Z-0009-2023 Class II Ongoing
FDA device recall Z-0009-2023 was initiated by B Braun Medical Inc on Sep 1, 2022 and is designated Class II. Reason for recall: Potential for leakage at the catheter hub. The recall status is ongoing. Affected quantity: 94,000 US.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 12, 2022
- Initiation Date
- Sep 1, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 94,000 US
Product Description
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.
Distribution Pattern
Domestic distribution to AZ CA FL GA MD MI MO MS NC NY OH PA TN TX WA. Foreign distribution to Canada
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0009-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026