Introcan Safety FEP 14G — Class II medical device recall Z-0009-2023
Ongoing recall by B Braun Medical Inc, reported 2022-10-12, distributed in AZ, CA, FL, GA, MD, MI, MO, MS…. Potential for leakage at the catheter hub.
| Recall number | Z-0009-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | B Braun Medical Inc, Breinigsville, PA, United States |
| Recall initiated | 2022-09-01 |
| Classified | 2022-10-06 |
| Reported by FDA | 2022-10-12 |
| Distributed | AZ, CA, FL, GA, MD, MI, MO, MS, NC, NY, OH, PA, TN, TX, WA |
| Countries outside the US | CA |
| Quantity | 94,000 us |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 04046963318154 |
| Lot numbers | 22D04G8241, 22D07G8241, 22D07G8242, 22E30G8241, 22E30G8242 |
Product
Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.
Reason for recall
Potential for leakage at the catheter hub.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0009-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.