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U.S. Department of Health and Human Services

Enforcement Report - Week of December 16, 2015

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Devices Brilliance 64 Computed Tomography X-Ray System, Model number 728231, running version 2.6.0. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories. Serial numbers: 4001, 4020, 4021, 9030, 9033, 9040, 9041, 9048, 9049, 9062, 9074, 9083, 9093, 9105, 9106, 9107, 9108, 9112, 9123, 9126, 9127, 9131, 9135, 9137, 9139, 9140, 9142, 9148, 9151, 9159, 9160, 9162, 9163, 9166, 9171, 9173, 9175, 9177, 9180, 9196, 9197, 9201, 9202, 9205, 9206, 9208, 9214, 9215,  ...
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Class II Multiple software defects which could impact the performance or reliability of the system. These impacts include, but are not limited to: error messages which prevent operation, incorrect scan region, couch movement failure, inaccurate CTDI reporting, image artifacts, lost images. There is a risk of misdiagnosis. Philips Medical Systems (Cleveland) Inc
Devices Brilliance CT (computed tomography) scanners, Big Bore configuration, Model number 728243. software version 2.0 The products are intended to provide cross sectional images of the human body and visualization of the internal organs of the body. Model # 728243 Software Version 2.0 Class II Brilliance Big Bore- An anomaly was identified with software version 2.0 tumor localization application when printing work sheets. this causes information regarding relative locations of marked regions of interest on the patient work sheets to be incorrect and may cause mistreatment. Philips Medical Systems (Cleveland) Inc
Devices Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are impacted by this issue: 866023 IntelliVue Info Center iX 866024 PIIC iX Upgrade 866117 PIIC Classic Upgrade The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, format data for strip chart recordings and printed reports, and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. An additional intended use of the Information Center Software is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors. Software systems Revision A.02.05 or lower Class II Sp02 and/or Non Invasive Blood Pressure (NBP) alarms may become disabled without visual notification Philips Medical Systems, Inc.
Devices The eCareManager system. Software intended for use in data collection, storage and clinical information management with independent bedside devices, and ancillary systems that are connected either directly or through networks. For use in a hospital environment. eCareManager allows clinicians to generate a PDF display of an order (new, change, discontinue), which is printed at the bedside and/or hospital pharmacy. This printed PDF should be reviewed by the clinician and verified by the hospital pharmacist and entered into the hospital pharmacy system. eCareManager v3.7, 3.7.1, v3.8, and v3.9 Class II A software defect may cause incorrect medication order change. If the user decides to edit the order prior to electronic signature AND selects the return to Previous Screen function, the previously selected medication is replaced with whatever medication is in the number one spot on the complete medication list. At the stage where the order is signed, the medication displayed may be incorrect. Visicu, Inc.
Food Taco de Camarón con Imitación de King Crab (Shrimp with Imitation King Crab Taco). Label reads in part : " *** Soto Fabrica & Confecciones"*** Tacos de Camarones*** Mantenganse Congelado"*** Peso Neto 5 lbs(2.3 kg)*** Manufacturado por: Fabrica Confecciones Soto, Inc. calle Autonomia #81 Canovanas, PR 00729***" none Class I Undeclared allergens. Egg whites Fabrica Confecciones Soto, Inc.
Biologics Source Plasma FS0297229; FS0297643; FS0298099; FS0298541; FS0300231; FS0305707; FS0306170; FS0307063; FS0307267; FS0308341; FS0309148; FS0309631; FS0309917; FS0310535; FS0310645; Class III Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. BPL Plasma, Inc
Devices Valeant Pharmaceuticals North America Model No. Spag-2 Small Particle Size Aerosol Generator SPAG-2 6000 is a pneumatic flow system indicated for the administration of Viazole uses a nebulizer to generate a fine aerosol of hydrated Virazole Lot #J3522070 Serial numbers 23461 23463 23466 23467 23468 23469 23472 23475 23477 23479 23480 23481 23482 23484 23485 23486 23487 23488 23489 23490 23491 23492 23493 23495 23503 23504 23505 23506 23507 23508 23509 23510 23512 23513 23514 23515 23517 23520 23521 23524 23529 23530 23531 23532 23535 23536 23540 23547 23558 23560 23568 23569 23570 23571 23572 23579 23587 23589 23590 23592 23593 Class II SPAG-2 6000 Lot J3522070 was released to commerce without being tested for particle size per quality control procedure SPAG-2515. Valeant Pharmaceuticals North America LLC
Food Albacore Tuna in gold pouches with stick-on label reading in part: ***SKIPANON BRAND SEAFOOD ALBACORE TUNA***INGREDIENTS: Albacore Tuna, Sea Salt. NET WT. 48 OZ. ***" UPC: 58071 00148 Code on pouch beginning with OCK TUNA 3#. Label has green, yellow and blue background with multiple color lettering. Canned Albacore Tuna with paper label reading in part: ***SKIPANON BRAND SEAFOOD ALBACORE TUNA***Ingredients: Albacore Tuna, Sea Salt. NET WT. 66.5 OZ. (1885g)***" UPC: 58071 00144 Can code beginning with OCK. Label has a yellow background and a blue strip on the bottom. Lettering is in multiple colors. Canned Albacore Tuna with paper label reading in part: ***SKIPANON BRAND SEAFOOD ALBACORE TUNA***INGREDIENTS: Albacore Tuna, Sea Salt. NET WT. 6 OZ. (170g)***" UPC: 58071 00117 Can code beginning with OCK. Label has a yellow background and a blue strip on the bottom. Lettering is in multiple colors. Canned Albacore Tuna 6oz, 7oz, and 64oz cans without labeling, salt added, distributed as brites. Can code beginning with OCK. All lots Class II All cans and pouches of Skipanon Brand seafood, including tuna products are being recalled due to lack of documentation and possible under-processed product. Under-processed seafood could lead to contamination with Clostridium botulinum. Skipanon Brand Seafoods LLC
Food Canned Chinook Salmon with paper label reading in part: ***SKIPANON BRAND SEAFOOD CHINOOK SALMON***Ingredients: Chinook Salmon, Sea Salt NET WT. 6 OZ. (170g)***" UPC: 58071 00118 Can code beginning with OCCR. Label background is yellow with a brown stripe at the bottom and multiple colored ink lettering. Chinook (aka King) Salmon with salt added, canned and distributed as brites in 6oz cans. Can code beginning with OCCR. All lots Class II All cans and pouches of Skipanon Brand seafood, including salmon products are being recalled due to lack of documentation and possible under-processed product. Under-processed seafood could lead to contamination with Clostridium botulinum. Skipanon Brand Seafoods LLC
Food Label reads in part "***SKIPANON BRAND SEAFOOD SMOKED ALBACORE TUNA***INGREDIENTS: Albacore Tuna, Sea Salt, Brown Sugar, Natural Hardwood Smoke. NET WT. 5.5 OZ. (156g) ***" UPC: 58071 00116 Can code beginning with OCKH. Label background is yellow with a blue strip on the bottom and multiple colored ink lettering. Smoked Albacore Tuna contains brown sugar, salt, and is smoked with hardwoods and distributed as brites in 5.5oz cans. Can code beginning with OCKH. All lots Class II All cans and pouches of Skipanon Brand seafood, including smoked tuna products are being recalled due to lack of documentation and possible under-processed product. Under-processed seafood could lead to contamination with Clostridium botulinum. Skipanon Brand Seafoods LLC
Food Canned Smoked Peppered Chinook Salmon with paper label reading in part: ***SKIPANON BRAND SEAFOOD Peppered SMOKED CHINOOK SALMON Ingredients: Salmon, Sea Salt, Brown Sugar, Cracked Peppercorns, Natural Hardwood Smoke***Net wt. 5 1/2 oz. (156g)***" UPC: 58071 00114 Can code beginning with OCCH. Label background is yellow with brown stripe on the bottom and multiple colored ink lettering. The word "Peppered" appears in a red bubble above the word Smoked. All lots Class II All cans and pouches of Skipanon Brand seafood, including smoked peppered salmon products are being recalled due to lack of documentation and possible under-processed product. Under-processed seafood could lead to contamination with Clostridium botulinum. Skipanon Brand Seafoods LLC
Food Canned Albacore Tuna Bellies with paper label reading in part: ***SKIPANON BRAND SEAFOOD ALBACORE TUNA BELLIES or Ventresca***Ingredients: Albacore Tuna Bellies, Sea Salt, Spanish Olive Oil***NET WT. 66.5 OZ. (1885g)***" UPC: 58071 00145 Can code beginning with OCKB. Label background is yellow with a blue stripe on the bottom and multiple colored ink lettering. All lots Class II All cans and pouches of Skipanon Brand seafood, including tuna bellies products are being recalled due to lack of documentation and possible under-processed product. Under-processed seafood could lead to contamination with Clostridium botulinum. Skipanon Brand Seafoods LLC
Food Canned Coho Salmon with paper label reading in part: ***SKIPANON BRAND SEAFOOD COHO SALMON***Ingredients: Coho Salmon, Sea Salt NET WT. 6 OZ. (170g)***" UPC: 58071 00119 Can code beginning with OCO. Label has a yellow background with a gray line on the bottom, multiple colored ink is used for lettering. Coho Salmon with salt added was distributed as brites in 6oz cans. Can code beginning with OCO. All lots Class II All cans and pouches of Skipanon Brand seafood, including salmon products are being recalled due to lack of documentation and possible under-processed product. Under-processed seafood could lead to contamination with Clostridium botulinum. Skipanon Brand Seafoods LLC
Food Canned Smoked Coho Salmon with paper label reading in part: ***SKIPANON BRAND SEAFOOD SMOKED COHO SALMON***Ingredients: Coho Salmon, Sea Salt, Brown Sugar, Natural Hardwood Smoke. NET wt. 5.5 oz. (156g)***" UPC: 58071 00113 Can code beginning with OCS. Product label has a yellow background with a brown strip on the bottom and multiple colored ink for lettering. Smoked Coho Salmon with brown sugar, salt, and smoked with hardwoods was distributed as brites in 6oz cans. Can code beginning with OCS. All lots Class II All cans and pouches of Skipanon Brand seafood, including smoked salmon products are being recalled due to lack of documentation and possible under-processed product. Under-processed seafood could lead to contamination with Clostridium botulinum. Skipanon Brand Seafoods LLC
Food Canned Smoked Chinook Salmon with paper label reading in part: "***SKIPANON BRAND SEAFOOD SMOKED CHINOOK SALMON***Ingredients: Salmon, Sea Salt, Brown Sugar Natural Hardwood Smoke. Net wt. 5 1/2 oz. (156g)***" UPC: 58071 00112 Can code beginning with OCC. Label has a yellow background with a red border on the bottom and multiple colored lettering. Smoked Chinook (aka King) Salmon with brown sugar, salt and smoked with hardwoods was distributed as brites in 5.5oz cans. Can code beginning with OCC. All lots Class II All cans and pouches of Skipanon Brand seafood, including smoked salmon products are being recalled due to lack of documentation and possible under-processed product. Under-processed seafood could lead to contamination with Clostridium botulinum. Skipanon Brand Seafoods LLC
Food COLUMBIA RIVER SOCKEYE (Old label) Canned Sockeye Salmon with paper label reading in part: ***SKIPANON BRAND DELUXE HANDFILLED COLUMBIA RIVER SOCKEYE*** Ingredients: Sockeye Salmon, Salt NET WT. 6 OZ. (170g)*** UPC: 58071 00120 Label has green and yellow background with a red border and multiple colored ink lettering. SOCKEYE SALMON (New label) Canned Sockeye Salmon with paper label reading in part: ***SKIPANON BRAND SEAFOOD SOCKEYE SALMON***Ingredients: Sockeye Salmon, Sea Salt. NET wt. 6 oz. (170g)***" UPC: 58071 00120 Can code beginning with OCBB Label has a yellow background with a blue/gray stripe on the bottom and multiple colored ink lettering. All lots Class II All cans and pouches of Skipanon Brand seafood, including salmon products are being recalled due to lack of documentation and possible under-processed product. Under-processed seafood could lead to contamination with Clostridium botulinum. Skipanon Brand Seafoods LLC
Food Canned Smoked Sockeye Salmon with paper label reading in part: ***SKIPANON BRAND SEAFOOD SMOKED SOCKEYE SALMON***Ingredients: Sockeye Salmon, Sea Salt, Brown Sugar, Natural Hardwood Smoke. NET wt. 5.5 oz. (170g)***" UPC: 58071 00140 Can code beginning with OCB. Label has a yellow background with a gray stripe at the bottom and multiple colored lettering. Smoked Sockeye Salmon with brown sugar, salt and smoked with hardwoods was distributed as brites in 5.5oz cans. Can code beginning with OCB. All lots Class II All cans and pouches of Skipanon Brand seafood, including smoked salmon products are being recalled due to lack of documentation and possible under-processed product. Under-processed seafood could lead to contamination with Clostridium botulinum. Skipanon Brand Seafoods LLC
Food Canned Steelhead with paper label reading in part: ***SKIPANON BRAND SEAFOOD FANCY STEELHEAD***Ingredients: Farm-Raised Steelhead, Sea Salt NET WT. 6 OZ. (170g)***" UPC: 58071 00141 Can code beginning with OCST. Label has a yellow background with a blue-gray stripe at the bottom and multiple colored lettering. All lots Class II All cans and pouches of Skipanon Brand seafood, including steelhead trout products are being recalled due to lack of documentation and possible under-processed product. Under-processed seafood could lead to contamination with Clostridium botulinum. Skipanon Brand Seafoods LLC
Food Canned Peppered Smoked Steelhead with paper label reading in part: ***SKIPANON BRAND SEAFOOD Peppered SMOKED STEELHEAD***Ingredients: Farm-Raised Steelhead, Sea Salt, Brown Sugar, Cracked Peppercorns, Natural Hardwood Smoke. Net WT. 5 1/2 oz. (156g)***" UPC: 58071 00143 Can code beginning with OCSTH. Label has a yellow background with a blue-green stripe at the bottom and multiple colored lettering. All lots Class II All cans and pouches of Skipanon Brand seafood, including smoked steelhead trout products are being recalled due to lack of documentation and possible under-processed product. Under-processed seafood could lead to contamination with Clostridium botulinum. Skipanon Brand Seafoods LLC
Food Canned Smoked Sturgeon with paper label reading in part: ***SKIPANON BRAND SEAFOOD SMOKED STURGEON***INGREDIENTS: Sturgeon, Sea Salt, Brown Sugar Natural Hardwood Smoke. NET WT. 5.5 OZ. (156g)***" UPC: 58071 00111 Can code beginning with OCP. Label has a yellow background with a green stripe at the bottom and multiple colored lettering. All lots Class II All cans and pouches of Skipanon Brand seafood, including smoked sturgeon products are being recalled due to lack of documentation and possible under-processed product. Under-processed seafood could lead to contamination with Clostridium botulinum. Skipanon Brand Seafoods LLC
Food Canned Sockeye Salmon with paper label reading in part: ***SKIPANON BRAND SEAFOOD SOCKEYE SALMON***INGREDIENTS: Sockeye Salmon, Sea Salt. NET WT. 6 OZ. (170g)***" UPC: 58071 00120 Code beginning with OCBB. Label has a yellow background with a light green stripe at the bottom and multiple colored lettering. Sockeye Salmon with salt added was distributed as brites in 6oz cans. Code beginning with OCBB. All lots Class II All cans and pouches of Skipanon Brand seafood, including salmon products are being recalled due to lack of documentation and possible under-processed product. Under-processed seafood could lead to contamination with Clostridium botulinum. Skipanon Brand Seafoods LLC
Food Canned Sockeye Salmon with paper label reading in part: ***SKIPANON BRAND SEAFOOD SMOKED STEELHEAD***Ingredients: Farm-Raised Steelhead, Sea Salt, Brown Sugar, Natural Hardwood Smoke. NET WT. 5 1/2 oz. (156g)***" UPC: 58071 00142 Code beginning with "OC" Label has a yellow background with a steel blue stripe at the bottom and multiple colored lettering. All lots Class II All cans and pouches of Skipanon Brand seafood, including smoked steelhead trout products are being recalled due to lack of documentation and possible under-processed product. Under-processed seafood could lead to contamination with Clostridium botulinum. Skipanon Brand Seafoods LLC
Food Texas Style HEB Charro Beans NET WT. 15 OZ (425g) in metal cans UPC: 041220927142. Texas Style HEB Charro Beans NET WT. 31 OZ (1.94 LB) 879g in metal cans UPC: 041220543692. SA15191, SA15206, SA15209, SA15196, SA15223, SA15231 Class II Foreign material, rocks. Durrset Amigos Ltd.
Food Texas Style HEB Charro Beans Spicy NET WT. 15 OZ (425g) in metal cans UPC: 041220927159. SA15205, SA15206, SA15217 Class II Foreign material, rocks. Durrset Amigos Ltd.
Food Texas Style HEB Borracho Beans Made with Shiner Rock NET WT. 15 OZ (425g) in metal cans; Texas Style HEB Borracho Beans Made with Shiner Rock NET WT. 31 OZ (1.94 LB) 879g in metal cans. SA15191, SA15205, SA15211, SA15182, SA15188, SA15196, SA15216 Class II Foreign material, rocks. Durrset Amigos Ltd.
Devices One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube. Material Number (UPN) M00563020, Lot # 18184947, Exp. April 30, 2017; Material Number M00563080, Lot # 18179867, Exp. April 30, 2017; & Lot # 18212410 , Exp. May 31, 2017; Material Number M00568510, Lot # 18296155, Exp. May 31, 2018. Class II Boston Scientific Corp. initiated a voluntary recall of specific lots of the EndoVive One Step Button, including the Decompression Tube and Low Profile Replacement Button devices because they may contain decompression tube adapters with a protrusion that could impede its ability to be introduced or removed from the PEG Button. Boston Scientific Corp
Food ALBACORE TUNA, sold under brand The Garibaldi Cannery, metal can, net weight 8 oz. (227 gram). No UPC Any codes starting with OC. Last date of distribution of recalled products was September 2015. Class II The canned Albacore tuna product is recalled because it has the potential to be contaminated with Clostridium botulinum. The Garibaldi Cannery, LLC
Food ALBACORE TUNA BELLIES, sold under brand The Garibaldi Cannery, Net weight 8 oz. (227 gram). The word "Bellies" is written on top of can. No UPC Any codes starting with OC. Last date of distribution of recalled products was September 2015. Class II The canned Albacore tuna bellies product is recalled because it has the potential to be contaminated with Clostridium botulinum. The Garibaldi Cannery, LLC
Food ALBACORE TUNA NO SALT, sold under brand The Garibaldi Cannery, metal cans, net weight 8 oz. (227 gram). No UPC Any codes starting with OC. Last date of distribution of recalled products was September 2015. Class II The canned Albacore tuna no salt product is recalled because it has the potential to be contaminated with Clostridium botulinum. The Garibaldi Cannery, LLC
Food JALAPEÑO ALBACORE TUNA , sold under brand The Garibaldi Cannery, metal can, net weight 8 oz. (227 gram). No UPC Any codes starting with OC. Last date of distribution of recalled products was September 2015. Class II The canned jalapeno Albacore tuna product is recalled because it has the potential to be contaminated with Clostridium botulinum. The Garibaldi Cannery, LLC
Food SMOKED ALBACORE TUNA, sold under brand The Garibaldi Cannery, metal can, net weight 8 oz. (227 gram). No UPC Any codes starting with OC. Last date of distribution of recalled products was September 2015. Class II The canned smoked Albacore tuna product is recalled because it has the potential to be contaminated with Clostridium botulinum. The Garibaldi Cannery, LLC
Food GARLIC ALBACORE TUNA, sold under brand The Garibaldi Cannery, metal can, net weight 8 oz. (227 gram). No UPC Any codes starting with OC. Last date of distribution of recalled products was September 2015. Class II The canned garlic Albacore tuna product is recalled because it has the potential to be contaminated with Clostridium botulinum. The Garibaldi Cannery, LLC
Food PACIFIC SALMON, sold under brand The Garibaldi Cannery, Net weight 6 oz. (170 gram). No UPC Any codes starting with OC. Last date of distribution of recalled product was September 2015. Class II The canned Pacific Salmon product is recalled because it has the potential to be contaminated with Clostridium botulinum. The Garibaldi Cannery, LLC
Food SMOKED PACIFIC SALMON, sold under brand The Garibaldi Net weight 6 oz. (170 gram). No UPC Any codes starting with OC. Last date of distribution of recalled products was September 2015. Class II The canned smoked Pacific salmon product is recalled because it has the potential to be contaminated with Clostridium botulinum. The Garibaldi Cannery, LLC
Food SILVER SALMON, sold under brand The Garibaldi Cannery, Net weight 6 oz. (170 gram). No UPC Any codes starting with OC. Last date of distribution of recalled products was September 2015. Class II The canned Silver salmon product is recalled because it has the potential to be contaminated with Clostridium botulinum. The Garibaldi Cannery, LLC
Food CHINOOK SALMON, sold under brand The Garibaldi Cannery, Net weight 6 oz. (170 gram). No UPC Any codes starting with OC. Last date of distribution of recalled products was September 2015. Class II The canned Chinook salmon product is recalled because it has the potential to be contaminated with Clostridium botulinum. The Garibaldi Cannery, LLC
Biologics Cryoprecipitated AHF, Pooled W20121547850200H, W20121547951800M, W20121553008500Q, W20121591137900C, W20121591138400I, W20121591139200I, W201215911410009, W20121591144800I, W20121591145700G, W201215911485008, W20121591152200U, W20121591169800J, W20121591169900H, W201215911761000, W20121591176900L, W20121591177700L, W20121591179400J, W20121591179800B, W201215911805008, W201215911806006, W20121591181800Z, W201215911821008, W20121591188500D, W201215911920002, W201215911975009, W201215911986003, W20121591200600H, W20121591201200L, W20121591203900*, W201215912106009, W20121591211200D, W201215912117003, W201215912118001, W201215912206001, W201215912212005, W201215912213003, W20121591221700W, W201215912357008, W201215912366006, W201215912375004, W201215912376002, W201215912381008, W20121591240100W, W20121591242100O, W20121591242700C, W20121591244300C, W20121591248800N, W20121591249200V, W20121591250300K, W20121591250800A,  ...
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Class III Blood products, collected using an improper arm scrub, were distributed. American National Red Cross (The)
Biologics Red Blood Cells, Leukocytes Reduced W20121547858300K, W20121543798300L, W20121545635200Z, W201215456397009, W201215456413004, W20121545644500P, W20121547533000, W20121547775400U, W20121547775800M, W20121547776000Y, W20121547776300S, W20121547776900G, W20121547777200Q, W20121547777800E, W20121547782500W, W20121547782800Q, W20121547783200Y, W20121547784300S, W20121547784600M, W20121547850200H, W20121547851300B, W201215478522009, W20121547857500K, W20121547858000Q, W20121547858600E, W20121547858700C, W20121547859000M, W201215478598006, W201215478603007, W20121547861500*, W20121547864500O, W20121547864900G, W20121547865600I, W20121547866000Q, W20121547866500G, W20121547867200I, W20121547919500S, W20121547927900K, W20121547928500O, W20121547928900G, W20121547929200Q, W20121547929400M, W20121547951400U, W20121547951800M, W20121547953300O, W20121547954500G, W20121547954700C, W20121547955100K, W201215479558006, W20121547956400A,  ...
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Class III Blood products, collected using an improper arm scrub, were distributed. American National Red Cross (The)
Biologics Cryoprecipitated AHF W20121539070600A, W20121541161900, W20121541247900C, W20121541510300S, W20121541511700G, W201215415571009, W20121541560600J, W20121541675300I, W20121543672600Y, W20121543673300, W20121543673700S, W20121543674200Y, W20121543674300W, W201215436787008, W20121543740700B, W20121543843300S, W201215447952003, W20121544802400U, W201215453514005, W20121545360800U, W20121545604800E, W20121545625000A, W20121545625700X, W20121545627200Z, W20121545627500T, W20121547533000, W20121547582100Z, W201215476914009, W20121547757800U, W20121547963000M, W20121553009200S Class III Blood products, collected using an improper arm scrub, were distributed. American National Red Cross (The)
Biologics Plasma Cryoprecipitated Reduced W20121538889100S, W20121538992500O, W201215390500001, W20121544687300H, W201215449392003, W20121545618500X, W20121547953300O Class III Blood products, collected using an improper arm scrub, were distributed. American National Red Cross (The)
Devices The "Pacifier Activated Lullaby" (PAL) System composed of three major components: 1) the PAL Player Module (aka Player Unit), 2) the PAL Pacifier Sensor, and 3) power supply. The system is designed to encourage and reinforce effective non-nutritive sucking of premature infants. Serial Numbers A1221, A1226 (Ship Date 07/2015); Serial  ...
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Class II PAL unit has undergone significant technological changes since the previous 510(k) and labeling is not consistent with the cleared indications of the 510(k). Powers Medical Devices, LLC
Food Red Bull Total Zero Energy Drink, 12 fl.oz. (355ml), UPC CODE(S): ON THE CAN: 6 11269 62373 4; ON THE CASE: 6 11269 61505 0 Lot#1425389 Class III Red Bull North America is recalling Red Bull Branded Total Zero Energy Drink because the cans are missing the statement "Phenylketonurics: Contains Phenylalanine", a mandatory requirement on all products that contain aspartame. Red Bull North America Inc
Drugs Kindest Kare Antimicrobial Foaming Handwash, Hand Soap, 0.75% Triclosan, 444 ml (15 fl oz) bottles, STERIS Corporation, 7501 Page Avenue, St. Louis, MO 63133, Reorder # 1452-RF, NDC 0519-1452-13, UPC (01)00724995 086251. Lot # 277120, Exp 06/01/17 Class II Labeling: Not Elsewhere Classified; Incorrect/Undeclared Excipients: Outdated previous version of label applied to products that incorrectly states one inactive ingredient. Steris Corp
Food Canned albacore tuna, Dungeness Seaworks brand, net weight 6 oz., packaged in metal cans. No UPC. Production codes starting with OC. The last date of distribution of recalled products is September 2015. Class II Canned albacore tuna, Dungeness Seaworks brand, with any code starting with "OC" was recalled because it has the potential to be contaminated with Clostridium botulinum. Dungeness Seaworks
Food Albacore Tuna Garlic, Dungeness Seaworks brand, net weight 6 oz., packaged in metal cans. No UPC. Production codes starting with OC. The last date of distribution of recalled products is September 2015. Class II Canned Albacore Tuna Garlic, Dungeness Seaworks brand, with any code starting with "OC" was recalled because it has the potential to be contaminated with Clostridium botulinum. Dungeness Seaworks
Food Albacore Tuna Jalepeno, Dungeness Seaworks brand, net weight 6 oz., packaged in metal cans. No UPC. Production codes starting with OC. The last date of distribution of recalled products is September 2015. Class II Canned Albacore Tuna Jalepeno, Dungeness Seaworks brand, with any code starting with "OC" was recalled because it has the potential to be contaminated with Clostridium botulinum. Dungeness Seaworks
Food Albacore Tuna Olive Oil, Dungeness Seaworks brand, net weight 6 oz., packaged in metal cans. No UPC. Production codes starting with OC. The last date of distribution of recalled products is September 2015. Class II Canned Albacore Tuna Olive Oil, Dungeness Seaworks brand, with any code starting with "OC" was recalled because it has the potential to be contaminated with Clostridium botulinum. Dungeness Seaworks
Food Albacore Tuna Hickory Smoke, Dungeness Seaworks brand, net weight 6 oz., packaged in metal cans. No UPC. Production codes starting with OC. The last date of distribution of recalled products is September 2015. Class II Canned Albacore Tuna Hickory Smoke, Dungeness Seaworks brand, with any code starting with "OC" was recalled because it has the potential to be contaminated with Clostridium botulinum. Dungeness Seaworks
Biologics Red Blood Cells, Leukocytes Reduced W036314039209 Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. BloodCenter of Wisconsin, Inc
Biologics Blood and Blood Products for Reprocessing W036314039209 Class III Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. BloodCenter of Wisconsin, Inc
Biologics Apheresis Platelets, Leukocytes Reduced W3985150485468; W398515049205Y (triple collection) Class II Plateletphersis products, with a low platelet yield, were distributed. Community Blood Center of Carolinas
Biologics Apheresis Platelets, Leukocytes Reduced W205515824969 Class II Blood product, possibly contaminated by air during collection, was distributed. American National Red Cross, Greater Ozark-Arkansas Region
Devices LeMaitre Over-the-Wire Embolectomy Catheter 3F, 40cm, Model 1651-34 and e1651-34. Indicated for the removal of arterial emboli and thrombi. Lot Codes: OTW3094 and OTW3098  Class II Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. LeMaitre Vascular, Inc.
Devices LeMaitre Over-the-Wire Embolectomy Catheter 3F, 80cm, Model 1651-38. Indicated for the removal of arterial emboli and thrombi. Lot Numbers: OTW3080 OTW3080  OTW3081  OTW3083  OTW3100  Class II Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. LeMaitre Vascular, Inc.
Devices LeMaitre Over-the-Wire Embolectomy Catheter 4F, 80cm, Model 1651-48 and e1654-48. Indicated for the removal of arterial emboli and thrombi. Lot Numbers: OTW3092 OTW3084 OTW3084 (sample) OTW3087 OTW3101  Class II Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. LeMaitre Vascular, Inc.
Devices LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 80cm, Model 1651-88 and e1654-88. Indicated for the removal of arterial emboli and thrombi. Lot Numbers: OTW3092 OTW3084 OTW3084 (sample) OTW3087 OTW3101  Class II Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. LeMaitre Vascular, Inc.
Devices LeMaitre Over-the-Wire Embolectomy Catheter 7F, 80cm, Model 1654-78 and e1654-78. Indicated for the removal of arterial emboli and thrombi. Lot Numbers: OTW3079 OTW3079 OTW3046    Class II Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. LeMaitre Vascular, Inc.
Devices LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 40 cm, Model e1651-84. Indicated for the removal of arterial emboli and thrombi. Lot Numbers: OTW3103 OTW3114 OTW3119    Class II Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. LeMaitre Vascular, Inc.
Devices LeMaitre Over-the-Wire Embolectomy Catheter 6F, 40 cm, Model e-1651-64. Indicated for the removal of arterial emboli and thrombi. Lot Number: OTW3108  Class II Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. LeMaitre Vascular, Inc.
Devices LeMaitre Over-the-Wire Embolectomy Catheter 6F, 80 cm, Model e-1651-68. Indicated for the removal of arterial emboli and thrombi. Lot Number: OTW3099  Class II Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. LeMaitre Vascular, Inc.
Devices LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm, Model 1601-38 and e1601-38. Indicated for the removal of arterial emboli and thrombi. Lot Number: SLC3672 SLC3663 SLC3663 SLC3667  Class II Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. LeMaitre Vascular, Inc.
Devices LeMaitre Single Lumen Embolectomy Catheter 4F, 80 cm, Model 1601-48 and e1601-48. Indicated for the removal of arterial emboli and thrombi. Lot Number: SLC3636 SLC3636 (sample) SLC3636 SLC3668 SLC3668 SLC3669 SLC3654  SLC3670  Class II Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. LeMaitre Vascular, Inc.
Devices LeMaitre Single Lumen Embolectomy Catheter 5F, 80 cm, Model 1601-58 and e1601-58. Indicated for the removal of arterial emboli and thrombi. Lot Number: SLC3673 SLC3637 SLC3637 SLC3666 SLC3676 SLC3689  Class II Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. LeMaitre Vascular, Inc.
Devices LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 6F, 80 cm, Model 1601-68. Indicated for the removal of arterial emboli and thrombi. Lot Number: NSE1663 Class II Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. LeMaitre Vascular, Inc.
Devices LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F, 60 cm, Model e1801-26. Indicated for the removal of arterial emboli and thrombi. Lot Number: NSE1658  Class II Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. LeMaitre Vascular, Inc.
Biologics Red Blood Cells, Leukocytes Reduced W200415241799 Class III Misbranded Red Blood Cells were distributed. Arc Blood Services, New England Region
Devices DGDE, DirectGuide Drill Extender. Instrument for use with dental implants. A manufactured device that adds a 6mm extension for a 25mm and 28mm tissue height capability suitable for individual patient needs. The thru hole in the DGDE allows existing surgical drills to be inserted and locked in place. Parts Numbers: DGDE, SPCST, IBST, BST, CST, ICST, IBST, RBST, RCST Lot Number: 61928, 64895, 64898, 64896, 65406, 65405, 65407, 65408, 65410, 65409, 65357, 67055, 67475, 67345, 37475, 67476, 67474, 67478, 67477, 67479, 67527, 68254, 68266, 68253, 68265, 68262 Class II Implant Direct Sybron Manufacturing, LLC is recalling 26 lots of DGDE DirectGuide Drill Extender because of a possible dropping of the drill. Implant Direct Sybron Manufacturing, LLC
Devices Trochanteric Fixation Nail- Advanced System-11MM/130 DEG TI CANN TFNA 420MM/Right Sterile (The TFN-ADVANCED Proximal Femoral Nailing System) The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures. Intramedullary fixation rod, orthopedic. Part Number Lot Number 04.037.162S 7950511 Class II TFNA nails may have the locking mechanism too close to the top of the nail. This may 1. Prevent the cannulated connecting screw from fully tightening the insertion handle to the nail resulting in a loose or toggling nail in the handle. Or 2. Cause the bottom of the cannulated connecting screw to tighten against the top of the locking mechanism preventing advancement of the locking mechanism. Synthes (USA) Products LLC
Biologics Apheresis Red Blood Cells, Leukocytes Reduced W047015201245 Class II Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. New York Blood Center, Inc.
Biologics Pooled Cryoprecipitated AHF W047015308020 Class II Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. New York Blood Center, Inc.
Biologics Red Blood Cells W050911045683 Class II Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed. HCSC-Blood Center
Biologics Red Blood Cells, Leukocytes Reduced W050911043503 Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. HCSC-Blood Center
Biologics Red Blood Cells, Leukocytes Reduced W050911047690 Class II Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed. HCSC-Blood Center
Biologics Red Blood Cells W050911047063 Class III Blood products, collected from a donor who may have received or had close contact with a smallpox vaccination, were distributed. HCSC-Blood Center
Biologics Fresh Frozen Plasma W050911047063 Class III Blood products, collected from a donor who may have received or had close contact with a smallpox vaccination, were distributed. HCSC-Blood Center
Food IQF FLAV-R-PAC Cut Wax Beans, there are 12/2 lbs. bags per case. Catalog # 07570. Product was distributed to Food Service accounts. The label has Cooking Directions and Safe Handling Instructions. The UPC 0 48800 07570 5 is observed on the bag. The Item No. 10048800075702 is observed on master case. The product is labeled in part: "***CUT WAX BEANS***FLAV-R-PAC***Keep Frozen***NET WT 32 OZ (2 LB)***DISTRIBUTED BY: NORPAC FOODS, INC. 4350 SW Galewood Street, Lake Oswego, OR 97035***COOKING DIRECTIONS***Safe Handling Instructions***". BEST BY MAY 2017. Packed on May 18, 2015. Code: 5I5 18X8 12 HHMM Code break down as follows: 5=NORPAC, I= packed in May, 5= 2015, 18= 18th day of May, X= place holder for period code, 8 = NORPAC Plant #8, 12= production line, HHMM = military time of packaging. Class II IQF FLAV-R-PAC Cut Wax Beans, 12/2 lbs. distributed to food service accounts, are recalled due to the contamination with Listeria monocytogenes. Norpac Foods, Inc. (Plant #8)
Food Kroger 100% natural apple FROM CONCENTRATE 64FL OZ. INGREDIENTS: APPLE JUICE FROM CONCENTRATE (FILTERED WATER, APPLE JUICE CONCENTRATE, ASCORBIC ACID (VITAMIN C). DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202 UPC 0 11110 82161 0 Sell By JUL 30 16 and Sell By AUG 10 16 Class II The firm received notification from the Alabama Dept. of Agriculture that a test came back indicating the levels of patulin was three times over the legal limit for patulin in two code dates of the Kroger Natural Apple Juice. The Kroger Co
Biologics Source Plasma BY0408035; BY0408806 Class II Blood products, collected from a donor who received body piercings within one year of donation, were distributed. BPL Plasma, Inc.
Food Wegmans Premium Dark Chocolate Pistachio Toffee, NET WT 9 OZ (255 g), UPC 0 77890 12698 1, Distributed By: Wegmans Food Markets, Inc., Rochester, NY 14603, Product contains tan and brown labels fixed to the top and bottom of the clear plastic tubs and shipped 12 units per case. all BEST BEFORE DATES Class II On November 11, 2015, First Source LLC initiated a recall for the Wegmans brand product due to the presence of undeclared cream (milk) in the toffee ingredient. First Source Llc
Devices RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), Dental Implant Lot 1404442 Class II An incorrect label reading 10.5mm and not the specified 15mm was placed on the implant inner vial packaging. BioHorizons Implant Systems Inc
Biologics Cryoprecipitated AHF 2278983 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Plasma Frozen, Cryoprecipitated Reduced 2278983 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Red Blood Cells 2100256; 2278983 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Fresh Frozen Plasma 2100256 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Devices WalkMed Infusion Triton Infusion Pump (model 300000). Packaged in a single pump box. Four pump boxes are place in an over-shipper for distribution. All devices manufactured since 07/04/09. Class II WalkMed Infusion is conducting a field action on the Triton Infusion Pumps (model numbers 300000 and 400000) because of the potential for the device to deliver more than 25% over the target infusion rate. WalkMed Infusion, LLC
Devices WalkMed InfusionTriton fp Infusion Pump (model 400000). Packaged in a single pump box. Four pump boxes are place in an over-shipper for distribution. All devices manufactured since 07/04/09. Class II WalkMed Infusion is conducting a field action on the Triton Infusion Pumps (model numbers 300000 and 400000) because of the potential for the device to deliver more than 25% over the target infusion rate. WalkMed Infusion, LLC
Devices AMS 4674 Custom Pack. For use in a general clinical procedure. Lot 84370, expiration date: 2/28/2017 Class II AMS 4674 Custom Pack is recalled because this kit containing U-SDN 2 Part Ultra Modified Seldinger Needle which is recalled by supplier. Windstone Medical Packaging, Inc.
Devices AMS 4675 Angio Pack. For use in a general clinical procedure. Lot 84371, expiration date: 2/28/2017 Class II AMS 4675 Angio Pack is recalled because this kit containing U-SDN 2 Part Ultra Modified Seldinger Needle which is recalled by supplier. Windstone Medical Packaging, Inc.
Biologics Apheresis Platelets, Leukocytes Reduced W036515265101 Class II Plateletpheresis product, which monthly product QC test for pH was not performed, was distributed. LifeShare Blood Centers
Devices GE Healthcare, Revolution CT Scanners. Revolution CT- The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. Mfg Lot or Serial # System ID 00000439632CN1 85109909185 00000439899CN6 83119074723 00000439913CN5 83119511730 00000441487CN6 83130644883 00000441818CN2 83132979115 00000443068CN2 GON-1510990 00000439432CN6 190059CT06 00000440338CN2 220078CT04 00000441574CN1 030355CT07 00000441779CN6 CT441683CN0 00000443105CN2 CT443038CN5 00000440186CN5 E416249CT1 00000437461CN7 519646REVO1 00000442492CN5 E416249CT2 00000443398CN3 905521RCT1 441961CN0 E416249CTE 442082CN4 403944RCT1 442220CN0 604988RCT1 442268CN9 416864RCT1 442573CN2 604682RCT1 AM13ECY81 00000440839CN9 82421040350 00000441053CN6 82421040345 00000441107CN0 82421050106 00000441563CN4 82421040359 00000441930CN5 82421040346 00000442030CN3 82421120479 00000442196CN2 82421030199 00000442749CN8 82421040369 00000443203CN5 82421300072 00000443282CN9 82421190317 00000443322CN3 82421120484 00000443348CN8 82421040370 442794CN4 GON-1510879 00000442517CN9 DK1051CT04 00000437837CN8 M2322254 00000440172CN5 P4192906 00000441238CN3 X41944012 00000441687CN1 M2800929 00000441895CN0 M41980112 00000442351CN3 E4191734 00000442588CN0 M44827197 00000442845CN4 M5480791 00000439243CN7  ...
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Class II GE Healthcare has recently become aware of a potential issue with routine head scans on your Revolution CT scanner. A potential hazardous situation can occur during a routine head scan with possible artifacts that may emulate pathology between the brain tissue and bone in the head images. No injuries have been reported to date related to this issue. GE Medical Systems, LLC
Food ORGANIC HOMESTAT FARM Quick STEEL CUT OATS & CHIA with Flax and Rye Flakes NET WT 42 OZ (2 LB. 10 OZ.) INGREDIENTS:***organic milled flaxseed*** Distributed by Homestat Farm LTD 6065 Frantz Rd. Suite 206, Dublin, OH 43017 UPC 8 35882 00620 4 BEST USE BY DATE: 03/16/17-1, 03/16/18-1, 03/19/17-1, 03/19/17-2, 03/23/17-1, 03/23/17-2, 03/24/17-1, 03/26/17-1, 03/26/17-2, & 04/08/17-2. Class II The firm was notified by their supplier that the Flax Meal delivered to them test positive for Salmonella Typhimurium. Homestat Farm Ltd
Biologics Apheresis Red Blood Cells, Leukocytes Reduced, Irradiated W041915027061S (double collection); W041915025974F; W041915026255O (double collection); W041915024157N (double collection); W0419150262081; W041915026666N; W041915024146T (double collection); W041915026002T (double collection); W041915024742Q; W041915026648R (double collection); W0419150224356; W041915024420P (double collection); W041915017660E; W041915023627B (double collection); W0419150259302 (double collection); W041915026665P (double collection); W041915023914Y; W041915026091W; W041915022519Z; W041915027170O; W041915023982A (double collection); W041915025929P; W041915024728M (double collection); W0419150236393; W041915023631J; W041915026673P;  ...
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Class III Apheresis blood products, possibly incorrectly labeled as having an extended expiration date, were distributed. Blood Systems, Inc. dba UBS -Coast
Biologics Source Plasma 11GMIF5491; 11GMIF3831; 11GMIF3151; 11GMIF2081; 11GMIF1074; 11GMIE3211; 11GMIE2196; 11GMIE1111; 11GMIH0195; 11GMIG6775; 11GMIG5914; 11GMIG4160; 11GMIG3246; 11GMIG1941; 11GMIG1426; 11GMIF9842; 11GMIF8332; 11GMIF7757; 11GMIE0450; 11GMID9303; 11GMID8188; 11GMID7131; 11GMID6204; 11GMID4318; 11GMID3291; 11GMID0548; 11GMIC9890; 11GMIC8613; 11GMIC7957; 11GMIC5640; 11GMIC4459; 11GMIF6550; 11GMIC3611; 11GMIC2826; 11GMIC0854; 11GMIB9593; 11GMIB8809; 11GMIB8048; 11GMIB7187; 11GMIB6201; 11GMIB5499; 11GMIB4435; 11GMIB3872; 11GMIA6037; 11GMIA4885; 11GMID5121; 11GMIA4334; 11GMIA3146; 11GMIA2732; 11GMIA1826;  ...
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Class II Blood products, collected from a donor considered to be at risk for variant Creutzfeldt- Jacob Disease (vCJD), were distributed. Biolife Plasma Services
Food French Style Green Beans packaged under the following labels: 1. Giant Eagle, Net Wt. 16 oz (1 LB) 454 g, UPC 30034-00978; 2. Shur fine, Net Wt. 16 oz, 1 LB (454 g), UPC 11161-13478 1. Giant Eagle: Packaging Code - TC15248; Production Code - MTAB7135; BEST BY 09/2017. 2. Shur fine: Packaging Code - TC65247; Production Code - MTAB7135; BEST BY 09/2017 Class II The 16 oz poly bags of IQF French Style Green Beans have the potential to be contaminated with Listeria monocytogenes. Lakeside Foods, Inc
Food 1.) Essential EVERYDAY Chocolate Flavored Dairy Whipped Topping, Made with Real Cream, Ultra-Pasteurized Grade A, NET WT 13 OZ (368g); 2.) HyVee Chocolate FLAVORED WHIPPED TOPPING ULTRA-PASTEURIZED GRADE A - SWEETENED, NET WT 13 OZ (368g); 3.) Lucerne DAIRY FARMS Chocolate Whipped Topping MADE WITH REAL CREAM, NET WT 13 OZ (368g). Lot Codes: 1.) APR296JF23, Sell By Date APRIL296; 2.) APR296JF32, Sell By Date APRIL296; 3.) Lot Code DEC145G171, Sell By Date DEC145, Lot Code DEC155G172, Sell By Date DEC155, Lot Code FEB166G196, Sell By Date FEB166 & Lot Code APR216G154, Sell By Date APRIL216 Class II Saputo Dairy Foods USA, LLC initiated a recall due to the presence of undeclared Red # 40, Yellow # 5, Yellow # 6 and Blue # 1 food colorings. Saputo Dairy Foods USA, LLC
Devices Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, LEFT - 62 MM, STERILE R, Rx only, REF Numbers: 71863110 Bone fixation plate. Batch # 14KT47574 Class II The devices were packaged and laser marked anatomically incorrect. The Left plates were laser marked and packaged as Right plates and the Right plates were laser marked and packaged as Left plates. Smith & Nephew, Inc.
Devices Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, RIGHT - 62 MM, STERILE R, Rx only, REF Numbers: 71863114 Bone fixation plate Batch # 14KT47575 Class II The devices were packaged and laser marked anatomically incorrect. The Left plates were laser marked and packaged as Right plates and the Right plates were laser marked and packaged as Left plates. Smith & Nephew, Inc.
Devices Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only. All lot numbers with expiration dates 2016-07 or prior. Lot Number 1720009 1757854 1758629 1768646 1774412 1784664 1786626 1795911 1797605 1800714 1801676 1802271 1805472 1807344 1807744 1809011 1809184 1809195 1809910 1810063 1812006 1812312 1812365 1812545 1812561 1812567 1812740 1812883 1813141 1813511 1813959 1814040 1814199 1814219 1814223 1814231 1814651 1814671 1814751  ...
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Class II Sterilmed, Inc. is voluntarily recalling all unexpired Reprocessed Tourniquet Cuffs. Sterilmed cannot assure the sterility of all units in the recalled lots. The introduction of non-sterile product into a sterile operative field raises the risk of potential infection. Sterilmed has not received any reports of Adverse Events for this issue. STERILMED, INC.
Food Organic blenditup Protein + Plant Based Smoothie Mix, No Dairy, Vitamin Fortified, 100% Vegan, Mild Natural Flavor with a Hint of Sweetness, Net Wt. 24 oz (682g), packaged in plastic canister, 12 packages per case. Distributed by: Blenditup, 504 W. Buena Vista, Suite 1, Washington, UT 84780 freeze by date of 08/22/2017 with a lot number of 151732; Item: 899352 Class II Product adulterated. End user found a wingnut inside their canister; the firm determined that it came from the outside of the magnet unit attached to the blender. The wingnut looks bent out of shape and as a precautionary measure the firm wanted to recall all canisters produced during the affected lot. Thrive Foods LLC
Devices Thin-Flex Venous Cannula, Model Number:TF292902A Lot No: 59384061 59677936 59985533 59430941 59723695 59999044 59456603 59746454 60010418 59498228 59779239 60106398 59545464 59846864 60113045 59580433 59883622 60121142 59608030 59931290 60172116 59649580 59963196 60181079 Class II Edwards Lifesciences initiated a field action for the Thin-Flex Venous Cannula (Model TF292902A) because the connector size is incorrectly described in the Edwards product guide as 3/8 inch. The actual and correct connector size is 1/2 inch. Edwards Lifesciences, LLC
Biologics Source Plasma 15JCTT6209; 15JCTT5806; 15JCTT5120; 15JCTT1731; 15JCTT5011 Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Plasma Biological Services Inc
Biologics Source Plasma 15NTNA1249 Class III Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed. Plasma Biological Services, Inc
Biologics Source Plasma 15MEMC6593; 15MEMC6020; 15MEMC5429; 15MEMD1605; 15MEMD0206; 15MEMC8551; 15MEMC4352; 15MEMC4029; 15MEMC3057; 15MEMC2754 Class III Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Plasma Biological Services Inc
Biologics Source Plasma 15JCTT2633 Class III Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed. Plasma Biological Services Inc
Biologics Blood and Blood Products for Reprocessing W041014135745J Class II Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed. United Blood Services
Drugs Humulin 70/30, 100 Units/mL Inj, Qty: 10 mL Vial, MFG by: Lilly USA, LLC, Indianapolis, IN 46285, Repackaged by: Remedy Repack, Inc, 625 Kolter Dr, Indiana, PA 15701, NDC 52125-0415-08 LOT # B0080702-042715, B0080695-042715, B0097444-082015, Exp 07/2017; B0097443-082015, Exp 02/2018. Class II Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions. RemedyRepack Inc.
Drugs Bicillin L-A 600000 Units/mL Inj., Qty: 20 mL Syringe, MFG by: King Pharma Inc., Bristol, TN 37620, Repackaged by: RemedyRepack, Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 61786-0253-03 Lot # B0077329-040215, Exp 07/2017; B0091342-070315, Exp 08/2017; B0109416-102815, Exp 03/2018 Class II Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions. RemedyRepack Inc.
Drugs Vitamin B-Complex 100, Multi MG Inj, Qty: 30 mL Vial, MFG by: Mylan Institutional, Rockford, IL 61103, Repackaged by: RemedyRepack Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 52125-0873-02 Lot # B0105037-100715, Exp 10/01/2016 Class II Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions. RemedyRepack Inc.
Drugs Ascorbic Acid 500 MG/ML Inj., Qty: 50 mL Vial, MFG by: Mylan Institutional, Rockford, IL 61103, Repackaged by: RemedyRepack Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 61786-0431-16 LOT # B0105052-100715, Exp 07/01/2017 Class II Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions. RemedyRepack Inc.
Drugs Lorazepam 2 mg/mL Inj., Qty: 1 mL Vial, MFG by: West-Ward Pharma, Eatontown, NJ 07724, Repackaged by: RemedyRepack Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 61786-0316-01 LOT#: B0085124-051915, B0086919-052815, Exp 12/01/2016; B0089280-061215, B0090023-061915, B0089996-061915, B0091581-070715, B0091564-070715, B0091515-070715, Exp 01/01/2017; B0094980-080415, B0094965-080415, B0097515-082415, B0100639-091415, B0100611-091415, Exp 03/01/2017; B0100933-091515, B0107165-101915, B0107118-101915, Exp 06/01/2017. Class II Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions. RemedyRepack Inc.
Drugs Novolin 70/30, 100 Units/mL Solu., Qty: 1 Vial, MFG by: Novo Nordisk, A/S, Bagsvaerd, Denmark DK-2880, Repackaged by: RemedyRepack Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 52125-0414-01 LOT#:QM114CZF0496, Exp 01/2016; B0025373-050514, B0029738-060914, Exp 02/2016; B0029737-060914, Exp 03/2016. Class II Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions. RemedyRepack Inc.
Drugs Rocuronium Bromide 50 MG/5ML INJ., Qty: 5 mL Vial, MFG by: Mylan Institutional, Rockford, IL 61103, Repackaged by: RemedyRepack Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 61786-0222-57 Lot#: B0073852-030915, Exp 04/2016 Class II Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions. RemedyRepack Inc.
Devices IBS - Osteosynthesis screws for bone fixation Model S25 ST014. 1509058 Class II One batch of osteosynthesis screws were manufactured with the incorrect Torx imprint on the screw head. In2Bones, SAS
Devices Olympus ENDOEYE HD II Video Telescopes. Models WA50040A ENDOEYE HD II, 10 mm, 0 degree, WA50042A ENDOEYE HD II 10 mm, 30 degree, W7100603 Repair cable 10 mm 0/30 degree. The ENDOEYE video Telescopes are used with other supporting equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including the female reproductive organs. Serial numbers 622483, 622523, 622553, 622566, 622568, 622569, 622573, 622576, 622614, 622615, 622616, 622617, 622618, 622619, 622620, 622632, 622643, 622644, 622645, 622646, 622647, 622654, 622655, 622656, 622657, 622658, 622664, 622666, 622667, 622687, 622688, 622693, 622704, 622705, 622706, 622710, 622711, 622712, 622718, 622719, 622720, 622722, 622723, 622750, 622753, 622764, 622766, 622767,  ...
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Class II A damaged temperature sensor at the ENDOEYE tip caused the distal end to become abnormally hot. Excessive heating of the ENDOEYE distal end could result in patient or user injury. Olympus Corporation of the Americas
Devices Persona EM Proximal Tube, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item 42-5399-001-00, part of the Persona Tibial Resection System. Proximal Tube Item Number 42-5399-001-00, Lots: 2137111, 62156913, 62222598. Class II Complaints that the ratchet teeth of the tube are not latching onto the rod. Zimmer, Inc.
Devices Persona EM Distal Rod, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item 42-5399-002-00, part of the Persona Tibial Resection System. Distal Rod Item Number 42-5399-002-00 Lots: 62137112, 62156914, 62222599. Class II Complaints that the ratchet teeth of the tube are not latching onto the rod. Zimmer, Inc.
Drugs Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, packaged in a) 100-count bottles (NDC 0025-2742-31), and b) 500-count bottles (NDC 0025-2742-51), Rx only, Distributed by G.D. Searle LLC, Division of Pfizer Inc, NY, NY 10017. Lot #: C150065; C150064, Exp 6/16 Class III Failed Dissolution Specification Pfizer Inc.
Drugs MECLIZINE HYDROCHLORIDE TABLETS, 12.5 mg, Packaged in 1000 ct Bottles, Rx Only. Manufactured by: Par Pharmaceuticals Companies Inc., Spring Valley, NY 10977. Packaged by: GSMS Incorporated, Carmarillo, CA 93012. NDC: 60429-204-10. Lot # GS007205 Expiry: Aug-17; Lot #:GS007344, Expiry: Aug-17; Lot #: GS008089, Expiry: Feb-18; Lot #: GS008842, Expiry: Feb-18; Lot #: GS009055, Expiry: Feb-18; Lot #: GS009131; Expiry: Feb-18. Class III Failed Impurities/Degradation Specifications: Out of specification for impurities. Golden State Medical Supply Inc.
Drugs MECLIZINE HYDROCHLORIDE TABLETS, 25 mg, Packaged in a) 100 ct Bottles (NDC: 60429-205-01) and b) 1000 ct Bottles (NDC: 60429-205-10), Rx Only. Manufactured by: Par Pharmaceuticals Companies Inc., Spring Valley, NY 10977. Packaged by: GSMS Incorporated, Carmarillo, CA 93012. a) Lot #: GS005224, Expiry: Jul-16, Lot:#: GS007553, Expiry: Nov-17;  ...
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Class III Failed Impurities/Degradation Specifications: Out of specification for impurities. Golden State Medical Supply Inc.
Drugs Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Rx Only, For Oral Inhalation Only, Net Wt. 18 g, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0682-20 Lot #s: 5ZP1708, Exp. 12/2016; 5ZP1951, Exp. 02/2017 Class II Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of shelf life. GlaxoSmithKline, LLC
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