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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device sterilizer, ethylene-oxide gas
Regulation Description Ethylene oxide gas sterilizer.
Product CodeFLF
Regulation Number 880.6860
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 3
ADVANCED STERILIZATION PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
  1.  K023290  STERRAD 50 & STERRAD 100S STERILIZERS
BEN VENUE LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
TSO3 INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Device displays error message 3
Not Applicable 2
Other (for use when an appropriate device code cannot be identified) 2
No code available 2
No Information 1
Changes in ambient temperature in device environment 1
Leak 1
Device emits odor 1
Total Device Problems 13

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 0 0 1 0 0 1 0 3 0 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 3M Company - Health Care Business II Apr-24-2016
2 3M Company - Health Care Business II Apr-02-2014
3 3M Company - Health Care Business II Oct-09-2012
4 Advanced Sterilization Products II Dec-22-2014
5 Advanced Sterilization Products II Jan-14-2014
6 Advanced Sterilization Products II Jun-15-2009

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