Recall Z-1431-2021— C.R. Bard, Inc.

Name: FDA recall Z-1431-2021
Creator: U.S. Food and Drug Administration
Published: 2021-01-11

Class II · Terminated

Class II FDA medical device recall by C.R. Bard, Inc., initiated 2021-01-11, terminated 2023-02-02. It names one FDA 510(k) clearance: K802665. Product: Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, urological) - Product Usage: for urological use only.. Reason: The device catheter tip was cut off (no tip) and the product packaging was not fully sealed..

Recalling firm: C.R. Bard, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-01-11
Terminated: 2023-02-02
Firm location: Covington, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K802665 — TOUCHLESS CLEAN-CATHDiamed Division Ill. Tool Works, Inc.·cleared 1980-11-12

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

Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, urological) - Product Usage: for urological use only.

Reason for recall

The device catheter tip was cut off (no tip) and the product packaging was not fully sealed.

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