FDA recall Z-2243-2018

C.R. Bard, Inc. · Class II · device

Product

CritiCore Automated Urine Output and Temperature Monitor

Reason for recall

Issues identified with the monitor including urine output measurement errors, temperature measurement errors and undesired alarms.

Distribution

AR, AZ, CA, FL, GA, HI, IN, JP, KS, LA, MD, MN, MO, MS, NC, NJ, OH, OK, TN, TX, VA, WA, WI, and WY

Key facts

Status
Ongoing
Initiation date
2017-11-10
Report date
2018-06-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Covington, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2243-2018