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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device indicator, biological sterilization process
Regulation Description Sterilization process indicator.
Product CodeFRC
Regulation Number 880.2800
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 9
ADVANCED STERILIZATION PRODUCTS
  SUBSTANTIALLY EQUIVALENT 15
ALBERT BROWNE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
DANA PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
GETINGE
  SUBSTANTIALLY EQUIVALENT 3
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
PROPPER MFG
  SUBSTANTIALLY EQUIVALENT 4
RAVEN
  SUBSTANTIALLY EQUIVALENT 12
SPS
  SUBSTANTIALLY EQUIVALENT 8
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
STERITEC, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Other (for use when an appropriate device code cannot be identified) 172
No code available 55
Use of Device Issue 24
Chemical issue 8
Device disinfection or sterilization issue 5
Device Issue 4
Leak 3
Incorrect or inadequate result 2
Improper or incorrect procedure or method 2
Defective item 2
Wrinkled 1
Component(s), broken 1
Total Device Problems 279

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

Recalls
Manufacturer Recall Class Date Posted
1 Advanced Sterilization Products II Dec-12-2012
2 Advanced Sterilization Products II Jul-27-2012
3 Advanced Sterilization Products II Jun-06-2012
4 Advanced Sterilization Products II Oct-20-2009

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