FDA recall Z-0554-2024

C.R. Bard Inc · Class II · device

Product

Sensica Urine Output System, Catalog Number SCCS1002

Reason for recall

BD (C.R. Bard) has received user complaints reporting that when the device was connected to WiFi/Internet, the time displayed on the Sensica device changed during a patient monitoring session which resulted in 1) incorrect time displayed on the monitoring screen, 2) incorrect hour block timestamps on the monitoring screen, 3) incorrect hour timestamps on data screens, and 4) incorrect catheter use time.

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2023-11-15
Report date
2023-12-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Covington, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0554-2024