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C.R. Bard, Inc. recalls BARD(R) CRITICORE(R) MONITOR, Model: 000002N Series The CritiCore(R) Automated Urine Output and Temperature Monitor i
Recalled February 21, 2018 · FDA recall Z-0565-2018 · C.R. Bard
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. · FDA Class II
Units
343 units
Sold at
US Distribution and Internationally to Japan
Description
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.
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.
Manufacturer(s)
C.R. Bard, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →