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U.S. Department of Health and Human Services

Enforcement Report - Week of February 10, 2016

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Veterinary Jump Your Bones Roo Bites (Cubes) - Packaged in 80g/2.82 oz. including samples of .32 oz.plastic bags in a re-sealable container No codes/lots #'s or Best By or Expiration date on the packages only UPC 63633010041 Class I The Colorado Department of Agriculture collected a sample and found that it was positive for Salmonella. They submitted the Salmonella isolate to the FDA for further identification. Jump Your Bones, Inc.
Veterinary Big Bark All Natural Beef Jerky Treat for Dogs, Guaranteed Analysis, Crude Protein 65%, Crude Fat 8.0%, Crude Fiber 2.0%, Moisture 10.0%, Ingredients: Dehydrated Beef Heart Made in USA Grill-Phoria LLC 1082 North Denver Ave, Loveland, Colorado 80537, Item #NS01701, 3.5 oz (99 g), 8 17894 01701 0 No lot codes are listed on the product. Product is packed in 3.5 oz resealable plastic pouches. It was manufactured and distributed from 9/20/14 through 1/02/15. Class I Grill-Phoria of Loveland, Colorado is recalling certain Big Bark All Natural Beef Jerky Treats for Dogs due to potential contamination with Salmonella. Grill-Phoria LLC
Veterinary Nutrisca Chicken and Chick Pea Recipe Dry Dog Food, Net Wt. 4 lbs. First five digits of Lot Codes: 4G29P, 4G31P, 4H01P, 4H04P, 4H05P, 4H06P. Best By Dates: Jul28 16, Jul 30 16, Jul 31 16, Aug 03 16, Aug 04 16, Aug 05 16. Class I Specific lots of Nutrisca Chicken and Chick Pea Recipe Dry Dog Food have the potential to be contaminated with Salmonella. Tuffy's Pet Food, Inc
Veterinary Eastern Colorado Recycling CO. 43465 Highway 24, Burlington, CO 80807, 25 pound cardboard boxes, 5 packages per case, frozen Lot number indicates the date of production: OCT 22 2014, OCT 27 2014, NOV 15 2014 Class I Triple A Brand Meat Company is recalling Horse Chunk due to potential contamination with barbiturates. Eastern Colorado Recycling dba Triple A Brand Meat Co.
Veterinary Vital Essentials Frozen Beef Tripe Patties, 6 lb package (heat sealed bag), 4 per case, product code #3809, UPC 33211 00809. Vital Essentials Frozen Tripe Treat Nibblets, 3 lb package (heat sealed bag), 6 per case, product code #3904, UPC 33211 00904. Tripe Patties - lot# 10930, product code# 3809, Best by date 20160210. Tripe Nibblets lot# 10719, Product code# 3904, Best by date 12022015. Class I Carnivore Meat Company LLC is recalling Frozen Beef Tripe Patties (Lot Number 10930) and Frozen Beef Tripe Nibblets (Lot Number 10719) because of the presence of Listeria monocytogenes in the product. Carnivore Meat Company, LLC
Veterinary Frozen Raw Cat Food (10 lbs. chubs and 50 lbs. block). No UPC code. Product is used for captive wild cats. The affected products are sold in 50 pound blocks or 10 lbs. chubs (the net weight per case of 10 lbs. chubs is 60 lbs.). Each chub is packaged in a white plastic bag labeled as Cat Food. The 10 lbs. product is labeled in parts: "***CAT FOOD***Northwest Farm Food***10 LBS. NET WEIGHT***INEDIBLE NOT FOR HUMAN CONSUMPTION DO NOT FEED TO CATTLE OR OTHER RUMINANTS***KEEP FROZEN***Crude Protein**Crude Fat***Crude Fiber***Moisture***Ingredients: Fish, Beef Liver, Beef, Chicken, Meat By-Products. Cooked Wheat, Cooked Barley, Mill run, Steamed Bone Meal, Vit E & Vit B-12. Use as supplement to your regular maintenance diet***". Jul12015B. The code is interpreted as manufacture date (07/01/15) and shift (B) Class I Frozen Raw "Cat Food" is recalled due to contamination with Salmonella. Northwest Farm Food Cooperative
Devices ADVIA Chemistry XPT Systems, Software Version 1.0.3, SMN 11127538 Clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes at a throughput rate of both 1800 photometric tests per hour and 600 electrolyte (ISE) tests per hour. Software Version 1.0.3 Class II Multiple Software issues. Auto Start-UP Fail, Calibration Interval Resets when a Reagent Blank is run, Control Definition screen assumes range defined is 2 SD, Laboratory Information System (LIS) communication/Laboratory Automation (LAS) issue, Printer Driver Resets, ISE Calibration Ranges are too conservative for Urine Sodium, Archiving and deletion may fail and Workstation services may restart. Siemens Healthcare Diagnostics, Inc.
Devices Allura Xper FD10, FD10 C, and FD10 F; Model Numbers: 722026 722010 722003 722002 722001 Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP). All serial numbers. Class II The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. Philips Electronics North America Corporation
Devices Allura Xper FD10/10; Model Numbers: 722027 722011 722005 Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP). All serial numbers Class II The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. Philips Electronics North America Corporation
Devices Allura Xper FD10 OR Table; Model Numbers: 722033 722022 Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP). All serial numbers Class II The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. Philips Electronics North America Corporation
Devices Allura Xper FD20/10; Model Numbers: 722029 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisations and thrombolysis. " Cardiac imaging applications including diagnostics, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations and ElectroPhysiology " Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures All serial numbers Class II The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. Philips Electronics North America Corporation
Devices Allura Xper FD20/15; Model Numbers: 722058 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisations and thrombolysis. " Cardiac imaging applications including diagnostics, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations and ElectroPhysiology " Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures All serial numbers Class II The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. Philips Electronics North America Corporation
Devices Allura Xper FD20; Model Numbers: 722028 722012 722006 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisations and thrombolysis. " Cardiac imaging applications including diagnostics, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations and ElectroPhysiology " Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures All serial numbers Class II The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. Philips Electronics North America Corporation
Devices UNIQ FD; Model Numbers: 722028 The Philips UNIQ is intended for use on human patients to perform: " Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis. " Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology (EP). " Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures All serial numbers Class II The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. Philips Electronics North America Corporation
Devices UNIQ FD OR table; Model Number 722035 The Philips UNIQ is intended for use on human patients to perform: " Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis. " Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology (EP). " Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures All serial numbers Class II The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. Philips Electronics North America Corporation
Devices Allura Xper FD20 OR Table; Model Numbers: 722035 722023 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisations and thrombolysis. " Cardiac imaging applications including diagnostics, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations and ElectroPhysiology " Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures. All serial numbers Class II The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. Philips Electronics North America Corporation
Devices Allura Xper FD20 Biplane; Model Numbers: 722013 722008 722015 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisations and thrombolysis. " Cardiac imaging applications including diagnostics, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations and ElectroPhysiology " Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures. All serial numbers Class II The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. Philips Electronics North America Corporation
Devices Allura Xper FD20 Biplane OR Table; Model Numbers: 722025 722020 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisations and thrombolysis. " Cardiac imaging applications including diagnostics, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations and ElectroPhysiology " Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures. All serial numbers Class II The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. Philips Electronics North America Corporation
Devices Allura Xper FD20/20; Model Number: 722038 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisations and thrombolysis. " Cardiac imaging applications including diagnostics, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations and ElectroPhysiology " Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures. All serial numbers Class II The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. Philips Electronics North America Corporation
Devices Allura Xper FD20/20 OR Table; Model Number: 722039 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisations and thrombolysis. " Cardiac imaging applications including diagnostics, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations and ElectroPhysiology " Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures. All serial numbers Class II The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. Philips Electronics North America Corporation
Devices Allura CV20; Model Number: 722031 The Allura CV2O is intended for physicians (e.g. cardiologists and radiologists), assisted by trained hospital staff (e.g. nurses and lab technicians), who are qualified to perform medical procedures on humans (having a maximum weight of 250 kg.) with probable internal diseases or injuries for: " Dedicated vascular and carotid imaging applications, including diagnostic and interventional procedures. " Cardiac imaging applications including diagnostics, interventional rocedures, pacemaker implantations and electrophysiology (EP). " Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures. All serial numbers Class II The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. Philips Electronics North America Corporation
Devices Cardiovascular Allura Centron; Model Number: 722400 The Allura CV2O is intended for physicians (e.g. cardiologists and radiologists), assisted by trained hospital staff (e.g. nurses and lab technicians), who are qualified to perform medical procedures on humans (having a maximum weight of 250 kg.) with probable internal diseases or injuries for: " Dedicated vascular and carotid imaging applications, including diagnostic and interventional procedures. " Cardiac imaging applications including diagnostics, interventional rocedures, pacemaker implantations and electrophysiology (EP). " Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures. All serial numbers Class II The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. Philips Electronics North America Corporation
Devices INTEGRIS H3000; Model Number: 72238 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions All serial numbers Class II The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. Philips Electronics North America Corporation
Devices INTEGRIS HM3000; Model Number: 72239 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions All serial numbers Class II The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. Philips Electronics North America Corporation
Devices INTEGRIS BN/BV3000; Model Number: 72240 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions All serial numbers Class II The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. Philips Electronics North America Corporation
Devices INTEGRIS BH3000; Model Number: 72242 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions All serial numbers Class II The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. Philips Electronics North America Corporation
Devices INTEGRIS V3000; Model Number: 72243, 72244, 72245 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions All serial numbers Class II The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. Philips Electronics North America Corporation
Devices INTEGRIS H5000; Model Number: 72246 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions All serial numbers Class II The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. Philips Electronics North America Corporation
Devices INTEGRIS BH5000; Model Number: 72247 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions All serial numbers Class II The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. Philips Electronics North America Corporation
Devices INTEGRIS V5000: Model Number: 72248 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions All serial numbers Class II The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. Philips Electronics North America Corporation
Devices INTEGRIS BV5000: Model Number: 72249 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions All serial numbers Class II The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. Philips Electronics North America Corporation
Devices INTEGRIS Allura 9 (biplane); Model Number: 722021 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions All serial numbers Class II The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. Philips Electronics North America Corporation
Devices INTEGRIS Allura 15-12 (mono); Model Number: 722043 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions All serial numbers Class II The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. Philips Electronics North America Corporation
Devices INTEGRIS Allura 15-12 (biplane); Product Code: 722044 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions All serial numbers. Class II The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. Philips Electronics North America Corporation
Devices INTEGRIS CV; Model Number: 722030 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions All serial numbers. Class II The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. Philips Electronics North America Corporation
Devices INTEGRIS BV3000 MONO; Model Number: 72241 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions All serial numbers. Class II The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. Philips Electronics North America Corporation
Food Bakery Oatmeal Raisin Cookies packaged in clear plastic clamshell container, 12-count, 18-count, and 20-count 12-count - UPC 00207995000002, SLU 7995; 18-count - UPC 00267987000007, SLU 67987; 20-count - UPC 00209699000005, SLU 9699 Class I Undeclared walnuts Southeastern Grocers Llc
Food Bakery Variety Pack Cookies Containing Oatmeal Rasin Cookies packaged in clear plastic clamshell container, 12-count, 18-count, and 20-count 12-count - UPC 00209700000000, SLU 9700; 18-count - UPC 00267982000002, SLU 67982; 20-count - UPC 00209701000009, SLU 9701 Class I Undeclared walnuts Southeastern Grocers Llc
Food Cookie Platter Containing Oatmeal Rasin Cookies packaged in plastic container, 48-count and 36-count 48-count - UPC 00269736000009, SLU 69736; 36-count - UPC 0020755000003, SLU 7550 Class I Undeclared walnuts Southeastern Grocers Llc
Biologics Source Plasma OL0494493; OL0495217; OL0496980; OL0497940; OL0499474; OL0500401 Class II Blood products, for which donor suitability was inadequately determined, were distributed. BPL Plasma, Inc.
Food Tonkutsu Ramen, Net Wt. 12 oz. Made by Sun Noodle Honolulu, HI 96819/Rancho Domingo, CA 90220/Teterboro, NJ 07605 UPC 0 85315 40003 5 PACKAGED IN PLASTIC CLEAR CLAMSHELL 3114350 3115013 3115040 3115071 3115141 3115176 3115229 3115267 3115299 3115328 3214350 3215013 3215040 3215071 3215141 3215176 3215229 3215267 3215299 3215328 3114352 3115015 3115043 3115072 3115149 3115187 3115246 3115271 3115304 3115336 3214352 3215015 3215043 3215072 3215149 3215187 3215246 3215271 3215304 3215336 3114360 3115028 3115055 3115084 3115161 3115195 3115254 3115275 3115314 3214360 3215028  ...
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Class I Tonkutsu Ramen may contain undeclared eggs. Sun Noodle New Jersey, LLC
Food Dockside Classics 4 Gourmet Crab Cakes Net Wt. 12 oz. UPC: 045425167143 UPC: 045425165446 Class II The product may not have been transported at a safe temperature. Albertsons Llc
Food Dockside Classics 4 Gourmet Lobster Cakes Net Wt. 12 oz. UPC: 045425167143 UPC: 045425167143 Class II The product may not have been transported at a safe temperature. Albertsons Llc
Devices Panorama Patient Monitoring Network. Software Kit 0020-00-0205-19A, View Station Software Kit 0020-00-0206-16A, Work Station Software Kit 0020-00-0207-16A, Software Kit Upgrade TECH-00-910. The Panaroma Patient Monitoring Network is intended for use in a fixed location in the healthcare facility setting as a central viewing station. It is not intended to be directly connected to patient at any time or installed in a patient's vicinity. version 11.5.1 Class II An issue with the Panorama Central Station may cause the system to spontaneously restart. This may occur after about 49 days of continuous operation. On restart, monitoring will be lost for about 2.5 minutes. Settings and configurations are maintained. Mindray DS USA, Inc. dba Mindray North America
Biologics Apheresis Red Blood Cells, Leukocytes Reduced W036815047136 (double collection) Class III Misbranded red blood cells, were distributed. OneBlood, Inc.
Food Zatarain's New Orleans Style RED BEANS AND RICE, ORIGINAL, NET WT 8 OZ, UPC 7142909849 BEST BY JUL 31 16Z Class I Zatarain's is initiating a voluntary recall of Zatarain's Red Beans And Rice Original 8 oz. package, USPC 7142909849 with date code of BEST BY JUL 31 16Z as it may contain Creamy Parmesan Rice Mix which has a dairy allergen (milk). Zatarain's Partnership, L.P.
Food Dove Chocolate Assortment Snowflakes Net. Wt. 24.0 oz. Distributed by Mars Chocolate na, llc Hackettstown, NJ 07840-1503 USA UPC 400050521 Code and Best Before Dates include: 537CG4PA30: Best Before 9/2016 537DG4PA30: Best Before 9/2016 538AG4PA30: Best Before 9/2016 538AM4PA30: Best Before 9/2016 541AG4PA20: Best Before 10/2016 542EM4PA20: Best Before 10/2016 Class I Dove Chocolate Assortment Snowflakes may contain undeclared peanuts, what and egg ingredients. Mars Chocolate North America
Food Signature Breads Frozen Parbaked French Dinner Roll 22245; 120 units - 1.25 OZ NET WT. 9.37 LB (4.25 KG), in a cardboard box Use by Date: 9/15/2016 Class II Product may contain metal fragments. Signature Breads, Inc.
Food Signature Breads Frozen Parbaked Baguette 22202, 25 UNITS - 8.75 OZ, NET WT. 13.67 LB (6.2 kg), in a cardboard box Use by Date: 9/14/2016 Class II Product may contain metal fragments. Signature Breads, Inc.
Food Signature Breads Frozen Parbaked French Petit Pain 22203, 144 UNITS - 1.75 OZ, NET WT. 15.75 LB (7.14 kg), in a cardboard box Use by Date: 9/14/2016 Class II Product may contain metal fragments. Signature Breads, Inc.
Food Signature Breads Frozen Parbaked French Sub Roll 22201, 72 UNITS - 3.25 OZ, NET WT. 14.62 LB (6.63 kg), in a cardboard box Use by Date: 9/14/2016 Class II Product may contain metal fragments. Signature Breads, Inc.
Food Piantedosi French Dinner rolls C-301, Signature Breads French Dinner Rolls 22200, 240 UNITS - 1.25 OZ, NET WT. 18.75 LB (8.5 kg), in a cardboard box Use by Date: 9/15/2016 Class II Product may contain metal fragments. Signature Breads, Inc.
Food Signature Breads Frozen Parbaked French Dinner Rolls 22251; 280 Units - 1 OZ, NET WT. 17.5 LB (7.93 kg), in a cardboard box Use by Date: 9/15/2016 Class II Product may contain metal fragments. Signature Breads, Inc.
Food Signature Breads Frozen Parbaked French Mini Baguette 22205; 48 UNITS - 5 OZ, NET WT. 15 LB (6.8 kg), in a cardboard box Use by Date: 9/16/2016 Class II Product may contain metal fragments. Signature Breads, Inc.
Food Signature Breads Frozen Parbaked French Sub Grande 22089; 36 UNITS - 5.9 OZ, NET WT. 13.27 LB (6.02 kg), in a cardboard box Use by Date: 9/17/2016 Class II Product may contain metal fragments. Signature Breads, Inc.
Food Signature Breads Frozen Parbaked Assorted Petit Pain 22032; 144 UNITS - 1.75 OZ, NET WT. 15.75 LB (7.14 kg), in a cardboard box Use by Date: 9/15/2016 Class II Product may contain metal fragments. Signature Breads, Inc.
Food Signature Breads Frozen Parbaked Assorted Dinner Rolls 22213; 240 UNITS - NET WT. 22.5 LB (10.2 kg), packed in a cardboard box Use by Date: 9/17/2016 Class II Product may contain metal fragments. Signature Breads, Inc.
Food Masago Lake Smelt Roe 6 oz. UPC Code:4866010101 N/A Class I Product contains undeclared soy and wheat. Ocean Group Inc.
Devices Biosure Driver, Product No: 72201887 For delivery and placement of orthopedic screws. Orthopedic Manual Surgical Instrument Lot Numbers: 50409038, 50404149, 50399964 Class II Driver does not meet specification, oversized. Driver may not be able to be fully inserted into the screw, or screw may become stuck on the driver. Smith & Nephew, Inc., Endoscopy Div.
Devices Biosure Ratchet Driver, Product No: 72201888 For delivery and placement of orthopedic screws. Arthroscopic surgical instrument Lot Numbers: 50410950 and 50407175 Class II Driver does not meet specification, oversized. Driver may not be able to be fully inserted into the screw, or screw may become stuck on the driver. Smith & Nephew, Inc., Endoscopy Div.
Food This Kid Saves Lives Chocolate Chip UPC #10858497004097 UPC# 858497004090 Inner pack(5 bar carton) - BEST BY APR APR2916 and BEST BY JUL2816 Case(8 inner packs) - BEST BY APR2916 and BEST BY JUL2816 Class II This Bar Saves Lives is recalling This Kid Saves Lives Chocolate Chip because the product contains whey protein and does not identify milk. This Bar Saves Lives
Devices MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent packaging]. General Hospital Use. Item No. Lot No. Expiration Date: CBN1103 12113H08A Oct-15, CBN1103 13033H08A Feb-16, CBN1103 13053H08A Apr-16, CBN1103 14013H08A Dec-16, CBN1103 14043H08A Mar-17, CBN1103 14053H08A Apr-17, CBN1103 14083H08A Jul-17, CBN1103 14063H08A May-17, CBN1103 15013H08A Dec-17, CBN1103 14123H08A Nov-17, CBN1103 14113H08A Oct-17, CBN1103 15023H08A Jan-18, CBN1103 15033H08A Feb-18, CBN1103 15043H08A Mar-18, CBN1103 15053H08A  ...
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Class II MediChoice sterile cohesive bandages imported and sold under a private brand by Owens & Minor were tested and found to have microbial contamination. Owens & Minor Distribution, Inc.
Devices MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent packaging] General Hospital Use. Item No. Lot No. Expiration Date: CBN1104 15023H09A Jan-18, CBN1104 15033H09A Feb-18, CBN1104 15043H09A Mar-18, CBN1104 15053H09A Apr-18, CBN1104 15063H09A May-18, CBN1104 15073H09A Jun-18, CBN1104 15083H09A Jul-18, CBN1104 14113H09A Oct-17, CBN1104 14123H09A Nov-17, CBN1104 15013H09A Dec-17, CBN1104 14063H09A May-17, CBN1104 14083H09A Jul-17, CBN1104 14093H09A Aug-17, CBN1104 14053H09A Apr-17, CBN1104 14043H09A  ...
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Class II MediChoice sterile cohesive bandages imported and sold under a private brand by Owens & Minor were tested and found to have microbial contamination. Owens & Minor Distribution, Inc.
Devices MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent packaging] General Hospital Use. Item No. Lot No. Expiration Date, CBN1106 12113H10A Oct-15, CBN1106 13033H10A Feb-16, CBN1106 13053H10A Apr-16, CBN1106 13083H10A Jul-16, CBN1106 13103H10A Sep-16, CBN1106 13113H10A Oct-16, CBN1106 14013H10A Dec-16, CBN1106 14043H10A Mar-17, CBN1106 14053H10A Apr-17, CBN1106 14063H10A May-17, CBN1106 14083H10A Jul-17, CBN1106 14093H10A Aug-17, CBN1106 14093H10A Aug-17, CBN1106 14113H10A Oct-17, CBN1106 14123H10A  ...
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Class II MediChoice sterile cohesive bandages imported and sold under a private brand by Owens & Minor were tested and found to have microbial contamination. Owens & Minor Distribution, Inc.
Devices ACIST Medical Systems, BT2000 Automated Manifold Kit (SKU 014613) and CPT2000 (SKU 014623) Automated Manifold Kits, Sterile R, Rx Only, Made in Mexico. The manifold body is identical in the BT2000 and CPT2000 kits. The BT2000 and CPT2000 kits facilitate connection to, and delivery of, either contrast or saline into the patient via a coronary catheter (not provided by ACIST). To be used for the controlled infusion of radiopaque contrast media for angiographic procedures Lot Number 08915J 09015T 09115H 09315D 09615N 09615U 09715X 09815F 10115D 10215G 10415D 10415W 10415Y 10515P 11015L 11115K 11215U 11315M 11715J 11815G 11915D 12415J 12615P 13115M 13415W 13815G 13915T 14015P 14115M 14615D 14615M 15415G 15715D 16115H 16315L 16515E 16615Z 16815J 16915N 17115F 17615U 17815F 18215J 18415D 18515N 18715U 18815K 18915P 19015N 19115H 19315D 19415P 19515X 19715G 19815M 19915D 20115M 20315E 20715D 20815M 20915X 21115W 21815J 21815U 22015D 23715D 23815D 23815P 24415P 24615U 25015D 25515D 26415N 26715F 26815J 26815K 27115L 27215U 27315Z 27415H 27515D 29115D 29915E 29915F 30015E 30015F 32115M 32715G 32715V 32815M Class II Reports related to ingress of air into the manifold. Acist Medical Systems
Devices Emergency Transport Ventilator Oxylog 2000 Plus Ventilator Catalog Number: 5705080. Volume controlled emergency and transport ventilator with pressure support. All Oxylog 2000 plus Ventilators with the identified catalog numbers distributed between April 2007 - December 2015. Class I Drager became aware of situations where the error message "Poti unplugged" was generated causing acoustic and visual alarms, the breathing system releases pressure and the ventilation function stops operating. Draeger Medical, Inc.
Devices Emergency Transport Ventilator Oxylog 3000 Ventilator and Oxylog 3000 plus Ventilator Catalog Numbers: 2M86300/2M86965 and 5704813/5704831. Volume controlled and pressure-controlled emergency and transport ventilators. All Oxylog 3000 Ventilators and Oxylog 3000 Plus Ventilators with the identified catalog numbers distributed between April 2007 - December 2015. Class I Drager became aware of situations where the error message "Poti unplugged" was generated causing acoustic and visual alarms, the breathing system releases pressure and the ventilation function stops operating. Draeger Medical, Inc.
Biologics Cornea 152213 Class II Human cornea, not tested adequately and appropriately to reduce the risk of transmission of relevant communicable diseases, was distributed. Alabama Eye Bank
Food Signature Cafe Traditional Stuffing; Turkey Broth, Seasoned Bread Crumb Mix, Celery, Yellow Onion. Net WT. 39 oz. (2 lbs 7 oz) 1.1 kg. Perishable, Keep refrigerated. UPC 21130-08320 Distributed by Lucerne Foods Inc. PO Box 99 Pleasanton, CA 94566 Lot Code of TFPV351; Use By Date of 12/26/2015 Class I Signature Cafe Traditional Stuffing may have the incorrect ingredient and nutritional label that does not declare the allergens soy, milk and wheat. Taylor Farms Pacific, Inc.
Devices Denali Filter-Jugular/Subclavian DL950J Denali Filter-Femoral Delivery DL950F. Intravascular filters. Product Code: DL950J Lot Number: GFYA3093, GFYC3745, GFYD2734, GFYF3878, GFYF3879, GFYG3877, GFYG3880, GFYI2699 Product Code: DL950F Lot Number: GFYA3093, GFYC3745, GFYD2734, GFYF3878, GFYF3879, GFYG3877, GFYG3880, GFYI2699 Class II IFU missing contraindications: Patients with uncontrolled sepsis and Patients with known hypersensitivity to nickel-titanium alloys. Bard Peripheral Vascular Inc
Devices Baxter, RAPIDFILL Syringe Strip, 10 ml. For use with RAPIDFILL Automated Syringe Filler (ASF) All Lots Class II Baxter Healthcare has issued an Urgent Product Recall communication for all lots of RAPIDFILL Syringe Strips due to lack of evidence supporting the packaging claim for 12-month shelf life on released product. Baxter Corporation Englewood
Devices AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers. Model Number: 933-599 Version 1.8.3 Class II The AQURE System has a design error regarding sample type in which sample type may be specified for some results and left blank for other results. The fact that the sample type field is left blank in some cases could lead to misinterpretation of results. Radiometer America Inc
Devices ADVIA Centaur PSA Assay; Catalog Number: 06574155/SMN 10310292 (100 test kit) and Catalog Number: 02676506/SMN 10310293 (500 test kit) Product Usage: This in vitro diagnostic assay is intended to quantitatively measure prostate-specific Antigen (PSA) in human serum using the ADVIA Centaur/XP/XPT/CP Systems. SMN 10310292-100 test kits Lot# UDI # 54637263 0063041420300354637263160223 55304263 0063041420300355304263160223 56249264 0063041420300356249264160327 76727264 0063041420300376727264160327 00825265 0063041420300300825265160424 92416265 0063041420300392416265160424 99151265 0063041420300399151265160424 12970266 0063041420300312970266160721 14158266 0063041420300314158266160721 23016266 0063041420300323016266160721 28881266 0063041420300328881266160721 40776268 0063041420300340776268160922 SMN 10310293-500 test kits Lot# UDI # 54448263 0063041420299054448263160223 55171263 0063041420299055171263160223 56171264 0063041420299056171264160327 77560264 0063041420299077560264160327 92415265 0063041420299092415265160424 96996265 0063041420299096996265160424 12971266 0063041420299012971266160721 13429266 0063041420299013429266160721 19651266 0063041420299019651266160721 27278266 0063041420299027278266160721 35089266 0063041420299035089266160721 39805268 0063041420299039805268160922 50851268 0063041420299050851268160922 Class II PSA assay is not meeting the High Dose Hook Effect expectation in the Instructions for Use (IFU). Siemens Healthcare Diagnostics, Inc
Devices HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL Streptokinase reagent and 2 x 2 mL Chromogenic substrate Lot No. N0455811, Expiration Date 03/31/2017 Class II Customer complaints identified and internal testing confirmed that HemoslL Plasminogen Lot N0455811 is not meeting labeled on-board instrument stability claims of 5 days. Instrumentation Laboratory Co.
Devices Synthes Small Electric Drive (SED). For use in general traumatology. All Lots Class II The affected Small Electric Drive (SED) may operate solely in reverse mode, not operate in reverse mode when intended, not function, or unintentionally start. The Anspach Effort, Inc.
Biologics Apheresis Platelets, Leukocytes Reduced, Irradiated W201815816599; W201815816609 (double) Class II Apheresis Leukoreduced products, with an elevated WBC count, were distributed. American National Red Cross Great Lakes Region
Devices PS-500 Scope Warmer; 10 units per box. Pre-heating scope for laparoscopy surgery. Lot# G154341 Exp: 4/14/18 Class II Damage to package seals potentially compromising sterility. JosNoe Medical, Inc.
Food Tong Ren Tang Shenjing Shuairuo Wan Herbal Supplement 240 pills UPC Code: 6 904579 129602 Distributed by: Solstice Medicine Company SMC Code: TRT10 Lot #2080130 Class II Madison One Acme, Inc. dba Solstice Medicine is recalling Tong Ren Tang Shenjing Shuairuo Wan because it contains the unapproved dietary ingredient human placenta which may transmit disease. Madison One Acme Inc
Devices DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #459800200621 Software Version 10.0.0 and 14.0.0 Class II In DS/US proton planning, there is a correction factor used internally to the dose engine that is calculating improperly in some cases. This can result in an incorrect dose calculation. Philips Medical Systems
Devices BacT/ALERT® SN, bioMérieux, Inc. Product Usage: BacT/ALERT® Culture Bottles are used with the BacT/ALERT® Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast). Reference number: 259790, Lot number: 1042739, Expiry: 09JAN2016. Class II Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and impact growth performance. bioMerieux, Inc.
Devices BacT/ALERT® FA, bioMérieux, Inc., Product Usage: BacT/ALERT® Culture Bottles are used with the BacT/ALERT® Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast). Reference number: 259791, Lot number: 1042923, Expiry: 25JAN2016 and Lot number 1042979, Expiry: 28JAN2016. Class II Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and impact growth performance. bioMerieux, Inc.
Devices The ABX PENTRA Cholesterol CP ref. A11A01634 is an in vitro diagnostic assay for quantitative determination of cholesterol in human serum and plasma based on an enzymatic photometric test (Trinders reaction). The assay is composed of a 99 ml mono-reagent cassette. Reagent is a chemical solution with additives. All Lots Class II N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide catalytic on aminoantipyrine and phenol, and can produce falsely low results with the reagents using the Trinder reaction method. Horiba Instruments Inc
Devices ABX PENTRA Enzymatic Creatinine CP ref. A11A01907 reagent is intended for the quantitative in vitro diagnostic determination of creatinine in human serum, plasma and urine based on an enzymatic method of using a multi-step approach ending with a photometric end-point reaction. All Lots Class II N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide catalytic on aminoantipyrine and phenol, and can produce falsely low results with the reagents using the Trinder reaction method. Horiba Instruments Inc
Devices ABX PENTRA Glucose PAP CP ref. A11A01668 reagent is intended for the quantitative in vitro diagnostic determination of glucose in human serum, plasma and urine using glucose oxidase method by colorimetry. All Lots Class II N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide catalytic on aminoantipyrine and phenol, and can produce falsely low results with the reagents using the Trinder reaction method. Horiba Instruments Inc
Devices ABX PENTRA Lactic Acid CP ref. A11A01721 reagent is intended for the quantitative in vitro diagnostic determination of lactic acid in plasma by colorimetry. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood). All Lots Class II N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide catalytic on aminoantipyrine and phenol, and can produce falsely low results with the reagents using the Trinder reaction method. Horiba Instruments Inc
Devices ABX PENTRA Triglycerides CP ref. A11A01640 is an in vitro diagnostic assay for the quantitative determination of triglycerides in human serum and plasma based on an enzymatic colorimetric test. It is composed of a 99 ml mono-reagent cassette. Reagent is a chemical solution with additives. All Lots Class II N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide catalytic on aminoantipyrine and phenol, and can produce falsely low results with the reagents using the Trinder reaction method. Horiba Instruments Inc
Devices ABX PENTRA Uric Acid CP ref. A11A01670 is an in vitro diagnostic assay for the quantitative determination of uric acid in human serum, plasma and urine based on the enzymatic determination of uric acid using a chromogenic system in the presence of peroxidase and uricase (Trinder method). All Lots Class II N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide catalytic on aminoantipyrine and phenol, and can produce falsely low results with the reagents using the Trinder reaction method. Horiba Instruments Inc
Drugs Lyrica (pregabalin) capsules, 50 mg, 90-count bottle, Rx only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY, NY 10017, NDC 0071-1013-68 Lot #: M07861, Exp 05/2018 Class II FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules. Pfizer Inc.
Drugs Lyrica (pregabalin) capsules, 75 mg, 90-count bottle, Rx only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY, NY 10017, NDC 0071-1014-68 Lot #: M07862, Exp 05/2018; M07865, Exp 06/2018 Class II FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules. Pfizer Inc.
Devices ET-20 Anesthesia Extension Tubes, 2.5 ml approximately, Sterile and Disposable, Wall Medical Inc., Made in China Lot Number 1505201 Class II Firm was notified of a potential product defect related to kinking (flattening) of anesthesia extension tubes which may represent a potential health hazard. Global Healthcare Inc
Devices Olympus TJF-Q180V flexible gastrointestinal Duodenoscope Product Usage: This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum. all codes Class II Olympus America Inc is conducting a voluntary removal/corrective action of all TJF-Q180V duodenoscopes in order to replace the forceps elevator mechanism Olympus is replacing the forceps elevator mechanism with a new forceps elevator design consistent with the design specification in the recently cleared TJF-Q180V 510k. Olympus Corporation of the Americas
Devices API ZYM Bx2 (Ref 70493) Product Usage: ZYM B reagent is an additional test used for revealing the results of some miniaturized biochemical test including in the involved API strips. Lot No. PF - 1003765610/Lot No. Ampules - 1003693040/Exp. date 1/15/16 Lot No. PF - 1003772410/Lot No. Ampules - 1003711170/Exp. date 1/19/16 Lot No. PF - 1003772470/Lot No. Ampules - 1003733320/Exp. date 1/29/16 Lot No. PF - 1003787970/Lot No. Ampules - 1003693020/Exp. date 1/12/16 Lot No. PF - 1003790030/Lot No. Ampules - 1003790010/Exp. date  ...
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Class II Discrepant identification results related to API identification strips. These discrepant identification results are due to false negative results on the tests of the strips linked to the ZYM B reagent. BioMerieux SA
Biologics Blood and Blood Products for Reprocessing W200315444309 Class III Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. The American National Red Cross - Southern Region
Biologics Pooled Cryoprecipitated AHF W200315913640 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. The American National Red Cross - Southern Region
Devices Astral 100, 150 Model: 27001, 27003 In the US, Astral devices are primarily used as non-invasive homecare devices, for example, the largest population of patients on the Astral device is COPD patients primarily using the device at night with some daytime use for recovery breathing. While it is possible that there may be scenarios where critically dependent patients may encounter this scenario, the likelihood of this leading to harm is negligible because critically dependent patients will have a form of backup ventilation as standard of care. Class II Resmed Corporation is recalling Astral 100, 150 External Battery because of a start-up issue. Resmed Corporation
Drugs Nystatin, USP Powder for Rx compounding, 50 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0405-05, UPC 305740404058. Lot #: 2015050194, Exp 2/2016 Class II Labeling: label error on declared strength. Perrigo Company PLC
Drugs Nystatin, USP Powder for Rx compounding, 150 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0404-15, UPC 305740404157 Lot #: 2015080484, Exp 02/2016 Class II Labeling: label error on declared strength. Perrigo Company PLC
Drugs Clonazepam Tablets, USP, 0.5 mg, 100-count carton, Rx only, Manufactured by Mylan Pharmaceuticals Inc., Morgantown, WV, 26505, NDC:51079-881-21 Lot # 3063759, Exp.07/16 Class III Failed Impurities/Degradation Specifications: out of specification result for known impurity at 6 month timepoint. Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
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