Device product

Catalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, Temperature Sensing, StatLock" Stabilization Device

Z-2527-2021

August 05, 2021

Class II

Product summary

Firm: C.R. Bard Inc
Event: Event 88499
Status: Ongoing
Classification: Class II
Quantity: 5950 units
Official record key: device-enforcement:Z-2527-2021

Official wording

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

Code information: Catalog A319416AM, Lots NGEVX107 (exp. 08/31/2022), UDI (01)00801741073861(17)201220(10); NGFR3116 (exp. 02/28/2023), UDI (01)00801741073861(17)201220(10); and NGFS1808 (02/28/2023) UDI (01)00801741073861(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.