Z-2538-2021 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
- 8170 units
Product Description
Catalog A319516AM, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete Care", Drainage Bag, 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 A319516AM, Lot NGFS1691, UDI (01)00801741073892(17)201228(10); NGFR3282, UDI (01)00801741073892(17)201228(10); and NGFR4423, UDI (01)00801741073892(17)201228(10) Expanded 10/8/2021 adding Lot NGFS1691 UDI (01)00801741073892(17)201228(10)