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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device solution-test standard-conductivity, dialysis
Regulation Description Hemodialysis system and accessories.
Product CodeFKH
Regulation Number 876.5820
Device Class 2

Device Problems
Calibration issue 1
Total Device Problems 1

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 0 0 1
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Mesa Laboratories, Inc. II May-16-2017

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