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
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-2527-2021 |
Event ID | 88499 |
Event Description | Catalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, Temperature Sensing, StatLock" Stabilization Device |
Product Type | Devices |
Distribution | US Nationwide distribution. |
Quantity | 5950 units |
Recall Reason | There is potential for packaging defects that may impact the sterile barrier. |
Device Classification | 20210929 |
Device Code Info | 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) |
Center Classification Date | 20210923 |
Recall Initiation Date | 20210805 |
Recalling Firm | C.R. Bard Inc |
Initial Notification | Letter |
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