FDA-Device2023-11-15Class II
30 ML 2PORT BURETTE ASSEMBLY, Article No. 7A3950, used in a contrast management system.
B. Braun Medical, Inc.
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.
Sold states
Worldwide distribution - US Nationwide and the countries of Canada and Singapore.
Affected count
350 units
Manufactured in
901 Marcon Blvd, Allentown, PA, United States
Products
30 ML 2PORT BURETTE ASSEMBLY, Article No. 7A3950, used in a contrast management system.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0131-2024Don't want to check this manually?
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