Device product
30 ML 2PORT BURETTE ASSEMBLY, Article No. 7A3950, used in a contrast management system.
Z-0131-2024
Product summary
- Event
- Event 93074
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 350 units
- Official record key
device-enforcement:Z-0131-2024
Official wording
Reason: 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.
Code information: UDI-DI: N/A Lots 0061766049
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada and Singapore.
Derived failure modes
-
Unknown
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.