Company:C.R. Bard, Inc.
Date of Enforcement Report 6/27/2018
Class II:
PRODUCT
CritiCore Automated Urine Output and Temperature Monitor Recall Number: Z-2243-2018
REASON
Issues identified with the monitor including urine output measurement errors, temperature measurement errors and undesired alarms..
RECALLING FIRM/MANUFACTURER
C.R. Bard, Inc. Covington, GA on 11/10/2017. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
DISTRIBUTION
Nationwide