FDA-Device2022-10-12Class II

Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.

B Braun Medical Inc
Hazard

Potential for leakage at the catheter hub.

Sold states
Domestic distribution to AZ CA FL GA MD MI MO MS NC NY OH PA TN TX WA. Foreign distribution to Canada
Affected count
94,000 US
Manufactured in
200 Boulder Dr, N/A, Breinigsville, PA, United States
Products
Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.

Official notice

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

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