Recall Z-0009-2023— B Braun Medical Inc

Name: FDA recall Z-0009-2023
Creator: U.S. Food and Drug Administration
Published: 2022-09-01

Class II · Ongoing

Class II FDA medical device recall by B Braun Medical Inc, initiated 2022-09-01. It names one FDA 510(k) clearance: K020785. Product: Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.. Reason: Potential for leakage at the catheter hub..

Recalling firm: B Braun Medical Inc
Classification: Class II
Status: Ongoing
Initiated: 2022-09-01
Firm location: Breinigsville, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K020785 — INTROCAN SAFETY IV CATHETERB.Braun Medical, Inc.·cleared 2002-08-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.