Date: December 24, 2015
The following new items were added to the CDRH web pages on December 23, 2015. Previous CDRH New Items can be found on theCDRHNew Page.
- Class I Medical Device Recall: Boston Scientific Corporation, Chariot Guiding Sheath May Break off During the Procedure
- Class I Medical Device Recall: Draeger Perseus A500 Anesthesia Workstation - Faulty Power Switch May Cause Device to Stop Working
- FUJIFILM Medical Systems, U.S.A., Inc. Validates Revised Reprocessing Instructions for Model ED-530XT Duodenoscopes: FDA Safety Communication
- Class I Medical Device Recall: Insulet Corporation OmniPod Insulin Management System: Needle May Fail to Deliver Insulin