November 2016 MedSun Newsletter
Willy Rusch Tracheostomy Tube Set by TeleFlex Medical: Class I Recall Recall due to the possibility that the connector may disconnect from the tracheostomy tube during use on a ventilated patient... Radiation Therapy Devices by Multidata Systems International: Discontinue Use The FDA knows of at least two Multidata medical devices that the company manufactured and distributed in the U.S. for which FDA never received nor reviewed 510(k) premarket notifications... Medtronic Neurovascular Products: Recall Recall due to the potential separation and detachment of the polytetrafluoroethylene (PTFE) coating on parts of these devices... Stӧckert 3T Heater-Cooler System by LivaNova PLC (formerly Sorin Group Deutschland GmbH): UPDATED Safety Communication FDA is updating its June 2016 Safety Communication to provide new information about Mycobacterium chimaera (M. chimaera) infections associated with the use of these devices...
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