Reported Jun 27, 2018 · Ongoing

CritiCore Automated Urine Output and Temperature Monitor

C.R. Bard, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: C.R. Bard, Inc. · 8195 Industrial Blvd NE · Covington, GA · 30014-1497

Is this the product you have?

  • CritiCore Automated Urine Output and Temperature Monitor
Lot codes and dates
  • 475 of 475 codes

    • DYZIAA003
    • DYAPAA017
    • DYARAA002
    • DYARAA047
    • DYBPAA012
    • DYBRAA022
    • DYBSAA022
    • DYBSAA067
    • DYZIAA004
    • DYAPAA018
    • DYARAA003
    • DYARAA048
    • DYBPAA013
    • DYBRAA023
    • DYBSAA023
    • DYBSAA068
    • DYZIAA005
    • DYAPAA019
    • DYARAA004
    • DYARAA049
    • DYBPAA014
    • DYBRAA024
    • DYBSAA024
    • DYBSAA069
    • DYZIAA006
    • DYAPAA020
    • DYARAA005
    • DYARAA050
    • DYBPAA015
    • DYBRAA025
    • DYBSAA025
    • DYBSAA070
    • DYZIAA007
    • DYAQAA001
    • DYARAA006
    • DYARAA051
    • DYBPAA016
    • DYBRAA026
    • DYBSAA026
    • DYBSAA071
    • DYZIAA008
    • DYAQAA002
    • DYARAA007
    • DYARAA052
    • DYBPAA017
    • DYBRAA027
    • DYBSAA027
    • DYBSAA072
    • DYZIAA009
    • DYAQAA003
    • DYARAA008
    • DYARAA053
    • DYBPAA018
    • DYBRAA028
    • DYBSAA028
    • DYBSAA073
    • DYZIAA010
    • DYAQAA004
    • DYARAA009
    • DYARAA054
Amount recalled
N/A

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:48 PM UTC

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