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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device indicator, physical/chemical sterilization process
Regulation Description Sterilization process indicator.
Product CodeJOJ
Regulation Number 880.2800
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 9
ADVANCED STERILIZATION PRODUCTS
  SUBSTANTIALLY EQUIVALENT 7
ALBERT BROWNE, LTD.
  SUBSTANTIALLY EQUIVALENT 16
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
CASE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
DANA PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 6
GETINGE
  SUBSTANTIALLY EQUIVALENT 1
HACH COMPANY
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
KIMBERLY-CLARK CORP.
  SUBSTANTIALLY EQUIVALENT 1
MINNESOTA MINING AND MFG. CO.
  SUBSTANTIALLY EQUIVALENT 2
PROPPER MFG
  SUBSTANTIALLY EQUIVALENT 11
RAVEN
  SUBSTANTIALLY EQUIVALENT 2
SERIM RESEARCH CORP.
  SUBSTANTIALLY EQUIVALENT 9
SPS
  SUBSTANTIALLY EQUIVALENT 17
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 22
STERITEC, INC.
  SUBSTANTIALLY EQUIVALENT 27
TSO3 INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Use of Device Issue 7
Other (for use when an appropriate device code cannot be identified) 3
Device expiration issue 2
Device disinfection or sterilization issue 1
No Information 1
Total Device Problems 14

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 2 0 1 1 0 1 1 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 3M Company / Medical Division II Aug-08-2008
2 Propper Mfg Co Inc II Sep-20-2008
3 Steris Corporation II Mar-10-2014
4 Steris Corporation II Aug-22-2011
5 Steritec Products Mfc. Co., Inc. II Jul-29-2013
6 Steritec Products Mfc. Co., Inc. II Apr-29-2010

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