Recalls:
CareFusion AVEA Ventilator: Recall - Failure May Lead to Lack of Ventilation
The ventilator may develop a failure where the ventilator activates a false extended high peak alarm, opens the safety valve and stops ventilating...
Smiths Medical Issues Urgent Device Recall of Certain Bivona Neonatal, Pediatric, and Flextend Tracheostomy Tubes
Customers have experienced difficulty disconnecting accessories from the connectors of affected tubes...
St. Jude Medical, Riata and Riata ST Silicone Endocardial Defibrillation Leads: Class 1 Recall - Failures with Lead Insulation
The silicone insulation covering these defibrillation leads is at risk of premature abrasion...
CooperVision Avaira (enfilcon A) Sphere Soft Contact Lens: Class 1 Recall - Unintended Residue on Lenses
Symptoms may range from hazy, blurry vision, discomfort to eye injuries requiring medical treatment...
Draeger Medical Inc., Infinity Acute Care System Monitoring Solution (M540)
This recall is being issued due to incorrect dosage values and vital signs delays at the Infinity Central Station...
Safety Alerts:
Steris System 1 (SS1) Processor: Second 6 Month Extension for Health Care Facilities to Replace STERIS System 1 with a Legally-Marketed Alternative
During this transition period, the FDA will monitor the availability and supply of legally-marketed replacement products...
FDA Targets Gastric Band Weight-Loss Claims
FDA has warned eight surgical centers and the marketing firm 1-800-GET-THIN LLC about misleading advertising of the Lap-Band...
FDA and Partners Working to Prevent Surgical Fires
This FDA Consumer Update provides information about how surgical fire events can happen and how to reduce their risk...
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