Medical device recalls Moderate risk

C.R. Bard, Inc. recalls CritiCore Automated Urine Output and Temperature Monitor

Recall date
November 10, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2243-2018
FDA classification
Class II
Brand / firm
C.R. Bard, Inc.
Sold / distributed
AR, AZ, CA, FL, GA, HI, IN, JP, KS, LA, MD, MN, MO, MS, NC, NJ, OH, OK, TN, TX, VA, WA, WI, and WY

Why it was recalled

Issues identified with the monitor including urine output measurement errors, temperature measurement errors and undesired alarms.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

CritiCore Automated Urine Output and Temperature Monitor

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