ErgoSafe Product LLC dba Prism Medical Services - Medcare Lift with Scale...
400003 Medcare Lift with Scale 400013 Medcare Lift w/Scale 600 lb 400600 Scale Hanger Assembly Product Usage: The intended use is a patient hanger bar (400600) attached to a 400003 or 400013 floor lift...
View ArticleDraeger Medical, Inc. - Drger Breathing Bag - Class 2 Recall
Reusable latex breathing bags with multiple part numbers and sold as part of test lung part number and reusable anaesthesia sets. Product Usage: The breathing bag is a component of the anesthesia set...
View ArticleDraeger Medical Systems, Inc. - Draeger Oxylog 3000 plus ventilators - Class...
Draeger Oxylog 3000 plus ventilators Product Usage: The Oxylog 3000 plus is a time-cycled, volume controlled and pressure-controlled emergency and transport ventilator for patients requiring mandatory...
View ArticleGambro Renal Products, Incorporated - Gambro Cartridge Blood Set - Class 2...
Gambro Cartridge" Blood Set blood transport system for hemodialysis, Model Number(s): 101025 (003410510) - Cartridge set, STND PRM LN and 103401 (003414500) - Cartridge set, PRM_LN_INJ_PT. The Gambro...
View ArticleDel Mar Reynolds Medical, Ltd. - Arkon Anesthesia Delivery System - Class 1...
Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator. Product Usage: The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital...
View ArticleSynthes, Inc. - Class 2 Recall
Synthes CMF Battery Powered Driver Used to place screws in the cranialfacial bones, and to drill and/or tap holes to prepare cranialfacial bones for screw insertion. The Product Quantity Distributed...
View ArticleSynthes, Inc. - The Synthes Hohmann Retractor - Class 2 Recall
The Synthes Hohmann Retractor, 43 mm Long Shank, Angled 235 mm Product Usage: Used to expose bone for procedures.
View ArticleBiomet 3i, LLC - BIOMET 3i Endosseous Dental Implant - Class 2 Recall
BIOMET 3i Endosseous Dental Implant The BIOMET 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations...
View ArticleNewport Medical Instruments Inc - Ventilator - Class 1 Recall
Newport HT70 and HT70 Plus Ventilators, Model Number: HT70 and HT70 Plus. Product Usage: The HT70 ventilator system is intended to provide continuous or intermittent positive pressure mechanical...
View ArticlePhilips Medical Systems (Cleveland) Inc - Ingenuity Core128 - Class 2 Recall
Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical Systems (Cleveland), Inc., Cleveland, Ohio 44143 The Ingenuity Core 128 scanners are whole body Computed Tomography X-ray systems...
View ArticleCareFusion 303, Inc. - SmartSite Extension Set - Class 2 Recall
SmartSite Extension Set, Model No. 20029E Product Usage: The SmartSite Extension Sets are used to administer fluid and medications through a needle or catheter inserted into the patient s artery or...
View ArticleSiemens Medical Solutions USA, Inc - Class 2 Recall
AXIOM Vertix MD Trauma systems radiographic X-ray
View ArticlePhilips Medical Systems (Cleveland) Inc - Brilliance CT 16, Brilliance CT 64,...
Brilliance CT 16, Brilliance CT 64, Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology, Brilliance iCT, Ingenuity CT, Ingenuity Core, Ingenuity Core 128 and Ingenuity Flex scanners are...
View ArticleSolta Medical, Inc. - Fraxel Laser System - Class 2 Recall
FRAXEL DUAL 1550/1927 Laser System (FRAXEL SR 1500 DUAL Laser System) Product Usage: Used for dermatological procedures requiring coagulation of soft tissue as well as for skin resurfacing, treatment...
View ArticleTerumo Cardiovascular Systems Corp - Terumo Cardiovascular Systems Kit...
Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE Catalog Number: 73431
View ArticleGE OEC Medical Systems, Inc - OEC 9900 Elite - Class 2 Recall
The OEC 9900 Elite mobile fluoroscopy system (image intensified fluoroscopic x-ray) is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional...
View ArticleEdwards Lifesciences, LLC - Edwards Lifesciences FemFlex II Arterial and...
Edwards Lifesciences Fem-Flex II" Arterial and femoral Cannulae, models listed below: FEMII016A, FEMII016AS, FEMII018A, FEMII018AS, FEMII020A, and FEMII020AS.
View ArticleEdwards Lifesciences, LLC - Edwards Lifesciences FemFlex II Arterial and...
Edwards Lifesciences Fem-Flex II" Arterial and femoral Cannulae with Duraflo Coating, models listed below:
View ArticleMicro Therapeutics Inc, Dba Ev3 Neurovascular - Alligator Retrieval Device...
Alligator Retrieval Device (ARD). The Alligator Retrieval device is intended for use in the peripheral and neurovasculature for foreign body removal.
View ArticleMicro Therapeutics Inc, Dba Ev3 Neurovascular - Pipeline Embolization Device...
Pipeline Embolization Device (PED). The Pipeline Embolization Device is indicated for the endovascular treatment of adults (22 years of age and older) with large or giant widenecked intracranial...
View Article
