) contains)***Guaifesin U.S.P. (200 mg)***Expectorant***Dextromethorphan Hydrobromide (U.S.P. 30 mg)***Cough Suppressant***Inactive Ingredients: Citric Acid, Glucose, Glycerin, High Fructose Corn Syrup, Glycerine, Propylene Glycol, Calbium Saccharin, Potassium Sorbate & Citrate, Methylparaben, Propylparaben , Menthol, Spearmint oil & Water***Uses: Temporarily relieves coughs due to minor throat and bronchial irritation as may occur with a cold and helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.***NDC-68532-920-08***" UPC 1 84125 00004 3. Recall # D-959-2011;
 
39) Product box label reads in part: "***LIQUID***SOAP***ANTISEPTIC***ANTIBACTERIAL***Another Fine Product By:***SANAFITIL®***Net wt 3.5 Fl. oz. (105 mL)***021003***INDICATIONS:***A cream cleanser. Containing antiseptic and bacteriostatic ingredients. The skin conditioners lanolin and glycerine are combined with a mild soap. Cleansing action is fast and efficient***CONTAINS: Water, Octadecanoic Acid, Para-chloro-metaxilenol, Lanoline, Glycerin, Cocodiethanolamine, Potassium Coconut Oil, Potassium Soap Toll Oil Fatty Acids, Fragrance***UPC 7 26576 01930 6. Recall # D-960-2011;
 
40) Product box label reads in part: "***SANAFITIL***NAIL CONTROL***WITH ALOE VERA***NET CONTENTS 1 Fl. oz. (30 mL.)***Temperature 59-86F (15-30C)***Ingredients/ 1 mL contains***Vitamin A***8500 IU***Vitamin C***1.0 mg***Vitamin E***30 IU***Salicylic Acid***1.0 mg***Vitamin B5***5 mg***Bezoic Acid***1.0 mg***Others: Carbomer, TEA 50%, Aloe Vera, Ethyl Alcohol, Propylene Glycol, Methyl Paraben, Propyl Paraben, Tween 80, Diazolidinyl Urea, Water DI*** Bottle label: ***SANAFITIL***NAIL CONTROL***WITH ALOE VERA GEL***MAINTENANCE FOR***A HEALTHY NAIL***1 oz. (30 mL)***Ingredients***Vitamin A, Vitamin E, Vitamin C, Vitamin B5, Aloe Vera, Salicylic Acid, Benzoic Acid, Gamben II, Polisorbate Tween 80, Carbomer, Ethyl Acetate, TEA, Water DI***UPC 7 26576 01219 2. Recall # D-961-2011;
 
41) Product box label reads in part: "***SANAFITIL***ANTIFUNGAL***SPRAY***FUNGICIDA***FOR THE TREATMENT OF ATHLETES FOOT, JOCK ITCH, AND RINGWORM***Tarmac***Products***Made in USA***Drug Facts***Active Ingredient***Undecylenic Acid 10%***Antifungal***Other Ingredients***Bemzocaine, Benzoic Acid, Boric Acid, Chorobutanol H, Methyl Salicylate, Salicylic Acid, Sodium Propionate, Thymol, Isopropyl Alcohol, Red Color #22, Water I.D.*** Bottle Label: ***SANAFITIL***ANTIFUNGAL***SPRAY***FOR THE TREATMENT OF ATHLETES FOOT, JOCK ITCH, AND RINGWORM***1 oz. (30 mL)***Drug Facts***Active Ingredient***Purpose*** Undecylenic Acid 10%***Antifungal***Uses***For the treatment of athletes foot, jock itch, ringworm and other fungus infections***Relieves itching, burning, cracking, scaling and discomfort which accompany these conditions*** UPC 7 26576 01732 6. Recall # D-962-2011;
 
42) Product box label reads in part: S***SANAFITIL®***ANTIFUNGAL***POWDER***FOR THE TREATMENT AND PREVENTION OF ATHLETE"S FOOT, JOCK-ITCH, RINGWORM AND OTHER FUNGUS INFECTIONS***Net wt 4 oz. (113.4g)***Drug Facts***Active Ingredients***Purpose***Undecyleic Acid 2%***Antifungal***Zinc Undecylenate 20 %***Antifungal***Other Ingredients talc***Made in U.S.A.*** UPC 7 26576 01480 6. Recall # D-963-2011;
 
43) Product box label reads in part: ***SANAFITIL***ANTIFUNGAL***FOR THE TREATMENT OF***JOCK ITCH***ATHLETES FOOT,***AND RINGWOM***Net wt 0.5 oz. (15G) CREAM***Tarmac***Products*** G***3***1193-7***Drug Facts***Active Ingredients***Purpose***Undecyleic Acid 10%***Antifungal***Zinc Undecylenate 27.5%***Antifungal***Other Ingredients: Purified Water, Tween 80, Petrolatum, Lanolin, Glycerin, Cetyl Alcohol, benzoic acid, salicylic acid, Bee-Wax, Peg-6, Glyceryl Monostearate, methyl salicylate*** UPC 7 26576 19161 3. Recall # D-964-2011;
 
44) Product box label reads in part: ***SANAFITIL***ANTIFUNGAL***LIQUID*** FOR THE TREATMENT***OF ATHLETES FOOT***JOCK ITCH, AND***RINGWORM.***2 Fl. oz.***Drug Facts***Active Ingredient***Purpose***Undecyleic Acid 10%***Antifungal***Other Ingredients***benzocaine, benzoic acid, boric acid, chlorobutanol h, isopropyl alcohol, methyl salicylate, red color #22, salicylic acid, sodium propionate, thymol, water***SANAFITIL***ANTIFUNGAL***LIQUID*** FOR THE TREATMENT OF*** ATHLETES FOOT, ***JOCK ITCH AND RINGWORM***2 oz. (60 mL)***Store at controlled room temperature 59-86F(15-30C)***Drug Facts***Active Ingredients***Quantity***Purpose***Undecylenic Acid***10.5%***Fungicide (topical)***Other Ingredients: Benzocaine, Salicylic Acid, Boric Acid, Benzoic Acid Crystalline, Methyl Salicylate, Methyl * Propyl Paraben, Menthol Crystals, Isopropyl Alcohol, Color and Purified Water***KEEP OUT OF THE REACH OF CHILDREN***EXTERNAL USE ONLY-NOT FOR DIAPER RASH*** UPC 7 26576 01585 8. Recall # D-965-2011;
 
45) Product box label reads in part: ***SANAFITIL***ANTIFUNGAL***1oz (28.35g)***FOR THE TREATMENT OF JOCK ITCH, ATHLETES FOOT, AND RINGWORM***OINTMENT***TARMAC PRODUCTS*** Drug Facts***Active Ingredients***Undecylenic Acid 10%***Antifungal***Other Ingredients***Benzocaine, Benzoic acid, boric acid, chlorobutanol h, methyl salicylate, paraffin, petrolatum, red color red #22, salicylic acid, sodium propionate, thymol***" UPC 7 26576 01322 9. Recall # D-966-2011;
 
46) Product box label reads in part: ***SANAFITIL***ANTIFUNGAL***LIQUID*** FOR THE TREATMENT***OF ATHLETES FOOT,***JOCK ITCH, AND***RINGWORM.*** 1 oz. (30 mL)***Drug Facts***Active Ingredient***Undecylenic Acid 10%***Antifungal***Uses***for the treatment of athletes foot, jock itch, ringworm and other fungus infections***relieves itching, burning, cracking, scaling and discomfort which accompany these conditions***Other Ingredients***isopropyl alcohol, purified water, benzoic acid, benzocaine, boric acid, methyl salicylate, salicylic acid, methyl paraben, menthol, D&C red #22*** UPC 7 26576 01430 1. Recall # D-967-2011;
 
47) Product box label reads in part: ***SANAFITIL***ANTIFUNGAL***ANTIFUNGAL OINTMENT*** TARMAC***PRODUCTS***2 oz (56.7g)*** FOR THE TREATMENT OF ATHLETES FOOT, JOCK ITCH AND RINGWORM***Drug Facts***Active Ingredients*** Undecylenic Acid 10%***Antifungal***Other Ingredients***Benzocaine, Benzoic acid, boric acid, chlorobutanol h, methyl salicylate, paraffin, petrolatum, red color #22, salicylic acid, sodium propionate, thymol. UPC 7 26576 01612 1. Recall # D-968-2011;
 
48) Product box label reads in part: ***VERMOCKS***TABLETA***ACABA CON LOS PARASITOS INTESTINALES EN UN 2 POR 3***Contains 6 Tablets***DRUG FACTS***Active Ingredients: (in each tablet)***Pyrantel Pamoate 144 mg***Paraciticide***OTHER INGREDIENTS: Stearic Acid, Calcium Phosphate, Utearic Acid, Magnesium Stearate, Sodium Crosscarmellose, Syloid, Mycrocantaline Cellulose. Prophyl Paraben, Natural Color, Natural and artificial Flavor" UPC 1 84125 00009 8. Recall # D-969-2011;
 
49) Product box label reads in part: ***VERMOCKS***TABLET***Contains 20 Tablets***Contiene 20 Tabletas***Drug Facts***Active Ingredient (in each tablet)***Pyrantel Pamoate 180 mg***Anthelmintic***62.5 mg pyrantel base per 180 mg of pyrantel pamoate)***Use: for the treatment of Pinworms***INACTIVE INGREDIENTS; Dicalcium Phosphate, Microcrystalline Cellulose,***Magnesium Stearate, Whey, Croscamellose Sodium. UPC 1 84125 00009 8. Recall # D-970-2011;
 
50) Product box label reads in part: ***NEOASMA***Expectorante***Jarabe***Nios***Alivia la tos y suaviza la flema***8 Fl. oz. (237 mL)***DRUG FACT***Active Ingredients (one teaspoon (5 mL) contains)***Guaifenesin 100 mg***Expectorant***Dextromethorphan Hydrobromide 10 mg***Coughs Suppressant***INACTIVE INGREDIENTS: Citric Acid, Flavor, Glycerin, HFCS, Sodium Benzoate, RO Water, Potassium Sorbate, Xantham Gum. UPC 7 26576 00003 8. Recall # D-971-2011;
 
51) Product box label reads in part: "***NEOASMA Expectorante***Jarabe***Adulto***Alivia la tos y suaviza la flema***8 Fl. oz. (237 mL)***DRUG FACT***Active Ingredients: (2 teaspoonful (10 mL) contains)***Guaifenesin 200 mg***Expectorant***Dextromethorphan Hydrobromide 30 mg***Coughs Suppressant***Inactive Ingredients: Citric acid, Flavor, glucose, glycerin, HFCS, Sodium Benzoate, Potassium Sorbate, Spearmint oil, Xantham Gum & Propelyne Glycol. UPC 7 26576 00002 1. Recall # D-972-2011;
 
52) Product box label reads in part: "******BUSCAPINA***POMADA***Rapido alivo para***el Dolor***Net Wt. 2 oz (58 g)***LOT/1340***EXP 08/08***DRUG FACTS***Active Ingredients:***Purpose***Methyl Salicylate (30%), Menthol (10%) Lidocaine (1%)***pain relief, topical analgesic***Inactive Ingredients: Sorbitol, Propylene Glycol, Methyl Paraben, propyl Paraben, Diazolidinyl Urea, Triethanolamine, FDA&C Blue # 1, Mineral Oil, Petrolatum, DC 345, Cetyl Alcohol, Stearic Acid, Sodium CHL, Aloe Vera Glucosamine Sulfate, Bark Extract, Tacopherol Acetate, Purified Water. Recall # D-973-2011;
 
53) Product box label reads in part: ***Pro-Mex***Temperatura***4 oz (120 mL)***FIEBRE***DRUG FACTS***For Ages 2 to 11***Active Ingredients: Each teaspoon (5 mL) contains***Acetaminophen 160 mg***Pain Reliever / fever reducer***Inactive Ingredients: artificial cherry flavor, benzoic acid, D & C Red #33, FD & C Red #40, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucrose." UPC 1 84125 00053. Recall # D-974-2011;
 
54) Product box label reads in part: "***With Propolis Eucalyptus & Honey Broncolimpio Plus Con Propolis Eucalypto Y Miel Dietary Supplement***8 oz (237 mL)***SUPPLEMENT FACTS: Serving Size 1 tablespoonful (15 mL) Servings per Container about 16 Calories 22***Amount per serving***Total FAT 0 g***Total carbohydrates 6 g***sugar 4 g***Sodium 10 g***Bee Propolis 3 mg***Been Honey 300 mg***Eucalyptus 150 mg***Watercress 150 mg***Myrrh 75 mg***Sambucus 4.6 mL***Menthol 1.3 g***Other Ingredients: Contain ethyl alcohol, guar gum, glycerine, potassium sorbate, sodium benzoate, citric acid, purified water & sweetener.***Propolis, Honey, Eucalyptus & Watercress are potent antioxidant properties, neutralize free radicals, strengthen natural body defenses." UPC 1 84125 00074 6. Recall # D-975-2011;
 
55) Product box label reads in part: "***ProMex***30 Tabletas FLA - NEX***Naproxeno Sodico Anti-inflamatorio / Alivia el dolor*** NDC # 68532-890-12***Drug Facts FLA-NEX***Active Ingredients (in each tablet) Naproxen Sodium (220 mg)***Pain reliever, anti-inflammatory***USE: Temporarily relieves minor aches and pains due to common cold, headache, toothache, muscular aches, backache, menstrual cramps, minor pains of arthritis***Temporarily reduces fever***Anti-Inflammatory***Inactive Ingredients: Coloidal silicon dioxide, FD&C blue #2AL Lake, hydrosxypropyl methylcelulose, lactose monohydrate, magnesium stearate, microcrystaline cellulose, providone, propylene glycol, talc, titanium dioxide." UPC 1 84125 00013 5. Recall # D-976-2011;
 
56) Product tube label reads in part: "***Knezteng***40g.***Pro-Mex***-Cura el Hongo de los ples***-Alivia comezn, plel partid a, dolor, ardor, etc***EFICAZ CONTRA EL PIE DE ATLETA Y HONGOS DE LA PIEL***Indications: Proven clinically effective in the treatment of athletes foot (tinea pedis) and ringworm (tinea corporis) is unscented and relieves the itching, scaling, burning, and discomfort that can accompany athletes foot***Active Ingredients: Miconazole Nitrate (2%)***Inactive Ingredients: Polyethylene Glycol 300, Polysorbate 20, SD Alcohol 40-B (15% w/w), Propellant: Dimethyl Ether. Recall # D-977-2011;
 
57) No label available: '***KNEZTENG VAGINAL***CLOTRIMAZOL***40 G.***"Note: product is the same as RES Product # 9 except the strength is 40 G. Recall # D-978-2011;
 
58) Product tube label reads in part: ***Ciklo-Ferol***5 GR***Crema para Fuegos***FEVER BLISTER CREAM***DRUG FACTS***Active Ingredient: Docosanol (10%) cold sores/fuegos***Uses: treats cold sores/fever blisters on face or lips***shortens healing time and duration of symptoms: tingling, pain, burning, and/or itch.***WARNINGS: For external use only.***Do Not Use: if you are allergic to any ingredients in this product.***When using this product: apply only to infected areas***do not use in or near the eyes***avoid applying directly inside your mouth***do not share this product with anyone, this may spread infection. Recall # D-979-2011;
 
59) Product tube label reads in part: ***OIDO SANA***Pro-Mex®***Fast Relief for***Ear-Aches***1 GR***DRUG FACTS***Active Ingredients: (in each application)***Purpose***Otic solution 2.75% Boric Acid***External ear canal***in Isopropyl Alcohol 95%***drying aid***Use: Bacteriostatic & Fungiastatic properties. Inhibits or destroys bacteria present in the ear canal. Recall # D-980-2011;
 
60) Product tube label reads in part: ***Ampitrexyl Antibitico***Pro-Mex***40 g/1.38 oz***USO EXTERNO SOLAMENTE***EXTERNAL USE ONLY***Drug Facts***Active Ingredients in each gram: Chloretracycline HCL, 30 mg in an ointment base***Uses: First aid to help prevent infection and a temporary relief of pain and discomfort in minor***cuts***scrapes***rashes***infections***Inactive Ingredients: Mineral Oil, Stearic Acid, Propylene Glycol, methyl & propyl paraben, petrolatum gel, lanoli, paraben, & purified water. Recall # D-981-2011;
 
61) Product tube label reads in part: ***T-Raojo Ophthalmic***OINTMENT***5 GR***Drug Facts***ACTIVE INGREDIENTS: Boric acid 10%***INDICATIONS: emergency flushing of foreign bodies, eye wash loosens foreign matter, soothes and cleans eye***Inactive Ingredients: Petrolatum USP, Mineral Oil, Lanolin, Methyl Parabens, Propyl Parabens. Recall # D-982-2011;
 
62) Product tube label reads in part: ***Crema***40 g/1.38 oz*** Cuadriderma***Tpica***USO EXTERNO SOLALMENTE***EXTERNAL USE ONLY***Drug Facts***Active Ingredients: in each gram***Neomycin***3.5 mg***Lidocaine HCL***0.5%***Polymyxin B Sulfate***10,000 units***USES: First aid to help prevent infection and a temporary relief of pain and discomfort in minor***cuts***scrapes***rashes***infections***Inactive Ingredients: Croton lechery, tea tree, cetearyl, alcohol, mineral oil, stearic acid, petrollatum gel, propylene glycol, methyl paraben, propyl paraben & water***NDC-68532-100-40. Recall # D-983-2011;
 
63) Product tube label reads in part: ***40g/1.38oz***VITA-UNGENTO***Antibiótico primeros auxilios con Retinol y Neomicina***Drug Facts***Active Ingredients:***Purpose***Neomycin Sulfate eq. to 3.5 mg of Neomycin 5 mg***First Aid Antibiotic***Uses: First aid ointment antibiotic to help prevent infections. For the temporary relief of***burns***rashes***itching***minor cuts***scrapes and minor infections***Indications: First aid Antiseptic, Analgesic & Disinfectant safe and effective to kills bacteria and provides expert protection against germs that cause infection and illness. Fast soothing relief of pain due to: Sunburn, Minor Burns, Cuts, Scrapes & Insect Bites***Inactive Ingredients: Retinol as Vitamin A Palmitate, Lanolin, Petrolatum, Methylparaben, Propylparaben and propylene glycol***Tarmac***Products***33014. Recall # D-984-2011;
 
64) Product label reads in part: ***Ciahalar®***Cream***40 GR/1.38oz***Drug Facts***Active ingredient (each application contains)***Purpose***Hydrocortisone (1.0%)***Anti-allergic, Anti-itch***Inactive ingredients: Light Mineral Oil, White Petrolatum, Stearic Acid, Isopropyl Myristate, Methyl Paraben, Propyl Paraben, Glyceryn***Matenga la caja para instrucciones en español. Recall # D-985-2011
CODE
All codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tarmac Products, Inc. d.b.a. Axara Pharmaceuticals, Hialeah, FL, by letter (certified mail), tele fax and telephone beginning July 26, 2011.
Manufacturers: PROMEX LLC, Hialeah, FL;
Tarmac Products, Inc. d.b.a. Axara Pharmaceuticals, Hialeah, FL;
Natural Vitamins Laboratory, Opa Locka, FL. FDA initiated recall is ongoing.
REASON
CGMP Deviations; products were not manufactured under cGMP's and not stored in controlled temperature and humidity conditions.
VOLUME OF PRODUCT IN COMMERCE
650,256 units
DISTRIBUTION
Nationwide
________________________________________
PRODUCT
1) Infants' Simethicone Drops, Active Ingredient (in each 0.3 mL) Simethicone 20 mg, 100 Doses, 1 fl oz (30mL) bottle, NDC 0603-0894-50. Recall # D-986-2011
 
2) Triamcinolone Acetonide Lotion, USP 0.1%, Each mL Provides: 1 mg of triamcinolone acetonide, 60 mL, Rx only, NDC 0603-7864-49. Recall # D-987-2011;
 
3) Griseofulvin Oral Suspension, USP (Microsize), 125mg/5mL, Contains 0.2% Alcohol, Rx only, 4 fl oz (118 mL), NDC 0603-9171-54. Recall # D-988-2011
CODE
1) L107E10A, exp. 08/2012; L045H10A, exp. 09/2012; L046H10A, exp. 09/2012; L107J10A, exp. 10/2012; L028K10A, exp. 10/2012; L029K10A, exp. 10/2012; and L087M09A exp 01/2012, L088M09A exo 01/2012, L065A10A exp 02/2012, L066A10A exp 02/2012, L066C10A exp 03/2012, L067C10A exp 03/2012, L169C10A exp 05/2012, L170C10A exp 05/2012, L192C10A exp 05/2012, L014E10A exp 06/2012, L015E10A exp 06/2012, L105E10A exp 06/2012, L106E10A exp 07/2012, L029L10A exp 12/2012, L030L10A exp 12/2012, L031L10A exp 12/2012, L006A11A exp 01/2013, L089A11A exp 02/2013, L020B11A exp 02/2013, L073B11A exp 02/2013, and L009C11A exp 02/2013;
 
2) L002K10A, exp. 10/2012, L004K10A, exp. 10/2012, L118M09A exp 02/12, L119M09A exp 02/2012, L068C10A exp 03/2012, L005F10A 06/2012, L073F10A exp 06/2012, L074F10A exp 06/2012, L014L10A exp 12/2012, L015L10A exp 12/2012, L037M10A exp 12/2012, L060M10A exp 01/2013, L061M10A exp 01/2013, L062M10A exp 01/2013, L063M10A exp 01/2013, L064M10A exp 02/2013, L065M10A exp 02/2013, L028A11A exp 01/2013, L029A11A exp 01/2013, L030A11A exp 02/2013, L088A11A exp 02/2013, L091A11A exp 02/2013, L062B11A exp 03/2013, L063B11A exp 03/2013, L084C11A exp 04/2013, L085C11A exp 04/2013, L086C11A exp 04/2013, L087C11A exp 04/2013, L088C11A exp 05/2013, and L089C11A exp 05/2013;
 
3) L012B10A, exp. 03/2012; L029C10A, exp. 03/2012; L030C10A, 03/2012; L053K10A, exp. 11/2012; and L001D11A, exp. 03/2013
RECALLING FIRM/MANUFACTURER
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals, Huntsville, AL, by letter on June 30, 2011 and August 31, 2011. Firm initiated recall is ongoing.
REASON
Microbial Contamination of Non Sterile Product; product may be contaminated with Burkholderia cepacia.
VOLUME OF PRODUCT IN COMMERCE
335,197 units
DISTRIBUTION
Nationwide & PR
________________________________________
PRODUCT
Albuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg / 3 mL, 60 x 3 mL Sterile Unit-Dose Vials. Recall # D-989-2011
CODE
Lot # A0B17A
RECALLING FIRM/MANUFACTURER
Nephron Pharmaceuticals Corp., Orlando, FL, by letter on February 3, 2011. Firm initiated recall is ongoing.
REASON
Labeling: Correct Labeled Product Miscart/Mispack: Nephron Pharmaceuticals Corporation is recalling Albuterol Sulfate Inhalation Solution 0.083%, lot # A0B17A, was found to have some pouches containing a different product Ipratropium Bromide.
VOLUME OF PRODUCT IN COMMERCE
22,224 cartons
DISTRIBUTION
Nationwide and PR
________________________________________
PRODUCT
Arthrotec 75, 75 mg diclofenac sodium/200 mcg misoprostol, 75 mg/200 mcg, 60 tablets, Rx only, NDC 0025-1421-60. Recall # D-1000-2011 
CODE
Lot #s: C090912, Exp. 02/13; C091184, Exp. 02/13; C091234, Exp. 04/13; C100256, Exp. 09/13; C100320, Exp.09/13
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pfizer Inc., New York, NY, by letters on September 7, 2011.   
Manufacturer: Pfizer Pharmaceuticals LLC, Caguas, PR. Firm initiated recall is ongoing.
REASON
Tablet separation: recalled lots may contain broken tablets.
VOLUME OF PRODUCT IN COMMERCE
356,281 bottles
DISTRIBUTION
Nationwide and PR
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
________________________________________
PRODUCT
Diflorasone Diacetate Ointment USP, 0.05%, NET WT 30 grams, Rx only, a) fougera label, NDC 0168-0243-30; b) PharmaDerm label ApexiCon Ointment (diflorasone diacetate ointment USP 0.05%), 30 grams, Rx only, NDC 0462-0394-30. Recall # D-990-2011
CODE
a) Batch 428G, exp. 09/2011; b) Batch 429G, exp. 09/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nycomed US, Inc., Melville, NY, by letters dated March 30, 2011.
Manufacturer: Nycomed Us Inc., Hicksville, NY. Firm initiated recall is ongoing.
REASON
Product lacks stability: Out-of-specification (OOS) result for low viscosity obtained during stability testing.
VOLUME OF PRODUCT IN COMMERCE
Batch 428G: 6158 tubes, Batch 429G: 14 tubes
DISTRIBUTION
Nationwide and PR
________________________________________
PRODUCT
1) Nicorette Gum (nicotine polacrilex gum); 2 mg; White Ice Mint; a) 20-count pieces per Unit, NDC 00135-474-01, UPC 3-0766-7750-52-2, b) 40-count pieces per Unit NDC 00135-474-07; UPC 3-0766-7750-40-9, c) 100-count pieces per Unit, NDC 00135-474-02 UPC 3-0766-7750-00-3, d) 120-count pieces per Unit, NDC 00135-474-06; UPC 3-0766-7750-05-8, e) 160-count pieces per Unit, NDC 00135-474-05; UPC 3-0766-7750-25-6, f) 190-count pieces per Unit, NDC 00135-474-03; UPC 3-0766-7750-30-0. Recall # D-991-2011;
 
2) Nicorette Gum (nicotine polacrilex gum), 4 mg, White Ice Mint, a) 20-count pieces per Unit, NDC 00135-475-01; UPC 3-0766-7760-52-1; b) 40-count pieces per Unit, NDC 00135-475-07; UPC 3-0766-7760-40-8; c) 100-count pieces per Unit, NDC 00135-475-02; UPC 3-0766-7760-00-2; d) 120-count pieces per Unit, NDC 00135-475-06; UPC 3-0766-7760-05-7; e) 160-count pieces per Unit, NDC 00135-475-05; UPC 3-0766-7760-25-5; f) 190-count pieces per Unit, NDC 00135-475-03; UPC 3-0766-7760-30-9. Recall # D-992-2011;
 
3) Nicorette Gum (nicotine polacrilex gum), 2 mg, Fresh Mint ,190-count pieces per Unit, NDC 00135-225-03; UPC 3-0766-7849-50-9. Recall # D-993-2011;
 
4) Nicorette Gum (nicotine polacrilex gum), 4 mg, Fresh Mint, 190-count pieces per Unit, NDC 00135-226-03; UPC 3-0766-7849-55-4. Recall # D-994-2011;
 
5) Nicorette Gum (nicotine polacrilex gum), 2 mg, Fruit Chill, 190-count pieces per Unit, NDC 00135-241-03; UPC 3-0766-7867-50-3. Recall # D-995-2011;
 
6) Nicorette Gum (nicotine polacrilex gum), 4 mg, Fruit Chill, 190-count pieces per Unit, NDC 00135-242-03; UPC 3-0766-7867-60-2. Recall # D-996-2011;
 
7) Nicorette Gum (nicotine polacrilex gum), Mixed Flavors, a) 6 piece counter unit, b) 12 piece counter unit. Recall # D-997-2011
CODE
1) Lot #'s: a) 10A07N; 10A21N; 10F10N; 10F28N; 10G29N; 10H18N; 10H24N; 10J15N; 10J16N; 10J16N1; 10J19N; 10K15N. b) LD879A; LE928A; LF839A; LG852A; LL905A; MI955A; 10A19N; 10E26N; 9I08N; 9I11W; 9I23N; 9J28N. c) 10K29N; 10K30N; 10L01N; 10L03N; 10L04N; 10L06N; LI893A; LK876A; LL800A; LL869A; LM800A; LM878A; MA803A; MA871A; MA872A; MB800A; MC800A; MC846A; MC894A; MD840A; MD922A; ME841A; ME925A; ME977A MF812A; MF893B; MF961A; MH800A; MH844A; MH845A; MI814A; MI861A MI956A; MK800A; MK851A; ML856A; ML858A; ML902A; MM814A; MM856A NA800A; NA874A; NA971A; 10A04N; 10C11N; 10C17N; 10C18N; 9L30N1. d) 10L09N e) LE928B; LF839B; LF840A; LG853A; LG854A; LI859A; MC843A; MC934A; ME976A; MF893A; MI907A; MK892A; MM816A; MM860A; NA923A. f) 10D07N;
 
2) Lot #s: a) 10A06N; 10A26N; 10D29N; 10E17N; 10F14N; 10G06N; 10H11N; 10H19N; 10I02N; 10J18N; 10J18N1; 10J19N; 10K03N; 10K23N; 10K29N; 10L11N; 11A11N; 11A11N1. b) LF801A; LF842A; LG855A; LH953A; LI895A; LI895B; MI916A. c) 10A21N; 10D15N; 10D28N; 10F07N; 11A12N; LK878A; LL804A; LL883A; LM808A; LM882A; MA808A; MA877A; MA878A; MB808A; ME882A; ME924A; ME987B; MF822B; MF891A; MG805A; MH802A; MH892A; MI873A; MK810A; MK855A; MK890A; MK945A; ML865A; ML870A; ML914A; NA809A; NA931A; 10C11N; 10C16N; 10C17N; 10C22N; 10C23N; 10D27N; 10D27N1; 9L04N. d) 10L10N e) LL914A; LL915A; LM883A; MA919A; MC851A; ME986A; MF924A;MI961A; MK944A; ML868A; ML954A; MM904A; MM905A; NA808A; NA934A. f) 9J23N; 9J23N1;
 
3) Lot #s: 10D07W; 10D22W; 10F14W;
 
4) Lot #s: 10D19W; 10F11W;
 
5) Lot #s: 10E25W; 10G14W;
 
6) Lot #: 10F02N; 10F10N; 10F17N;
 
7) Lot #: a) 10K22N; 10K23N; 10F28N; b) 10K17N; 10K18N; 10K19N; 10K22N; 10K24W
RECALLING FIRM/MANUFACTURER
Recalling Firm: Glaxo Smith Kline. Parsippany, NJ, by letters dated May 6, 2011.
Manufacturer: Pfizer Health AB, Helsingborg, Sweden. Firm initiated recall is ongoing.
REASON
Misbranded: Labeling bears unapproved therapeutic claims; The primary display panel for Nicorette gum contains the following statement "Whitens Teeth;" an unapproved statement.
VOLUME OF PRODUCT IN COMMERCE
2,024,672 boxes
DISTRIBUTION
Nationwide and PR
________________________________________
PRODUCT
Betamethasone Valerate Ointment USP, 0.1%, Net wt 45 grams, Rx only, NDC 0168-0033-46. Recall # D-998-2011 
CODE
Batch 600G, exp. 3/2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nycomed US, Inc., Melville, NY, by letters dated March 30, 2011. 
Manufacturer: Nycomed US, Inc., Hicksville, NY. Firm initiated recall is complete.
REASON
Labeling; illegible lot number and/or expiration date.
VOLUME OF PRODUCT IN COMMERCE
27,936 tubes
DISTRIBUTION
Nationwide and PR
________________________________________
PRODUCT
Econazole Nitrate Cream, 1%, Net wt 30 grams, Rx only, NDC 0168-0312-30. Recall # D-999-2011
CODE
Batch 823G, exp. 05/2012; 559G, exp. 03/2012; and 657H, exp. 07/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nycomed US, Inc., Melville, NY, by letters dated March 30, 2011.
Manufacturer: Nycomed US, Inc., Hicksville, NY. Firm initiated recall is ongoing.
REASON
Labeling illegible; lot number and expiration date are not legible on some tubes.
VOLUME OF PRODUCT IN COMMERCE
Batch 823G: 63,378 tubes; Batch 559G: 60,887 tubes; Batch 657H: 62,508 tubes
DISTRIBUTION
Nationwide and PR
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
________________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1925-11
CODE
Units: 3086979, 4542662, 3081299, 5530323, 5532072, 3086286, 6394471, 530547, 5529625, 3086267, 5531404, 4541647, 4542768, 3089165, 6399646, 805034, 3083917, 6396876, 9802633, 3088109
RECALLING FIRM/MANUFACTURER
Northern California Community Blood Bank, Eureka, CA, by telephone on August 26, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose medical history screening was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
20 units
DISTRIBUTION
CA
________________________________________
PRODUCT
1) Platelets, Pheresis, Leukocytes Reduced. Recall # B-2079-11;
2) Platelet Pheresis, Leukocytes Reduced Irradiated. Recall # B-2080-11 
CODE
1) Units: 38GP42971 Part A, 38GP42971 Part B; 38GP42972 Part A, 38GP42972 Part B; 38GP42973 Part B, 38GP42979 Part A, 38GP42979 Part B, 38GP42984, 38GP42987 Part A, 38GP42987 Part B, 38GP42988 Part A, 38GP42988 Part B 38GP42993 Part A, 38GP42993 Part B; 38GP43007 Part A, 38GP43007 Part B; 38GP43007 Part C; 38GP43009, 38GP43014 Part A, 38GP43014 Part B; 38GP43017, 38GP43019, 38GP43028 Part A, 38GP43028 Part B, 38GP43030 Part A, 38GP43030 Part B; 38GP43032 Part A ; 38GP43032 Part B; 38GP43032Part C; 38GP43034 Part A; 38GP43034 Part B; 38GP43034 Part C; 38GP43041 Part A; 38GP43042 Part A; 38GP43049 Part A, 38GP43049 Part B; 38GP43049 Part C; 38GP43054 Part A, 38GP43054 Part B; 38GP43059 Part A, 38GP43059 Part B; 38GP43063 Part A, 38GP43063 Part B; 38GP43063 Part C; 38GP43067, 38GP43080 Part A, 38GP43080 Part B, 38GP43086 Part A, 38GP43086 Part B; 38GP43092 Part A, 38GP43092 Part B, 38GP43097 Part A, 38GP43097 Part B, 38GP43098 Part A, 38GP43109;
 
2) Units: 38GP43041 Part A; 38GP43042 Part C, 38GP43098 Part C, 38GP42973 Part 1
RECALLING FIRM/MANUFACTURER
American National Red Cross Indiana-Ohio Region, Fort Wayne, IN, by letter on December 29, 2009 and March 30, 2010. Firm initiated recall is complete.
REASON
Blood products, which did not meet the acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
59 units
DISTRIBUTION
OH, IN
________________________________________
PRODUCT
1) Cryoprecipitated AHF. Recall # B-2115-11;
2) Plasma. Recall # B-2116-11;
3) Red Blood Cells. Recall # B-2117-11;
4) Fresh Frozen Plasma. Recall # B-2118-11 
CODE
1) Unit: 4033561;
2) Units: W038511380013; 4033561; 3036603;
3) Units: W038511380013; 4033561; 3036603; 3034408;
4) Unit: 3034408
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by fax on July 14, 2011 and July 28, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
FL, SC, GA
________________________________________
PRODUCT
1) Red Blood Cells. Recall # B-2119-11;
2) Platelets. Recall # B-2120-11
CODE
1) and 2) Unit: W067109064634
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on June 15, 2001, email on June 16, 2011 and letter on July 13, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a deferred donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
LA
________________________________________
PRODUCT
Recovered Plasma. Recall # B-2124-11
CODE
Recall # W038111071236
RECALLING FIRM/MANUFACTURER
Recalling Firm: Florida's Blood Centers, Inc., Orlando, FL, by fax on Jun 10, 2011.
Manufacturer: Florida's Blood Centers, Inc., Rockledge, FL. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
________________________________________
PRODUCT
1) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-2126-11;
2) Platelets Pooled Leukocytes Reduced. Recall # B-2127-11;
3) Fresh Frozen Plasma. Recall # B-2128-11;
4) Cryoprecipitated AHF. Recall # B-2129-11;
5) Platelets. Recall # B-2130-11;
6) Plasma Frozen Cryoprecipitated Reduced. Recall # B-2131-11;
7) Red Blood Cells. Recall # B-2132-11
CODE
1) Unit: W036810128962;
2) Unit: 2401972;
3) Units: W036810128962; 2450269; 2358993;
4) Unit: 2290334;
5) Unit: 2290334;
6) Unit: 2290334;
7) Units: 2401972; 2450269; 2358993; 2313607; 2290334; 1792661
RECALLING FIRM/MANUFACTURER
Community Blood Centers/S Florida Inc., Lauderhill, FL, by telephone and letter on July 28, 2011. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
14 units
DISTRIBUTION
FL
________________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-2134-11;
2) Recovered Plasma.  Recall # B-2135-11
CODE
1) and 2) Unit: W089811650295
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Inova Blood Donor Services, Sterling, VA, by facsimile on June 24, 2011 and letter/email on July 5, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NJ, DC
________________________________________
PRODUCT
 Red Blood Cells Leukocytes Reduced. Recall # B-2138-11
CODE
Units: W045011042311; W045011007926; W045010114709
RECALLING FIRM/MANUFACTURER
Community Blood Center Of Greater Kansas City, Kansas City, MO, by telephone on July 19, 2011. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
MO, KS
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
________________________________________
PRODUCT
Source Plasma. Recall # B-1834-11
CODE
Unit: LP171210
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corp., Las Vegas, NV, by fax on October 4, 2005. 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
Austria
________________________________________
PRODUCT
Source Plasma. Recall # 2058-11
CODE
Units: 5070108285; 5070105201; 5070104806; 5070104551; 5070104191; 5070103944; 5070103614; 5070103362; 5070103056; 5070102702; 5070102462; 5070102104; 5070101900; 5070101565; 5070101169; 5010100949; 5070100708
RECALLING FIRM/MANUFACTURER
Octapharma Plasma Inc., Birmingham, AL, by electronic mail on July 1, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
17 units
DISTRIBUTION
NC
________________________________________
PRODUCT
Source Plasma. Recall # B-2059-11
CODE
Units: 3870130158, 3870127475, 3870127046, 3870126685
RECALLING FIRM/MANUFACTURER
Octapharma Plasma, Springfield, IL, by electronic mail on July 1, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
NC
________________________________________
PRODUCT
Source Plasma. Recall # B-2060-11
CODE
Units: 3870106395, 3870123809, 3870123061
RECALLING FIRM/MANUFACTURER
Octapharma Plasma, Springfield, IL, by electronic mail on July 1, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 Units
DISTRIBUTION
NC
________________________________________
PRODUCT
Source Plasma. Recall # B-2061-11
CODE
Unit: 3870128476
RECALLING FIRM/MANUFACTURER
Octapharma Plasma, Springfield, IL, by electronic mail on July 1, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
________________________________________
PRODUCT
Source Plasma. Recall # B-2062-11
CODE
Units: 3870152492, 3870151502, 3870150948, 3870150124, 3870149727, 3870149195, 3870148938, 3870148159 3870147812
RECALLING FIRM/MANUFACTURER
Octapharma Plasma, Springfield, IL, by electronic mail on July 1, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
NC
________________________________________
PRODUCT
Source Plasma. Recall # B-2063-11
CODE
Units: 3870118498, 3870112066, 3870107151
RECALLING FIRM/MANUFACTURER
Octapharma Plasma, Springfield, IL, by electronic mail on July 1, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NC
________________________________________
PRODUCT
Source Plasma. Recall # B-2064-11
CODE
Units: 5070101157; 5070099564; 5070102545; 5070102209; 5070102759; 5070101679
RECALLING FIRM/MANUFACTURER
Octapharma Plasma Inc., Birmingham, AL, by electronic mail on July 1, 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
6 units
DISTRIBUTION
NC
________________________________________
PRODUCT
Source Plasma. Recall # B-2065-11
CODE
Units: 5070100729; 5070100506; 5070100215
RECALLING FIRM/MANUFACTURER
Octapharma Plasma Inc., Birmingham, AL, by electronic mail on July 1, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NC
________________________________________
PRODUCT
Source Plasma. Recall # B-2066-11
CODE
Units: 5170031903; 5170029641; 5170029247; 5170028247; 5170027933; 5170024835; 5170024446
RECALLING FIRM/MANUFACTURER
Octapharma Plasma, Inc., Florence, AL, by electronic mail on July 1, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
Austria
________________________________________
PRODUCT
Source Plasma. Recall # B-2067-11
CODE
Units: 4290033104; 4290032759; 4290032208; 4290031878; 4290030765; 4290029893; 4290029400; 4290029023; 4290028684; 4290027953; 4290027710; 4290026687; 4290026269; 4290025866
RECALLING FIRM/MANUFACTURER
IBR PlasmaCenters, LLC, Garland, TX, by electronic mail on July 1 and July 5, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
14 units
DISTRIBUTION
Austria, CA
________________________________________
PRODUCT
Source Plasma. Recall # B-2068-11
CODE
Units: 5280060185; 5280060606
RECALLING FIRM/MANUFACTURER
IBR PlasmaCenters, LLC, Lubbock, TX, by electronic mail on July 1, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Austria
________________________________________
PRODUCT
Source Plasma. Recall # B-2069-11
CODE
Units: 4290044464; 4290043920; 4290042058
RECALLING FIRM/MANUFACTURER
IBR PlasmaCenters, LLC, Garland, TX, by electronic mail on July 5, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA
________________________________________
PRODUCT
Source Plasma. Recall # B-2070-11
CODE
Units: 3890146869; 3890146198; 3890145150; 3890134157; 3890127889
RECALLING FIRM/MANUFACTURER
Octapharma Plasma, Inc., Lynchburg, VA, by electronic mail on July 1, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
Austria
________________________________________
PRODUCT
Source Plasma. Recall # B-2071-11      
CODE
Units: 3890115036; 3890105242
RECALLING FIRM/MANUFACTURER
Octapharma Plasma, Inc., Lynchburg, VA, by electronic mail on July 1, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Austria
________________________________________
PRODUCT
Source Plasma. Recall # B-2072-11
CODE
Units: 3890117522; 3890117109; 3890116451
RECALLING FIRM/MANUFACTURER
Octapharma Plasma, Inc., Lynchburg, VA, by electronic mail on July 1, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Austria
________________________________________
PRODUCT
Source Plasma. Recall # B-2073-11
CODE
Units: 4580108215; 4580107208; 4580106933; 4580105665
RECALLING FIRM/MANUFACTURER
Octapharma Plasma, Inc., North Charleston, SC, by electronic mail on July 5, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
NC
________________________________________
PRODUCT
Source Plasma. Recall # B-2074-11
CODE
Units: 4270013906; 4270013044; 4270012062; 4270011378; 4270010874
RECALLING FIRM/MANUFACTURER
Octapharma Plasma, Inc., Charlotte, NC, by electronic mail on July 1, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
Austria
________________________________________
PRODUCT
Source Plasma. Recall # B-2075-11
CODE
Units: 4640169486; 4640169181; 4640167411; 4640167060
RECALLING FIRM/MANUFACTURER
Octapharma Plasma, Inc., Las Vegas, NV, by electronic mail on July 1, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
Austria
________________________________________
PRODUCT
Source Plasma. Recall # B-2076-11
CODE
Units: 5220029732; 5220029953
RECALLING FIRM/MANUFACTURER
Octapharma Plasma, Inc., Evansville, IN, by electronic mail on July 1, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Austria
________________________________________
PRODUCT
Source Plasma. Recall # B-2077-11
CODE
Units: 4620116774; 4620116538; 4620113479; 4620113223; 4620112687; 4620112448; 4620111956; 4620111214; 4620111032; 4620111755
RECALLING FIRM/MANUFACTURER
Octapharma Plasma Inc., Colton, CA, by electronic mail on July 1, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
Austria
________________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2114-11
CODE
Unit: W071211026432
RECALLING FIRM/MANUFACTURER
Medic Inc., Knoxville, TN, by telephone and letter on June 22, 2011. Firm initiated recall is complete.
REASON
Blood product, which was not quarantined subsequent to receiving post donation illness information, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
________________________________________
PRODUCT
Recovered Plasma. Recall # B-2121-11
CODE
Unit: W067109064634
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on June 15, 2001, email on June 16, 2011 and letter on July 13, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a deferred donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
________________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-2122-11
CODE
Unit: 11631177202600I Part 1; 11631177202600I Part 2
RECALLING FIRM/MANUFACTURER
Florida Blood Services, Inc., Pensacola FL, by telephone and fax on August 3, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom there was no documentation on the donor record of an arm inspection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
________________________________________
PRODUCT
Recovered Plasma. Recall # B-2125-11 
CODE
Unit: 041LZ33429
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Birmingham, AL, using the LOGIC system on June 22, 2011. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
______________________________________
PRODUCT
Source Plasma. Recall # B-2133-11
CODE
Unit: 11SLMA4919
RECALLING FIRM/MANUFACTURER
Interstate Blood Bank Inc., Mo, Saint Louis, MO, by fax on June 27, 2011. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
________________________________________
PRODUCT
Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Product Code: 2M8161. Product Usage: Intended for use in a wide variety of patient environments for adult, pediatric and neonatal patients. Electronic infusion pumps indicated for continuous or intermittent delivery of solution through clinically acceptable routes of administration, such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural or irrigation of fluid spaces applications. Recall # Z-2958-2011
CODE
Serial Number: 12020525CC
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by telephone on July 22, 2011, and by letter dated July 25, 2011.
Manufacturer: Baxter Healthcare SA, Singapore, Singapore. FDA initiated recall is ongoing.
REASON
Baxter's Service Center tested and returned to the user the Colleague infusion pump that did not meet PSIG (Pounds-force per Square Inch) specifications.
VOLUME OF PRODUCT IN COMMERCE
1 pump
DISTRIBUTION
MN
________________________________________
PRODUCT
Clinac, Trilogy. Trilogy Tx and Novalis Tx Linear Accelerators. Varian Medical Systems, Inc. Oncology Systems Intended for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions in the body where radiation treatment is indicated. Recall # Recall # Z-2978-2011
CODE
Units: H14, H18, H27 and H29. Serial numbers: H140001 H140063 H140123 H140227 H140745 H140803 H140861 H140921 H180107 H180226 H180324 H180474 H180549 H140002 H140064 H140124 H140228 H140746 H140804 H140862 H140923 H180108 H180228 H180325 H180475 H180550 H140003 H140065 H140125 H140229 H140747 H140805 H140863 H140924 H180115 H180229 H180326 H180476 H180551 H140004 H140066 H140126 H140230 H140748 H140806 H140864 H140925 H180116 H180230 H180327 H180477 H180552 H140005 H140067 H140127 H140231 H140749 H140807 H140865 H140926 H180117 H180235 H180328 H180478 H180553 H140007 H140068 H140128 H140232 H140750 H140808 H140866 H140927 H180119 H180236 H180329 H180479 H180554 H140008 H140069 H140129 H140233 H140751 H140809 H140867 H140929 H180122 H180237 H180401 H180480 H180555 H140009 H140070 H140130 H140234 H140752 H140810 H140868 H140930 H180124 H180238 H180402 H180482 H180556 H140010 H140071 H140131 H140235 H140753 H140811 H140869 H140931 H180128 H180240 H180404 H180484 H180557 H140011 H140072 H140132 H140236 H140754 H140812 H140870 H140932 H180129 H180242 H180405 H180485 H180559 H140012 H140073 H140133 H140237 H140755 H140813 H140871 H140933 H180131 H180243 H180407 H180486 H180560 H140014 H140074 H140134 H140238 H140756 H140814 H140872 H140934 H180132 H180245 H180409 H180487 H180561 H140015 H140075 H140135 H140239 H140757 H140815 H140873 H140935 H180133 H180246 H180410 H180489 H180562 H140016 H140076 H140136 H140240 H140758 H140816 H140874 H140936 H180135 H180249 H180411 H180490 H180563 H140017 H140077 H140137 H140700 H140759 H140817 H140875 H140938 H180143 H180250 H180412 H180491 H180564 H140018 H140078 H140138 H140701 H140760 H140818 H140876 H140940 H180144 H180251 H180413 H180492 H180565 H140019 H140079 H140139 H140702 H140761 H140819 H140877 H140941 H180147 H180254 H180414 H180493 H180566 H140021 H140080 H140140 H140703 H140762 H140820 H140878 H140944 H180148 H180255 H180417 H180494 H180567 H140022 H140082 H140141 H140704 H140763 H140821 H140879 H140945 H180151 H180256 H180419 H180495 H180569 H140023 H140083 H140142 H140705 H140764 H140822 H140881 H140947 H180154 H180257 H180420 H180496 H180570 H140024 H140084 H140143 H140706 H140765 H140823 H140882 H180003 H180157 H180258 H180422 H180498 H180571 H140025 H140085 H140144 H140707 H140766 H140824 H140883 H180004 H180158 H180260 H180424 H180499 H180572 H140026 H140086 H140145 H140708 H140767 H140825 H140884 H180007 H180159 H180262 H180425 H180501 H180573 H140027 H140087 H140146 H140709 H140768 H140826 H140885 H180008 H180161 H180264 H180426 H180505 H180574 H140028 H140088 H140147 H140710 H140769 H140827 H140886 H180016 H180164 H180267 H180427 H180507 H180575 H140029 H140089 H140148 H140711 H140770 H140828 H140887 H180017 H180166 H180268 H180432 H180508 H180576 H140030 H140090 H140149 H140712 H140771 H140829 H140888 H180019 H180167 H180271 H180433 H180509 H180577 H140031 H140091 H140150 H140713 H140772 H140830 H140889 H180025 H180168 H180272 H180436 H180510 H180578 H140032 H140092 H140151 H140714 H140773 H140831 H140890 H180026 H180170 H180273 H180437 H180511 H180579 H140033 H140093 H140152 H140715 H140774 H140832 H140891 H180028 H180171 H180275 H180440 H180513 H180580 H140034 H140094 H140153 H140716 H140775 H140833 H140892 H180040 H180173 H180283 H180441 H180514 H180581 H140035 H140095 H140154 H140717 H140776 H140834 H140893 H180043 H180178 H180284 H180442 H180515 H180583 H140036 H140096 H140201 H140718 H140777 H140835 H140895 H180044 H180179 H180285 H180443 H180518 H180584 H140037 H140097 H140202 H140719 H140778 H140836 H140896 H180045 H180181 H180287 H180444 H180519 H180585 H140038 H140098 H140203 H140720 H140779 H140837 H140897 H180048 H180182 H180289 H180445 H180520 H180586 H140039 H140099 H140204 H140721 H140780 H140838 H140898 H180049 H180185 H180290 H180446 H180521 H180587 H140040 H140100 H140205 H140722 H140781 H140839 H140899 H180050 H180186 H180291 H180447 H180522 H180588 H140041 H140101 H140206 H140723 H140782 H140840 H140900 H180052 H180188 H180292 H180449 H180524 H180590 H140042 H140102 H140207 H140724 H140783 H140841 H140901 H180053 H180192 H180293 H180450 H180525 H180591 H140043 H140103 H140208 H140725 H140784 H140842 H140902 H180056 H180193 H180294 H180451 H180527 H180592 H140044 H140105 H140209 H140726 H140785 H140843 H140903 H180058 H180195 H180295 H180452 H180528 H180593 H140045 H140106 H140210 H140727 H140786 H140844 H140904 H180059 H180197 H180296 H180453 H180529 H180595 H140046 H140107 H140211 H140728 H140787 H140845 H140905 H180065 H180199 H180298 H180454 H180530 H180596 H140047 H140108 H140212 H140729 H140788 H140846 H140906 H180066 H180201 H180299 H180455 H180531 H180597 H140048 H140109 H140213 H140730 H140789 H140847 H140907 H180073 H180203 H180303 H180456 H180532 H180598 H140049 H140110 H140214 H140731 H140790 H140848 H140908 H180075 H180204 H180304 H180457 H180533 H180599 H140051 H140111 H140215 H140732 H140791 H140849 H140909 H180079 H180206 H180305 H180459 H180534 H180600 H140052 H140112 H140216 H140733 H140792 H140850 H140910 H180080 H180208 H180307 H180460 H180535 H180601 H140053 H140113 H140217 H140734 H140793 H140851 H140911 H180082 H180209 H180309 H180461 H180536 H180603 H140054 H140114 H140218 H140735 H140794 H140852 H140912 H180083 H180210 H180310 H180463 H180538 H180604 H140055 H140115 H140219 H140736 H140795 H140853 H140913 H180087 H180214 H180311 H180466 H180539 H180605 H140056 H140116 H140220 H140737 H140796 H140854 H140914 H180088 H180215 H180312 H180467 H180540 H180606 H140057 H140117 H140221 H140738 H140797 H140855 H140915 H180093 H180217 H180314 H180468 H180541 H180607 H140058 H140118 H140222 H140739 H140798 H140856 H140916 H180098 H180218 H180318 H180469 H180542 H180608 H140059 H140119 H140223 H140740 H140799 H140857 H140917 H180099 H180220 H180319 H180470 H180543 H180613 H140060 H140120 H140224 H140742 H140800 H140858 H140918 H180102 H180221 H180321 H180471 H180544 H180614 H140061 H140121 H140225 H140743 H140801 H140859 H140919 H180103 H180222 H180322 H180472 H180545 H180616 H140062 H140122 H140226 H140744 H140802 H140860 H140920 H180106 H180225 H180323 H180473 H180548 H180618 H180619 H180693 H180776 H180856 H181030 H181108 H181181 H270134 H270353 H270474 H270635 H270739 H270845 H180620 H180694 H180777 H180857 H181031 H181109 H181182 H270136 H270355 H270476 H270637 H270740 H270846 H180621 H180695 H180778 H180858 H181032 H181112 H181183 H270138 H270356 H270477 H270639 H270741 H270847 H180622 H180696 H180779 H180859 H181033 H181113 H181184 H270144 H270360 H270479 H270641 H270746 H270848 H180624 H180697 H180780 H180860 H181036 H181114 H181185 H270201 H270361 H270482 H270642 H270749 H270852 H180625 H180698 H180781 H180861 H181038 H181115 H181187 H270209 H270364 H270483 H270643 H270751 H270854 H180626 H180699 H180784 H180862 H181039 H181116 H181189 H270211 H270365 H270484 H270644 H270752 H270855 H180627 H180703 H180785 H180863 H181041 H181117 H181191 H270214 H270370 H270486 H270645 H270755 H270857 H180628 H180704 H180786 H180864 H181042 H181118 H181192 H270215 H270371 H270487 H270646 H270757 H270858 H180629 H180705 H180788 H180866 H181043 H181119 H181193 H270216 H270373 H270489 H270647 H270760 H270859 H180630 H180706 H180791 H180867 H181045 H181120 H181194 H270219 H270375 H270490 H270648 H270761 H270861 H180631 H180707 H180792 H180868 H181046 H181121 H181195 H270227 H270378 H270491 H270649 H270762 H270863 H180632 H180709 H180793 H180869 H181047 H181124 H181196 H270228 H270380 H270495 H270651 H270763 H270864 H180633 H180710 H180794 H180870 H181048 H181125 H181197 H270229 H270384 H270498 H270652 H270766 H270865 H180634 H180715 H180795 H180871 H181049 H181126 H181198 H270230 H270385 H270499 H270653 H270767 H270866 H180635 H180716 H180796 H180872 H181052 H181127 H181199 H270232 H270386 H270500 H270654 H270769 H270867 H180636 H180717 H180803 H180873 H181053 H181128 H181200 H270235 H270391 H270501 H270656 H270777 H270868 H180637 H180718 H180804 H180874 H181055 H181129 H181201 H270240 H270392 H270502 H270660 H270778 H270869 H180639 H180719 H180805 H180877 H181056 H181130 H181202 H270242 H270395 H270503 H270661 H270781 H270870 H180640 H180720 H180806 H180878 H181057 H181132 H181203 H270244 H270397 H270504 H270662 H270782 H270871 H180641 H180721 H180807 H180879 H181058 H181133 H181205 H270245 H270398 H270505 H270663 H270783 H270872 H180642 H180722 H180808 H180880 H181059 H181134 H181209 H270251 H270399 H270506 H270664 H270785 H270873 H180643 H180723 H180809 H180881 H181060 H181135 H181210 H270252 H270400 H270508 H270665 H270786 H270875 H180644 H180724 H180810 H180882 H181061 H181136 H181211 H270254 H270401 H270511 H270667 H270787 H270877 H180645 H180725 H180811 H180883 H181062 H181137 H181212 H270255 H270404 H270512 H270669 H270788 H270878 H180646 H180726 H180812 H180884 H181065 H181138 H182000 H270256 H270409 H270513 H270670 H270789 H270879 H180647 H180728 H180815 H180885 H181066 H181139 H182001 H270260 H270410 H270514 H270671 H270791 H270880 H180649 H180729 H180816 H180886 H181067 H181140 H182002 H270261 H270412 H270516 H270675 H270793 H270881 H180650 H180730 H180817 H180887 H181068 H181142 H182003 H270264 H270416 H270518 H270680 H270794 H270882 H180651 H180731 H180819 H180888 H181069 H181143 H182005 H270267 H270418 H270520 H270681 H270796 H270883 H180652 H180733 H180820 H180890 H181070 H181145 H182006 H270271 H270419 H270522 H270682 H270797 H270884 H180653 H180734 H180821 H180891 H181071 H181146 H182007 H270273 H270420 H270525 H270684 H270799 H270885 H180654 H180735 H180822 H180894 H181073 H181147 H182008 H270274 H270421 H270526 H270685 H270800 H270886 H180655 H180736 H180823 H180895 H181074 H181148 H182009 H270277 H270425 H270529 H270686 H270801 H270888 H180657 H180737 H180824 H180896 H181075 H181149 H182010 H270280 H270426 H270530 H270690 H270803 H270889 H180659 H180738 H180825 H180898 H181076 H181151 H182012 H270281 H270427 H270532 H270692 H270804 H270890 H180660 H180739 H180826 H180899 H181077 H181152 H182016 H270282 H270428 H270534 H270693 H270805 H270891 H180661 H180741 H180827 H180901 H181078 H181153 H182017 H270285 H270430 H270535 H270697 H270806 H270892 H180662 H180742 H180828 H180907 H181079 H181154 H270004 H270290 H270431 H270539 H270698 H270808 H270893 H180663 H180744 H180829 H181002 H181082 H181155 H270009 H270293 H270433 H270540 H270699 H270812 H270894 H180664 H180745 H180830 H181003 H181083 H181156 H270010 H270297 H270435 H270542 H270700 H270813 H270895 H180665 H180746 H180831 H181004 H181084 H181157 H270021 H270302 H270436 H270544 H270705 H270814 H270896 H180667 H180747 H180832 H181005 H181085 H181158 H270026 H270303 H270437 H270547 H270708 H270817 H270897 H180668 H180749 H180833 H181006 H181086 H181159 H270027 H270307 H270438 H270550 H270709 H270819 H270898 H180669 H180750 H180834 H181007 H181087 H181160 H270029 H270310 H270439 H270601 H270710 H270820 H270899 H180670 H180751 H180835 H181008 H181089 H181161 H270030 H270314 H270443 H270602 H270711 H270821 H271000 H180671 H180752 H180836 H181009 H181090 H181162 H270038 H270320 H270445 H270605 H270712 H270822 H271002 H180672 H180753 H180837 H181010 H181091 H181163 H270045 H270321 H270446 H270606 H270714 H270823 H271004 H180674 H180754 H180838 H181011 H181092 H181164 H270047 H270323 H270447 H270607 H270715 H270825 H271005 H180676 H180756 H180839 H181012 H181093 H181165 H270073 H270324 H270448 H270613 H270716 H270826 H271006 H180678 H180757 H180840 H181013 H181094 H181166 H270074 H270329 H270450 H270615 H270718 H270827 H271009 H180679 H180758 H180841 H181015 H181095 H181167 H270079 H270332 H270451 H270616 H270719 H270828 H271013 H180680 H180759 H180842 H181018 H181096 H181168 H270088 H270335 H270452 H270622 H270722 H270829 H271015 H180681 H180760 H180843 H181019 H181097 H181170 H270094 H270337 H270454 H270623 H270725 H270833 H271016 H180682 H180761 H180844 H181020 H181098 H181173 H270096 H270338 H270455 H270624 H270726 H270835 H271017 H180683 H180762 H180848 H181021 H181101 H181174 H270106 H270341 H270458 H270625 H270727 H270836 H271018 H180684 H180763 H180850 H181022 H181102 H181175 H270107 H270343 H270461 H270626 H270728 H270837 H271019 H180685 H180765 H180851 H181023 H181103 H181176 H270110 H270344 H270462 H270627 H270732 H270838 H271020 H180687 H180768 H180852 H181026 H181104 H181177 H270111 H270345 H270464 H270631 H270733 H270840 H271021 H180690 H180769 H180853 H181027 H181105 H181178 H270118 H270346 H270466 H270632 H270735 H270841 H271023 H180691 H180774 H180854 H181028 H181106 H181179 H270126 H270351 H270470 H270633 H270736 H270842 H271024 H180692 H180775 H180855 H181029 H181107 H181180 H270128 H270352 H270473 H270634 H270737 H270844 H271025 H271026 H271113 H271199 H271275 H271342 H271413 H271483 H271549 H271616 H271682 H271748 H271810 H271872 H271027 H271114 H271200 H271276 H271343 H271414 H271484 H271550 H271617 H271683 H271749 H271811 H271873 H271029 H271115 H271201 H271277 H271344 H271415 H271485 H271551 H271618 H271684 H271750 H271812 H271874 H271031 H271116 H271202 H271278 H271345 H271416 H271486 H271552 H271619 H271685 H271751 H271813 H271875 H271032 H271117 H271204 H271280 H271347 H271417 H271487 H271553 H271620 H271686 H271752 H271814 H271876 H271033 H271118 H271205 H271281 H271349 H271418 H271488 H271554 H271621 H271687 H271753 H271815 H271877 H271034 H271120 H271206 H271282 H271350 H271419 H271490 H271555 H271622 H271688 H271754 H271816 H271878 H271035 H271121 H271207 H271283 H271351 H271420 H271492 H271557 H271624 H271689 H271755 H271817 H271879 H271037 H271123 H271208 H271284 H271353 H271421 H271493 H271559 H271625 H271691 H271756 H271818 H271880 H271038 H271125 H271209 H271285 H271355 H271422 H271494 H271560 H271626 H271692 H271757 H271819 H271881 H271039 H271127 H271210 H271286 H271356 H271423 H271495 H271561 H271627 H271693 H271758 H271820 H271882 H271041 H271131 H271211 H271287 H271357 H271424 H271497 H271562 H271628 H271695 H271759 H271821 H271883 H271042 H271132 H271212 H271288 H271358 H271425 H271498 H271563 H271629 H271696 H271760 H271822 H271884 H271043 H271135 H271214 H271289 H271359 H271426 H271499 H271564 H271630 H271697 H271761 H271823 H271885 H271044 H271136 H271216 H271290 H271360 H271427 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H291107 H291170 H291232 H293317 H273099 H273164 H290108 H290203 H290273 H290339 H290403 H290542 H291044 H291108 H291171 H291233 H293318 H273100 H273165 H290109 H290205 H290274 H290340 H290404 H290543 H291045 H291109 H291172 H291234 H293319 H273101 H273166 H290110 H290206 H290275 H290341 H290405 H290544 H291046 H291111 H291173 H291235 H293320 H273102 H273167 H290111 H290208 H290276 H290342 H290406 H290545 H291047 H291112 H291174 H291236 H293321 H273103 H273168 H290113 H290209 H290277 H290343 H290408 H290546 H291048 H291113 H291175 H291237 H293322 H273104 H273169 H290114 H290210 H290278 H290344 H290409 H290547 H291049 H291114 H291176 H291238 H293323 H273105 H273170 H290116 H290211 H290279 H290345 H290410 H290548 H291050 H291115 H291177 H291239 H293324 H273106 H273171 H290118 H290212 H290280 H290346 H290411 H290549 H291051 H291116 H291178 H291240 H293325 H273107 H273172 H290121 H290213 H290281 H290347 H290412 H290550 H291052 H291117 H291179 H291241 H293326 H273108 H273173 H290122 H290214 H290282 H290348 H290413 H290551 H291053 H291118 H291180 H291242 H293327 H273109 H273174 H290123 H290215 H290283 H290349 H290414 H290552 H291054 H291119 H291181 H291243 H293328 H273110 H273175 H290125 H290216 H290284 H290350 H290415 H290553 H291055 H291120 H291182 H291244 H293329 H273111 H273176 H290128 H290217 H290285 H290351 H290416 H290554 H291056 H291121 H291183 H291245 H293330 H273112 H273177 H290130 H290219 H290286 H290352 H290417 H290555 H291057 H291122 H291184 H291246 H293331 H273113 H273178 H290132 H290220 H290287 H290353 H290422 H290556 H291059 H291123 H291185 H291247 H293332 H273114 H273179 H290135 H290221 H290288 H290354 H290423 H290557 H291060 H291124 H291186 H291248 H293333 H273115 H273180 H290137 H290222 H290289 H290355 H290424 H290558 H291061 H291125 H291187 H291249 H293334 H273116 H273181 H290138 H290223 H290290 H290356 H290425 H290559 H291062 H291126 H291188 H291250 H293335 H273117 H273182 H290139 H290224 H290291 H290357 H290426 H290560 H291063 H291127 H291189 H291251 H293336 H273118 H273183 H290141 H290225 H290292 H290358 H290427 H290561 H291064 H291128 H291190 H291252 H293337 H273119 H273184 H290142 H290226 H290293 H290359 H290500 H290600 H291065 H291129 H291191 H291253 H293338 H273120 H273185 H290143 H290227 H290295 H290360 H290501 H291001 H291066 H291130 H291192 H291254 H293339 H273121 H273186 H290144 H290228 H290296 H290362 H290502 H291003 H291067 H291131 H291193 H291255 H293340 H273122 H273187 H290145 H290229 H290297 H290363 H290503 H291004 H291068 H291132 H291194 H291256 H293341 H273123 H273188 H290146 H290230 H290299 H290364 H290504 H291005 H291069 H291133 H291195 H291257 H293342 H273124 H273189 H290151 H290231 H290301 H290365 H290505 H291006 H291070 H291134 H291196 H291258 H293343 H273125 H273190 H290152 H290232 H290302 H290366 H290506 H291007 H291071 H291135 H291197 H291259 H293344 H293345 H293409 H293471 H293534 H293598 H293661 H293725 H293788 H293850 H293913 H293977 H294040 H294104 H293346 H293410 H293472 H293535 H293599 H293662 H293726 H293789 H293851 H293914 H293978 H294041 H294105 H293347 H293411 H293473 H293536 H293600 H293663 H293727 H293790 H293852 H293915 H293979 H294042 H294106 H293348 H293412 H293474 H293537 H293601 H293664 H293728 H293791 H293854 H293916 H293980 H294043 H294107 H293349 H293413 H293475 H293538 H293602 H293665 H293729 H293792 H293855 H293917 H293981 H294044 H294108 H293350 H293414 H293476 H293539 H293603 H293666 H293730 H293793 H293856 H293918 H293982 H294045 H294109 H293351 H293415 H293477 H293540 H293604 H293667 H293731 H293794 H293857 H293919 H293983 H294046 H294110 H293352 H293416 H293478 H293541 H293605 H293668 H293732 H293795 H293858 H293920 H293984 H294047 H294111 H293353 H293417 H293479 H293542 H293606 H293669 H293733 H293796 H293859 H293921 H293985 H294048 H294112 H293354 H293418 H293480 H293543 H293607 H293670 H293734 H293797 H293860 H293922 H293986 H294049 H294113 H293355 H293419 H293481 H293544 H293608 H293671 H293735 H293798 H293861 H293923 H293987 H294050 H294114 H293356 H293420 H293482 H293545 H293609 H293672 H293736 H293799 H293862 H293924 H293988 H294051 H294115 H293357 H293421 H293483 H293546 H293610 H293673 H293737 H293800 H293863 H293925 H293989 H294052 H294116 H293358 H293422 H293484 H293548 H293611 H293674 H293738 H293801 H293864 H293926 H293990 H294053 H294117 H293359 H293423 H293485 H293549 H293612 H293675 H293739 H293802 H293865 H293927 H293991 H294054 H294118 H293360 H293424 H293486 H293550 H293613 H293676 H293740 H293803 H293866 H293928 H293992 H294055 H294119 H293361 H293425 H293487 H293551 H293614 H293677 H293741 H293804 H293867 H293929 H293993 H294056 H294120 H293362 H293426 H293488 H293552 H293615 H293678 H293742 H293805 H293868 H293930 H293994 H294057 H294121 H293363 H293427 H293489 H293553 H293616 H293679 H293743 H293806 H293869 H293931 H293995 H294058 H294122 H293364 H293428 H293490 H293554 H293617 H293681 H293744 H293807 H293870 H293932 H293996 H294059 H294123 H293365 H293429 H293491 H293555 H293618 H293682 H293745 H293808 H293871 H293933 H293997 H294060 H294124 H293366 H293430 H293492 H293556 H293619 H293683 H293746 H293809 H293872 H293934 H293998 H294061 H294125 H293367 H293431 H293493 H293557 H293620 H293684 H293747 H293810 H293873 H293935 H293999 H294062 H294126 H293368 H293432 H293494 H293558 H293621 H293685 H293748 H293811 H293874 H293936 H294000 H294063 H294127 H293369 H293433 H293495 H293559 H293622 H293686 H293749 H293812 H293875 H293937 H294001 H294064 H294128 H293370 H293434 H293496 H293560 H293623 H293687 H293750 H293813 H293876 H293938 H294002 H294065 H294129 H293371 H293435 H293497 H293561 H293624 H293688 H293751 H293814 H293877 H293940 H294003 H294066 H294130 H293372 H293436 H293498 H293562 H293625 H293689 H293752 H293815 H293878 H293941 H294004 H294067 H294131 H293373 H293437 H293499 H293563 H293626 H293690 H293753 H293816 H293879 H293942 H294005 H294068 H294132 H293374 H293438 H293500 H293564 H293627 H293691 H293754 H293817 H293880 H293943 H294006 H294069 H294133 H293375 H293439 H293501 H293565 H293628 H293692 H293755 H293818 H293881 H293944 H294007 H294070 H294134 H293376 H293440 H293502 H293566 H293629 H293693 H293756 H293819 H293882 H293945 H294008 H294071 H294135 H293377 H293441 H293503 H293567 H293630 H293694 H293758 H293820 H293883 H293946 H294009 H294072 H294136 H293378 H293442 H293504 H293568 H293631 H293695 H293759 H293821 H293884 H293947 H294010 H294073 H294137 H293379 H293443 H293505 H293569 H293632 H293696 H293760 H293822 H293885 H293948 H294011 H294074 H294139 H293380 H293444 H293506 H293570 H293633 H293697 H293761 H293823 H293886 H293949 H294012 H294075 H294140 H293381 H293445 H293507 H293571 H293634 H293698 H293762 H293824 H293887 H293950 H294013 H294076 H294141 H293382 H293446 H293508 H293572 H293635 H293699 H293763 H293825 H293888 H293951 H294014 H294077 H294142 H293383 H293447 H293509 H293573 H293636 H293700 H293764 H293826 H293889 H293952 H294015 H294078 H294143 H293384 H293448 H293510 H293574 H293637 H293701 H293765 H293827 H293890 H293953 H294016 H294079 H294144 H293385 H293449 H293511 H293575 H293638 H293702 H293766 H293828 H293891 H293954 H294017 H294080 H294145 H293386 H293450 H293512 H293576 H293639 H293703 H293767 H293829 H293892 H293955 H294018 H294081 H294146 H293387 H293451 H293513 H293577 H293640 H293704 H293768 H293830 H293893 H293956 H294020 H294083 H294147 H293388 H293452 H293514 H293578 H293641 H293705 H293769 H293831 H293894 H293957 H294021 H294084 H294148 H293389 H293453 H293515 H293579 H293642 H293706 H293770 H293832 H293895 H293958 H294022 H294085 H294149 H293390 H293454 H293516 H293581 H293643 H293707 H293771 H293833 H293896 H293959 H294023 H294086 H294150 H293391 H293455 H293517 H293582 H293644 H293708 H293772 H293834 H293897 H293960 H294024 H294087 H294151 H293393 H293456 H293518 H293583 H293645 H293709 H293773 H293835 H293898 H293961 H294025 H294088 H294152 H293394 H293457 H293519 H293584 H293646 H293710 H293774 H293836 H293899 H293962 H294026 H294089 H294153 H293395 H293458 H293520 H293585 H293648 H293712 H293775 H293837 H293900 H293963 H294027 H294090 H294154 H293396 H293459 H293521 H293586 H293649 H293713 H293776 H293838 H293901 H293964 H294028 H294091 H294155 H293397 H293460 H293522 H293587 H293650 H293714 H293777 H293839 H293902 H293965 H294029 H294092 H294156 H293398 H293461 H293523 H293588 H293651 H293715 H293778 H293840 H293903 H293966 H294030 H294093 H294157 H293399 H293462 H293524 H293589 H293652 H293716 H293779 H293841 H293904 H293967 H294031 H294094 H294158 H293401 H293463 H293525 H293590 H293653 H293717 H293780 H293842 H293905 H293968 H294032 H294095 H294159 H293402 H293464 H293527 H293591 H293654 H293718 H293781 H293843 H293906 H293969 H294033 H294097 H294160 H293403 H293465 H293528 H293592 H293655 H293719 H293782 H293844 H293907 H293970 H294034 H294098 H294161 H293404 H293466 H293529 H293593 H293656 H293720 H293783 H293845 H293908 H293971 H294035 H294099 H294162 H293405 H293467 H293530 H293594 H293657 H293721 H293784 H293846 H293909 H293972 H294036 H294100 H294163 H293406 H293468 H293531 H293595 H293658 H293722 H293785 H293847 H293910 H293974 H294037 H294101 H294164 H293407 H293469 H293532 H293596 H293659 H293723 H293786 H293848 H293911 H293975 H294038 H294102 H294165 H293408 H293470 H293533 H293597 H293660 H293724 H293787 H293849 H293912 H293976 H294039 H294103 H294166 H294167 H294229 H294292 H294355 H294418 H294483 H294545 H294615 H294677 H294743 H294806 H294871 H294938 H294168 H294230 H294293 H294356 H294419 H294484 H294546 H294616 H294678 H294744 H294807 H294872 H294940 H294169 H294231 H294294 H294357 H294420 H294485 H294547 H294617 H294679 H294745 H294808 H294874 H294941 H294170 H294232 H294295 H294358 H294421 H294486 H294548 H294618 H294680 H294746 H294809 H294875 H294942 H294171 H294233 H294296 H294359 H294422 H294487 H294549 H294619 H294681 H294747 H294810 H294876 H294943 H294172 H294234 H294297 H294360 H294423 H294488 H294550 H294620 H294682 H294748 H294811 H294877 H294945 H294173 H294235 H294298 H294361 H294424 H294489 H294551 H294621 H294683 H294749 H294812 H294878 H294946 H294174 H294236 H294299 H294362 H294425 H294490 H294552 H294622 H294684 H294750 H294813 H294879 H294947 H294175 H294237 H294300 H294363 H294426 H294491 H294553 H294623 H294685 H294751 H294814 H294880 H294949 H294176 H294238 H294301 H294364 H294427 H294492 H294554 H294624 H294686 H294752 H294815 H294881 H294950 H294177 H294239 H294302 H294365 H294428 H294493 H294555 H294625 H294687 H294753 H294816 H294882 H294951 H294178 H294240 H294303 H294366 H294429 H294494 H294556 H294626 H294688 H294754 H294817 H294883 H294952 H294179 H294241 H294304 H294367 H294430 H294495 H294557 H294627 H294689 H294755 H294818 H294884 H294953 H294180 H294242 H294305 H294368 H294431 H294496 H294564 H294628 H294690 H294756 H294820 H294885 H294954 H294181 H294243 H294306 H294369 H294432 H294497 H294565 H294629 H294691 H294757 H294821 H294886 H294956 H294182 H294244 H294307 H294370 H294433 H294498 H294567 H294630 H294692 H294758 H294822 H294887 H294957 H294183 H294245 H294308 H294371 H294434 H294499 H294568 H294631 H294693 H294759 H294823 H294888 H294958 H294184 H294246 H294309 H294372 H294435 H294500 H294569 H294632 H294694 H294760 H294824 H294889 H294959 H294185 H294247 H294310 H294373 H294436 H294501 H294570 H294633 H294695 H294761 H294825 H294890 H294960 H294186 H294248 H294311 H294374 H294437 H294502 H294571 H294634 H294696 H294762 H294826 H294891 H294961 H294187 H294249 H294312 H294376 H294438 H294503 H294572 H294635 H294697 H294763 H294827 H294892 H294962 H294188 H294250 H294313 H294377 H294439 H294504 H294573 H294636 H294698 H294764 H294828 H294893 H294963 H294189 H294251 H294314 H294378 H294440 H294505 H294574 H294637 H294699 H294765 H294829 H294894 H294965 H294190 H294252 H294315 H294379 H294441 H294506 H294575 H294638 H294700 H294766 H294830 H294895 H294966 H294191 H294253 H294316 H294380 H294442 H294507 H294576 H294639 H294701 H294767 H294831 H294896 H294967 H294192 H294254 H294317 H294381 H294443 H294508 H294577 H294640 H294702 H294768 H294832 H294897 H294969 H294193 H294255 H294318 H294382 H294444 H294509 H294578 H294641 H294704 H294769 H294833 H294898 H294970 H294194 H294256 H294319 H294383 H294445 H294510 H294579 H294642 H294705 H294770 H294834 H294899 H294971 H294195 H294257 H294320 H294384 H294446 H294511 H294580 H294643 H294706 H294771 H294835 H294900 H294972 H294196 H294258 H294321 H294385 H294447 H294512 H294581 H294644 H294707 H294772 H294836 H294901 H294974 H294197 H294259 H294322 H294386 H294448 H294513 H294582 H294645 H294708 H294773 H294837 H294902 H294975 H294198 H294260 H294323 H294387 H294449 H294514 H294583 H294646 H294709 H294774 H294838 H294903 H294976 H294199 H294261 H294324 H294388 H294450 H294515 H294584 H294647 H294710 H294775 H294839 H294904 H294977 H294200 H294262 H294325 H294389 H294451 H294516 H294585 H294648 H294711 H294776 H294840 H294905 H294978 H294201 H294263 H294326 H294390 H294452 H294517 H294586 H294649 H294712 H294777 H294841 H294906 H294979 H294202 H294264 H294327 H294391 H294454 H294518 H294587 H294650 H294713 H294778 H294842 H294907 H294980 H294203 H294265 H294328 H294392 H294457 H294519 H294588 H294651 H294714 H294779 H294843 H294908 H294981 H294204 H294266 H294329 H294393 H294458 H294520 H294589 H294652 H294715 H294780 H294844 H294910 H294982 H294205 H294267 H294330 H294394 H294459 H294521 H294590 H294653 H294716 H294781 H294845 H294911 H294984 H294206 H294268 H294331 H294395 H294460 H294522 H294591 H294654 H294717 H294782 H294846 H294914 H294986 H294207 H294269 H294332 H294396 H294461 H294523 H294592 H294655 H294718 H294783 H294847 H294915 H294987 H294208 H294270 H294333 H294397 H294462 H294524 H294593 H294656 H294719 H294784 H294848 H294916 H294988 H294209 H294271 H294334 H294398 H294463 H294525 H294594 H294657 H294720 H294785 H294850 H294917 H294989 H294210 H294272 H294335 H294399 H294464 H294526 H294595 H294658 H294721 H294786 H294851 H294918 H294990 H294211 H294273 H294336 H294400 H294465 H294527 H294596 H294659 H294723 H294787 H294853 H294919 H294991 H294212 H294274 H294337 H294401 H294466 H294528 H294597 H294660 H294724 H294788 H294854 H294920 H294992 H294213 H294275 H294338 H294402 H294467 H294529 H294598 H294661 H294726 H294789 H294855 H294921 H294995 H294214 H294276 H294339 H294403 H294468 H294530 H294599 H294662 H294727 H294790 H294856 H294922 H294996 H294215 H294277 H294340 H294404 H294469 H294531 H294600 H294663 H294728 H294791 H294857 H294923 H294997 H294216 H294278 H294341 H294405 H294470 H294532 H294601 H294664 H294729 H294792 H294858 H294924 H294998 H294217 H294279 H294342 H294406 H294471 H294533 H294602 H294665 H294730 H294793 H294859 H294925 H294999 H294218 H294280 H294343 H294407 H294472 H294534 H294603 H294666 H294731 H294794 H294860 H294926 H295001 H294219 H294281 H294345 H294408 H294473 H294535 H294604 H294667 H294732 H294795 H294861 H294928 H295002 H294220 H294283 H294346 H294409 H294474 H294536 H294605 H294668 H294733 H294796 H294862 H294929 H295003 H294221 H294284 H294347 H294410 H294475 H294537 H294606 H294669 H294734 H294797 H294863 H294930 H295004 H294222 H294285 H294348 H294411 H294476 H294538 H294607 H294670 H294735 H294798 H294864 H294931 H295006 H294223 H294286 H294349 H294412 H294477 H294539 H294608 H294671 H294736 H294799 H294865 H294932 H295008 H294224 H294287 H294350 H294413 H294478 H294540 H294610 H294672 H294737 H294800 H294866 H294933 H295009 H294225 H294288 H294351 H294414 H294479 H294541 H294611 H294673 H294738 H294801 H294867 H294934 H295010 H294226 H294289 H294352 H294415 H294480 H294542 H294612 H294674 H294739 H294802 H294868 H294935 H295011 H294227 H294290 H294353 H294416 H294481 H294543 H294613 H294675 H294740 H294803 H294869 H294936 H295012 H294228 H294291 H294354 H294417 H294482 H294544 H294614 H294676 H294742 H294804 H294870 H294937 H295013 H295014 H295034 H295058 H295080 H295114 H295015 H295035 H295059 H295082 H295116 H295016 H295036 H295060 H295083 H295117 H295017 H295037 H295062 H295084 H295118 H295018 H295038 H295063 H295085 H295119 H295019 H295041 H295064 H295087 H295121 H295021 H295042 H295065 H295090 H295122 H295022 H295044 H295066 H295094 H295126 H295023 H295045 H295067 H295095 H295127 H295024 H295046 H295068 H295096 H295128 H295025 H295047 H295070 H295097 H295131 H295026 H295048 H295071 H295100 H295132 H295027 H295049 H295072 H295101 H295134 H295028 H295050 H295073 H295102 H295139 H295029 H295051 H295074 H295103 H295140 H295030 H295053 H295075 H295105 H295142 H295031 H295054 H295076 H295109 H295144 H295032 H295056 H295077 H295111 H295150 H295033 H295057 H295078 H295112 H295151
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter dated May 26, 2011. Firm initiated recall is ongoing.  
REASON
On Varian Linear Accelerators where the customer may calibrate the collimator angle position readout in reverse, switching the 90 degree and 270 degree positions.
VOLUME OF PRODUCT IN COMMERCE
5,685 units
DISTRIBUTION
Nationwide and Internationally
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PRODUCT
Symbia Radiation Therapy Pallet. An accessory to the Symbia T Series Emission Computed Tomography System/X-Ray Computed Tomography System. This specialty pallet is used for performing SPECT and/or SPECT/CT Scans on oncology patients with the goal of fusing the SPECT and/or SPECT/CT data with CT simulation data for planning radiation therapy. The pallet attaches to the patient beds carbon fiber pallet. Material number 10412621. Recall # Z-2980-2011
CODE
Serial numbers: 1023, 1045, 1052, 1067, 1073, 1076, 1083, 1110, 1116, 1118, 1136, 1137, 1141, 1146, 1154, 1155, 1167 and 1241
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Hoffman Estates, IL, by letter dated June 06, 2011. Firm initiated recall is ongoing.
REASON
There a potential patient safety issue when using the Symbia Radiation Therapy Pallet. When a patient is not iso-centered before starting a scan with the Symbia T Series Systems and a non-circular orbit is selected, it is possible that one of the detectors may come into contact with the patient.
VOLUME OF PRODUCT IN COMMERCE
18 units
DISTRIBUTION
Nationwide and Canada, China, Italy, Mexico, Poland, Portugal and Russia
________________________________________
PRODUCT
GYNDisposables Inc, IUD Insertion Kit 935K, Sterile, Single Use, Tenaculum 356T, Uterine Sound 906S, Scissors, Povidone-Iodine Solution, (3) Swabsticks, Paper Towel, Sterile EO, REF 935K, qty 1, Intended for intrauterine device (IUD) insertion. Recall # Z-3025-2011
CODE
Lot number: 61034034
RECALLING FIRM/MANUFACTURER
Recalling Firm: GYN Disposables Inc., Memphis, TN, by letter dated July 29, 2011.  
Manufacturer: B. Braun Medical, Inc., Allentown, PA. Firm initiated recall is ongoing.
REASON
Lack of sterility assurance.
VOLUME OF PRODUCT IN COMMERCE
3,987 units
DISTRIBUTION
Nationwide
________________________________________
PRODUCT
ARCHITECT C-Peptide Reagent Kit; a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of C-Peptide in human serum, plasma and urine on the ARCHITECT i System; list 3L53-25 The ARCHITECT C-Peptide assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of C-Peptide in human serum, plasma and urine on the ARCHITECT i System. The ARCHITECT C-Peptide assay is used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus. Recall # Z-3031-2011
CODE
Lot numbers 03610K000 exp. 10/26/2011; 01711A000 exp. 12/12/2011; 00110L000 exp. 10/29/2011; 01411B000 exp. 01/12/2012; 00611E000 exp. 04/16/2012;
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories, Abbott Park, IL, by letter dated July 11, 2011.
Manufacturer: Biokit Sa, Llica d'Amunt, Spain. Firm initiated recall is ongoing.
REASON
C-Peptide lots 03610K000 and 01711A000 have the potential to generate falsely elevated results with certain patient samples and with non-Abbott Controls.
VOLUME OF PRODUCT IN COMMERCE
3,049 kits
DISTRIBUTION
Nationwide and Internationally
________________________________________
PRODUCT
1) MagNA Pure LC 1.0 (software version 3.0.11). An automated instrument used for isolation of nucleic acids (DNA, total RNA, total viral nucleic acids) from different kinds of biological research sample material (whole blood, serum, blood cells, culture cells, tissue, bacteria, fungi) using the specially designed MagNA Pure LC kits, for the purpose of life science research only and automated filling of different kinds of PCR reaction vessels (LightCycler Capillaries, 96-well PCR plates, PCR tube strips) with PCR reaction mixes and template nucleic acid, or other reaction tubes for the making of dilution series, reaction mixes. Series 1.0 software version 3.0.11, Part number 12236931001. Recall # Z-3077-2011;
 
2) MagNA Pure LC 2.0 (software version 1.1.23 and 1.1.24). An automated instrument used for isolation of nucleic acids (DNA, total RNA, total viral nucleic acids) from different kinds of biological research sample material (whole blood, serum, blood cells, culture cells, tissue, bacteria, fungi) using the specially designed MagNA Pure LC kits, for the purpose of life science research only and automated filling of different kinds of PCR reaction vessels (LightCycler Capillaries, 96-well PCR plates, PCR tube strips) with PCR reaction mixes and template nucleic acid, or other reaction tubes for the making of dilution series, reaction mixes. Part number 05197686001. Recall # Z-3078-2011
CODE
1) Ser Numbers 28KN9Z70VE, LCPG0398, US03910905, US94800252, LCPD0020, LCPF0163, LCPG1291, LCPG1291, MXL5040CBZ, LCPE0042, CZC5252BDQ, LCPG1314, 2UA40207G6, LCPG0723, FRB3270KYX, LCPG0876, CZC5240354, US14111136, LCPG0426, USC326024W, LCPG0627, 29KN9ZP27C, LCPG0492, FRB3270H1D, LCPG0952, 2UA402049J, LCPG0711, LCPG0431, LCPG1070, LCPG0431, LCPG1070, USC3260241, USC3260241, CZC52403GR, CZC52403GR, CZC5252BDC, CZC5252BDC, LCPG0613, LCPG0613, LCPG1041, LCPG1041, CZC5251H2N, FRB3270JV7, FRB3270L5Y, LCPG0955, LCPG0956, 70018557, LCPG1252, FRB3270LQJ, LCPG0976, FRB3270KCK, LCPG0950, US14111105, CZC5231GH2, LCPG0320, LCPG1143, 2UA33504CM, LCPG0654, 2UB3370CMH, LCPG0689, 2UA4110GFH, MXL5310FQ7, CZC5251H5Z, LCPG0807, LCPG1161, LCPG1290, LCPG1290, US14110908, CZC5251G3F, LCPG0244, US10570146, CZC52402Y9, LCPF0131, US03910992, LCPF0178, USC325070Z, USU32703WY, LCPG0629, LCPG0663, USU32703WZ, LCPG0664, 28KN9ZK0Y9, CZC5252B9Z, LCPG0427, CZC521G1L, LCPG1071, FRB3270LQL, LCPG0983, LCPG1176, FRB3270LQT, LCPG1272, LCPG0973, 2AKN9Z0EM, LCPG0447, MXL4390NJC, LCPG0768, USC3250712, LCPG0626, 28KN9Z7039, US10570100, US13804158, US94800391, CZC5252BGI, LCPE0041, LCPF0128, LCPG0310, LCPG0432, FRB3270L25, LCPG0761, 51KN9ZE957, LCPG0524, US14110777, LCPG0418, US14110777, LCPG0418, LCPG1268, CZC5251GCB, US04552506, LCPF0165, LCPF0165, FRB3270G5Z, LCPG0942, 28KN9ZL0MV, USC3220T8R, LCPG1045, FRB3270LSD, LCPG0982, FRB3270LSD, LCPG0982, CZC52403GM, LCPG1033, 429000KH, LCPG0894, 70018555, 70018230, LCPG1226, CZC524038J, LCPG1042, LCPG1152, 2UA33503SQ, LCPG0637, 2UA33503SQ, LCPG0637, 2UA33503SQ, LCPG0637, FRB32806ZY, LCPG0772, US14111131, LCPG0393, MXL4390NJB, LCPG0881, MXL4360D21, US14110727, SCZC52529XT, LCPG0306, FRB3270L1D, LCPG0842, 2UA43304Z2, LCPG0801, LCPG1292, LCPG1128, 2UB42002SG, CZC5252BHC, FRB32806D7, SVC1, LCPG0812, LCPG0930, LCPG0762, LCPG1306, 51KN9ZE943, LCPG0468, 2UA412033Z, 2UB33709S5, CZC5231GKS, FRB3270KYV, LCPG0875, 2UA412033Z, 2UB33709S5, CZC5231GKS, FRB3270KYV, LCPG0739, LCPG0740, LCPG0875, 2UB3370CRC, MXL4390NFJ, LCPG0769, LCPG0638, LCPG1036, CZC523187N, LCPG0294, MXL4360D1V, MXL4390NGT, USC326023Y, CZC5231FX5, CZC524035H, CZC5252B7K, CZC5252BOP, LCPG0572, LCPG0790, LCPG0791, LCPG1062, LCPG1162, LCPG1315, LCPG1318, FRB328070C, US14110905, CZC5240316, LCPG0396, LCPG1237, 2UB3370C62, LCPG0544, 29KN9ZP257, LCPG0537, US11303448, LCPG0252, FRB3270L0V, FRB3270L6P, LCPG0987, LCPG0932, FRB3270L1G, 2UA4020LMG, US04552507, LCPF0162, LCPF0162, LCPG0725, LCPG0725, 2UA431044W, CZC5257GHS, FRB32806CW, LCPG0411, LCPG0988, LCPG1037, 2UB3370CPR, US14111094, LCPG0399, LCPG0399, USU32703XT, 70018561, CZC5251GD5, CZC5252B76, LCPG0667, USC3220TSM, CZC5252BCV, LCPG0625, LCPG1069, 51KN9ZE964, LCPG0528, 2UB42002RV, LCPG0809, FRB3270LV3, LCPG0844, 2UB423087N, MXL4360CZS, USC325070H, 70018262, 70018263, 70018264, 70018558, 70018559, 70018560, LCPG0425, LCPG0634, LCPF0136, LCPF0136, LCPF0136, LCPG0265, LCPG0421, LCPG0421, LCPG0425, LCPG0425, LCPG0634, LCPG0634, LCPG0803, LCPG0803, FRB328070L, LCPF0136, LCPG0265, LCPG0421, LCPG0425, LCPG0634, LCPG0634, LCPG0803, LCPG0879, SCZC5252B5W, LCPG1321, LCPG1289, CZC5252BFR, LCPG00001289, 2UA4020483, LCPG0726, LCPG1032, CZC52403GH, LCPG1032, 429000KR, CZC5251G3L, CZC5251GSM, CZC5252B2Q, LCPG0893, LCPG1172, 28KN9ZX0T3, MXL4390NJ1, MXL4390NJ1, US04552482, US04552482, US13053013, US13053013, CZC5240314, CZC5252BCC, CZC525GZK, CZC525GZK, FRB3270L1V, FRB3270L1V, LCPF0173, LCPF0173, LCPG0293, LCPG0293, LCPG0376, LCPG0718, LCPG0718, LCPG0934, LCPG0934, LCPG1067, LCPG1067, LCPG1129, LCPG1129, LCPG1139, LCPG1139, LCPG1239, LCPG1239, LCPG1307, LCPG1307, LCPG1322, LCPG1324, LCPG1326, USW3190C0K, FRB3270L5V, LCPG0576, LCPG0971, 29KN9ZP1EE, LCPG0488, 51KN9ZE919, MXL4420B96, LCPG0895, FRB3270L0W, LCPG0864, CZC5252B9H, LCPG1282, 2UB3370B15, CZC52403GC, LCPG0730, LCPG1027, 2UA4020LFK, LCPG0641, FRB3270L09, LCPG0758, USC326023W, LCPG0631, 28KN9ZP0T0, LCPG0386, USU32703Y3, USU32703Y3, FRB3270LQR, FRB32806GB, LCPG0972, 2UB3370CQK, 2UB33803P7, CZC52529Z3, LCPG0669, FRB328072N, LCPG0891, MXL4420B9X, LCPG0901, 51KN9ZE929, LCPG0526, LCPG1288, 28KN9Z70VB, 2UB3370C1Z, 2UB3370CJZ, MXL4360D1N, MXL4390NGV, MXL4390NH1, MXL4390NJD, US14110846, LCPG0281, LCPG0373, LCPG0557, LCPG0566, LCPG0759, LCPG0767, FRB3270L4P, LCPG0985, FRB32806GD, FRB32806Y, LCPG1003, LCPG0783, CZC5252BGV, US04552498, LCPF0168, LCPF0168, FRB3270L12, LCPG0843, FRB3280732, LCPG0892, US04552474, US10570127, CZC52316, CZC5231GH5, LCPF0171, LCPF0130, CZC5251G1H, LCPG1253, LCPG0307, US94800162, LCPD0023, US03570619, LCPF0159, LCPG0786, US03910949, US13809040, LCPF0176, FRB3270KZL, LCPG0770, FRB328072F, LCPG0936, 2AKN9ZG01T, LCPG0440, US04552496, LCPF0169, MXL5040CBX, LCPG0680, MXL4390NHC, US14110747, LCPG0424, LCPG1113, LCPG0721, 2UA4020L7C, LCPG0540, US12754765, CZC5252BH3, 2UB3370C5S, LCPG0556, 2UB42002SF, LCPG0813, LCPG1312, 51KN9ZE925, 51KN9ZE971, LCPG0460, LCPG0467, 2UB33709QM, CZC5251GBX, LCPG0729, CZC5251H5V, SCZC52529X7, LCPG0302, CZC5231G6P, LCPG0616, LCPG1076, USC3260255, LCPG0616, LCPG1025, FRB328070R, LCPG0887, 2UA4020480, 2AKN9ZG011, 2AKN9ZG01E, LCPG0438, US14110776, US14111133, CZC52403G3, FRB3270L1Z, FRB328070H, LCPG0283, LCPG0300, 2UA4330426, MXL4360D0S, LCPG0793, 2UA4110GFC, 2UA4110GFB, LCPG0814, LCPG0299, US14110937, LCPG0420, US13804192, US14110820, LCPG1285, US14110820, USW3190C0R, LCPG0615, 2UA4020LMD, FRB3270LRT, LCPG0722, LCPG0975, US11303388, US11303620, US14014730, LCPG0251, LCPG0254, LCPG0423, 29KN9ZP1BP, LCPG0493, US14110994, SCZC5252B61, 28KN9Z70EX, LCPG0397, LCPG0383, US14110995, LCPG0232, USU32703VY, LCPG0571, US13804183, LCPG0295, 2UB3370C67, 2UB3370CR0, LCPG0677, LCPG0688, CZC52402Q4, LCPG1171, US14110928, LCPG0416, 2UA402048M, LCPG0715, US14014714, LCPG0241, US14014501, LCPG0243, 29KN9ZP1E8, LCPG0446, SCZC5252B4N, CZC5251GZH, FRB32806F8, LCPG0959, 29KN9ZP1TM, 2UA433044P, 2UB3370C5B, LCPG0495, LCPG0555, LCPG0787, US14111137, LCPG1310, LCPG0412, CZC5252BDW, LCPG0763, 2UA4220137, LCPG0763, 28KN9ZP0RJ, USU32703YD, LCPG0388, LCPG0665, LCPG1313, 2UA4020LB0, LCPG0705, USC2340J87, 29KN9ZP24L, CZC5252BHF, LCPG1107, CZC52402QY, LCPG0445, US03910979, LCPF0177, US14110854, LCPG0308, US11302407, LCPG0253, US13804157, CZC524030N, LCPG0301, 2UB33803QK, LCPG0437, FRB3270L1Q, LCPG0933, FRB3280727, LCPG1043, CZC524030P, CZC5240311, LCPG1174, LCPG1175, CZC52402QM, LCPG1244, LCPG1286, USW3190C09, LCPG0612, 2UB3370C6S, LCPG0558, MXL51603JZ, LCPG0962, FRB3270L08, LCPG0878, 2UB33706CW, LCPG0653, 2UB3370CR1, LCPG0687, 2UB3370C33, LCPG0543, 2UB3370CQ1, LCPG0685, MXL4360D1R, CZC2403GK, LCPG1026, LCPG0820, CZC524035C, FRB3280720, LCPG1110, SCZC52529Y6, SCZC5252B3T, LCPG0889, LCPG1319, LCPG1320, 29KN9ZP1ED, LCPG0533, US10570124, LCPF0129, 2UA431043K, LCPG0818, FRB3270L3X, LCPG0984, CZC52402PT, LCPG1164, FRB3270LL9, LCPG0951, MXL4390NHR, LCPG0771, MXL5040CC0, LCPG0968, FRB3270HKQ, LCPG0953, MXL4360D1L, LCPG0827, 2UA422011R, 2UA422088D, 2UA423087T, MXL4360D1Z, CZC5252BKP, CZC5252BL5, LCPD0019, LCPG0678, LCPG0802, LCPG0678, LCPG0802, LCPG0804, LCPG0678, LCPG0802, LCPG0804, CZC52403GP, LCPG1034, FRB32806DV, LCPG0989, US03570598, LCPF0158, CZC52403G2, LCPG1051, CZC5231FX1, CZC5252B9K, LCPG1061, 28KN9Z70SB, CZC5252BLC, LCPG1092, CZC524032R, LCPG1109, 2CKN9ZM19L, LCPG0534, CZC5252B7T, LCPG1166, USC3260246, LCPG0614, LCPG0553, CZC5252BBP, LCPG0405, FRB328072L, LCPG0681, 28KN9ZP1F5, LCPG0385, MXL5100795, CZC5251G63, LCPG1205, US14110830, FRB3270HJK, FRB3270LQ3, LCPG0417, 70018261, LCPG1228, 2UA433040P, LCPG0795, 28KN9ZL17N, LCPG0410, 2UA433032P, LCPG0764, CZC5231GHO, LCPG1073, CZC5252BJ3, LCPG0401, US13809118, LCPG0311, US04552493, LCPF0180, US94362911, LCPD0022, FRB32806F9, LCPG1000, USU32703XC, CZC52403GL, SU94362917, US03908709, LCPF0157, CZC524031G, US14110926, LCPG0415, LCPG1311, 51KN9ZE953, LCPG0456, CZC5251GW5, LCPG1046, 2UA4020LBG, LCPG0565, CZC5231FWZ, LCPG1056, 2AKN9ZG00B, LCPG0381, LCPG0381, 2UA4020LB3, CZC52402XX, LCPG1165, 2AKN9ZG00V, LCPG0434, SCZC5252B4G, 29KN9ZP1V5, LCPG0494, FRB32806FH, LCPG-0990, US03570644, LCPF0138, US14111089, US14111116, LCPG0309, CZC5251G2B, LCPG1072, FRB3270L84, LCPG0960, 2UA4110GFR, LCPG0784, LCPG1273, CZC524030F, PULLED, US14110814, LCPG0321, US14111141, LCPG0404, CZC525BQ5, 2AKN9ZF29B, LCPG0382, 2UA412034M, LCPG0785, LCPG0785, SCZC5252BD4, 2UA43104, LCPG0765, CZC5251GPH, LCPG1054, US14110879, LCPG00428, 28KN9ZL0DX, 28KN9ZL01J, LCPG0406, 2UB42002RY, CZC5251GDT, CZC5251GQH, FRB3270LQV, SCZC5252BOT, LCPG0810, LCPG0974, LCPG1090, LCPG1130, 28KN9ZL0HH, 28KN9ZL164, 2CKN9ZM11V, 2CKN9ZM19H, 2CKN9ZM1LV, 2CKN9ZV1M0, 2UA422010N, 2UB42002S4, US11303368, US11856174, US13813372, US94800510, CZC5240305, CZC5251GHN, LCPD0018, LCPG0255, LCPG0290, LCPG0387, LCPG0394, LCPG0403, LCPG0529, LCPG0530, LCPG0568, LCPG0569, LCPG0806, LCPG0811, LCPG0296, US13804095, US10570024, LCPF0126, 2UB42002SC, LCPG0815, LCPG0535, FRB3270KDV, LCPG0969, USW3190C0S, LCPG0623, US14111088, LCPG0298, FRB3270L6B, LCPG0986, CZC52402Y6, CZC5251GQF, LCPG0430, MXL5310FQK, CZC5252B4N, 28KN9ZN0H7, LCPG0584, 2CKN9ZV1M7, 2CKN9ZV1M7, LCPG0575, LCPG0575, LCPG0808, LCPG0828, 28KN9ZL027, LCPG0408, 2UA4330438, LCPG0766, CZC5252BHQ, LCPG1098, CZC5252BF7, LCPG1275, LCPG0491, 2UA42200Z1, LCPG0496, 28KN9ZL0PZ, 2UA41106JL, US94800373, CZC5231FWQ, CZC5251H0Z, CZC5252BJP, FRB3270LRH, FRB32806FY, 90314720(LCPG0310), LCP-E0042, LCPG-0297, LCPG0250, LCPG0384, LCPG0392, LCPG0405, LCPG0414, LCPG0422, LCPG0531, LCPG0564, LCPG1163 and LCPG1213;
 
2) Ser Numbers LC2C00000383, LC2C00000566, LC2C00000572, LC2C00000428, LC2C00000482, LC2C00000266, LC2C00000192, LC2C00000216, LC2C00000233, LC2C00000419, LC2C00000531, LC2C00000033, LC2C00000583, LC2C00000127, LC2C00000170, LC2C00000563, LC2C00000234, LC2C00000561, LC2C00000205, LC2C00000394, LC2C00000329, LC2C00000418, LC2C00000420, LC2C00000569, LC2C00000570, LC2C00000564, LC2C00000486, LC2C00000483, LC2C00000158, LC2C00000214, LC2C00000215, LC2C00000265, LC2C00000309, LC2C00000217, LC2C00000254, LC2C00000081, LC2C00000159, LC2C00000212, LC2C00000213, LC2C00000293, LC2C00000427, LC2C00000232, LC2C00000242, LC2C00000134, LC2C00000168, LC2C00000219, LC2C00000479, LC2C00000228, LC2C00000580, LC2C00000243, LC2C00000263, LC2C00000393, LC2C00000155, LC2C00000203, LC2C00000204, LC2C00000267, LC2C00000268, LC2C00000193, LC2C00000206, LC2C00000381, LC2C00000381, LC2C00000429, LC2C00000588, LC2C00000449, LC2C00000218, LC2C00000253, LC2C00000110, LC2C00000156, LC2C00000128, LC2C00000162, LC2C00000178, LC2C00000118, LC2C00000079, LC2C00000273, LC2C00000431, LC2C00000477, LC2C00000196, LC2C00000130, LC2C00000310, LC2C00000264, LC2C00000414, LC2C00000276, LC2C00000312, LC2C00000313, LC2C00000361, LC2C00000363, LC2C00000331, LC2C00000330, LC2C00000236, LC2C00000360, LC2C00000294, LC2C00000298, LC2C00000532, LC2C00000220, LC2C00000270, LC2C00000413, LC2C00000120, LC2C00000274, LC2C00000227, LC2C00000384, LC2C00000275, LC2C00000364, LC2C00000269, LC2C00000252, LC2C00000119, LC2C00000250, LC2C00000235, LC2C00000169, LC2C00000244, LC2C00000108, LC2C00000256, LC2C00000272, LC2C00000173, LC2C00000582, LC2C00000064, LC2C00000255, LC2C00000179, LC2C00000562, LC2C00000581, LC2C00000035, LC2C00000080, LC2C00000172, LC2C00000412, LC2C00000032, LC2C00000131, LC2C00000195, LC2B00000042, LC2C00000039, LC2C00000043, LC2C00000034, LC2C00000132, LC2C00000133, LC2C00000060, LC2C00000180, LC2C00000578, LC2C00000314, LC2C00000571, 2C00000565, LC2C00000415, LC2C00000430, LC00000529, LC2C00000044, LC2C00000129, LC2C00000297, LC2C00000358, LC2C00000359, LC2C00000392 and LC2C00000434
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Operations, Inc., Indianapolis, IN, letter dated July 21, 2011. Firm initiated recall is ongoing.
REASON
Roche has detected a problem with the MagNA Pure LC 1.0 (software version 3.0.11) and the MagNA Pure LC 2.0 (software versions 1.1.23 and 1.1.24) instruments. Under certain circumstances, only a fraction of each sample is processed which may lead to false negative results, and an impact to patient health if used in a homebrew diagnostic application.
VOLUME OF PRODUCT IN COMMERCE
570 units
DISTRIBUTION
Nationwide, PR
________________________________________
PRODUCT
HiArt versions 4.0.x, and HD versions 1.0.x, H-0000-0003. The TomoTherapy HI-ART System is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non-modulated (non-IMRT/three dimensional conformal) format in accordance with the physician approved plan. Recall # Z-3108-2011
CODE
Serial numbers: 110002 110056 110110 110162 110214 110267 110319 110003 110057 110111 110164 110215 110268 110320 110004 110058 110112 110165 110216 110269 110321 110005 110059 110113 110166 110217 110271 110322 110006 110060 110114 110167 110218 110272 110323 110007 110061 110115 110168 110219 110273 110324 110008 110063 110116 110169 110220 110275 110325 110009 110064 110117 110170 110221 110276 110326 110012 110065 110118 110171 110222 110277 110327 110013 110066 110119 110172 110223 110278 110328 110014 110067 110120 110173 110224 110279 110329 110015 110068 110122 110174 110225 110280 110330 110016 110069 110123 110175 110227 110281 110331 110017 110071 110124 110176 110228 110282 110332 110018 110072 110125 110177 110229 110283 110333 110020 110073 110126 110178 110230 110284 110334 110021 110074 110127 110179 110233 110285 110335 110022 110075 110128 110180 110234 110286 110336 110023 110076 110129 110181 110235 110287 110337 110024 110077 110130 110182 110236 110288 110339 110025 110078 110131 110183 110237 110289 110340 110026 110079 110132 110184 110238 110290 110341 110027 110081 110133 110185 110239 110291 110342 110028 110082 110134 110186 110240 110292 110343 110029 110083 110135 110187 110241 110293 110344 110030 110084 110136 110188 110242 110294 110345 110031 110085 110137 110189 110243 110295 110346 110032 110086 110138 110190 110244 110296 110347 110033 110087 110139 110191 110245 110297 110348 110034 110088 110140 110192 110246 110298 110349 110035 110089 110141 110193 110247 110299 110350 110036 110090 110142 110194 110248 110300 110351 110037 110091 110143 110195 110249 110301 110352 110038 110092 110144 110196 110250 110302 110353 110039 110093 110145 110198 110251 110303 110354 110040 110094 110146 110199 110252 110304 110356 110041 110095 110148 110200 110253 110305 110357 110042 110096 110149 110201 110254 110306 110358 110044 110097 110150 110202 110255 110307 110359 110045 110098 110151 110203 110256 110308 110360 110046 110099 110152 110204 110257 110309 110363 110047 110100 110153 110205 110258 110310 110364 110048 110101 110154 110206 110259 110311 110365 110049 110103 110155 110207 110260 110312 110367 110050 110104 110156 110208 110261 110313 110369 110051 110105 110157 110209 110262 110314 110377 110052 110106 110158 110210 110263 110315 110053 110107 110159 110211 110264 110316 110054 110108 110160 110212 110265 110317 110055 110109 110161 110213 110266 110318
RECALLING FIRM/MANUFACTURER
Accuray Inc., Madison, WI, by letter dated July 13, 2011. Firm initiated recall is ongoing.
REASON
During DICOM export of plan level images with a non square exported Field of View (FOV), an anomaly in the process of squaring the plan level image may cause the image to shift with respect to ROIs and dose. When the anomaly occurs, the magnitude of the image shift can be a full IEC-X voxel, a full IEC-Z voxel, or full voxels in both IEC-X and IEC-Z. Please note that while square images are required for successfully importing via DICOM, the process of inserting the couch and moving the patient with the couch can result in non square images internal to TomoTherapy. Even when a plan level image is exported with non square FOV, the anomaly does not occur with every export and is dependent on specific image dimensions and voxel sizes.
VOLUME OF PRODUCT IN COMMERCE
346 units
DISTRIBUTION
Nationwide and Internationally
________________________________________
PRODUCT
Reliance Vision Single Chamber Washer/Disinfector, Model # 1802983, The Vision Single Chamber Washer is intended for use in the cleaning and intermediate level disinfection of soiled reusable utensils, trays, glassware, bedpans and urinals, rubber and plastic goods, simple hard-surfaced rigid surgical instruments such as forceps and clamps, theatre shoes and other similar and related articles found in healthcare facilities. Recall # Z-3118-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Steris Corp., Mentor, OH, by letter dated May 9, 2011.
Manufacturer: Steris Canada, Beauport, Canada. Firm initiated recall is ongoing.
REASON
STERIS learned that Vision SC Washer users were experiencing nuisance alarms and/or aborted cycles that are adversely affecting the reliability and operation of their unit.
VOLUME OF PRODUCT IN COMMERCE
404 units
DISTRIBUTION
Nationwide, Australia, Canada, Hong Kong, and South Korea
________________________________________
PRODUCT
Kyphon brand KyphoPak Express Tray First Fracture, 15/2 with KyphX Osteo Introducer System; Catalog Number: KPE1003; Designed to reduce kyphosis that results from vertebral body collapse due to osteoporosis. Recall # Z-3175-2011
CODE
Lot Number: 0001653390
RECALLING FIRM/MANUFACTURER
Medtronic Spine LLC, formerly Kyphon Inc., Sunnyvale, CA, by letter on March 23, 2011. Firm initiated recall is ongoing.
REASON
Device was shipped past the labeled expiration date.
VOLUME OF PRODUCT IN COMMERCE
44 units
DISTRIBUTION
Nationwide
________________________________________
PRODUCT
STOCKERT 70 Radio Frequency Generator, Catalog Number 57001 Indicated for use with a Biosense Webster, Inc. diagnostic/ablation deflectable tip catheter to deliver radio frequency energy during cardiac ablation procedures. Stockert 70 in foreign countries is also known as: EP-Shuttle/Stockert J50/Stockert J70 With software versions: 1.035/1.035J/1.035J70 to 1.037/1.037J70. Recall # Z-3178-2011
CODE
Software version: 1.035J
RECALLING FIRM/MANUFACTURER
Recalling Firm: Biosense Webster, Inc., Irwindale, CA, by letters on July 8, 2011 and July 11, 2011.
Manufacturer: Stockert Gmbh, Freiburg Im Breisgau, Germany. Firm initiated recall is ongoing.
REASON
Biosense Webster has initiated a voluntary field notification to all customers that have a Stockert 70 Radio Frequency Generator, to communicate undetected software anomalies in the form of software release note in order to amend the labeling and thereby enhance the safety of the product.
VOLUME OF PRODUCT IN COMMERCE
3,397 units
DISTRIBUTION
Nationwide and Internationally
________________________________________
PRODUCT
Varian Medical Systems Inc., Millennium and HD-120 MultiLeaf Collimators (MLC), a component of the Clinac, All Varian Clinac using the collimator cover P/N 1106900-xx, Model Numbers: H14, H18, H27, H29, HCX; part of the Trilogy Radiotherapy Delivery System. Recall # Z-3204-2011
CODE
Serial Numbers: H140001, H140049, H140097, H140144, H140235, H140742, H140788,    H140856 ,H180473 ,H180645 ,H180718 ,H140002 ,H140051 ,H140098 ,H140145,  H140236 ,H140743 ,H140789 ,H140882 ,H180485 ,H180647 ,H180719 ,H140003, H140052 ,H140099 ,H140146 ,H140237 ,H140744 ,H140790 ,H140889 ,H180487 ,H180649 ,H180720 ,H140004 ,H140053 ,H140100 ,H140147 ,H140238 ,H140745 ,H140791 ,H180003 ,H180529 ,H180650 ,H180721 ,H140005 ,H140054 ,H140101 ,H140148 ,H140239 ,H140746 ,H140792 ,H180056 ,H180532 ,H180651 ,H180722 ,H140006 ,H140055 ,H140102 ,H140149 ,H140240 ,H140747 ,H140793 ,H180088 ,H180535 ,H180655 ,H180723 ,H140007 ,H140056 ,H140103 ,H140150 ,H140700 ,H140748 ,H140794 ,H180102 ,H180536 ,H180657 ,H180724 ,H140008 ,H140057 ,H140105 ,H140151 ,H140701 ,H140749 ,H140795 ,H180115 ,H180542 ,H180659 ,H180725 ,H140009 ,H140058 ,H140106 ,H140152 ,H140702 ,H140750 ,H140796 ,H180117 ,H180548 ,H180660 ,H180726 ,H140010 ,H140060 ,H140107 ,H140153 ,H140703 ,H140751 ,H140797 ,H180144 ,H180550 ,H180661 ,H180728 ,H140011 ,H140061 ,H140108 ,H140154 ,H140704 ,H140752 ,H140798 ,H180166 ,H180553 ,H180665 ,H180729 ,H140012 ,H140062 ,H140110 ,H140201 ,H140705 ,H140753 ,H140799 ,H180167 ,H180555 ,H180667 ,H180730 ,H140014 ,H140063 ,H140111 ,H140202 ,H140707 ,H140754 ,H140800 ,H180173 ,H180556 ,H180668 ,H180731 ,H140015 ,H140064 ,H140112 ,H140203 ,H140708 ,H140755 ,H140801 ,H180201 ,H180559 ,H180669 ,H180733 ,H140016 ,H140065 ,H140113 ,H140204 ,H140709 ,H140756 ,H140802 ,H180204 ,H180561 ,H180670 ,H180734 ,H140017 ,H140066 ,H140114 ,H140205 ,H140710 ,H140757 ,H140803 ,H180206 ,H180575 ,H180671 ,H180735 ,H140018 ,H140067 ,H140115 ,H140206 ,H140711 ,H140758 ,H140804 ,H180210 ,H180581 ,H180672 ,H180736 ,H140019 ,H140068 ,H140116 ,H140207 ,H140712 ,H140759 ,H140805 ,H180217 ,H180588 ,H180674 ,H180737 ,H140021 ,H140069 ,H140117 ,H140208 ,H140713 ,H140760 ,H140806 ,H180220 ,H180591 ,H180676 ,H180738 ,H140022 ,H140070 ,H140118 ,H140209 ,H140714 ,H140761 ,H140807 ,H180221 ,H180593 ,H180679 ,H180739 ,H140023 ,H140071 ,H140119 ,H140210 ,H140715 ,H140762 ,H140808 ,H180222 ,H180596 ,H180680 ,H180741 ,H140024 ,H140072 ,H140120 ,H140211 ,H140716 ,H140763 ,H140809 ,H180228 ,H180597 ,H180681 ,H180744 ,H140025 ,H140073 ,H140121 ,H140212 ,H140717 ,H140764 ,H140810 ,H180235 ,H180599 ,H180682 ,H180745 ,H140026 ,H140074 ,H140122 ,H140213 ,H140718 ,H140765 ,H140811 ,H180255 ,H180600 ,H180683 ,H180746 ,H140027 ,H140075 ,H140123 ,H140214 ,H140719 ,H140766 ,H140812 ,H180256 ,H180601 ,H180684 ,H180747 ,H140028 ,H140076 ,H140124 ,H140215 ,H140720 ,H140767 ,H140813 ,H180260 ,H180603 ,H180685 ,H180750 ,H140029 ,H140077 ,H140125 ,H140216 ,H140721 ,H140768 ,H140814 ,H180268 ,H180604 ,H180687 ,H180751 ,H140030 ,H140078 ,H140126 ,H140217 ,H140722 ,H140769 ,H140815 ,H180271 ,H180605 ,H180690 ,H180752 ,H140032 ,H140079 ,H140127 ,H140218 ,H140723 ,H140770 ,H140817 ,H180283 ,H180607 ,H180691 ,H180753 ,H140033 ,H140080 ,H140128 ,H140219 ,H140724 ,H140771 ,H140818 ,H180284 ,H180608 ,H180692 ,H180754 ,H140034 ,H140082 ,H140129 ,H140220 ,H140725 ,H140772 ,H140819 ,H180290 ,H180614 ,H180693 ,H180756 ,H140035 ,H140083 ,H140130 ,H140221 ,H140727 ,H140773 ,H140820 ,H180292 ,H180619 ,H180694 ,H180757 ,H140036 ,H140084 ,H140131 ,H140222 ,H140728 ,H140774 ,H140821 ,H180294 ,H180625 ,H180695 ,H180758 ,H140037 ,H140085 ,H140132 ,H140223 ,H140729 ,H140775 ,H140822 ,H180298 ,H180626 ,H180696 ,H180759 ,H140038 ,H140086 ,H140133 ,H140224 ,H140730 ,H140776 ,H140823 ,H180324 ,H180627 ,H180698 ,H180760 ,H140039 ,H140087 ,H140134 ,H140225 ,H140731 ,H140778 ,H140824 ,H180405 ,H180629 ,H180699 ,H180761 ,H140040 ,H140088 ,H140135 ,H140226 ,H140732 ,H140779 ,H140825 ,H180407 ,H180630 ,H180703 ,H180763 ,H140041 ,H140089 ,H140136 ,H140227 ,H140733 ,H140780 ,H140826 ,H180409 ,H180632 ,H180704 ,H180769 ,H140042 ,H140090 ,H140137 ,H140228 ,H140734 ,H140781 ,H140827 ,H180415 ,H180633 ,H180707 ,H180770 ,H140043 ,H140091 ,H140138 ,H140229 ,H140735 ,H140782 ,H140828 ,H180427 ,H180634 ,H180709 ,H180774 ,H140044 ,H140092 ,H140139 ,H140230 ,H140736 ,H140783 ,H140829 ,H180446 ,H180637 ,H180710 ,H180775 ,H140045 ,H140093 ,H140140 ,H140231 ,H140737 ,H140784 ,H140830 ,H180447 ,H180640 ,H180714 ,H180776 ,H140046 ,H140094 ,H140141 ,H140232 ,H140738 ,H140785 ,H140837 ,H180466 ,H180641 ,H180715 ,H180777 ,H140047 ,H140095 ,H140142 ,H140233 ,H140739 ,H140786 ,H140844 ,H180467 ,H180643 ,H180716 ,H180778 ,H140048 ,H140096 ,H140143 ,H140234 ,H140740 ,H140787 ,H140849 ,H180470 ,H180644 ,H180717 ,H180780 ,H180784 ,H180863 ,H181043 ,H181142 ,H270209 ,H270473 ,H270783 ,H271027 ,H271238 ,H271372 ,H271465 ,H180785 ,H180864 ,H181045 ,H181143 ,H270214 ,H270476 ,H270787 ,H271029 ,H271248 ,H271375 ,H271466 ,H180786 ,H180866 ,H181046 ,H181145 ,H270215 ,H270483 ,H270789 ,H271033 ,H271249 ,H271376 ,H271468 ,H180791 ,H180870 ,H181047 ,H181146 ,H270216 ,H270489 ,H270791 ,H271035 ,H271250 ,H271377 ,H271471 ,H180792 ,H180871 ,H181053 ,H181147 ,H270219 ,H270498 ,H270796 ,H271038 ,H271251 ,H271378 ,H271473 ,H180794 ,H180872 ,H181055 ,H181148 ,H270227 ,H270501 ,H270797 ,H271041 ,H271256 ,H271381 ,H271474 ,H180795 ,H180873 ,H181057 ,H181149 ,H270229 ,H270502 ,H270800 ,H271051 ,H271257 ,H271384 ,H271475 ,H180796 ,H180877 ,H181058 ,H181152 ,H270235 ,H270503 ,H270803 ,H271061 ,H271258 ,H271385 ,H271476 ,H180803 ,H180878 ,H181061 ,H181155 ,H270244 ,H270504 ,H270804 ,H271067 ,H271260 ,H271386 ,H271477 ,H180804 ,H180879 ,H181062 ,H181156 ,H270256 ,H270505 ,H270805 ,H271071 ,H271264 ,H271387 ,H271478 ,H180806 ,H180880 ,H181065 ,H181157 ,H270260 ,H270512 ,H270806 ,H271076 ,H271266 ,H271390 ,H271479 ,H180807 ,H180881 ,H181066 ,H181158 ,H270270 ,H270513 ,H270808 ,H271079 ,H271271 ,H271391 ,H271481 ,H180810 ,H180882 ,H181068 ,H181159 ,H270273 ,H270514 ,H270813 ,H271085 ,H271273 ,H271393 ,H271485 ,H180812 ,H180883 ,H181069 ,H181160 ,H270280 ,H270518 ,H270814 ,H271086 ,H271276 ,H271398 ,H271487 ,H180815 ,H180884 ,H181070 ,H181161 ,H270281 ,H270522 ,H270817 ,H271093 ,H271277 ,H271399 ,H271490 ,H180816 ,H180885 ,H181071 ,H181162 ,H270285 ,H270526 ,H270822 ,H271101 ,H271280 ,H271401 ,H271492 ,H180817 ,H180886 ,H181073 ,H181163 ,H270293 ,H270532 ,H270825 ,H271108 ,H271281 ,H271404 ,H271493 ,H180819 ,H180887 ,H181075 ,H181164 ,H270297 ,H270607 ,H270826 ,H271109 ,H271282 ,H271406 ,H271494 ,H180820 ,H180888 ,H181077 ,H181165 ,H270302 ,H270613 ,H270828 ,H271113 ,H271285 ,H271407 ,H271495 ,H180821 ,H180890 ,H181078 ,H181166 ,H270323 ,H270622 ,H270829 ,H271114 ,H271286 ,H271410 ,H271497 ,H180822 ,H180894 ,H181082 ,H181167 ,H270345 ,H270635 ,H270833 ,H271115 ,H271287 ,H271411 ,H271498 ,H180823 ,H180895 ,H181083 ,H181168 ,H270352 ,H270639 ,H270836 ,H271123 ,H271288 ,H271412 ,H271499 ,H180824 ,H180896 ,H181084 ,H181170 ,H270356 ,H270644 ,H270837 ,H271124 ,H271289 ,H271413 ,H271500 ,H180825 ,H180898 ,H181085 ,H181173 ,H270360 ,H270646 ,H270840 ,H271126 ,H271291 ,H271414 ,H271501 ,H180826 ,H181002 ,H181086 ,H181175 ,H270370 ,H270647 ,H270842 ,H271132 ,H271296 ,H271415 ,H271502 ,H180827 ,H181003 ,H181089 ,H181177 ,H270371 ,H270649 ,H270844 ,H271141 ,H271299 ,H271417 ,H271503 ,H180828 ,H181004 ,H181090 ,H181180 ,H270378 ,H270652 ,H270846 ,H271142 ,H271304 ,H271419 ,H271504 ,H180829 ,H181005 ,H181091 ,H181181 ,H270384 ,H270669 ,H270847 ,H271143 ,H271305 ,H271420 ,H271505 ,H180830 ,H181006 ,H181092 ,H181184 ,H270386 ,H270671 ,H270848 ,H271149 ,H271307 ,H271422 ,H271506 ,H180831 ,H181007 ,H181093 ,H181185 ,H270391 ,H270675 ,H270852 ,H271151 ,H271308 ,H271424 ,H271507 ,H180832 ,H181008 ,H181097 ,H260915 ,H270392 ,H270684 ,H270854 ,H271157 ,H271309 ,H271425 ,H271509 ,H180834 ,H181009 ,H181098 ,H260916 ,H270397 ,H270690 ,H270861 ,H271159 ,H271314 ,H271426 ,H271511 ,H180835 ,H181011 ,H181101 ,H260923 ,H270399 ,H270699 ,H270863 ,H271163 ,H271315 ,H271427 ,H271512 ,H180837 ,H181012 ,H181103 ,H260924 ,H270401 ,H270703 ,H270864 ,H271166 ,H271317 ,H271428 ,H271514 ,H180839 ,H181013 ,H181108 ,H260928 ,H270410 ,H270711 ,H270865 ,H271167 ,H271319 ,H271429 ,H271515 ,H180840 ,H181015 ,H181109 ,H260931 ,H270416 ,H270712 ,H270877 ,H271175 ,H271322 ,H271430 ,H271516 ,H180842 ,H181018 ,H181114 ,H260932 ,H270420 ,H270714 ,H270879 ,H271183 ,H271325 ,H271431 ,H271517 ,H180843 ,H181019 ,H181116 ,H260938 ,H270421 ,H270715 ,H270880 ,H271199 ,H271327 ,H271432 ,H271518 ,H180844 ,H181020 ,H181118 ,H260939 ,H270426 ,H270717 ,H270883 ,H271201 ,H271332 ,H271435 ,H271519 ,H180850 ,H181022 ,H181119 ,H260942 ,H270427 ,H270718 ,H270888 ,H271204 ,H271333 ,H271436 ,H271520 ,H180852 ,H181023 ,H181124 ,H260946 ,H270430 ,H270726 ,H270889 ,H271205 ,H271334 ,H271438 ,H271522 ,H180853 ,H181026 ,H181127 ,H260947 ,H270431 ,H270727 ,H270890 ,H271209 ,H271338 ,H271439 ,H271523 ,H180854 ,H181029 ,H181128 ,H260948 ,H270437 ,H270735 ,H270891 ,H271214 ,H271347 ,H271440 ,H271525 ,H180855 ,H181030 ,H181132 ,H260950 ,H270438 ,H270739 ,H270894 ,H271218 ,H271349 ,H271447 ,H271526 ,H180856 ,H181031 ,H181133 ,H260951 ,H270439 ,H270741 ,H271002 ,H271222 ,H271355 ,H271448 ,H271527 ,H180857 ,H181032 ,H181134 ,H260952 ,H270447 ,H270757 ,H271005 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,H291113 ,H291166 ,H273068 ,H273123 ,H273178 ,H290206 ,H290305 ,H290370 ,H290506 ,H291001 ,H291055 ,H291114 ,H291167 ,H273069 ,H273124 ,H273179 ,H290208 ,H290306 ,H290371 ,H290508 ,H291003 ,H291056 ,H291115 ,H291168 ,H273070 ,H273125 ,H273180 ,H290210 ,H290307 ,H290372 ,H290510 ,H291004 ,H291057 ,H291116 ,H291169 ,H273071 ,H273126 ,H273181 ,H290211 ,H290308 ,H290373 ,H290511 ,H291005 ,H291059 ,H291117 ,H291170 ,H273072 ,H273127 ,H273182 ,H290216 ,H290312 ,H290374 ,H290512 ,H291006 ,H291060 ,H291118 ,H291171 ,H273074 ,H273128 ,H273183 ,H290223 ,H290313 ,H290375 ,H290513 ,H291007 ,H291061 ,H291119 ,H291172 ,H273075 ,H273130 ,H273184 ,H290224 ,H290314 ,H290376 ,H290514 ,H291008 ,H291062 ,H291120 ,H291173 ,H273077 ,H273131 ,H273186 ,H290225 ,H290315 ,H290377 ,H290515 ,H291009 ,H291063 ,H291121 ,H291174 ,H273078 ,H273132 ,H273187 ,H290228 ,H290317 ,H290378 ,H290516 ,H291010 ,H291064 ,H291122 ,H291175 ,H273079 ,H273133 ,H273188 ,H290233 ,H290319 ,H290379 ,H290517 ,H291011 ,H291065 ,H291123 ,H291176 ,H273080 ,H273134 ,H273189 ,H290235 ,H290320 ,H290380 ,H290518 ,H291013 ,H291067 ,H291124 ,H291177 ,H273081 ,H273135 ,H273190 ,H290236 ,H290321 ,H290381 ,H290519 ,H291014 ,H291068 ,H291125 ,H291178 ,H273082 ,H273136 ,H273191 ,H290240 ,H290322 ,H290382 ,H290520 ,H291015 ,H291069 ,H291126 ,H291179 ,H273083 ,H273137 ,H273192 ,H290241 ,H290323 ,H290383 ,H290521 ,H291016 ,H291070 ,H291127 ,H291180 ,H273084 ,H273138 ,H273193 ,H290243 ,H290326 ,H290384 ,H290522 ,H291017 ,H291071 ,H291128 ,H291181 ,H273085 ,H273139 ,H273195 ,H290246 ,H290327 ,H290386 ,H290523 ,H291018 ,H291072 ,H291129 ,H291183 ,H273086 ,H273140 ,H273196 ,H290249 ,H290328 ,H290387 ,H290524 ,H291019 ,H291073 ,H291130 ,H291184 ,H273087 ,H273141 ,H273197 ,H290255 ,H290329 ,H290388 ,H290525 ,H291020 ,H291074 ,H291131 ,H291185 ,H273088 ,H273142 ,H273198 ,H290256 ,H290331 ,H290389 ,H290526 ,H291021 ,H291075 ,H291132 ,H291186 ,H273089 ,H273143 ,H273199 ,H290259 ,H290332 ,H290390 ,H290527 ,H291022 ,H291079 ,H291133 ,H291187 ,H273090 ,H273144 ,H273200 ,H290260 ,H290334 ,H290392 ,H290529 ,H291023 ,H291080 ,H291134 ,H291188 ,H273091 ,H273145 ,H273201 ,H290261 ,H290335 ,H290393 ,H290530 ,H291024 ,H291081 ,H291135 ,H291189 ,H273092 ,H273146 ,H273202 ,H290262 ,H290336 ,H290394 ,H290531 ,H291025 ,H291082 ,H291136 ,H291190 ,H273093 ,H273147 ,H273203 ,H290267 ,H290337 ,H290395 ,H290532 ,H291026 ,H291083 ,H291137 ,H291191 ,H273094 ,H273148 ,H273204 ,H290268 ,H290338 ,H290396 ,H290533 ,H291027 ,H291084 ,H291138 ,H291192 ,H273095 ,H273149 ,H273205 ,H290269 ,H290340 ,H290398 ,H290535 ,H291028 ,H291085 ,H291140 ,H291193 ,H273097 ,H273150 ,H273206 ,H290271 ,H290341 ,H290399 ,H290536 ,H291029 ,H291086 ,H291141 ,H291194 ,H291195 ,H291248 ,H293324 ,H293377 ,H293432 ,H293484 ,H293540 ,H293594 ,H293649 ,H293703 ,H293760 ,H291196 ,H291249 ,H293325 ,H293378 ,H293433 ,H293485 ,H293541 ,H293595 ,H293650 ,H293705 ,H293762 ,H291197 ,H291250 ,H293326 ,H293379 ,H293434 ,H293486 ,H293542 ,H293596 ,H293651 ,H293706 ,H293763 ,H291198 ,H291251 ,H293327 ,H293380 ,H293435 ,H293487 ,H293543 ,H293597 ,H293652 ,H293707 ,H293764 ,H291199 ,H291252 ,H293328 ,H293381 ,H293436 ,H293488 ,H293544 ,H293598 ,H293653 ,H293708 ,H293765 ,H291200 ,H291253 ,H293329 ,H293382 ,H293437 ,H293489 ,H293545 ,H293599 ,H293654 ,H293710 ,H293766 ,H291201 ,H291254 ,H293330 ,H293383 ,H293438 ,H293490 ,H293546 ,H293600 ,H293655 ,H293712 ,H293767 ,H291202 ,H291255 ,H293331 ,H293384 ,H293439 ,H293491 ,H293548 ,H293601 ,H293656 ,H293713 ,H293769 ,H291203 ,H291256 ,H293332 ,H293385 ,H293440 ,H293492 ,H293549 ,H293602 ,H293657 ,H293714 ,H293770 ,H291204 ,H291257 ,H293333 ,H293386 ,H293441 ,H293493 ,H293550 ,H293603 ,H293658 ,H293715 ,H293771 ,H291205 ,H291258 ,H293334 ,H293387 ,H293442 ,H293494 ,H293551 ,H293604 ,H293659 ,H293716 ,H293772 ,H291206 ,H291259 ,H293335 ,H293388 ,H293443 ,H293495 ,H293552 ,H293605 ,H293660 ,H293717 ,H293773 ,H291207 ,H291260 ,H293336 ,H293389 ,H293444 ,H293496 ,H293553 ,H293606 ,H293661 ,H293718 ,H293774 ,H291208 ,H291261 ,H293338 ,H293390 ,H293445 ,H293497 ,H293554 ,H293609 ,H293662 ,H293719 ,H293775 ,H291209 ,H291262 ,H293339 ,H293391 ,H293446 ,H293498 ,H293555 ,H293610 ,H293663 ,H293720 ,H293776 ,H291211 ,H291263 ,H293340 ,H293393 ,H293447 ,H293499 ,H293556 ,H293611 ,H293664 ,H293721 ,H293777 ,H291212 ,H291264 ,H293341 ,H293394 ,H293448 ,H293500 ,H293557 ,H293612 ,H293665 ,H293723 ,H293778 ,H291213 ,H291265 ,H293342 ,H293395 ,H293449 ,H293501 ,H293558 ,H293613 ,H293666 ,H293724 ,H293779 ,H291214 ,H291267 ,H293343 ,H293396 ,H293450 ,H293502 ,H293559 ,H293614 ,H293667 ,H293725 ,H293780 ,H291215 ,H291268 ,H293344 ,H293397 ,H293451 ,H293503 ,H293560 ,H293616 ,H293668 ,H293726 ,H293781 ,H291216 ,H291269 ,H293345 ,H293399 ,H293452 ,H293504 ,H293561 ,H293617 ,H293669 ,H293727 ,H293783 ,H291217 ,H291270 ,H293346 ,H293401 ,H293453 ,H293505 ,H293562 ,H293618 ,H293670 ,H293728 ,H293784 ,H291218 ,H291271 ,H293347 ,H293402 ,H293454 ,H293506 ,H293563 ,H293619 ,H293671 ,H293729 ,H293785 ,H291219 ,H291272 ,H293348 ,H293403 ,H293455 ,H293508 ,H293564 ,H293620 ,H293672 ,H293730 ,H293786 ,H291220 ,H291273 ,H293349 ,H293404 ,H293456 ,H293509 ,H293565 ,H293621 ,H293673 ,H293731 ,H293787 ,H291221 ,H292832 ,H293350 ,H293405 ,H293457 ,H293510 ,H293566 ,H293622 ,H293674 ,H293732 ,H293788 ,H291222 ,H293207 ,H293351 ,H293406 ,H293458 ,H293512 ,H293567 ,H293623 ,H293675 ,H293733 ,H293789 ,H291223 ,H293300 ,H293352 ,H293407 ,H293459 ,H293513 ,H293568 ,H293624 ,H293676 ,H293734 ,H293790 ,H291224 ,H293301 ,H293353 ,H293408 ,H293460 ,H293514 ,H293569 ,H293625 ,H293677 ,H293735 ,H293791 ,H291225 ,H293302 ,H293354 ,H293409 ,H293461 ,H293515 ,H293570 ,H293626 ,H293678 ,H293736 ,H293792 ,H291226 ,H293303 ,H293355 ,H293410 ,H293462 ,H293516 ,H293571 ,H293627 ,H293679 ,H293737 ,H293793 ,H291227 ,H293304 ,H293356 ,H293411 ,H293463 ,H293517 ,H293572 ,H293628 ,H293681 ,H293738 ,H293794 ,H291228 ,H293305 ,H293357 ,H293412 ,H293464 ,H293518 ,H293573 ,H293629 ,H293682 ,H293739 ,H293795 ,H291229 ,H293306 ,H293359 ,H293413 ,H293465 ,H293519 ,H293574 ,H293630 ,H293683 ,H293740 ,H293796 ,H291230 ,H293307 ,H293360 ,H293414 ,H293466 ,H293521 ,H293575 ,H293631 ,H293684 ,H293741 ,H293797 ,H291231 ,H293308 ,H293361 ,H293415 ,H293468 ,H293522 ,H293576 ,H293632 ,H293685 ,H293742 ,H293798 ,H291232 ,H293309 ,H293362 ,H293416 ,H293469 ,H293523 ,H293577 ,H293633 ,H293686 ,H293743 ,H293799 ,H291233 ,H293310 ,H293363 ,H293417 ,H293470 ,H293524 ,H293578 ,H293634 ,H293687 ,H293744 ,H293800 ,H291234 ,H293311 ,H293364 ,H293418 ,H293471 ,H293525 ,H293579 ,H293635 ,H293688 ,H293745 ,H293801 ,H291235 ,H293312 ,H293365 ,H293419 ,H293472 ,H293527 ,H293581 ,H293637 ,H293689 ,H293746 ,H293802 ,H291236 ,H293313 ,H293366 ,H293420 ,H293473 ,H293529 ,H293583 ,H293638 ,H293692 ,H293747 ,H293803 ,H291237 ,H293314 ,H293367 ,H293421 ,H293474 ,H293530 ,H293584 ,H293639 ,H293693 ,H293748 ,H293804 ,H291238 ,H293315 ,H293368 ,H293422 ,H293475 ,H293531 ,H293585 ,H293640 ,H293694 ,H293749 ,H293805 ,H291239 ,H293316 ,H293369 ,H293423 ,H293476 ,H293532 ,H293586 ,H293641 ,H293695 ,H293750 ,H293806 ,H291240 ,H293317 ,H293370 ,H293424 ,H293477 ,H293533 ,H293587 ,H293642 ,H293696 ,H293751 ,H293807 ,H291241 ,H293318 ,H293371 ,H293425 ,H293478 ,H293534 ,H293588 ,H293643 ,H293697 ,H293752 ,H293808 ,H291242 ,H293319 ,H293372 ,H293426 ,H293479 ,H293535 ,H293589 ,H293644 ,H293698 ,H293753 ,H293809 ,H291243 ,H293320 ,H293373 ,H293428 ,H293480 ,H293536 ,H293590 ,H293645 ,H293699 ,H293754 ,H293812 ,H291244 ,H293321 ,H293374 ,H293429 ,H293481 ,H293537 ,H293591 ,H293646 ,H293700 ,H293755 ,H293813 ,H291245 ,H293322 ,H293375 ,H293430 ,H293482 ,H293538 ,H293592 ,H293647 ,H293701 ,H293756 ,H293814 ,H291247 ,H293323 ,H293376 ,H293431 ,H293483 ,H293539 ,H293593 ,H293648 ,H293702 ,H293758 ,H293815 ,H293816 ,H293869 ,H293920 ,H293976 ,H294031 ,H294085 ,H294147 ,H294203 ,H294257 ,H294484 ,H293817 ,H293870 ,H293921 ,H293977 ,H294034 ,H294086 ,H294148 ,H294204 ,H294258 ,H294500 ,H293818 ,H293871 ,H293922 ,H293978 ,H294035 ,H294087 ,H294149 ,H294205 ,H294260 ,H294519 ,H293819 ,H293872 ,H293924 ,H293979 ,H294036 ,H294088 ,H294150 ,H294206 ,H294261 ,H294542 ,H293820 ,H293873 ,H293925 ,H293980 ,H294037 ,H294089 ,H294151 ,H294207 ,H294262 ,H294550 ,H293821 ,H293874 ,H293926 ,H293981 ,H294038 ,H294090 ,H294152 ,H294208 ,H294263 ,H294565 ,H293822 ,H293875 ,H293928 ,H293982 ,H294039 ,H294091 ,H294153 ,H294209 ,H294264 ,H294572 ,H293823 ,H293876 ,H293929 ,H293983 ,H294040 ,H294092 ,H294154 ,H294210 ,H294265 ,H294573 ,H293824 ,H293877 ,H293930 ,H293984 ,H294041 ,H294093 ,H294155 ,H294211 ,H294266 ,H294592 ,H293825 ,H293878 ,H293931 ,H293985 ,H294042 ,H294094 ,H294156 ,H294212 ,H294267 ,H294595 ,H293826 ,H293879 ,H293932 ,H293986 ,H294043 ,H294095 ,H294157 ,H294213 ,H294268 ,H294603 ,H293827 ,H293880 ,H293933 ,H293987 ,H294044 ,H294097 ,H294158 ,H294214 ,H294269 ,H294618 ,H293828 ,H293881 ,H293934 ,H293988 ,H294045 ,H294098 ,H294159 ,H294215 ,H294270 ,H294637 ,H293829 ,H293882 ,H293935 ,H293989 ,H294046 ,H294099 ,H294160 ,H294216 ,H294271 ,H294653 ,H293830 ,H293883 ,H293936 ,H293990 ,H294047 ,H294100 ,H294161 ,H294217 ,H294272 ,H294656 ,H293831 ,H293884 ,H293937 ,H293991 ,H294048 ,H294101 ,H294162 ,H294218 ,H294273 ,H294658 ,H293832 ,H293885 ,H293938 ,H293992 ,H294049 ,H294102 ,H294163 ,H294219 ,H294274 ,H294660 ,H293834 ,H293886 ,H293940 ,H293993 ,H294050 ,H294103 ,H294164 ,H294220 ,H294275 ,H294674 ,H293835 ,H293887 ,H293941 ,H293994 ,H294051 ,H294107 ,H294165 ,H294221 ,H294276 ,H294679 ,H293836 ,H293888 ,H293942 ,H293995 ,H294052 ,H294108 ,H294166 ,H294222 ,H294277 ,H294681 ,H293837 ,H293889 ,H293943 ,H293996 ,H294053 ,H294109 ,H294167 ,H294224 ,H294278 ,H294698 ,H293838 ,H293890 ,H293944 ,H293997 ,H294054 ,H294110 ,H294168 ,H294225 ,H294279 ,H294713 ,H293839 ,H293891 ,H293946 ,H293998 ,H294055 ,H294111 ,H294169 ,H294226 ,H294280 ,H294714 ,H293840 ,H293892 ,H293947 ,H293999 ,H294056 ,H294112 ,H294170 ,H294227 ,H294281 ,H294715 ,H293841 ,H293893 ,H293948 ,H294000 ,H294057 ,H294113 ,H294171 ,H294228 ,H294283 ,H294719 ,H293842 ,H293894 ,H293949 ,H294001 ,H294058 ,H294114 ,H294172 ,H294229 ,H294284 ,H294723 ,H293843 ,H293895 ,H293950 ,H294002 ,H294059 ,H294116 ,H294173 ,H294230 ,H294285 ,H294726 ,H293844 ,H293896 ,H293951 ,H294003 ,H294060 ,H294117 ,H294174 ,H294231 ,H294286 ,H294735 ,H293845 ,H293897 ,H293952 ,H294004 ,H294061 ,H294118 ,H294175 ,H294232 ,H294287 ,H294737 ,H293846 ,H293898 ,H293953 ,H294005 ,H294062 ,H294119 ,H294176 ,H294233 ,H294288 ,H294752 ,H293847 ,H293899 ,H293954 ,H294006 ,H294063 ,H294120 ,H294177 ,H294234 ,H294301 ,H294820 ,H293848 ,H293900 ,H293955 ,H294007 ,H294064 ,H294122 ,H294179 ,H294235 ,H294302 ,HCX4138 ,H293849 ,H293901 ,H293956 ,H294008 ,H294065 ,H294123 ,H294180 ,H294236 ,H294308 ,H293850 ,H293902 ,H293957 ,H294009 ,H294066 ,H294124 ,H294181 ,H294237 ,H294311 ,H293851 ,H293903 ,H293958 ,H294010 ,H294067 ,H294125 ,H294182 ,H294238 ,H294341 ,H293852 ,H293904 ,H293959 ,H294011 ,H294068 ,H294126 ,H294183 ,H294239 ,H294351 ,H293854 ,H293905 ,H293960 ,H294012 ,H294069 ,H294127 ,H294184 ,H294240 ,H294355 ,H293855 ,H293906 ,H293961 ,H294013 ,H294070 ,H294128 ,H294185 ,H294241 ,H294358 ,H293856 ,H293907 ,H293962 ,H294015 ,H294071 ,H294129 ,H294186 ,H294242 ,H294362 ,H293857 ,H293908 ,H293963 ,H294016 ,H294072 ,H294130 ,H294187 ,H294243 ,H294380 ,H293858 ,H293909 ,H293964 ,H294017 ,H294073 ,H294131 ,H294188 ,H294244 ,H294395 ,H293859 ,H293910 ,H293965 ,H294021 ,H294074 ,H294132 ,H294190 ,H294245 ,H294408 ,H293860 ,H293911 ,H293966 ,H294022 ,H294075 ,H294133 ,H294191 ,H294246 ,H294413 ,H293861 ,H293912 ,H293967 ,H294023 ,H294076 ,H294134 ,H294194 ,H294247 ,H294421 ,H293862 ,H293913 ,H293968 ,H294024 ,H294077 ,H294135 ,H294195 ,H294248 ,H294427 ,H293863 ,H293914 ,H293969 ,H294025 ,H294078 ,H294136 ,H294197 ,H294250 ,H294447 ,H293864 ,H293915 ,H293970 ,H294026 ,H294079 ,H294140 ,H294198 ,H294252 ,H294448 ,H293865 ,H293916 ,H293971 ,H294027 ,H294080 ,H294141 ,H294199 ,H294253 ,H294450 ,H293866 ,H293917 ,H293972 ,H294028 ,H294081 ,H294142 ,H294200 ,H294254 ,H294458 ,H293867 ,H293918 ,H293974 ,H294029 ,H294083 ,H294143 ,H294201 ,H294255 ,H294465 ,H293868 ,H293919 ,H293975 ,H294030 ,H294084 ,H294146 ,H294202 ,H294256 ,H294482
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter on March 17, 2011. Firm initiated recall is ongoing.
REASON
An improperly installed collimator cover may detach and fall from the machine, potentially striking the patient or nearby personnel.
VOLUME OF PRODUCT IN COMMERCE
3,791 units
DISTRIBUTION
Nationwide and Internationally
________________________________________
PRODUCT
1) Victory 10, 3 Wheel (SC610) Mobility medical devices. Recall # Z-3211-2011
2) Victory 10, 4 Wheel (SC710) Mobility medical devices. Recall # Z-3212-2011
CODE
1) SC610;
2) SC710
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pride Mobility Products Corp., Exeter, PA, by letter dated June 2011.  
Manufacturer: Melton Industrial Co., ltd., New City Science Ind., Dong Guan City, China. Firm initiated recall is ongoing.
REASON
Contract manufacturer error. Component part(s) (fuses) specifications were not adhered to as outlined in Pride's Engineering drawings.
VOLUME OF PRODUCT IN COMMERCE
17,341 units
DISTRIBUTION
Nationwide, Australia, Canada, France, and United Kingdom
________________________________________
PRODUCT
Sarns 8000 Cardioplegia Monitor, a) Catalog Number 16414; also known as PROG COMP BD AMPRO 420 CPG 8K, b) Catalog Number 816373 The Sarns 8000 Cardioplegia Monitor is indicated to measure extracorporeal line pressure and signal when the pressure exceeds the operator-set limit. Recall # Z-3214-2011
CODE
a) Serial Numbers 2060, 3305, 3763, 3823, 3834, 3835, 3851-3876, 3878-3899, 3901, 3902, 3904, 3906-3913, 3915-3933 and 3935. b) Serial numbers 491212, 498329, 505891, 505892, 509307, 510221, 512688, 514493, 517238, 522537, 524438, 527767, 534182, 541101, 545173, 551503, 557425, 563225, 568962 and 576045
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by letter dated August 29, 2011. Firm initiated recall is ongoing.
REASON
The Cardioplegia Monitor for the Sarns Modular Perfusion System 8000 may fail to track cardioplegia delivery volume.
VOLUME OF PRODUCT IN COMMERCE
85 units
DISTRIBUTION
Nationwide, Belgium, Columbia, Hong Kong, India, Singapore, and Taiwan
________________________________________
PRODUCT
1) 7 F Therapy Ablation Catheter, 4 mm Tip Thermistor, Model (Reorder #) 83724, Description: 1304-7-25-M-TH. A sterile, single use catheter with one 4mm ablation electrode at the tip and three 2mm diagnostic electrodes. The catheter includes a temperature sensor in the tip electrode for temperature monitoring and the handle is equipped with a steering mechanism to detect the distal tip of the catheter; both uni-directional and bi-directional versions are available. The catheter is available with various distal curve configurations; the curve is indicated on the catheter label. Recall # Z-3255-2011;
 
2) 7 F Therapy Ablation Catheter, 4 mm Tip Thermistor, Model (Reorder #) 83725, Description: 1304-7-25-L-TH. A sterile, single use catheter with one 4mm ablation electrode at the tip and three 2mm diagnostic electrodes. The catheter includes a temperature sensor in the tip electrode for temperature monitoring and the handle is equipped with a steering mechanism to detect the distal tip of the catheter; both uni-directional and bi-directional versions are available. The catheter is available with various distal curve configurations; the curve is indicated on the catheter label. Recall # Z-3256-2011;
 
3) 7 F Therapy Ablation Catheter, 4 mm Tip Thermistor, Model (Reorder #) 83726, Description: 1304-7-25-XL-TH. A sterile, single use catheter with one 4mm ablation electrode at the tip and three 2mm diagnostic electrodes. The catheter includes a temperature sensor in the tip electrode for temperature monitoring and the handle is equipped with a steering mechanism to detect the distal tip of the catheter; both uni-directional and bi-directional versions are available. The catheter is available with various distal curve configurations; the curve is indicated on the catheter label. Recall # Z-3257-2011
CODE
1) Lots: 3197680, 3238970, 3276122, K23315, K23598, K26899, K27935, and K30436;
 
2) Lots: 3200476, K21432, K24495, K25197, K28752, K30681, and K30881;
 
3) Lots: 3167515, 3174474, 3183198, 3276124, K17381, K18242, K28491, K29692, K30008, and K30240
RECALLING FIRM/MANUFACTURER
Recalling Firm: St Jude Medical, Saint Paul, MN, by letter dated February 22, 2011.
Manufacturer: St Jude Medical Co., Irvine, CA. Firm initiated recall is ongoing.
REASON
The recall was initiated because St. Jude Medical has confirmed that the Therapy Ablation Catheter, 4 mm Tip Thermistor Quadripolar, were packaged with the incorrect Instructions for Use (IFU). To ensure accuracy of device labeling, St. Jude Medical is requesting that the incorrect IFU be replaced with the enclose, correct version.
VOLUME OF PRODUCT IN COMMERCE
179 units
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III
________________________________________
PRODUCT
BardPort Titanium Implanted Port. Bard Access Systems. Assembled in Mexico. A totally implantable vascular access device designed to provide long term repeated access to the vascular system. Prod Number: 0602290. Recall # Z-3173-2011
CODE
Lot Numbers: RESF1061, RESI0209, RESI0672, RESI1072, RESK0055, RESK0806, RETA0584, RETC0929, RETF0739, RETH0830
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bard Access Systems, Salt Lake City, UT, by letter dated August 30, 2011.
Manufacturer: Bard Reynosa S.A. De C.V., Tamaulipas, Mexico. Firm initiated recall is ongoing.
REASON
Implanted port has discrepant product information on package labeling.
VOLUME OF PRODUCT IN COMMERCE
1,375 units
DISTRIBUTION
Nationwide, Canada and Belgium
 
END OF ENFORCEMENT REPORT FOR SEPTEMBER 21, 2011
 
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