News and Updates
FDA Early Alert: Extracorporeal Blood Circuit Issue from Nuwellis
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 and One Lot of ASTAGRAF XL® 0.5mg
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
Infusion Pump Battery Recall
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
Infusion Pump Administration Set Recall: Fresenius Kabi USA Removes Certain Ivenix Large Volume Pump Primary Administration Sets
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
Disruption in Availability of BD BACTEC Blood Culture Media Bottles – Letter to Health Care Providers
The U.S. Food and Drug Administration (FDA) is aware that the U.S. is experiencing interruptions in the supply of BD BACTEC blood culture media bottles because of recent supplier issues.
Fresenius Medical Care Recalls Sanxin Single-Use Syringes for Leakages
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Device Use The Fresenius
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