CDRH New - February 20, 2020

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on February 19, 2020. To view listings for other dates, see CDRH New - News and Updates.

Class I Recall: Teleflex Medical Recalls Comfort Flo Humidification Systems Due to Malfunction That May Cause Water to Enter Airway Class I Recall: Abbott Vascular Recalls NC Trek RX and NC Traveler RX Coronary Dilatation Catheters Due to Failure of Balloon (diameter 4.0mm, 4.5mm and 5.00mm) to Deflate Class I Recall: ResMed Recalls Stellar 100 and 150 Non-invasive and Invasive Ventilators Due to Sound Alarm Failure Mammography Facility Adverse Event and Action Report - February 19, 2020: Winchester Medical Center - Diagnostic Center