Device product
BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS14C
Z-0666-2022
Product summary
- Firm
- C.R. Bard Inc
- Event
- Event 89288
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2120 units
- Official record key
device-enforcement:Z-0666-2022
Official wording
Reason: There is a potential to leak from the catheter where it connects to the drain bag
Code information: Serial Number/UDI NGEWX106/(01)00801741183232(17) NGEWX143/(01)00801741183232(17) NGFQ0368/(01)00801741183232(17) NGEW9106/(01)00801741183232(17)
Distribution pattern: US Nationwide distribution in the states of GA, ME, NJ, WI, MN, SD, CO, ND, ID, IL, FL, LA, MD, PA, OH, NE.
Derived failure modes
-
Unknown
There is a potential to leak from the catheter where it connects to the drain bag