Home / Recalls / B Braun Medical Inc / Z-0009-2023

Z-0009-2023 Class II Ongoing

Recalled by B Braun Medical Inc — Breinigsville, PA

Recall Details

Product Type
Devices
Report Date
October 12, 2022
Initiation Date
September 1, 2022
Termination Date
N/A
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

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