FDA recall Z-2528-2021

C.R. Bard Inc · Class II · device

Product

Catalog A399400A, SureStep" Foley Tray, Add-a-Foley, Complete Care", 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-2528-2021