Date: August 26, 2016
The following new items were added to the CDRH web pages on August 25, 2016. Previous CDRH New Items can be found on theCDRHNew Page.
- Class I Medical Device Recall: Alere Recalls INRatio® and INRatio2® PT/INR Monitoring System Due to Incorrect Test Results
- Syringe Pump Labeling Request Letter
- Syringe Pump Problems with Fluid Flow Continuity at Low Infusion Rates Can Result in Serious Clinical Consequences: FDA Safety Communication
- Webinar - Regulatory Advice for Investigators and Sponsors of Neurological Devices and the Path to Initiating Human Studies - Wednesday, September 14, 2016