If your email program has trouble displaying this email, view as a webpage.

April 26, 2024

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on April 25, 2024. To view listings for other dates, see CDRH New - News and Updates.

• Class I Recall: Fresenius Medical Care Recalls Stay-Safe Catheter Extension Sets and Stay-Safe/Luer Lock Adapter for Risk of Patient Exposure to Higher Than Allowable Levels of Toxic Compound NDL-PCBA
• Class I Recall: Outset Medical, Inc. Recalls Certain Tablo Hemodialysis Systems for Risk of Patient Exposure to Higher Than Allowable Levels of Toxic Compound NDL-PCBAs
• Class I Recall: Draeger, Inc. Recalls Perseus A500 Anesthesia System for Risk of Sudden Unexpected Shutdown When Used on Battery Power
• Class I Recall: InfuTronix, LLC Recalls Nimbus and Nimbus II Infusion Pump Systems for Multiple Device Failures That May Cause Severe Injury and Death
• UPDATE: Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication
• COVID-19 Tests Granted Traditional Marketing Authorization by the FDA (Updated)
• Printable Slides: Medical Device Sterilization Town Hall: Topics and Formats for the Continuing Sterilization Series - 04/29/2024