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U.S. Department of Health and Human Services

Enforcement Report - Week of February 17, 2016

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Veterinary Signature brand FEP-862S Q STATUS PELLET FORMULA Pelleted Maintenance & Light Exercise Ration 50 lb bag (paper bags, poly-lined, sewn at both ends) Lot Number 14-280 Manufacture Date: October 7 Class I Products may contain monensin. Lakeland Animal Nutrition, Inc.
Veterinary Busters Natural Pet Supply Brand 6" Beef Trachea, 12 pack in plastic pouch Lot #54, 8501450; UPC #8501450 Class I Samples collected by the Colorado Department of Agriculture and tested in FDA laboratory tested positive for Salmonella Pet International Inc.
Veterinary Primal Formula for Cats; Turkey - 93% Turkey, 7% produce and supplements. 1 oz. nuggets - Keep Frozen: Net wt. 3 lbs. (1.35 kg) Feline Turkey Formula Ingredients: Turkey, Turkey Necks, Turkey Hearts, Turkey Livers, Organic Collard Greens, Organic Squash, Organic Celery, Cranberries, Blueberries, Organic Pumpkin Seeds, Organic Sunflower Seeds, Minerals (Zinc Sulfate, Copper Carbonate, Selenium), Almonds, Organic Apple Cider Vinegar, Sardine Oil, Taurine, Organic Quinoa Sprout Powder, Dried Organic Kelp, Organic Cilantro, Organic Coconut Oil, Cod Liver Oil, Organic Ginger, Natural Vitamin E. Primal Pet Foods Inc. Best By date 060815 B22 UPC 8 50334-00414 0. Class I One lot of Feline Turkey Raw Frozen Formula 3 pound bag tested FDA was found to be low in Thiamine. Primal Pet Foods Inc.
Veterinary Bravo Blends All Natural Chicken Blend diet for dogs & cats, Item #: 21­-102, 2 lb (32 oz.) chub; UPC: 829546211028 12-05-16 Class I Product tested positive for Salmonella spp. Poly A BRAVO! LLC
Veterinary Bravo Balance Chicken Dinner for dogs, Patties, Item #: 21­401; 3 lb (48 oz.) bag UPC: 829546214012 12-05-16 Class I Product did not test positive for Salmonella, but is being voluntarily recalled out of an abundance of caution because it was manufactured in the same manufacturing facility on the same day as the product that tested positive for Salmonella spp. Poly A. BRAVO! LLC
Veterinary Bravo Balance Chicken Dinner for dogs, Chub, Item Code: 21­402, 2 lb., (32 oz.) UPC: 829546214029 12-05-16 Class I Product did not test positive for Salmonella, but is being voluntarily recalled out of an abundance of caution because it was manufactured in the same manufacturing facility on the same day as the product that tested positive for Salmonella spp. Poly A. BRAVO! LLC
Veterinary Bravo Blend Chicken diet for dogs & cats, Patties, Item Number: 21­508, 5 lb. (80 oz.) bag, UPC: 829546215088 12-05-16 Class I Product did not test positive for Salmonella, but is being voluntarily recalled out of an abundance of caution because it was manufactured in the same manufacturing facility on the same day as the product that tested positive for Salmonella spp. Poly A. BRAVO! LLC
Devices Philips Healthcare TraumaDiagnost; Codes: 72001, 720011, 720013, 720020; A radiological examination unit for emergency work and routine skeletal diagnosis. All TraumaDiagnost products that were delivered before the week of July 2, 2007. Class II If arm is not fastened securely it could fall down. Philips Electronics North America Corporation
Veterinary START A300 PAC, 2000# tote, Manufactured by Provimi North America, Inc., Brookville, Ohio 45309 F0002474302 Class I Elevated levels of vitamin A can lead to elevated levels of morbidity and mortality in swine. Provimi North American Inc
Food Kraft Singles American packaged in a blue box with white lettering. Best When Used By date between 13 DEC 15 and 18 FEB 16, Best When Used By date between 09 DEC 15 and 19 FEB 16, Best When Used By date between 24 JAN 16 and 6 FEB 16. Class II Kraft Singles wrapped American slices due to the possibility that a thin strip of the individual packaging film may remain adhered to the slice after the wrapper has been removed. If the film sticks to the slice and is not removed, it could potentially cause a choking hazard. The Kraft Heinz Company
Food Kraft Singles White American singles packaged in a blue box with white lettering. Best When Used By date between 12 DEC 15 and 13 FEB 16, Best When Used By date of 12 JAN 16, Best When Used By date of 11 JAN 16 Class II Kraft Singles wrapped American slices due to the possibility that a thin strip of the individual packaging film may remain adhered to the slice after the wrapper has been removed. If the film sticks to the slice and is not removed, it could potentially cause a choking hazard. The Kraft Heinz Company
Food Kraft Singles Deli Deluxe American Slices packaged in a blue box with white lettering. Best When Used By date between 21 JAN 16 and 02 MAR 16 Class II Kraft Singles wrapped American slices due to the possibility that a thin strip of the individual packaging film may remain adhered to the slice after the wrapper has been removed. If the film sticks to the slice and is not removed, it could potentially cause a choking hazard. The Kraft Heinz Company
Veterinary CORDEL GF5 DDG 20 C-M, Swine Grower/Finisher, Complete to Increase the Digestibility of Phytin-Bound Phosphorus in Swine Diets B00923811 Class I Excessive magnesium in pig feed Ridley USA, Inc
Devices MEVION S250 Radiation therapy system Manufacturing Lot or Serial Number: S250-0004 Class II The treatment table positioning belt can slip gear positions, resulting in deviation of patient setup and treatment positions from the time of slippage until the discovery of slippage and the halting of treatment. Mevion Medical Systems, Inc.
Veterinary DQ Goat Grower 15% RU-27 Medicated - A Feed for Goats, Monensin Sodium 27 g/ton, packaged as bulk in 1000 lb. plastic totes. The responsible firm is MFA Incorporated, Columbia, MO 65201. lot 194632 Class III Product contains monensin and excess copper. MFA Inc
Veterinary DQ Goat Grower 15% RU-27 Medicated - A Feed for Goats, Monensin Sodium 27 g/ton, packaged as bulk in 1000 lb. plastic totes. The responsible firm is MFA Incorporated, Columbia, MO 65201. lot 197180 Class III Product contains monensin. MFA Inc
Veterinary OC Raw Dog Chicken, Fish & Produce Raw Frozen Canine Formulation 3lb Meat Rox UPC Code: 022099069171 4lb Sliders UPC Code: 095225852640 6.5lb Doggie Dozen Patty Bags UPC Code: 022099069225 Lot #1819 Use by Date 050516 Class I OC Raw Dog, LLC is recalling OC Raw Dog Chicken, Fish & Produce Raw Frozen Canine Formulation due to potential Salmonella contamination. oc Raw Dog
Drugs Morphine Sulfate, 2 mg per mL (60 mg per 30 mL) 30 mL total volume in a 35 mL Monoject Barrel Syringes in Sodium Chloride 0.9%, Rx only, Contains Sulfites, Compounded Drug, Not for Resale, Hospital/Office Use only, IV use only, NDC 61553-401-44. Lot #:151370066M, Exp. 08/15/2015 Class I Subpotent Drug Pharmedium Services, LLC
Food Inclusion chocolate bar 66% Cacao topped with pistachios, cranberries & Sea Salt in a white and green wrapping with white and gray lettering. Sku: CB1022 expiration date range of 10/21/2015 to 4/15/2016 Class I Undeclared Milk on the labels of various dark chocolate bars. FDA samples came back positive for milk. E3 Artisan
Food Mendiant Orange apricot & carmelized hazelnut packaged in a clear plastic bag with brown label with white lettering. Sku: MDOACH Expiration date range: 10/21/2015 - 4/15/2016 Class I Undeclared Milk on the labels of various dark chocolate bars. FDA samples came back positive for milk. E3 Artisan
Food Inclusion bar-macadamia nuts, raspberries, and kaffir lime Sku: CB1021 Expiration date range: 10/21/2015 - 4/15/2016 Class I Undeclared Milk on the labels of various dark chocolate bars. FDA samples came back positive for milk. E3 Artisan
Food Inclusion bar-candied ginger, candied orange peel, and coriander. Sku: CB1023 Expiration date range: 10/21/2015 - 4/15/2016 Class I Undeclared Milk on the labels of various dark chocolate bars. FDA samples came back positive for milk. E3 Artisan
Food Inclusion bar-strawberries, rose petals, and pink peppercorns. Sku: CB1024 Expiration date range: 10/21/2015 - 4/15/2016 Class I Undeclared Milk on the labels of various dark chocolate bars. FDA samples came back positive for milk. E3 Artisan
Food Inclusion bar-strawberries, rose petals, and pink peppercorns. Sku: CB1024 Expiration date range: 10/21/2015 - 4/15/2016 Class I Undeclared Milk on the labels of various dark chocolate bars. FDA samples came back positive for milk. E3 Artisan
Food Inclusion bar-cherries, cocoa nibs, cayenne. Sku: CB1026 Expiration date range: 10/21/2015 - 4/15/2016 Class I Undeclared Milk on the labels of various dark chocolate bars. FDA samples came back positive for milk. E3 Artisan
Food Inclusion bar-strawberries, mangoes, and chiles. Sku: CB1027 Expiration date range: 10/21/2015 - 4/15/2016 Class I Undeclared Milk on the labels of various dark chocolate bars. FDA samples came back positive for milk. E3 Artisan
Food Inclusion bar-expresso, cherries, and hazelnuts. Sku: CB1028 Expiration date range: 10/21/2015 - 4/15/2016 Class I Undeclared Milk on the labels of various dark chocolate bars. FDA samples came back positive for milk. E3 Artisan
Food Inclusion bar-scorpion pepper, bourbon, smoked sea salt, and caramel pecans. Sku: CB1029 Expiration date range: 10/21/2015 - 4/15/2016 Class I Undeclared Milk on the labels of various dark chocolate bars. FDA samples came back positive for milk. E3 Artisan
Food Inclusion bar-Cocao Nibs, caramel almonds, and sea salt. Sku: CB1030 Expiration date range: 10/21/2015 - 4/15/2016 Class I Undeclared Milk on the labels of various dark chocolate bars. FDA samples came back positive for milk. E3 Artisan
Food Meltaway bar-black cherry lemonade. Sku: MB1021 Expiration date range: 10/21/2015 - 1/15/2016 Class I Undeclared Milk on the labels of various dark chocolate bars. FDA samples came back positive for milk. E3 Artisan
Food Meltaway bar- Sweet basil & Cherry blossom. Sku: MB1022 Expiration date range: 10/21/2015 - 1/15/2016 Class I Undeclared Milk on the labels of various dark chocolate bars. FDA samples came back positive for milk. E3 Artisan
Food Meltaway bar- Blood Orange & Vanilla bean. Sku: MB1023 Expiration date range: 10/21/2015 - 1/15/2016 Class I Undeclared Milk on the labels of various dark chocolate bars. FDA samples came back positive for milk. E3 Artisan
Food Mendiant- Pistachio, Rose Petal & Candied Ginger. Sku: MDPRC Expiration date range: 10/21/2015 - 1/15/2016 Class I Undeclared Milk on the labels of various dark chocolate bars. FDA samples came back positive for milk. E3 Artisan
Food Meltaways- 3 piece peppermint meltaways. Sku: ML1031 Expiration date range: 10/21/2015 - 1/15/2016 Class I Undeclared Milk on the labels of various dark chocolate bars. FDA samples came back positive for milk. E3 Artisan
Food Meltaways- 3 piece Vanilla Sea Salt meltaways. Sku: ML1032Expiration date range: 10/21/2015 - 1/15/2016 Class I Undeclared Milk on the labels of various dark chocolate bars. FDA samples came back positive for milk. E3 Artisan
Food Meltaways- 3 piece Tahitian Vanilla Lemon Meltaways. SKU: ML1034 Expiration date range: 10/21/2015- 1/15/2016. Class I Undeclared Milk on the labels of various dark chocolate bars. FDA samples came back positive for milk. E3 Artisan
Food Meltaways- 3 piece Blood Orange meltaways. SKU: ML1033 Expiration date range: 10/21/2015- 1/15/2016. Class I Undeclared Milk on the labels of various dark chocolate bars. FDA samples came back positive for milk. E3 Artisan
Food Meltaways- 3 piece meltaways assorted. SKU: ML1035 Expiration date range: 10/21/2015- 1/15/2016. Class I Undeclared Milk on the labels of various dark chocolate bars. FDA samples came back positive for milk. E3 Artisan
Food Meltaway bar- French Vanilla & salted Almond. SKU: MB1024 Expiration date range: 10/21/2015- 1/15/2016. Class I Undeclared Milk on the labels of various dark chocolate bars. FDA samples came back positive for milk. E3 Artisan
Devices Philips Allura Xper FD20 Ceiling version only; 722028; imaging applications. Ceiling version only. Class II Normally, movement of the C-arc is initially stopped by the motor (holding torque) then by the electromagnetic brake, leading to a full stop of the C-arc. Because of improper adjustment and tolerances, when the C-arc is initially stopped in an unbalanced position, the air gap of the brake can become too large, resulting in continued C-arc movement (C-arc is looking for balanced position). Philips Electronics North America Corporation
Devices Allura Xper FD OR Table, Ceiling version only; 722035; imaging applications. Ceiling version only. Class II Normally, movement of the C-arc is initially stopped by the motor (holding torque) then by the electromagnetic brake, leading to a full stop of the C-arc. Because of improper adjustment and tolerances, when the C-arc is initially stopped in an unbalanced position, the air gap of the brake can become too large, resulting in continued C-arc movement (C-arc is looking for balanced position). Philips Electronics North America Corporation
Devices Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures. All lots/serial numbers sold prior to August 2014. Class II Improper targeted temperature therapy was delivered to patients because the Temperature Simulator Key was connected to the patient temperature cable instead of the patient temperature probe. C.R. Bard, Inc.
Devices VS200 radiographic Cassette Holder or Wall Stand. For use in radiology department. Product # Serial # 110-5010G1 , 00504-0214 110-5010G1  ...
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Class II The wall stand cassette holder can suddenly fall to the bottom of its travel, near the ground and contact patient. Del Medical, Inc.
Devices VS300 radiographic Cassette Holder or Wall Stand. For use in radiology department. Product # Serial # 110-5124G1 , 00019-0114 110-5124G1  ...
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Class II The wall stand cassette holder can suddenly fall to the bottom of its travel, near the ground and contact patient. Del Medical, Inc.
Food Sunbest Natural Lemon Juice 33.5 Fl. Oz. Distributed by Sunco & Frenchie LLC Clifton, NJ 07011 UPC 089625403007 LOT: IHR1 Class II Lemon juice contains unapproved color and undeclared color. SUNCO & FRENCHIE LLC.
Food WATCHAREE'S thai peanut sauce (UPC 094368999977), product is in a glass jar, NET WT 11.75 OZ (333 g) Best By: 9/16/2017 and 10/28/2017 Class II Sauces may not meet quality standards due to the presence of mold. Thai Culinary Arts Studio LLC
Food WATCHAREE'S Thai Massaman curry sauce (UPC 094368999984), product is in a glass jar, NET WT 11.5 OZ (326 g) Best by 9/15/2017 and 10/28/2017 Class II Sauces may not meet quality standards due to the presence of mold. Thai Culinary Arts Studio LLC
Food Watcharee's Thai Green Curry Sauce (UPC 094368999991), product is in a glass jar, NET WT 11.5 OZ (326 g) Best by 9/15/17, 9/16/17 and 10/20/2017 Class II Sauces may not meet quality standards due to the presence of mold. Thai Culinary Arts Studio LLC
Drugs SyrSpend SF, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneous preparation of oral liquid dose forms, Rx Only, Shake Well, 500 mL bottle, Manufactured by Fagron Inc., St. Paul, MN 55120, NDC 51552-1079-5. Lot #s: 15I21-U01-027370; 15I21-U01-026920; 15J19-U05-027406 Class II Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast. Fagron, Inc
Drugs SyrSpend SF, Suspending Base, Grape Flavored, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneous preparation of oral liquid dose forms, Rx Only, Shake Well, 4 L bottle, Manufactured by Fagron Inc., St. Paul, MN 55120, NDC 51552-1167-9. Lot #s: 15A05-U03-022765; 15G29-U03-025975; 15A05-U06-023277 Class II Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast. Fagron, Inc
Drugs SyrSpend SF, Suspending Base, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneous preparation of oral liquid dose forms, Rx Only, Shake Well, 4 L bottle, Manufactured by Fagron Inc., St. Paul, MN 55120, NDC 51552-1079-9. Lot #s: 15J26-U05-027457; 15J26-U05-027473 Class II Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast. Fagron, Inc
Food Label reading in part: "CRIADA***PREMIUM GANDULES VERDES GREEN PIGEON PEAS***In water with salt*** NET WT. 15 oz (425g)***Producido para/Produced for Empresas La Famosa, Inc.: P.O. Box 51968 Toa Baja, P.R. 00949***Product of Peru/Producto de Peru". lot ID GGVBG 2915 Class II Product in Import Alert (99-38) inadvertently released for distribution. A.R.Food Brokerage Corp.
Food Label reading in part: "ECONO***Gandules Verde***Hervidos en Agua y Sal*** Green Pigeon Peas***PREMIUM***NET WT. 15 oz (425g)***PRODUCTO DE PERU***EMPACADO PARA: SUPERMERCADOS ECONO, INC. Carolina, P.R. 00984". lot ID GGVBG-3615 Class II Product in Import Alert (99-38) inadvertently released for distribution. A.R.Food Brokerage Corp.
Devices Moog Curlin Infusion, Ambulatory Infusion Pump The Curlin Ambulatory Infusion System includes Curlin Ambulatory multi-therapy and PainSmart pumps. Curlin 4000, catalog number 340; Curlin 6000, 6000 CMS, and PainSmart IOD, catalog number 360; and Curlin Pump Calibration Set, catalog number 340-4038. All manufactured or serviced by MMDG between March 18, 2015 and November 6, 2015. Curlin 4000, catalog number 340; Curlin 6000, 6000 CMS, and PainSmart IOD, catalog number 360; and Curlin Pump Calibration Set, catalog number 340-4038. Class II Moog is recalling Curlin 4000, 6000, and Painsmart Infusion Pumps manufactured or serviced by MMDG between March 18, 2015 and November 6, 2015 because the master pumps used to calibrate them were out of tolerance and may cause an over delivery of medications and solutions at a rate of 1.2 - 6.8% faster than programmed. MOOG Medical Devices Group
Devices Mizuho OSI Trios, Table Base; Voltage: 100-240V ~ 50/60 Hz Amps: 5,0-5.0A; Model 7803 and 7803AP Orthopaedic: Operating room tablebase - an electronically powered mobile operating table is created, designed for temporary (<24 hours) support and positioning of a patient in a prone, supine, or lateral position depending on the specific table top utilized. Model numbers 7803, 7803AP. Serial numbers 228-261. Class II Table Bases may have been assembled incorrectly, missing a retaining ring from the head end assembly. Over time, the parts could go out of alignment, making clutch engagement or disengagement difficult. If the clutch cannot disengage, the user would be unable to rotate the patient from supine to prone. Mizuho OSI
Food Zzang! Original Candy Bar, 2.5 oz., packaged in preprinted cardboard boxes, UPC 8 44397 00014 0 Lot and Batch Nos are the sell-by dates 12/17/2015 03/16/2016, Product/Catalog No. 100 Class II Product recalled due to undeclared soy and milk (butter declared). Zingerman's Candy Manufactory
Food Zzang! Cashew Cow Candy Bar,2 oz., packaged in reprinted cardboard boxes, UPC 8 44397 00015 7 Lot and Batch Nos are sell-by dates 12/17/2015 02/16/2016, Product/Catalog No. 120 Class II Product recalled due to undeclared sub-ingredient soy. Zingerman's Candy Manufactory
Food Zzang! Wowza Candy Bar,3 oz., packaged in reprinted cardboard boxes, UPC 8 44397 00072 0 Lot and Batch Nos are sell-by dates 12/17/2015 02/16/2016, Product/Catalog No. 160 Class II Product recalled due to undeclared soy; and undeclared milk (cream declared). Zingerman's Candy Manufactory
Food Zzang! Holiday 4 pack Candy Bars, 10.5 oz., packaged in preprinted cardboard boxes Lot and Batch Nos are the sell-by dates 12/17/2015 03/16/2016, Product/Catalog No. 100 Class II Product recalled due to undeclared soy; and undeclared allergen milk (cream and butter declared). Zingerman's Candy Manufactory
Food Chocolate Marshmallows, 8 oz., packaged in plastic bags, UPC 8 44397 00077 5 Lot and Batch No is sell-by date 12/24/15 (only 1 batch). Class II Product recalled due to undeclared soy. Zingerman's Candy Manufactory
Food Bearded Brothers BOLD Coconut Curry Net Wt. 1.5 oz/43 g UPC: 8-50430-00513-5. Coconut Curry Lot/Exp. 081316 Class II Mold on energy bars. Bearded Brothers LLC
Food Bearded Brothers BOLD The Greek Net Wt. 1.5 oz/43 g UPC: 8-50430-00414-2. The Greek Lot/Exp.: 072316 Class II Mold on energy bars. Bearded Brothers LLC
Devices Mavig Monitor Suspension System, Model GD60, contained in the following Fluoroscopic imaging systems: Advantx LCV+, Advantx LCN+, Advantx LCLP+, Advantx LCA, INNOVA 2000, INNOVA 4100, INNOVA 3100, INNOVA 3131IQ, INNOVA 2121IQ, INNOVA 2100IQ, INNOVA 3100IQ, and INNOVA 4100IQ Mfg Lot or Serial #/System ID, 1003/219326IN41, 20116/573632CRA, 30173/229434INNOV, 9110080/502587LAB4, 40410078/904276SP, 50410007/703689LCA2, 100300002/315448RM2, 104100042/650369SV5, 104100047/810342A41, 104100051/573632CRC1, 104100057/843674INNOVA, 106100046/603669ELCV, 110300023/315448RM1, 110310015/724656ANG, 110420162/251435I12, 120310008/804285CATH2, 123100037/617789IN1, 204110049/513861INNOVA, 204110065/623848LAB1, 304110059/908522CATH2, 304110070/519663INNOVA2, 304110071/850494WSP1, 404110063/903CSM4100, 404110077/808547QCV1A, 404110079/985867INNOVA2, 504110085/5094744100, 704120114/904202SP1, 704120117/619340VA8, 909110081/570969CATH, 1003100012/972335LIB, 1103100019/904202CATH2, 1103100026/315448RM3, 1104120128/812283IN20, 1203100022/702616INNOVA, 1203100032/515263IL4100, 1204130176/412623LAB3, 1204130198/918744JC4100, 1204930184/803329CL31, 000000007U0099/083016802100337, 00000007C20164/2706080, 00000007C20229/0835160022, 00000007C20367/MA1251VA01, 00000007C20369/00065VAS01, 00000007C20385/BY4066VA01,  ...
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Class II GE Healthcare has recently become aware of a reported incident in which a Mavig suspension arm with monitor assembly fell to the floor. GE Medical Systems, LLC
Drugs Midazolam HCl Syrup, 10 mg/5 mL, 5 mL unit dose cups, packaged in 2 shelf boxes, one shelf box containing 72 cups and one shelf box containing 60 cups, Cherry Brandy Flavor, Rx only, MFG: Roxane; PKG BY Safecor, Woburn, MA; Barcode 0054356605. Lot: 932333, Exp 08/04/16 Class II Presence of Foreign Substance: customer complaint that one unit dose cup contained a small piece of cardboard contaminant. Safecor Health, LLC
Devices GE Healthcare, Optima XR220amx, Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images. Lot or Serial numbers including but not limited to: 00001033715WK2, 12535HL3, 00000078321HL7, 00000096815HL6, 00000081147HL1, 00001032621WK3, 00000092076HL9, 00000092382HL1, 00000460115GE9, 00000079932HL0, D3s14793, 00000088642HL4, 116635HL4, 120632HL5, GEGR2411, GEGR5073, 00001027151WK8, 00000129105HL3, 261417HP0, 261416HP2, 1035189WK8, 00000084720HL2, 00000087109HL5, 00000100735HL0, 121206HL7, 125007HL5, 125019HL0, 1028231WK7, 00000126237HL7, 00000102072HL6, 00000092394HL6, 00000115802HL1, 124167HL8, 00001033721WK0, 00000108520HL8, 00000087928HL8, 00000111794HL4, 00000110657HL4, 00000092629HL5, 119090HL9, 00000442129GE3,  ...
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Class II Potential safety latch mechanism failure. The safety latch, within the column that supports the horizontal arm, is a backup in the unlikely event the primary safety cable breaks. A fall of the arm assembly could result in bodily harm to a person. GE Medical Systems, LLC
Devices GE Healthcare, Brivo XR285amx Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images. Lot or serial numbers include but not limited to: 00000086177HL3, 00001028564WK1, 115226HL3, 00000083538HL9, 00000092940HL6, 00000084909HL1, 00000081798HL1, 120634HL1, 00000084729HL3, 00000084161HL9, 00000082463HL1, 00000080868HL3, 120832HL1, 00000089868HL4, 00000082736HL0, 00000093379HL6, 00000092616HL2, 00000092633HL7, 00000081160HL4, 00000077253HL3, 00000076913HL3, 00000078498HL3, 00000084160HL1, 00000078315HL9, 00000082726HL1, 00000085039HL6, 00000080635HL6, 00000091403HL6, 00000085598HL1, 00000085661HL7, 00000077923HL1, 00000081481HL4, 00001027046WK0, 00000081152HL1, 00000086364HL7, 00000092622HL0, 00000085000HL8, 00000084999HL2, 00000084725HL1, 00000083029HL9, 00000078313HL4,  ...
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Class II Potential safety latch mechanism failure. The safety latch, within the column that supports the horizontal arm, is a backup in the unlikely event the primary safety cable breaks. A fall of the arm assembly could result in bodily harm to a person. GE Medical Systems, LLC
Devices GE Healthcare, Optima XR200amx, Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images. Lot or serial numbers include, but not limited to: 00001031869WK9, 00001031925WK9, 00000081156HL2, GEGR2170, 00001033726WK9, 00000119120HL4, 00000084104HL9, 00001033405WK0, 00000085648HL4, 00001033548WK7, 1035415WK7, 124175HL1, 122205HL8, 1036207WK7, 00000086387HL8, 00000104902HL2, 00000087904HL9, 00000087902HL3, 00000106045HL8, 00000105791HL8, 00000083607HL2, 00000090594HL3, 00000090597HL6, 00001030061WK4, 00001030140WK6, 00001030142WK2, 114185HL2, 00001031534WK9, 00001031533WK1, 00001031696WK6, 00000092062HL9, 00001028273WK9, 00000106054HL0, 00000106067HL2, 00000105797HL5, 00000106074HL8, 00000105801HL5, 00000104928HL7, 00000093370HL5, 00000089482HL4, 00000085430HL7,  ...
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Class II Potential safety latch mechanism failure. The safety latch, within the column that supports the horizontal arm, is a backup in the unlikely event the primary safety cable breaks. A fall of the arm assembly could result in bodily harm to a person. GE Medical Systems, LLC
Food FATwater bottle, 16.9 fl. oz., Berry flavor, UPC 6 09015 50477 2 LOT numbers: B150608-2U; B150710-2U; B150720-2U; B150819-2U; B150820-2U; B151005-1U; B151020-2U; EXPIRATION DATES: 7/9/2016; 7/28/2016; 8/19/2016; 8/20/2016; 10/5/2016; 10/20/2016; Class III FATwater bottles, Berry flavor, are recalled due to microbial growth detection. No E.coli or other pathogens were detected. Bulletproof Digital Inc
Food FATwater bottle, 16.9 fl. oz., Lemon flavor, UPC 6 09015 50475 8 LOT numbers: B150608-1U; B150710-1U; B150720-1U; B150819-1U; B150820-1U; B151005-2U; EXPIRATION DATES: 7/9/2016 7/28/2016 8/19/2016 8/20/2016 10/5/2016 Class III FATwater bottles, Lemon flavor, are recalled due to microbial growth detection. No E.coli or other pathogens were detected. Bulletproof Digital Inc
Food FATwater bottle, 16.9 fl. oz., Tangerine flavor, UPC 6 41871 93693 9 LOT number: B151005-4U. EXPIRATION DATE: 10/5/2016. Class III FATwater bottles, Tangerine flavor, are recalled due to microbial growth detection. No E.coli or other pathogens were detected. Bulletproof Digital Inc
Devices RadSuite, a picture archive and communications system. Model Numbers Versions 5.30.0, 5.30.1, 5.30.2, 5.30.2 SB0344, 5.30.3, 5.30.4, 5.30.4 HF0418E, 5.30.5, 5.30.5 HF0404E, 5.30.5 HF0413E, 5.30.5 HF390E, 5.30.5 SB0368, 5.30.6, 5.30.6 HF0405E, 5.30.6 HF0406E, 5.30.7, 5.30.7 HF0429E, 5.30.7 HF0441E, 5.30.7 HF0446E, 5.30.7 HF0470E, 5.30.7 HF0473E, 5.30.8, 5.30.8 HF0477E, 5.30.8 HF0490E, 5.30.8 HF0495 SB0508E, 5.30.8 HF0495E, 5.30.8 HF0495E SB504E, 5.30.8 HF0550, 5.30.8 SB0485E, 5.30.8 SB0486E, 5.30.X SB0381E, 5.35.1, 5.35.1 HF0487E, 5.35.1 HF0489E, 5.35.2, 5.35.3, 5.35.4, 5.35.4 HF0513, 5.35.4 HF0518, 5.35.4 HF0528, 5.35.4 HF0531, 5.35.4 HF0535, 5.35.4 HF0546, 5.35.4 HF0555, 5.35.4 HF0555.1, 5.35.4 HF0555.2, 5.35.4 HF0555.3, 5.35.4 HF0560, 5.35.4 Powerscribe Validation, 5.35.5, 5.35.5 From CCS, 5.35.5.1, 8.30.0, 8.30.1, 8.30.3, 8.30.3.1, 8.30.4, 8.30.5, 8.30.6, 8.30.6.1, 8.30.6.2, 8.30.6.3, 8.30.7, 8.30.7.1, 8.30.7.2, 8.30.7.3, 8.30.7.3-Hopkins, 8.30.7.4, 8.30.7.5, 8.30.7.5.b, 8.30.7.6, 8.30.7.7, 8.30.7.8. Versions 5.30.0, 5.30.1, 5.30.2, 5.30.2 SB0344, 5.30.3, 5.30.4, 5.30.4 HF0418E, 5.30.5, 5.30.5 HF0404E, 5.30.5 HF0413E, 5.30.5 HF390E, 5.30.5 SB0368, 5.30.6, 5.30.6 HF0405E, 5.30.6 HF0406E, 5.30.7, 5.30.7 HF0429E, 5.30.7 HF0441E, 5.30.7 HF0446E, 5.30.7 HF0470E, 5.30.7 HF0473E,  ...
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Class II Potential incorrect Standardized Uptake Values (SUV) measurements in RadSuite. Merge Healthcare, Inc.
Devices IMPLANT,TM, MTX 4.1 mm x 10 mm diameter 3.5 mm Catalog #TMM4B10 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. Lot # 63192993 63216163 Class II Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections. Zimmer Dental Inc
Devices IMPLANT,TM, MTX 4.1 mm x 11.5 mm diameter 3.5 mm Catalog #TMM4B11 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. Lot # 63192991 63207953 Class II Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections. Zimmer Dental Inc
Devices IMPLANT,TM, MTX 4.1 mm x 13 mm diameter 3.5 mm Catalog #TMM4B13 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. Lot # 63203121 63207952 63216164 Class II Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections. Zimmer Dental Inc
Devices IMPLANT,TM, MTX 3.7 mm x 10 mm diameter 3.5 mm Catalog #TMMB10 Product Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. Lot # 63193919 63212189 Class II Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections. Zimmer Dental Inc
Devices IMPLANT,TM, MTX 3.7 mm x 11.5 mm diameter 3.5 mm Catalog #TMMB11 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. Lot # 63212190 Class II Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections. Zimmer Dental Inc
Devices IMPLANT,TM, MTX 3.7 mm x 13 mm diameter 3.5 mm Catalog #TMMB13 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. Lot # 63216838 Class II Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections. Zimmer Dental Inc
Devices IMPLANT,TM, MTX FULL 4.1 mm x 10 mm diameter 3.5 mm Catalog #TMT4B10 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. Lot # 63187148 63192992 63212188 63216161 Class II Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections. Zimmer Dental Inc
Devices IMPLANT,TM, MTX FULL 4.1 mm x 11.5 mm diameter 3.5 mm Catalog #TMT4B11 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. Lot # 63192990 63203112 63236810 Class II Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections. Zimmer Dental Inc
Devices IMPLANT,TM, MTX FULL 4.1 mm x 13 mm diameter 3.5 mm Catalog #TMT4B13 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. Lot # 63203119 63207951 63232552 Class II Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections. Zimmer Dental Inc
Devices IMPLANT,TM, MTX FULL 3.7 mm x 10 mm diameter 3.5 mm Catalog #TMTB10 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. Lot # 63193918 63223934 Class II Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections. Zimmer Dental Inc
Devices IMPLANT,TM, MTX FULL 3.7 mm x 11.5 mm diameter 3.5 mm Catalog #TMTB11 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. Lot # 63193920 63244217 Class II Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections. Zimmer Dental Inc
Devices IMPLANT,TM, MTX FULL 3.7 mm x 13 mm diameter 3.5 mm Catalog #TMTB13 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. Lot # 63193921 63236806 Class II Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections. Zimmer Dental Inc
Devices IMPLANT,TM, MTX FULL 3.7 mm x 16 mm diameter 3.5 mm Catalog #TMTB16 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. Lot # 63192173 Class II Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections. Zimmer Dental Inc
Drugs Pramipexole Dihydrochloride Tablets 0.125 mg, 90 Ct Bottles, Rx Only. Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, INDIA. NDC: 33342-031-10. Lot #: BPA512A; Expiry: 06/2017. Class II Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet. Macleods Pharma Usa Inc
Devices Bard Distaflo Vascular Bypass Graft; Product Code: DF6006SC; 8 mm x 60 cm. Intended for bypass or reconstruction of peripheral arterial blood vessels. Product Code: DF6006SC Lot Number: VTZE1782 Class II Size mislabeling; the graft is labeled as a 6 mm diameter graft when the actual packaged product is an 8 mm graft. Bard Peripheral Vascular Inc
Devices Bard Distaflo Vascular Bypass Graft; Product Code: DF8006SC; 6 mm x 80 cm. Intended for bypass or reconstruction of peripheral arterial blood vessels. Product Code: DF8006SC Lot Number: VTZE1783 Class II Size mislabeling; the graft is a 6 mm diameter graft when the actual packaged product is an 8 mm graft. Bard Peripheral Vascular Inc
Drugs Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) 90 count (NDC 00781-5938-92) bottles, Rx Only, Manufactured by Mylan Laboratories Limited Hyderabad 500 034, India for Sandoz Inc. Princeton, NJ 08540 a) 3022288 12/2015 3025988 03/2016 3025989 04/2016 3030459 08/2016 3030460 08/2016 3032087 10/2016 3032088 10/2016 3034506 12/2016 3035952 01/2017 3035953 01/2017 b) 3022287 12/2015 3025990 04/2016 3030458 08/2016 3032086 09/2016 3035954 01/2017 Class III Failed Impurities/Degradation Specifications; 9 month stability timepoint Sandoz Inc
Food Open Nature Whole Grain White Hot Dog Buns; 8 buns; NET WT 12 oz (340 g) UPC 0 79893 11057 8; Distributed by: Lucerne Foods, inc. Pleasanton, CA 94566 Contains: Wheat, milk May Contain egg, milk. Sell by 1/20/2016 and 1/21/2016 Class II Cloth material that is part of the production equipment may be in the product. Albertsons Companies, Inc.
Food Open Nature Seeded Sandwich Rolls; 8 buns; NET WT 21 oz (1 lb 5 oz) 595 g UPC 0 79893 11439 2; Distributed by: Lucerne Foods, inc. Pleasanton, CA 94566 Contains: Wheat May Contain egg, milk. Sell by dates 1/19/16, 1/20/16 and 1/21/16. Class II Cloth material that is part of the production equipment may be in the product. Albertsons Companies, Inc.
Food Safeway Kitchens Enriched Hamburger Buns; 8 buns; NET WT 17 oz (1 lb 1 oz) 482 g UPC 0 21130 18456 9; Distributed by:Safeway Inc. Pleasanton, CA 94566 Contains: Wheat May Contain eggs, milk. Sell by Date 1/25/16 Class II Cloth material that is part of the production equipment may be in the product. Albertsons Companies, Inc.
Food Pantry Essentials Hot Dog Buns; 8 buns; NET WT 12 oz 340 g UPC 0 21130 27084 2; Distributed for: Lucerne Foods Inc. Pleasanton, CA 94566 Contains: Wheat May Contain eggs, milk. Sell by 1/25/16 Class II Cloth material that is part of the production equipment may be in the product. Albertsons Companies, Inc.
Food Pantry Essentials Hamburger Buns; 8 buns; NET WT 12 oz 340 g UPC 0 21130 27085 9; Distributed for: Lucerne Foods Inc. Pleasanton, CA 94566 Contains: Wheat May Contain eggs, milk. Sell by 1/25/16 Class II Cloth material that is part of the production equipment may be in the product. Albertsons Companies, Inc.
Food Signature Kitchens 100% Whole Wheat Hot Dog Buns; 8 buns; NET WT 16 oz 454 g UPC 0 21130 15456 2; Distributed by Living Better Brands, LLC, Pleasanton, CA 94566 Contains: Wheat May Contain eggs, milk. Sell by 1/25/16 Class II Cloth material that is part of the production equipment may be in the product. Albertsons Companies, Inc.
Food Signature Kitchens Enriched Hamburger Buns, Sesame; 8 buns; NET WT 12 oz 340 g UPC 0 21130 18467 5; Distributed by Living Better Brands, LLC, Pleasanton, CA 94566 Contains: Wheat May Contain eggs, milk. Sell by 1/25/16 Class II Cloth material that is part of the production equipment may be in the product. Albertsons Companies, Inc.
Food Signature Kitchens Crushed Wheat Hot Dog; 8 buns; NET WT 12 oz 340 g UPC 0 21130 18496 5; Distributed by Living Better Brands, LLC, Pleasanton, CA 94566 Contains: Wheat May Contain eggs, milk. Sell by 1/25/16 Class II Cloth material that is part of the production equipment may be in the product. Albertsons Companies, Inc.
Food Signature Kitchens Enriched Hot Dog; 8 buns; NET WT 12 oz 340 g UPC 0 21130 18501 6; Distributed by Living Better Brands, LLC, Pleasanton, CA 94566 Contains: Wheat May Contain eggs, milk. Sell by 1/26/16 Class II Cloth material that is part of the production equipment may be in the product. Albertsons Companies, Inc.
Food Coast to Coast Parisian Style French 6 Hoagie Rolls; 6 Hoagie Rolls; NET WT 16.5 oz 468 g UPC 0 21130 18090 5; Distributed by Living Better Brands, LLC, Pleasanton, CA 94566 Contains: Wheat May Contain eggs, milk. Sell by 1/25/16 Class II Cloth material that is part of the production equipment may be in the product. Albertsons Companies, Inc.
Food Coast to Coast San Francisco Style Sourdough 6 Hoagie Rolls; 6 Hoagie Rolls; NET WT 16.5 oz 468 g UPC 0 21130 18091 2; Distributed by Living Better Brands, LLC, Pleasanton, CA 94566 Contains: Wheat May Contain eggs, milk. Sell by 1/25/16 Class II Cloth material that is part of the production equipment may be in the product. Albertsons Companies, Inc.
Food Coast to Coast Traditional Hawaiian Sweet 12 Dinner Rolls; 12 Dinner Rolls; NET WT 14 oz 397 g UPC 0 21130 18580 1; Distributed by Living Better Brands, LLC, Pleasanton, CA 94566 Contains: Wheat. milk May Contain eggs Sell by 1/25/16 Class II Cloth material that is part of the production equipment may be in the product. Albertsons Companies, Inc.
Food Old Fashioned White Diner Rolls 8 Count Pack size 20 oz. UPC 2 24246 00000 Julian Date 009 Class II Cloth material that is part of the production equipment may be in the product. Albertsons Companies, Inc.
Food Old Fashioned Wheat Diner Rolls 8 Count Pack size 20 oz. UPC 2 24247 00000 Julian Date 009 Class II Cloth material that is part of the production equipment may be in the product. Albertsons Companies, Inc.
Devices PharmaCaribe PulmoSal 7% Sodium chloride, Inhalation Solution, 7% Sterile, Preservative -free, Non-pyrogenic, pH 7.4 For Inhalation Only Rx Product Usage: The contents of these vials are used in conjunction with a nebulizer for the induction of sputum production where sputum production is indicated. Lot # CIY Exp.Date August 2017 UPC Number: 030915339988 (on the box of 60 vials) UPC Number: 10030915339985 (on the shipping case of 12 boxes) Class II Vials were labeled as USP 7% Hypertonic saline instead of PulmoSal 7% (pH+) Pharmacaribe llc
Devices Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512) Intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/llium). BS535418105, BS535419118, BS535420030, BS535419124, BS562325021, BS535418158, BS535418038, BS535418138, BS535418012, BS535419006, BS535420039, BS535418127, BS549024010, BS535419141, BS535418081, BS535418111, BS535418117, BS535420041, BS535418144, BS535420081, BS535419151, BS562325006, BS546825008, BS535418002, BS535418013, BS535418131, BS535420006, BS535420010, BS535420026, BS535420047, BS556219012, BS556219026, BS535418109, BS535420082, BS557717009, and BS562325023. Class II There is a possibility that the device may deliver a torque value less than the required setting after initial sterilization. In worst case, the unexpected drop in torque value may lead to the spinal construct loosening and requiring corrective surgical intervention. Orthofix, Inc
Biologics Apheresis Platelets, Leukocytes Reduced W115115004338G Class II Apheresis Platelet product, for which pH testing was invalid, was distributed. Lifesouth Community Blood Centers, Inc. - Mobile Region
Biologics Red Blood Cells, Leukocytes Reduced, Irradiated W089810602600 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Inova Health Care Services
Biologics Red Blood Cells, Leukocytes Reduced W089810412636 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Inova Health Care Services
Biologics Apheresis Platelets, Leukocytes Reduced Class II Apheresis products, in which leuko reduced units did not meet WBC count specification, were distributed. Central California Blood Center
Devices SIGMA HP MBT Non-Keel Punch Knee Instrument. Designed to be used as an option in stabilizing the tibial trial during trial reduction. Cat. No. GTIN Lot Description 950502016 10603295227366 ABB92402 SIGMA HP  ...
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Class II Increased punch height, causing a 0.063 in (1.6 mm) gap between the trial and the instrument. This may cause the surgeon to select an insert that is too thin. Surgical delay may result if the punch dislodges from the inserter and needs to be removed from the joint space. Insert Dislocation or Spin Out, or Poor Joint Mechanics may result, if not noted during surgery. May require revision surgery. DePuy Orthopaedics, Inc.
Devices INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems Serial Numbers ACA1492002, AAA1492001, W4B1442020, and W4B1432018. Class II When a fontal DA (Digital Angiography) acquisition was done, scattered x-ray came into the dose meter on the lateral side. As a result, the dose meter sent a minus value to the software. Consequently, the software defined the data as an "abnormal value" and it stopped displaying dose data and the dose data was lost. The following message was displayed, "Dose meter abnormal, Dose info disabled". Toshiba American Medical Systems Inc
Food Celestial Seasonings Roastaroma Herbal Tea Lot code: Best Before 20DEC17 Pack size: 6 retail units (20 count)/ per case Best Before 02DEC17 Retail UPC # 070734-050138 Class II Hain Celestial Seasoning is recalling Celestial Seasonings Roastaroma Herbal Tea due to conflicting labeling (some packages state "Gluten Free", although it contains barley.) Hain Celestial Group
Devices Smith & Nephew BEAVER Blade 4.0mm Part Number: 72203307 Orthopedic surgical instrument used in hip arthroscopy. Lot Codes: ( Devices within Expiry) 3009063 3009559 3010117 3010720 3011688 3012095 3012366 3014560 3016455 3018390 3020194 3022929 3025736 3027818 3030178 3032892 3036529 3071312 3071546 3074279 3074280 3076377 3076427 3085969 3089220 3093258 3098516 3101929 3104300 3107341 3111387 3114657 3115976 3119607 3123832 3124356 3124896 3125448 3128384 Class II Blade exhibiting fracture during hip arthroscopy procedures Smith & Nephew, Inc.
Biologics Source Plasma CD0495598 Class III Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed. BPL Plasma
Devices The round burr is an attachment or accessory to the air-powered device intended for use during surgical procedures to cut hard tissue or bone and soft tissue. General hospital and plastic surgery use. Affected lot 4500170289. Class II Weak weld in the reusable rotary blade/abrader (burr) may result in inner part breaks at the distal or proximal end making the product dysfunctional. Richard Wolf Medical Instruments Corp.
Devices The oval burr laterally hooded is an attachment or accessory to the air-powered device intended for use during surgical procedures to cut hard tissue or bone and soft tissue. General hospital and plastic surgery use. Affected lot 0207201502. Class II Weak weld in the reusable rotary blade/abrader (burr) may result in inner part breaks at the distal or proximal end making the product dysfunctional. Richard Wolf Medical Instruments Corp.
Devices The oval burr frontally hooded is an attachment or accessory to the air-powered device intended for use during surgical procedures to cut hard tissue or bone and soft tissue. General hospital and plastic surgery use. Affected lot 4500166254. Class II Weak weld in the reusable rotary blade/abrader (burr) may result in inner part breaks at the distal or proximal end making the product dysfunctional. Richard Wolf Medical Instruments Corp.
Devices 2.3mm Turbo-Power OTW, Manual, Model No 423-050 Product Usage The Turbo-Power System (Laser Atherectomy Catheter) is a laser atherectomy device designed for use with the CVX-300" Excimer Laser System. The Turbo-Power Laser Atherectomy Catheter is a sterile, single use, prescription only device used for peripheral atherectomy. Turbo-Power is used exclusively with SPNC s CVX 300" Excimer Laser System and is a Type CF device, Defibrillation proof. Turbo-Power is a laser atherectomy catheter designed for treatment of de novo or restenotic lesions in native infrainguinal arteries and for the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, with adjunctive Percutaneous Transluminal Angioplasty (PTA). Turbo-Power is used to directionally ablate infrainguinal concentric and eccentric lesions in vessels that are 3.5 mm or greater in diameter. The device is comprised of three parts: the working length of the catheter shaft (also the applied part), the motor drive unit (MDU), and the proximal laser shaft which connects the catheter fiber optics to the CVX-300" Excimer Laser System. Lot CMP15J28A Class II The product is labeled with an expiration date that is past its shelf life. Spectranetics Corp.
Devices Patient transport Shuttle with Trendelenburg quick adjustment function (Jupiter, Mars, Titan, TruSystem and Saturn operating table systems). The shuttle is intended for the following applications: 1. Transfer, transport and storage of exchangeable table tops in the Trumpf Medical TruSystem 7500, JUPITER, and SATURN SM operating table systems 2. Patient transport to an operating table top (without a column) from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system 3. Transporting the TruSystem 7500 SM, JUPITER SM or SATURN SM operating table column with table top (without a patient) within the operating theatre. Product: Shuttle 2.7, Material Number: 1254362, Serial Number Range: 100801175  101349420; Product: Shuttle 2.7 360, Material Number: 1459862, Serial Number Range: 100843669-101212847; Product: Shuttle 3.7, Material Number: 1254363, Serial Number Range: 100180383-101290987 and Product: Shuttle 3.7 360, Material Number: 1459863, Serial Number Range: 100787418-101334652. Class II Complaints were received of the table top on the transporter (shuttle) tilting down quickly in a maximum Trendelenburg position. Trumpf Medical Systems, Inc.
Biologics Apheresis Platelets, Leukocytes Reduced W200915852327; W200915852044 Class II Apheresis products, for which quality control testing was not performed, were distributed. American National Red Cross (The) - North Central Region
Biologics Apheresis Platelets, Leukocytes Reduced, Irradiated W041215056116J Class II Apheresis product, in which the platelet yield was below 3.0x10^11, was distributed. Blood Systems, Inc. dba United Blood Services Texas
Biologics Apheresis Platelets, Leukocytes Reduced, Irradiated W201615820625 (double collection) Class II Platelet Pheresis products, labeled as leuko reduced, in which WBC testing was not performed, were distributed. American National Red Cross
Biologics Source Plasma 15MEME0651; 15MEMD7227; 15MEMD6887; 15MEMD6277; 15MEMD5408 Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Plasma Biological Services Inc
Biologics Apheresis Platelets, Leukocytes Reduced, Irradiated W20031585819000 Class II Apheresis product, for which product QC test for pH and platelet yield were not performed, was distributed. The American National Red Cross - Southern Region
Devices T-piece Nebulizer with in-line connectors, Part number 8915-7-50. Single patient use, non-sterile prescription device designed for use in a hospital or home care environment. Lot No. 083115, 090715, and 122815 Class II Reports that the T-piece does not fit on the nebulizer. Salter Labs
Biologics Source Plasma GL0604760; GL0606811; GL0613060 Class II Blood products, collected from a donor who had been incarcerated, were distributed. DCI Biologicals Greenville, Inc
Biologics Apheresis Platelets, Leukocytes Reduced W040815601412; W040815601415; W0408156014161; W0408156014162; W0408156014171; W0408156014172; W040815601418; W040815601419; W040815601420; W0408156014211; W0408156014212; W040815601422; W0408156014231; W0408156014232; W040815601425; W040815601426 Class III Apheresis products, lacking assurance of leukoreduction, were distributed. West TN Regional Blood Ctr, Inc dba Lifeline Blood Services
Biologics Pooled Cryoprecipitated AHF W042015020226E Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. Blood Systems, Inc. DBA United Blood Services
Biologics Blood and Blood Products for Reprocessing W0420150156380 Class III Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. Blood Systems, Inc. DBA United Blood Services
Biologics Red Blood Cells, Leukocytes Reduced W0420150156380 Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. Blood Systems, Inc. DBA United Blood Services
Devices Endobon-Xenograft Granules, Zimmer Biomet, Synthetic Bone Grafting Material, used in dental and/or surgical procedures. Endobon Xenograft Granules, Bone Grafting Material, Synthetic are used in the following dental and/or surgical procedures: " Alveolar ridge augmentation/reconstruction, " Sinus elevation, " Filling of resection defects in benign bone tumor, bone cysts, or other defects in the alveolar ridge or wall, " Filling of bone defects after apicectomy, " Filling alveoli after tooth extraction. This product should not be used in non-peridontal mandibular applications. Item Numbers &Lot Numbers: ROX05 S016303 ROX05 S016304  ...
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Class II Cytotoxicity tests were not passed at 36 months. Use of Endobon-Xenograft Granules past 18 months of its specified shelf life may result in patient illness/injury. Biomet France SARL
Biologics Apheresis Platelets, Leukocytes Reduced W115115289303I (double collection) Class II Apheresis products for which pH testing was not documented, were distributed. LifeSouth Community Blood Centers, Inc.
Biologics Red Blood Cells W036811020370 Class II Blood products, for which donor suitability was inadequately determined, were distributed. OneBlood, Inc.
Biologics Pooled Platelets, Leukocytes Reduced, Irradiated W036811800715 Class II Blood products, for which donor suitability was inadequately determined, were distributed. OneBlood, Inc.
Biologics Blood and Blood Products for Reprocessing W036811020370 Class III Blood products, for which donor suitability was inadequately determined, were distributed. OneBlood, Inc.
Biologics Red Blood Cells, Leukocytes Reduced W050911015854 Class III Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. HCSC-Blood Center
Biologics Cryoprecipitated AHF W050911015854 Class III Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. HCSC-Blood Center
Drugs Candesartan Cilexetil Tablets, 16 mg, 30 Tablets (5 x 6) blister pack, Rx, Distributed by: American Health Packaging Columbus, Ohio 43217, NDC 68084-877-25(carton), NDC 68084-877-95(individual dose) Lot # 153855, exp 01/2017 Class III Failed Impurities/Degradation Specifications; 9 month stability (manufacturer) Amerisource Health Services
Devices CyberKnife Robotic; Catalog/part number 032000 and 033000 Cosmetic cover package. Product Usage: The CyberKnife Robotic Radiosurgery System is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated. Catalog/part numbers 032000 and 033000; Serial numbers: United States: C0063 C0064 C0074 C0088 C0090 C0091 C0092 C0095 C0096 C0098 C0099 C0100 C0101 C0102 C0103 C0104 C0106 C0108 C0111 C0112 C0114 C0118 C0119 C0123 C0126 C0127 C0128 C0131 C0133 C0134 C0135 C0136 C0137 C0143 C0144 C0146 C0149 C0150 C0151 C0152 C0155 C0158 C0159 C0162 C0163 C0165 C0172 C0174 C0177 C0178 C0179 C0181 C0182 C0183 C0184 C0186 C0192 C0194 C0196 C0197 C0198 C0199 C0200 C0201 C0203 C0205 C0206 C0207 C0208 C0209 C0210 C0213 C0214 C0219 C0220 C0222 C0224 C0226 C0233 C0244 C0246 C0247 C0248 C0252 C0253 C0254 C0256 C0259 C0260 C0261 C0262 C0263 C0273 C0274 C0278 C0283 C0284 C0285 C0290 C0291 C0293 C0296 C0303 C0304 C0312 C0316 C0323 C0328 C0353 C0355 C0124: International: C0170 C0171 C0180 C0216 C0236 C0264 C0269 C0326 C0204 C0125 C0175 C0189 C0191 C0215 C0227 C0279 C0315 C0166 C0147 C0168 C0187 C0105 C0242 C0185 C0286 C0306 C0188 C0218 C0237 C0240 C0265 C0268 C0288 C0314 C0324 C0251 C0272 C0322 C0153 C0289 C0235 C0267 C0120 C0138 C0148 C0157 C0212 C0229 C0239 C0297 C0241 C0281 C0300 C0307 C0308 C0313 C0320 C0327 C0329 C0331 C0333 C0340 C0341 C0347 C0350 C0392 C0115 C0117 C0154 C0161 C0228 C0255 C0266 C0270 C0294 C0339 C0176 C0195 C0309 C0319 C0321 C0093 C0221 C0234 C0249 C0275 C0277 C0299 C0305 C0325 C0110 C0113 C0130 C0232 C0245 C0276 C0287 C0295 C0217 C0282 C0107 C0258 C0271 C0280 C0298 C0301 C0302 C0310 C0317 C0357 C0365 C0202 C0231 C0238 C0230. Class II The gun box mounting bracket may fail to support the weight of the gun box when in vertical (inverted) position. If this failure occurs the gun box may become loose and could come into contact with a patient. Accuray Incorporated
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