Device product
Catalog A300314A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device
Z-2522-2021
Product summary
- Firm
- C.R. Bard Inc
- Event
- Event 88499
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1760 units
- Official record key
device-enforcement:Z-2522-2021
Official wording
Reason: There is potential for packaging defects that may impact the sterile barrier.
Code information: Catalog A300314A, Lot NGFR3627, UDI (01)00801741073724(17)201228(10)
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
There is potential for packaging defects that may impact the sterile barrier.