Device product

Catalog A319516AM, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete Care", Drainage Bag, StatLock" Stabilization Device

Z-2538-2021

August 05, 2021

Class II

Product summary

Firm: C.R. Bard Inc
Event: Event 88499
Status: Ongoing
Classification: Class II
Quantity: 8170 units
Official record key: device-enforcement:Z-2538-2021

Official wording

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

Code information: Catalog A319516AM, Lot NGFS1691, UDI (01)00801741073892(17)201228(10); NGFR3282, UDI (01)00801741073892(17)201228(10); and NGFR4423, UDI (01)00801741073892(17)201228(10) Expanded 10/8/2021 adding Lot NGFS1691 UDI (01)00801741073892(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.