Z-2522-2021 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
- 1760 units
Product Description
Catalog A300314A, SureStep" Foley Tray, Bardex" I.C., 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 A300314A, Lot NGFR3627, UDI (01)00801741073724(17)201228(10)