Class II — B. Braun Medical, Inc.
| Recalling firm | B. BRAUN MEDICAL INC. |
|---|---|
| Registered facility | View this company's 5 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | 30ML BURETTE ASSY WITH STOPCOCK, BNS, Article No. 7A3970. used in a contrast management system. |
| Quantity | 400 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada and Singapore. |
| Initiated | 2023-09-26 |
| Classified | 2023-11-03 |
| Recall number | Z-0135-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — B. Braun Medical, Inc. (Z-0135-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93074/
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