Device product

Catalog A800365, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray

Z-2532-2021

August 05, 2021

Class II

Product summary

Firm: C.R. Bard Inc
Event: Event 88499
Status: Ongoing
Classification: Class II
Quantity: 18,060 units
Official record key: device-enforcement:Z-2532-2021

Official wording

Reason: There is potential for packaging defects that may impact the sterile barrier.

Code information: Catalog A800365, Lots: NGFR3131, UDI (01)00801741073960(17)201220(10); NGFR3295, UDI (01)00801741073960(17)201220(10); NGFR4413, UDI (01)00801741073960(17)201220(10); NGFR4599, UDI (01)00801741073960(17)201220(10); and NGFS3150 UDI (01)00801741073960(17)201220(10)

Distribution pattern: US Nationwide distribution.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

There is potential for packaging defects that may impact the sterile barrier.