FDA Device recall Z-0565-2018

BARD(R) CRITICORE(R) MONITOR, Model: 000002N Series The CritiCore(R) Automated Urine Output and Temperature Monitor is indicated to monitor…

FDA Device
Class II
terminated
Published 2018-02-21

On 2018-02-21 the FDA classified a Class II recall of BARD(R) CRITICORE(R) MONITOR, Model: 000002N Series The CritiCore(R) Automated Urine Output and Temperature Monitor is indicated to monitor… by C R Bard, citing BMD has identified that some lots of CritiCore(R) monitors may experience failures involving urine output volume measurement fluctuations, core bladder temperature measurement flu….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0565-2018
Classification	Class II
Status	terminated
Initiated	2017-11-10
Published	2018-02-21
Last updated	2026-09-13 11:54 UTC
Company	C R Bard
Distribution	n/a

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

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.

Identifiers

code_info	CritiCore(R) Monitor Affected Serial Numbers DYZIAA001 DYAPAA015 DYAQAA040 DYARAA045 DYBPAA010 DYBRAA020 DYBSAA0… CritiCore(R) Monitor Affected Serial Numbers DYZIAA001 DYAPAA015 DYAQAA040 DYARAA045 DYBPAA010 DYBRAA020 DYBSAA020 DYBSAA065 DYZIAA002 DYAPAA016 DYARAA001 DYARAA046 DYBPAA011 DYBRAA021 DYBSAA021 DYBSAA066 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 DYBPAA019 DYBRAA029 DYBSAA029 DYBSAA074 DYZJAA001 DYAQAA005 DYARAA010 DYARAA055 DYBPAA020 DYBRAA030 DYBSAA03

code_info

CritiCore(R) Monitor Affected Serial Numbers DYZIAA001 DYAPAA015 DYAQAA040 DYARAA045 DYBPAA010 DYBRAA020 DYBSAA0…

CritiCore(R) Monitor Affected Serial Numbers DYZIAA001 DYAPAA015 DYAQAA040 DYARAA045 DYBPAA010 DYBRAA020 DYBSAA020 DYBSAA065 DYZIAA002 DYAPAA016 DYARAA001 DYARAA046 DYBPAA011 DYBRAA021 DYBSAA021 DYBSAA066 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 DYBPAA019 DYBRAA029 DYBSAA029 DYBSAA074 DYZJAA001 DYAQAA005 DYARAA010 DYARAA055 DYBPAA020 DYBRAA030 DYBSAA03

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0565-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.