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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device disinfectant, medical devices
Regulation Description General purpose disinfectants.
Product CodeLRJ
Regulation Number 880.6890
Device Class 1


Premarket Reviews
ManufacturerDecision
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 2
METREX RESEARCH CORP.
  SUBSTANTIALLY EQUIVALENT 3
MINNTECH
  SUBSTANTIALLY EQUIVALENT 2
OR SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Other (for use when an appropriate device code cannot be identified) 175
Use of Device Issue 25
No Known Device Problem 9
Chemical issue 8
Device expiration issue 5
Bacterial contamination of device 5
Fluid leak 4
Device disinfection or sterilization issue 4
Fumes or vapors 4
Device Rinsing Issue 3
No code available 2
Environmental Particulates 2
Chemical spillage 2
Disinfection or Sterilization Issue at User Location 1
Maintenance does not comply to manufacturers recommendations 1
Ventilation issue in device environment 1
No Information 1
Device Issue 1
Unknown (for use when the device problem is not known) 1
Unintended ejection 1
Total Device Problems 255

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 0 0 1 0 1 1 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Medtrol, Inc. II Jun-22-2010
2 Metrex Research, LLC. II Aug-24-2012
3 Wexford Labs Inc II Nov-19-2013

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