medical Class II Updated 2023-11-15

B. Braun Medical, Inc. recalls 30 ML 2PORT BURETTE ASSEMBLY, Article No. 7A3950, used in a

Recalled Product

30 ML 2PORT BURETTE ASSEMBLY, Article No. 7A3950, used in a contrast management system.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: N/A Lots 0061766049
View official government recall

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