Reported Feb 21, 2018 · Terminated
BARD(R) CRITICORE(R) MONITOR, Model: 000002N Series The CritiCore(R) Automated Urine Output and Temperature Monitor is…
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?
- BARD(R) CRITICORE(R) MONITOR
- Model000002N Series The CritiCore(R) Automated Urine Output and Temperature Monitor is indicated to monitor urine output and core bladder temperature
- Lot codes and dates
- CritiCore(R) Monitor Affected Serial Numbers
491 of 491 codes
DYZIAA001DYAPAA015DYAQAA040DYARAA045DYBPAA010DYBRAA020DYBSAA020DYBSAA065DYZIAA002DYAPAA016DYARAA001DYARAA046DYBPAA011DYBRAA021DYBSAA021DYBSAA066DYZIAA003DYAPAA017DYARAA002DYARAA047DYBPAA012DYBRAA022DYBSAA022DYBSAA067DYZIAA004DYAPAA018DYARAA003DYARAA048DYBPAA013DYBRAA023DYBSAA023DYBSAA068DYZIAA005DYAPAA019DYARAA004DYARAA049DYBPAA014DYBRAA024DYBSAA024DYBSAA069DYZIAA006DYAPAA020DYARAA005DYARAA050DYBPAA015DYBRAA025DYBSAA025DYBSAA070DYZIAA007DYAQAA001DYARAA006DYARAA051DYBPAA016DYBRAA026DYBSAA026DYBSAA071DYZIAA008DYAQAA002DYARAA007DYARAA052
- CritiCore(R) Monitor Affected Serial Numbers
- Amount recalled
- 343 units
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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