B. Braun Medical, Inc.: Infusomat UNIV. 15 DROP PUMP SET W/3 SAFELINE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 36303

Hazard

Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

Details from the source

Reason for recall: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood. Distribution: Worldwide distribution - US Nationwide and the country of Canada. Quantity: 37776 units Lot/code info: UDI-DI 04046964294259; All Lots Distributed After 02AUG2023.

UPC codes

04046964294259

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.