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C.R. Bard Inc Recall 88499

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

C.R. Bard Inc Recall 88499 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2527-2021
Event ID88499
Event DescriptionCatalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, Temperature Sensing, StatLock" Stabilization Device
Product TypeDevices
DistributionUS Nationwide distribution.
Quantity5950 units
Recall ReasonThere is potential for packaging defects that may impact the sterile barrier.
Device Classification20210929
Device Code InfoCatalog 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)
Center Classification Date20210923
Recall Initiation Date20210805
Recalling FirmC.R. Bard Inc
Initial Notification Letter
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