B. Braun Medical, Inc.: 30 ML 2PORT BURETTE ASSEMBLY, Article No. 7A3950, used in a contrast management system.

Hazard

Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur requiring additional medical intervention.

Details from the source

Reason for recall: Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur requiring additional medical intervention. Distribution: Worldwide distribution - US Nationwide and the countries of Canada and Singapore. Quantity: 350 units Lot/code info: UDI-DI: N/A Lots 0061766049

Source

Official record: FDA (Device enforcement) ↗

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