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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device sterilizer, chemical
Regulation Description Ethylene oxide gas sterilizer.
Product CodeMLR
Regulation Number 880.6860
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCED STERILIZATION PRODUCTS
  SUBSTANTIALLY EQUIVALENT 9
STERILUCENT, INC
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 10

Device Problems
Other (for use when an appropriate device code cannot be identified) 961
No code available 241
Device emits odor 200
Environmental Particulates 168
Chemical issue 128
Use of Device Issue 88
Human-Device Interface Issue 36
Device-device incompatibility 34
Fogging 23
Fumes or vapors 18
Residue after decontamination 16
Component falling 15
Device operates differently than expected 13
No Known Device Problem 10
Malfunction 10
Device damaged prior to use 9
Disinfection or Sterilization Issue at User Location 9
Unknown (for use when the device problem is not known) 9
Smoking 9
Filter, assembly 8
Device Issue 7
Hot oil leak 7
Bacterial contamination of device 6
Improper or incorrect procedure or method 5
Electrical power problem 4
Melted 4
Fluid leak 4
Component incompatible 4
Failure to disinfect 3
Device or device component damaged by another device 3
Device maintenance issue 3
No Information 3
Device disinfection or sterilization issue 3
Device ingredient or reagent issue 3
Device Cleaning Issue 2
Failure to sterilize 2
Electrical issue 2
Device unsafe to use in environment 2
Defective item 2
Mechanical issue 2
Break 2
Peeled 2
Leak 2
Loose 1
Chemical spillage 1
Misapplication 1
Use of Incorrect Control Settings 1
Loss of power 1
User used incorrect product for intended use 1
Failure to run on AC/DC 1
Moisture or humidity problem 1
Positioning Issue 1
Device markings issue 1
Shock counters, resetting of 1
Device Rinsing Issue 1
Close, difficult to 1
Spillage, accidental 1
Ventilation issue in device environment 1
Component missing 1
Water treatment 1
Spark 1
Failure to cycle 1
Fire 1
Device sensing issue 1
Defective component 1
Material discolored 1
Total Device Problems 2105

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 5 2 0 2 3 9 2 1 0
Class III 0 0 0 1 0 1 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Advanced Sterilization Products II Aug-13-2015
2 Advanced Sterilization Products II Dec-22-2014
3 Advanced Sterilization Products II Jan-14-2014
4 Advanced Sterilization Products II Nov-26-2013
5 Advanced Sterilization Products II Nov-08-2013
6 Advanced Sterilization Products II Oct-22-2013
7 Advanced Sterilization Products II Oct-22-2013
8 Advanced Sterilization Products II Sep-10-2013
9 Advanced Sterilization Products II Mar-30-2013
10 Advanced Sterilization Products II Mar-26-2013
11 Advanced Sterilization Products II Jan-09-2013
12 Advanced Sterilization Products III Sep-07-2012
13 Advanced Sterilization Products II Jan-13-2012
14 Advanced Sterilization Products II Jan-11-2012
15 Advanced Sterilization Products II Jun-30-2009
16 Advanced Sterilization Products II Jun-15-2009
17 Advanced Sterilization Products II Dec-02-2008
18 Advanced Sterilization Products II Nov-21-2008
19 Advanced Sterilization Products II Aug-08-2008
20 Advanced Sterilization Products II Feb-08-2008
21 Advanced Sterilization Products II Feb-07-2008
22 Steris Corporation II Dec-31-2013
23 Steris Corporation II Sep-20-2012
24 Steris Corporation II Sep-01-2011
25 Steris Corporation II Aug-19-2011
26 Steris Corporation III Dec-28-2010

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