FDA recall Z-0488-2018

C.R. Bard, Inc. · Class II · device

Product

BARD UROS AUTOMATED URINE OUPTUT AND TEMPERATURE MONITOR, MODEL BK10001M The Uros(TM) Automated Urine Output and Temperature Monitor is indicated to monitor urine output and core bladder temperature.

Reason for recall

The possibility exists that use of the Uros Automated Urine Output and Temperature Monitor may lead to the loss of urine output measurement data and/or urine output measurement inaccuracies resulting in an impact on clinical treatment decisions.

Distribution

US Distribution to the state of: FL

Key facts

Status: Terminated
Initiation date: 2017-09-29
Report date: 2018-02-07
Termination date: 2021-07-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Covington, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0488-2018