Z-2521-2021 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 29, 2021
- Initiation Date
- August 5, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,150 units
Product Description
Catalog A119216M, SureStep" Foley Tray, Lubri-Sil", Urine Meter, Temperature Sensing Dual, StatLock" Stabilization Device
Reason for Recall
There is potential for packaging defects that may impact the sterile barrier.
Distribution Pattern
US Nationwide distribution.
Code Information
Catalog A119216M; Lots NGFR2561, UDI (01)00801741073687(17)201228(10) and NGFS1312, UDI (01)00801741073687(17)201228(10)