FDA-Device2018-02-21Class II
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.
C.R. Bard, Inc.
Hazard
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.
Sold states
US Distribution and Internationally to Japan
Affected count
343 units
Manufactured in
8195 Industrial Blvd NE, Covington, GA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0565-2018Don't want to check this manually?
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