FDA recall Z-0009-2023

B Braun Medical Inc · Class II · device

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.

Distribution

Domestic distribution to AZ CA FL GA MD MI MO MS NC NY OH PA TN TX WA. Foreign distribution to Canada

Key facts

Status
Ongoing
Initiation date
2022-09-01
Report date
2022-10-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
Breinigsville, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0009-2023