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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, pasteurization, hot water
Regulation Description Medical washer.
Product CodeLDS
Regulation Number 880.6991
Device Class 2


Premarket Reviews
ManufacturerDecision
MIELE, INC.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 2
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Misplacement 1
No Information 1
Improper or incorrect procedure or method 1
Difficult to remove 1
Total Device Problems 4

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 1 0 0 1 0 0 0 2 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Cenorin II Oct-12-2010
2 Cenorin II Apr-04-2007
3 Cenorin, LLC II Jul-06-2014
4 Cenorin, LLC II Jun-06-2014

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