FDA recall Z-2535-2021
C.R. Bard Inc · Class II · device
Product
Catalog A902616, SureStep" Foley Tray, Bardex" I.C., Lubricath", Urine Meter
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-2535-2021