Class II — B Braun Medical Inc
| Recalling firm | B. BRAUN MEDICAL SAS |
|---|---|
| Registered facility | B. BRAUN MEDICAL (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Potential for leakage at the catheter hub. |
| Product | Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access. |
| Quantity | 94,000 US |
| Distribution | Domestic distribution to AZ CA FL GA MD MI MO MS NC NY OH PA TN TX WA. Foreign distribution to Canada |
| Initiated | 2022-09-01 |
| Classified | 2022-10-06 |
| Recall number | Z-0009-2023 |
| 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-0009-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90830/
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