Device product
Catalog A119216M, SureStep" Foley Tray, Lubri-Sil", Urine Meter, Temperature Sensing Dual, StatLock" Stabilization Device
Z-2521-2021
Product summary
- Firm
- C.R. Bard Inc
- Event
- Event 88499
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 10,150 units
- Official record key
device-enforcement:Z-2521-2021
Official wording
Reason: There is potential for packaging defects that may impact the sterile barrier.
Code information: Catalog A119216M; Lots NGFR2561, UDI (01)00801741073687(17)201228(10) and NGFS1312, UDI (01)00801741073687(17)201228(10)
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
There is potential for packaging defects that may impact the sterile barrier.