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High RiskFDA
Perkin Elmer Life Sciences Inc
Perkin Elmer Specimen Gate, Screening Center. Data management of neonatal screening test results and demographics by qualified laborator...
Medical Devices·6 affected·Aug 24, 2015
High RiskFDA
Terumo Cardiovascular Systems Corp
Terumo Custom Cardiovascular Procedure Kit Tubing Pack P/N: 66041-1 Terumo Cardiovascular Procedure Kits are manufactured and customize...
Medical Devices·5 affected·Aug 24, 2015
High RiskFDA
Terumo Cardiovascular Systems Corp
Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack with FX25RE P/N: 7928-03 Terumo Cardiovascular Procedure Kits are ma...
Medical Devices·30 affected·Aug 24, 2015
High RiskFDA
Terumo Cardiovascular Systems Corp
Terumo Custom Cardiovascular Procedure Kit X-Coated Pediatric Pack P/N: 74039-02 Terumo Cardiovascular Procedure Kits are manufacture...
Medical Devices·6 affected·Aug 24, 2015
High RiskFDA
Terumo Cardiovascular Systems Corp
Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75185 Terumo Cardiovascular Procedure Kits are manufactu...
Medical Devices·19 affected·Aug 24, 2015
High RiskFDA
Terumo Cardiovascular Systems Corp
Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack P/N: 74077-01 Terumo Cardiovascular Procedure Kits are manufacture...
Medical Devices·15 affected·Aug 24, 2015
High RiskFDA
Terumo Cardiovascular Systems Corp
Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75529 Terumo Cardiovascular Procedure Kits are manufactu...
Medical Devices·17 affected·Aug 24, 2015
High RiskFDA
Teleflex Medical
Rusch Flexi-slip tracheal tube Stylet, Size Ch 6, Sterile, Teleflex Medical.
Medical Devices·233,641 affected·Aug 24, 2015
High RiskFDA
Siemens Healthcare Diagnostics Inc
Siemens RAPIDPoint 500 Measurement Cartridge Lactate (100) tests Part Number: 10844813 Product Usage: The RAPIDPoint 500 system is d...
Diabetes Devices·49 affected·Aug 24, 2015
High RiskFDA
Cantrell Drug Company
HEPARIN Sodium in 0.45% Sodium Chloride, 1 USP Unit/2 mL (0.5 USP Units/mL), Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-14...
Drugs·4,170 affected·Aug 21, 2015
High RiskFDA
Nephron Pharmaceuticals Corp.
Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator, Starter Kit (Racepinephrine 11.25 mg) 10 individual foil wrapped vials wi...
Drugs·47,754 affected·Aug 21, 2015
High RiskFDA
Nephron Pharmaceuticals Corp.
Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator Refills (Racepinephrine USP 11.25 mg), 30 individual foil wrapped vials p...
Drugs·32,490 affected·Aug 21, 2015
High RiskFDA
Nephron Pharmaceuticals Corp.
Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution, packaged in 30x3 mL Sterile Unit-Dose Vials, a) 30 count (NDC ...
Drugs·85,248 affected·Aug 21, 2015
High RiskFDA
Cantrell Drug Company
MIDAZOLAM HCl in 0.9% Sodium Chloride Injection, 2 mg/2 mL (1 mg/mL), in 2 mL syringe, Rx only, Cantrell Drug Co., Little Rock, AR --- ND...
Injectable Drugs·1,570 affected·Aug 21, 2015
High RiskFDA
Cantrell Drug Company
Midazolam HCl in 0.9% Sodium Chloride Injection, 0.5 mg/mL 1 mL (0.5 mg/mL), 1 mL syringes, Rx Only, Cantrell Drug Co., Little Rock AR --...
Injectable Drugs·3,853 affected·Aug 21, 2015
High RiskFDA
Cantrell Drug Company
LIDocaine HCl 1% BUFFERED WITH SODIUM BICARBONATE Injection, packaged in 3 mL Syringes, Rx Only, Cantrell Drug Co., Little Rock, AR --- U...
Injectable Drugs·450 affected·Aug 21, 2015
High RiskFDA
Cantrell Drug Company
HEParin Sodium 0.5 USP UNITS/mL in 0.225% SODIUM CHLORIDE, in 3 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999992212
Drugs·352 affected·Aug 21, 2015
High RiskFDA
Cantrell Drug Company
MIDAZolam HCl 0.1 mg/mL in 5% DEXTROSE 2.5 mL syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999993721
Drugs·212 affected·Aug 21, 2015
High RiskFDA
Brett Anthony Foods
The product is in the form of a salad kit. It contains two plastic bags and one plastic container. The contents are; salad 3.7 lbs/bag, a...
Produce·0 affected·Aug 20, 2015
High RiskFDA
Hospira Inc.
Ketamine Hydrochloride Injection, USP (100 mg/mL) packaged in 5 mL multi-dose glass fliptop vials, 10 vials per box, Rx only, Manufacture...
Injectable Drugs·83,320 affected·Aug 20, 2015
High RiskFDA
Orthovita, Inc., Dba Stryker Orthobiologics.
Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakene...
Medical Devices·9,805 affected·Aug 20, 2015
High RiskFDA
Pharmakon Pharmaceuticals
Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.0625 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKO...
Injectable Drugs·0 affected·Aug 19, 2015
High RiskFDA
Pharmakon Pharmaceuticals
Ketamine 50 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Injectable Drugs·250 affected·Aug 19, 2015
High RiskFDA
Pharmakon Pharmaceuticals
Ephedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 25 mg/ 5mL, Rx only, PHARMAKON Pharmaceuti...
Injectable Drugs·4,123 affected·Aug 19, 2015
High RiskFDA
Pharmakon Pharmaceuticals
Phenylephrine (PF) 100 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 500 mcg/ 5mL, Rx only, PHARMAKON Pharm...
Injectable Drugs·0 affected·Aug 19, 2015
High RiskFDA
Pharmakon Pharmaceuticals
Ketamine 100 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Injectable Drugs·600 affected·Aug 19, 2015
High RiskFDA
Pharmakon Pharmaceuticals
Midazolam (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.2 mg/ 2mL, Rx only, PHARMAKON Pharmaceuti...
Injectable Drugs·665 affected·Aug 19, 2015
High RiskFDA
Pharmakon Pharmaceuticals
Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 4 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pha...
Injectable Drugs·0 affected·Aug 19, 2015
High RiskFDA
Pharmakon Pharmaceuticals
Rocuronium 10 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Injectable Drugs·5,875 affected·Aug 19, 2015
High RiskFDA
Pharmakon Pharmaceuticals
Midazolam (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.5 mg/ 1mL, Rx only, PHARMAKON Pharmaceuti...
Injectable Drugs·210 affected·Aug 19, 2015
High RiskFDA
Pharmakon Pharmaceuticals
Ondansetron 2 mg/mL, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.
Injectable Drugs·4,100 affected·Aug 19, 2015
High RiskFDA
Pharmakon Pharmaceuticals
Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 1 mg/ 1mL, Rx only, PHARMAKON Pharmaceutic...
Injectable Drugs·8,000 affected·Aug 19, 2015
High RiskFDA
Pharmakon Pharmaceuticals
Succinylcholine 20 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Injectable Drugs·2,750 affected·Aug 19, 2015
High RiskFDA
Pharmakon Pharmaceuticals
Epinephrine (PF) 10 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only, PHARMAKON Pharmaceut...
Injectable Drugs·1,150 affected·Aug 19, 2015
High RiskFDA
Pharmakon Pharmaceuticals
Morphine Sulfate (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.5 mg/ 1mL, Rx only, PHARMAKON Phar...
Injectable Drugs·475 affected·Aug 19, 2015
High RiskFDA
Pharmakon Pharmaceuticals
Fentanyl Citrate (PF) 50 mcg/mL, injectable packed in syringes a) Total dosage 250 mcg/ 5mL, b) Total dosage 100 mcg/ 2mL, Rx only, PHARM...
Injectable Drugs·7,100 affected·Aug 19, 2015
High RiskFDA
Pharmakon Pharmaceuticals
Lidocaine HCI (PF) Inj, USP 2%, injectable packed in syringes, Total dosage 100 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Injectable Drugs·400 affected·Aug 19, 2015
High RiskFDA
Pharmakon Pharmaceuticals
Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 16 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Ph...
Injectable Drugs·378 affected·Aug 19, 2015
High RiskFDA
Pharmakon Pharmaceuticals
Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.25 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON ...
Injectable Drugs·0 affected·Aug 19, 2015
High RiskFDA
Pharmakon Pharmaceuticals
Midazolam 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 2 mg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Injectable Drugs·5,000 affected·Aug 19, 2015
High RiskFDA
Pharmakon Pharmaceuticals
Glycopyrrolate 0.2 mg/mL, injectable packed in syringes, Total dosage 1 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Injectable Drugs·1,530 affected·Aug 19, 2015
High RiskFDA
Pharmakon Pharmaceuticals
Morphine Sulfate (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.1 mg/ 1mL, Rx only, PHARMAKON Phar...
Injectable Drugs·525 affected·Aug 19, 2015
High RiskFDA
Pharmakon Pharmaceuticals
Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 1 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pha...
Injectable Drugs·0 affected·Aug 19, 2015
High RiskFDA
Resource Optimization & Innovation Llc
Regard Custom Surgical Pack, Item Number: 800208002; Sterile, CV0361B - CABG A&B. Used in cardiovascular surgical procedures.
Surgical Devices·67 affected·Aug 19, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON SC2000 Ultrasound System with software versions VB10B and lower; Model 10433816; Product Usage: The SC2000 ultrasound imaging ...
Cardiac Devices·2,039 affected·Aug 19, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Force; computed tomography x-ray system. Intended to generate and process cross-sectional images of patients.
Medical Devices·21 affected·Aug 18, 2015
High RiskFDA
Medtronic Perfusion Systems
MEDTRONIC PERFUSION TUBING PACKS (with potentially affected Hemoconcentrators). Model # 7U65R2, 8C72R4, 6N21R2, BB7M38R11, TL2Q68R17, H...
Medical Devices·1,594 affected·Aug 18, 2015
High RiskFDA
Brainlab Ag
Disposable Reflective Marker Spheres The Disposable Reflective Marker Spheres used in conjunction with a stereotaxic instrument consis...
Surgical Devices·28 affected·Aug 18, 2015