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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 10

Device Problems
Other (for use when an appropriate device code cannot be identified) 161
Chemical issue 87
Use of Device Issue 67
Device disinfection or sterilization issue 47
Fumes or vapors 42
Improper or incorrect procedure or method 26
No code available 25
Instruction for use issue 21
Device Rinsing Issue 21
Disinfection or Sterilization Issue at User Location 15
No Known Device Problem 14
Device Cleaning Issue 12
Device expiration issue 8
Fluid leak 8
Ventilation issue in device environment 7
Inadequate training 6
Human-Device Interface Issue 5
No Information 4
Shelf life exceeded 4
Leak 3
Environmental Particulates 3
Chemical spillage 2
Unknown (for use when the device problem is not known) 2
Device Issue 2
Failure to cycle 2
User used incorrect product for intended use 2
Burst 1
Spillage, accidental 1
Failure to disinfect 1
Failure to remove enzymatic cleaner 1
Crack 1
Mechanical issue 1
Misconnection 1
Overfill 1
Patient-device incompatibility 1
Ambient temperature issue 1
Residue after decontamination 1
Device Contamination with biological material 1
Device operates differently than expected 1
Environmental control or utility issue 1
Improper chemical reaction 1
Issue with displayed error message 1
Maintenance does not comply to manufacturers recommendations 1
Not Applicable 1
Device handling issue 1
Total Device Problems 615

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 3 2 0 0 1 4 1 0 2 2 0
Class III 0 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 Best Sanitizers Inc II Sep-02-2016
5 I-Flow Corporation II Oct-06-2007
6 Steris Corp II Sep-23-2008
7 Steris Corp II Aug-05-2008
8 Steris Corp II Jun-21-2007
9 Steris Corporation II Mar-16-2016
10 Steris Corporation II Jun-26-2013
11 Steris Corporation II Sep-07-2012
12 Steris Corporation II Aug-28-2012
13 Steris Corporation Hopkins Facility II Jan-25-2012
14 Steris Corporation Hopkins Facility II Apr-12-2011
15 Steris Corporation Hopkins Facility II Oct-24-2007

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