Jun

2018

Cl II CritiCore Automated Urine Monitor

Company:C.R. Bard, Inc.
Date of Enforcement Report 6/27/2018
Class lI:

PRODUCT

CritiCore Automated Urine Output and Temperature Monitor
Recall Number: Z-2243-2018

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

RECALLING FIRM/MANUFACTURER
C.R. Bard, Inc. Covington, GA on 11/10/2017. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

DISTRIBUTION
Nationwide

___________________________________

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl II CritiCore Automated Urine Monitor

Amy Sellers

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