FDA recall Z-2527-2021

C.R. Bard Inc · Class II · device

Product

Catalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, Temperature Sensing, 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-2527-2021