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High RiskFDA
Perry Drug Inc.
Sodium Tetradecyl SO4 0.3% Inj., 30 Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-6427-90
Drugs·20 affected·Nov 7, 2014
High RiskFDA
Perry Drug Inc.
HCG 10,000 U/ 10 mL PF Inj, 8Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5012-34
Drugs·3 affected·Nov 7, 2014
High RiskFDA
Perry Drug Inc.
Tri Mix PF SYR 0.5 mL Inj., Compounded Rx, 10 each, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5036-49
Drugs·20 affected·Nov 7, 2014
High RiskFDA
Perry Drug Inc.
Tri-mix Antidote 10 each Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-0205-17
Drugs·10 affected·Nov 7, 2014
High RiskFDA
Perry Drug Inc.
Testosterone CYP-250/PROP-20 mg, 10 Ml Syringe, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-0326-44
Drugs·1 affected·Nov 7, 2014
High RiskFDA
Perry Drug Inc.
2Ml HCG 10,000 U/ MB12 - 12,000 MCG/10 Ml Inj, 0.25ML (250IU), Rx, Perry Drug Compounding Pharmacy, Overland Park, KS ---NDC 88888-7945-17
Drugs·1 affected·Nov 7, 2014
High RiskFDA
Perry Drug Inc.
Cyclosporine 0.045 % Sol PF, 12 mL bottle, Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5120-67
Drugs·3 affected·Nov 7, 2014
High RiskFDA
Depuy Orthopaedics, Inc.
Ceramic Femoral Head. Intended for use in total hip arthroplasty applications to replace the articular surface of the femoral head i...
Medical Devices·19 affected·Nov 7, 2014
High RiskFDA
Biomet 3i, Llc
OSSEOTITE Tapered Certain Implant Rx Only; 3.25 x 18.5 - 15.0 mm. Dental Implants.
Medical Implants·620 affected·Nov 7, 2014
High RiskFDA
Ion Beam Applications S.a.
adaPT insight (12C), v1.3.2, PAT.109 (US), Treatment room 4: I2C is used with a charged particle or photon radiation therapy system for ...
Medical Devices·1 affected·Nov 7, 2014
High RiskFDA
Biomet 3i, Llc
OSSEOTITE Certain 2 Implant Rx only; 3.25 x 8.5 - 18 mm. Dental Implants.
Medical Implants·620 affected·Nov 7, 2014
High RiskFDA
Unomedical As
Comfort 5+5 Pack w/110cm Tube & 17mm Cann. UPC# 3-89110-14147-7; Comfort 5+5 Pack w/60cm Tube & 17mm Cann. UPC# 3-89110-14127-9; Comfort ...
Diabetes Devices·22,114 affected·Nov 7, 2014
High RiskFDA
Unomedical As
AC TenderLink 13/30 10 pcs; AC TenderLink I 13/60 10 pcs; AC TenderLink I 13/80 10 pcs; AC TenderLink I 17/110 10 pcs; AC TenderLink I 17...
Diabetes Devices·653,280 affected·Nov 7, 2014
High RiskFDA
Unomedical As
Contact Detach, 8mm, 23", G29; Contact Detach 8 mm, 43", G29; Contact Detach, 6mm, 23" G29; Infusion Set, Contact Detach, 6mm x 23"; Infu...
Diabetes Devices·664,000 affected·Nov 7, 2014
High RiskFDA
Integra Lifesciences Corp.
Integra Licox Brain Tissue Oxygen Monitoring Integra Licox Recon Tissue Oxygen Monitoring 1) LICOX¿ Complete Brain Probe Kit (compris...
Respiratory Devices·2,506 affected·Nov 7, 2014
High RiskFDA
Unomedical As
SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29 6mm 32"' SureT G29 6mm, 32", Paradigm; SureT G29...
Diabetes Devices·4,748,000 affected·Nov 7, 2014
High RiskFDA
Becton Dickinson & Co.
BD Viper LT System, catalog number 442839 when used in conjunction with the BD ProbeTec Chlamydia trachomatis (CT) Qx Assay (cat. #442959...
Diagnostic Devices·7 affected·Nov 7, 2014
High RiskFDA
Unomedical As
Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm...
Diabetes Devices·9,782,880 affected·Nov 7, 2014
High RiskFDA
Schwartz Brothers Restaurants Dba Schwartz Brothers Bakery
"Everything Bagels" product is packed in a clear 4-pack plastic bag, with visible image of cheese melted on top of the bagels. This pro...
Dairy·321 affected·Nov 6, 2014
High RiskFDA
Zimmer Biomet, Inc.
ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments.
Surgical Devices·31 affected·Nov 6, 2014
High RiskFDA
Abbott Medical Optics Inc (amo)
Abbott Healon EndoCoat Ophthalmic Viscosurgical Device 3% sodium hyaluronate 0.85 mL 30 mg/mL Sterile A Solution Sterile EO Packaging...
Surgical Devices·484,881 affected·Nov 6, 2014
High RiskFDA
Fisher & Paykel Healthcare, Ltd.
Fisher and Paykel Healthcare (FPH) IW900-Series Infant Warmer Fisher and Paykel; Healthcare CosyCot and Kit Replacement Head Case Asse...
Medical Devices·661 affected·Nov 6, 2014
High RiskFDA
Synthes (usa) Products Llc
Synthes Small Electric Drive (SED), part number: 05.001.175: The Small Electric Drive is designed for use in general traumatology, especi...
Surgical Devices·12 affected·Nov 6, 2014
High RiskFDA
Sushi House Inc.
Frozen Raw Yellowfin Tuna Ground Meat (Thunnus albacares), Grade: AAA, Net Weight: 10 lbs (100%), Wild Caught, Product of Indonesia, Impo...
Meat & Poultry·280 affected·Nov 5, 2014
High RiskFDA
Philips Ultrasound, Inc.
Additional devices identified in new FSN MA-FCO 83000190: QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins installed with Philips Xc...
Medical Devices·52 affected·Nov 5, 2014
High RiskFDA
Philips Ultrasound, Inc.
EPIQ 7 Ultrasound System, EPIQ 7 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug-ins are affected. Model: ...
Diagnostic Devices·701 affected·Nov 5, 2014
High RiskFDA
Gambro Renal Products Inc
Polyflux Revaclear Max Dialyzer, Model Number 110634. The Polyflux Revaclear¿ and Polyflux Revaclear¿ Max Dialyzers are single use dev...
Medical Devices·20 affected·Nov 5, 2014
High RiskFDA
Gambro Renal Products Inc
Polyflux Revaclear Dialyzer, Model Number 110633. The Polyflux Revaclear¿ and Polyflux Revaclear¿ Max Dialyzers are single use devices...
Medical Devices·20 affected·Nov 5, 2014
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating; Part Number BEQ-HMOD-30000 For cardiac surgery in comb...
Cardiac Devices·28 affected·Nov 5, 2014
High RiskFDA
Custom Healthcare Systems, Inc.
Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 - 12 pr case. Packaged for Physician use only.
Medical Devices·3 affected·Nov 5, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista 500 Intelligent Lab System or Dimension Vista 1500 Intelligent Lab System: An in vitro diagnostic device intended to ...
Diagnostic Devices·1,949 affected·Nov 5, 2014
High RiskFDA
R And S Gourmet Warehouse
Gourmet Warehouse, Island Jerk Marinade, 16 fl oz. (473 mL), Ingredient: Soy Sauce, Lemon Juice, Thyme, Allspice, Onion, Garlic, Cayenne ...
Beverages·0 affected·Nov 4, 2014
High RiskFDA
R And S Gourmet Warehouse
Gourmet Warehouse, Red Wine Marinade, 16 fl.oz. (473 mL), Ingredient: Soy Sauce, Salt, Black Pepper, Cayenne Pepper, Garlic, Red Wine, Vi...
Produce·698 affected·Nov 4, 2014
High RiskFDA
Medtronic Minimed Inc.
Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion Sets; Paradigm Silhouette infusion sets: MMT-368, MMT-368600, MMT-371, MMT-37...
Diabetes Devices·12,400,098 affected·Nov 4, 2014
High RiskFDA
Philips Medical Systems (cleveland) Inc
BrightView product code: 882478 BrightView X product code: 882480 BrightView XCT product code: 882482 and 882454
Medical Devices·85 affected·Nov 4, 2014
High RiskFDA
Aircraft Medical Limited
McGrath MAC2 Video Laryngoscope Blades Product supplied in box of 50 items, each individually peel-pouched and EtO sterilized. Prod...
Medical Devices·40,900 affected·Nov 4, 2014
High RiskFDA
Smith & Nephew, Inc.
LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 5, RIGHT, REF 71426005, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.
Medical Implants·45 affected·Nov 4, 2014
High RiskFDA
Advanced Sterilization Products
STERRAD NX, Product Code 10133 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpo...
Medical Devices·19,978 affected·Nov 4, 2014
High RiskFDA
Pulsion Medical Inc
Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor, one unit per plastic sterilizable package. Product Usa...
Cardiac Devices·90 affected·Nov 4, 2014
High RiskFDA
Advanced Sterilization Products
STERRAD 200, Product Code 10118 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purp...
Medical Devices·19,978 affected·Nov 4, 2014
High RiskFDA
Raymond-hadley Corp.
Pride of Africa brand Farina, Net Wt. 5 lb. (2.27 kg), UPC 016712016840 --- A Product of Raymond-Hadley Corp. Spencer, NY 14883 1-800-25...
Food·3,972 affected·Nov 3, 2014
High RiskFDA
Raymond-hadley Corp.
Pride of Africa brand Semo "Semolina", Net Wt. 5 lb., UPC 016712016918 --- A Product of Raymond-Hadley Corp. Spencer, NY 14883 1-800-252...
Food·5,706 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM RESANO FORCEPS,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·509 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM,MICRO BIPOLAR FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·509 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM PERMANENT CAUTERY HOOK,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·509 affected·Nov 3, 2014
High RiskFDA
Elekta, Inc.
MOSAIQ Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planing and delivery. It suppor...
Medical Devices·15 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM, CARDIAC PROBE GRASPER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Cardiac Devices·509 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM,POTTS SCISSORS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·509 affected·Nov 3, 2014