FDA Device recall Z-0009-2023
Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02
- FDA Device
- Class II
- ongoing
- Published 2022-10-12
On 2022-10-12 the FDA classified a Class II recall of Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02 by B Braun Medical, citing potential for leakage at the catheter hub.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0009-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-09-01 |
| Published | 2022-10-12 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | B Braun Medical |
| Distribution | AZ, CA, FL, GA, MD, MI, MO, MS, NC, NY, OH, PA, TN, TX, WA |
Product
Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.
Reason
Potential for leakage at the catheter hub.
Identifiers
| code_info | UDI-DI (GTIN): 04046963318154 Lot Number/Expiration Date: 22D04G8241 01 Apr 2027 22D07G8241 01 Apr 2027 22D07G8242 01…UDI-DI (GTIN): 04046963318154 Lot Number/Expiration Date: 22D04G8241 01 Apr 2027 22D07G8241 01 Apr 2027 22D07G8242 01 Apr 2027 22E30G8241 01 May 2027 22E30G8242 01 May 2027 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0009-2023%22
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