News and Updates

Early Alert: Infusion Pump Software Issue from Fresenius Kabi USAAffected Product The FDA is aware that Fresenius Kabi USA has issued a letter to affected health care providers recommending certain

Affected Product The FDA is aware that Baxter Healthcare Corporation has issued a letter to affected healthcare providers recommending certain lots of Solution Sets with Duo-Vent Spikes be removed from

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the

Astellas Pharma US, Inc. Issues Voluntary Nationwide Recall of One Lot of PROGRAF® 0.5mg (Tacrolimus) and One Lot of ASTAGRAF XL® 0.5mg (Tacrolimus Extended-Release Capsules) Because Bottles Shipped to U.S. May

ICU Medical Removes Some CSB Batteries Intended For Use With Plum 360, A+, and A+3 Infusion Systems Due to Reports of Allegedly Counterfeit, Untested Batteries In Use This recall involves removing certain

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or