Recall Z-0131-2024— B. Braun Medical, Inc.
Class II · Ongoing
Class II FDA medical device recall by B. Braun Medical, Inc., initiated 2023-09-26. FDA's recall record names no specific 510(k) clearance for this event. Product: 30 ML 2PORT BURETTE ASSEMBLY, Article No. 7A3950, used in a contrast management system.. 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..
- Recalling firm
- B. Braun Medical, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-09-26
- Firm location
- Allentown, PA, United States
Product description
30 ML 2PORT BURETTE ASSEMBLY, Article No. 7A3950, used in a contrast management system.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.