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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 12
ADVANCED STERILIZATION PRODUCTS
  SUBSTANTIALLY EQUIVALENT 17
ALBERT BROWNE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
DANA PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
GETINGE
  SUBSTANTIALLY EQUIVALENT 3
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
PROPPER MFG
  SUBSTANTIALLY EQUIVALENT 4
RAVEN
  SUBSTANTIALLY EQUIVALENT 12
SPS
  SUBSTANTIALLY EQUIVALENT 9
STERILUCENT, INC
  SUBSTANTIALLY EQUIVALENT 2
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 7
  1.  K073244  VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VH2 ...
  2.  K073618  VERIFY SIRIUS BIOLOGICAL INDICATOR CHALLENGE PACK
  3.  K083665  VERIFY SCBI 275F 3-10
  4.  K090514  VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAP ...
  5.  K092906  VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAP ...
  6.  K140499  VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR FOR ...
  7.  K140708  VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR
STERITEC, INC.
  SUBSTANTIALLY EQUIVALENT 3
TSO3 INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No code available 301
Other (for use when an appropriate device code cannot be identified) 172
Chemical issue 112
Use of Device Issue 24
Device disinfection or sterilization issue 5
Device Issue 4
Improper or incorrect procedure or method 3
Leak 3
Incorrect or inadequate result 2
Shelf life exceeded 2
Defective item 2
Device operates differently than expected 2
Environmental Particulates 1
No Information 1
Wrinkled 1
Sterility 1
Material separation 1
Component(s), broken 1
False positive result 1
Material fragmentation 1
Chemical spillage 1
Total Device Problems 641

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 1 0 0 3 6 1 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 3M Company - Health Care Business II Jul-07-2014
2 Advanced Sterilization Products II Dec-28-2013
3 Advanced Sterilization Products II Apr-26-2013
4 Advanced Sterilization Products II Dec-12-2012
5 Advanced Sterilization Products II Jul-27-2012
6 Advanced Sterilization Products II Jun-06-2012
7 Advanced Sterilization Products II Oct-20-2009
8 Getinge USA Inc II Aug-21-2013
9 Mesa Laboratories, Inc., Bozeman Manufacturing Facility II Aug-01-2013
10 Steris Corporation II Dec-28-2013
11 Steritec Products Mfc. Co., Inc. II Jul-29-2013

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