C.R. Bard, Inc. recalls BARD(R) CRITICORE(R) MONITOR, Model: 000002N Series The CritiCore(R) Automated Urine Output and Temperature Monitor is…
- Recall date
- November 10, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0565-2018
- FDA classification
- Class II
- Brand / firm
- C.R. Bard, Inc.
- Sold / distributed
- US Distribution and Internationally to Japan
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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