Device product

Catalog A300316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device

Z-2523-2021

August 05, 2021

Class II

Product summary

Firm: C.R. Bard Inc
Event: Event 88499
Status: Ongoing
Classification: Class II
Quantity: 11,780 units
Official record key: device-enforcement:Z-2523-2021

Official wording

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

Code information: Catalog A300316A, Lots: NGEVX104 (exp. 08/31/2022), UDI (01)00801741073731(17)201228(10); NGFR3628 (02/28/2023), UDI (01)00801741073731(17)201228(10); GFS1114 (02/28/2023), UDI (01)00801741073731(17)201228(10); and NGFS1166 (02/28/2023), UDI (01)00801741073731(17)201228(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.