Device product
Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.
Z-0009-2023
Product summary
- Event
- Event 90830
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 94,000 US
- Official record key
device-enforcement:Z-0009-2023
Official wording
Reason: Potential for leakage at the catheter hub.
Code information: 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
Distribution pattern: Domestic distribution to AZ CA FL GA MD MI MO MS NC NY OH PA TN TX WA. Foreign distribution to Canada
Derived failure modes
-
Unknown
Potential for leakage at the catheter hub.