FDA Enforcement
Class II
Ongoing
Catalog A119216M, SureStep" Foley Tray, Lubri-Sil", Urine Meter, Temperature Sensing Dual, StatLock" Stabilization Device
Recall: Z-2521-2021
·
Reported September 29, 2021
Enforcement
- Recall Number
- Z-2521-2021
- Event ID
- 88499
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- C.R. Bard Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 29, 2021
- Initiation Date
- August 5, 2021
- Classification Date
- September 23, 2021
- Address
- 8195 Industrial Blvd NE, Covington, GA, 30014-1497, United States
Description
Catalog A119216M, SureStep" Foley Tray, Lubri-Sil", Urine Meter, Temperature Sensing Dual, StatLock" Stabilization Device
Reason
There is potential for packaging defects that may impact the sterile barrier.
Code Info
Catalog A119216M; Lots NGFR2561, UDI (01)00801741073687(17)201228(10) and NGFS1312, UDI (01)00801741073687(17)201228(10)
Distribution
US Nationwide distribution.
Quantity
10,150 units