The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).
Reason for recall: The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion). Distribution: US Nationwide distribution in the states of GA, OR, TN, and WA. Quantity: 475 units Lot/code info: UDI-DI: B098AMS144330; Lot Numbers: 204612 206723 210211 213641 216064 222060 224073 225012 236012 236910
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.