Brand
Fresenius Kabi
49 federal recalls on file, showing the 33 from the last 12 months. We monitor every CPSC, FDA, USDA, and NHTSA notice for Fresenius Kabi and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-12-10FDA-DeviceClass IIVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump Administration Set.
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
- 2025-12-03FDA-DrugClass IFamotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11 (unit of use), 63323-739-12 (unit of sale).
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
- 2025-11-05FDA-DeviceClass IIIvenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
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