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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device sterilant, medical devices
Regulation Description Liquid chemical sterilants/high level disinfectants.
Product CodeMED
Regulation Number 880.6885
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCED INFUSION, INC.
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED STERILIZATION PRODUCTS
  SUBSTANTIALLY EQUIVALENT 5
HEALTHPOINT, LTD.
  SUBSTANTIALLY EQUIVALENT 2
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 2
KELLER AND HECKMAN
  SUBSTANTIALLY EQUIVALENT 1
MEDIVATORS REPROCESSING SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
METREX RESEARCH CORP.
  SUBSTANTIALLY EQUIVALENT 3
MICROCHEM LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MINNTECH
  SUBSTANTIALLY EQUIVALENT 2
PURICORE, INC.
  SUBSTANTIALLY EQUIVALENT 1
SERIM RESEARCH CORP.
  SUBSTANTIALLY EQUIVALENT 2
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 8

Device Problems
Other (for use when an appropriate device code cannot be identified) 161
Chemical issue 79
Use of Device Issue 66
Fumes or vapors 41
Device disinfection or sterilization issue 37
No code available 24
Disinfection or Sterilization Issue at User Location 15
Device Rinsing Issue 14
No Known Device Problem 12
Improper or incorrect procedure or method 12
Device Cleaning Issue 12
Fluid leak 8
Device expiration issue 7
Ventilation issue in device environment 5
Human-Device Interface Issue 5
No Information 4
Environmental Particulates 2
Device Issue 2
Chemical spillage 2
Failure to cycle 2
Unknown (for use when the device problem is not known) 2
Leak 2
User used incorrect product for intended use 2
Spillage, accidental 1
Inadequate training 1
Misconnection 1
Failure to disinfect 1
Crack 1
Burst 1
Instruction for use issue 1
Device operates differently than expected 1
Overfill 1
Patient-device incompatibility 1
Not Applicable 1
Improper chemical reaction 1
Issue with displayed error message 1
Maintenance does not comply to manufacturers recommendations 1
Device handling issue 1
Total Device Problems 531

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 3 2 0 0 1 4 1 0 2 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Advanced Sterilization Products II Sep-16-2015
2 Advanced Sterilization Products II Aug-25-2015
3 Advanced Sterilization Products II Aug-27-2012
4 I-Flow Corporation II Oct-06-2007
5 Steris Corp II Sep-23-2008
6 Steris Corp II Aug-05-2008
7 Steris Corp II Jun-21-2007
8 Steris Corporation II Mar-16-2016
9 Steris Corporation II Jun-26-2013
10 Steris Corporation II Sep-07-2012
11 Steris Corporation II Aug-28-2012
12 Steris Corporation Hopkins Facility II Jan-25-2012
13 Steris Corporation Hopkins Facility II Apr-12-2011
14 Steris Corporation Hopkins Facility II Oct-24-2007

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