Device product
Catalog A800360, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
Z-2530-2021
Product summary
- Firm
- C.R. Bard Inc
- Event
- Event 88499
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1140 units
- Official record key
device-enforcement:Z-2530-2021
Official wording
Reason: There is potential for packaging defects that may impact the sterile barrier.
Code information: Catalog A800360, Lot NGFR3570, UDI (01)00801741073922(17)251228(10)
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
There is potential for packaging defects that may impact the sterile barrier.