FDA recall Z-0565-2018

C.R. Bard, Inc. · Class II · device

Product

BARD(R) CRITICORE(R) MONITOR, Model: 000002N Series The CritiCore(R) Automated Urine Output and Temperature Monitor is indicated to monitor urine output and core bladder temperature.

Reason for recall

BMD has identified that some lots of CritiCore(R) monitors may experience failures involving urine output volume measurement fluctuations, core bladder temperature measurement fluctuations and alarm errors.

Distribution

US Distribution and Internationally to Japan

Key facts

Status: Terminated
Initiation date: 2017-11-10
Report date: 2018-02-21
Termination date: 2021-09-22
Voluntary/Mandated: Voluntary: Firm initiated
Location: Covington, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0565-2018