FDA-Device2018-06-27Class II

CritiCore Automated Urine Output and Temperature Monitor

C.R. Bard, Inc.
Hazard

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

Sold states
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
Affected count
N/A
Manufactured in
8195 Industrial Blvd NE, N/A, Covington, GA, United States
Products
CritiCore Automated Urine Output and Temperature Monitor

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2243-2018

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