05
Dec
2012

Cl ll Kimberly-Clark Patient Warming System

0

Company:Kimberly-Clark Corporation
Date of Enforcement Report 12/5/12
Class ll:

PRODUCT

Kimberly-Clark Patient Warming System – Model 1000 Control Unit The product is a thermal regulating system, indicated for monitoring and controlling patient temperature. Recall Number Z-0451-2013

REASON
Error 85 alarm on the Model 1000 Control Unit was occasionally triggered inappropriately

RECALLING FIRM/MANUFACTURER
Kimberly-Clark Corporation, Roswell, GA on 9/16/2010. Voluntary: Firm Initiated recall is complete.

VOLUME OF PRODUCT IN COMMERCE
400 units

DISTRIBUTION
Nationwide

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About the author

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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