Device product
Catalog A303416A, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete Care", Drainage Bag, StatLock" Stabilization Device
Z-2540-2021
Product summary
- Firm
- C.R. Bard Inc
- Event
- Event 88499
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 6440 units
- Official record key
device-enforcement:Z-2540-2021
Official wording
Reason: There is potential for packaging defects that may impact the sterile barrier.
Code information: Catalog A303416A, Lot NGFS1844, UDI (01)00801741073823(17)201228(10); NGFS1845, UDI (01)00801741073823(17)201228(10)
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
There is potential for packaging defects that may impact the sterile barrier.