Class II — B.Braun Medical S.A.S.
| Recalling firm | B. BRAUN MEDICAL SAS |
|---|---|
| Registered facility | B. BRAUN MEDICAL (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | The potential for minor injury such as damage to the vessel and/or tearing of the vessel wall. |
| Product | Brand Name: CELSITE Product Name: CELSITE BABYPORT SET PUR 4,5F IV USA Model/Catalog Number: 5433742 Software Version: N/A Product Description: CELSITE BABYPORT SET PUR 4,5F IV USA Component: N/A |
| Quantity | 58 units |
| Distribution | US Nationwide distribution in the state of PA. |
| Initiated | 2025-07-21 |
| Classified | 2025-09-05 |
| Recall number | Z-2528-2025 |
| 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 S.A.S. (Z-2528-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97407/
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