CDRH New Update

CDRHNew

Date: January 12, 2017

The following new items were added to the CDRH web pages on January 11, 2017. Previous CDRH New Items can be found on the CDRHNew Page.

• Class I Medical Device Recall: Bayer Recalls Medrad Intego PET Infusion System Source Administration Sets due to Particulates Generated in Vial
• Safety Concerns with Implantable Infusion Pumps in the Magnetic Resonance (MR) Environment: FDA Safety Communication