FDA recall Z-0666-2022

C.R. Bard Inc · Class II · device

Product

BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS14C

Reason for recall

There is a potential to leak from the catheter where it connects to the drain bag

Distribution

US Nationwide distribution in the states of GA, ME, NJ, WI, MN, SD, CO, ND, ID, IL, FL, LA, MD, PA, OH, NE.

Key facts

Status
Ongoing
Initiation date
2022-01-27
Report date
2022-03-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Covington, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0666-2022