FDA recall Z-1431-2021

C.R. Bard, Inc. · Class II · device

Product

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.

Distribution

Worldwide distribution - US Nationwide distribution and the countries of Australia, Canada.

Key facts

Status
Terminated
Initiation date
2021-01-11
Report date
2021-04-28
Termination date
2023-02-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Covington, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1431-2021