FDA recall Z-2533-2021

C.R. Bard Inc · Class II · device

Product

Catalog A897514, SureStep" Foley Tray, Silicone, Drainage Bag, StatLock" Stabilization Device

Reason for recall

There is potential for packaging defects that may impact the sterile barrier.

Distribution

US Nationwide distribution.

Key facts

Status: Ongoing
Initiation date: 2021-08-05
Report date: 2021-09-29
Voluntary/Mandated: Voluntary: Firm initiated
Location: Covington, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2533-2021