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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
  1.  K923744  CIDEX PLUS 28 DAY SOLUTION
  2.  K924434  CIDEX ACTIVATED DIALDEHYDE SOLUTION
METREX RESEARCH CORP.
  SUBSTANTIALLY EQUIVALENT 4
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
Chemical issue 7
No Known Device Problem 7
Bacterial contamination of device 5
Fluid leak 4
Fumes or vapors 4
Environmental Particulates 2
No code available 2
Ventilation issue in device environment 1
No Information 1
Chemical spillage 1
Disinfection or Sterilization Issue at User Location 1
Device disinfection or sterilization issue 1
Device operational issue 1
Device expiration issue 1
Unintended ejection 1
Device Issue 1
Unknown (for use when the device problem is not known) 1
Total Device Problems 241

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

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