Device product

BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C

Z-0667-2022

January 27, 2022

Class II

Product summary

Firm: C.R. Bard Inc
Event: Event 89288
Status: Terminated
Classification: Class II
Quantity: 1620 units
Official record key: device-enforcement:Z-0667-2022

Official wording

Reason: There is a potential to leak from the catheter where it connects to the drain bag

Code information: Serial Number/UDI NGEWX117 (01)00801741183249(17) NGEXX133/(01)00801741183249(17) NGEY0842/(01)00801741183249(17) NGEZ1823/(01)00801741183249(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
reason.no_named_rule · v1.0.0

There is a potential to leak from the catheter where it connects to the drain bag