FDA Enforcement
Class II
Ongoing
Catalog A943216, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device
Recall: Z-2537-2021
·
Reported September 29, 2021
Enforcement
- Recall Number
- Z-2537-2021
- 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 A943216, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device
Reason
There is potential for packaging defects that may impact the sterile barrier.
Code Info
Catalog A943216, Lot NGEVX108, UDI (01)00801741100833(17)201228(10)
Distribution
US Nationwide distribution.
Quantity
40 units