February 2016 MedSun Newsletter
Recalls and Safety Alerts:
Automated Endoscope Reprocessors (AERs) Validation Testing
FDA has updated its’ Reprocessing of Reusable Medical Devices webpage with information on which manufacturers completed their AER validation testing with adequate results. The page will be updated as FDA accepts validation test results for other AER manufacturers...
Moves Ventilator System by Thornhill Research: Class I Recall
Excess glue on the battery connectors may prevent the battery from powering the device after the battery is stored…
Baxter IV Solutions (Select Lots): Recall
Baxter is voluntarily recalling four lots of intravenous (IV) solutions to the hospital/user level due to the potential for leaking containers and particulate matter…
Optisure Dual Coil Defibrillation Leads by St. Jude Medical: Class I Recall
A manufacturing error may have caused damage to the insulation layer of one of the shock coils…
Brainlab Cranial Image-Guided Surgery (IGS) System: Class I Recall
Recall due to potential inaccuracies in the display by the navigation system compared to the patient anatomy…
Duodenoscope Model TJF-Q180V by Olympus: FDA Safety Communication
Updated status information about the Agency's 510(k) clearance decision on the device…
Pleural and Pneumopericardial Drainage Sets by Stryker Fuhrman - Class I Recall
The manufacturer received two reports that the catheter included in the drainage set broke off in the pleural cavity while inserting the device into the patient…
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