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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 2
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 7

Device Problems
Other (for use when an appropriate device code cannot be identified) 161
Use of Device Issue 65
Chemical issue 60
Fumes or vapors 41
No code available 22
Disinfection or Sterilization Issue at User Location 15
No Known Device Problem 11
Device Rinsing Issue 8
Improper or incorrect procedure or method 8
Fluid leak 8
Device Cleaning Issue 6
Human-Device Interface Issue 5
Ventilation issue in device environment 4
No Information 4
Device disinfection or sterilization issue 3
Chemical spillage 2
Environmental Particulates 2
Failure to cycle 2
Unknown (for use when the device problem is not known) 2
Device Issue 2
Overfill 1
Patient-device incompatibility 1
Failure to disinfect 1
Crack 1
Instruction for use issue 1
Leak 1
Misconnection 1
User used incorrect product for intended use 1
Spillage, accidental 1
Facilities issue 1
Human factors issue 1
Issue with displayed error message 1
Device operates differently than expected 1
Burst 1
Not Applicable 1
Total Device Problems 446

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 3 2 0 0 1 4 0
Class III 0 0 0 0 0 0 0

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

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