Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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 7
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 8

Device Problems
Other (for use when an appropriate device code cannot be identified) 961
Chemical issue 114
Use of Device Issue 87
No code available 84
Environmental Particulates 81
Device emits odor 44
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 12
Malfunction 10
No Known Device Problem 10
Disinfection or Sterilization Issue at User Location 9
Device damaged prior to use 9
Unknown (for use when the device problem is not known) 9
Smoking 8
Filter, assembly 8
Device Issue 7
Hot oil leak 7
Bacterial contamination of device 6
Fluid leak 4
Melted 4
Electrical power problem 4
Component incompatible 4
Failure to disinfect 3
Device or device component damaged by another device 3
Device disinfection or sterilization issue 3
No Information 3
Device maintenance issue 3
Improper or incorrect procedure or method 3
Device ingredient or reagent issue 3
Peeled 2
Leak 2
Defective item 2
Break 2
Electrical issue 2
Device unsafe to use in environment 2
Device operational issue 2
Failure to sterilize 2
Device Cleaning Issue 2
Use of Incorrect Control Settings 1
Failure to cycle 1
Fire 1
Water treatment 1
Loss of power 1
User used incorrect product for intended use 1
Spark 1
Close, difficult to 1
Ventilation issue in device environment 1
Device markings issue 1
Shock counters, resetting of 1
Spillage, accidental 1
Device Rinsing Issue 1
Failure to run on AC/DC 1
Mechanical issue 1
Component missing 1
Loose 1
Material discolored 1
Misapplication 1
Device sensing issue 1
Defective component 1
Chemical spillage 1
Total Device Problems 1685

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 5 2 0 2 3 3
Class III 0 0 0 1 0 1 0

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

-
-