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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device sterilizer, steam
Regulation Description Steam sterilizer.
Product CodeFLE
Regulation Number 880.6880
Device Class 2


Premarket Reviews
ManufacturerDecision
A-DEC, INC.
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED STERILIZATION PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
  1.  K954142  STERRADD STERILIZATION SYSTEM
BELIMED
  SUBSTANTIALLY EQUIVALENT 3
DEPT. OF THE ARMY
  SUBSTANTIALLY EQUIVALENT 1
GETINGE
  SUBSTANTIALLY EQUIVALENT 11
HARVARD APPARATUS, INC.
  SUBSTANTIALLY EQUIVALENT 2
KAVO
  SUBSTANTIALLY EQUIVALENT 1
MEDILINE ITALIA S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
MEDIN CORP.
  SUBSTANTIALLY EQUIVALENT 1
MIDMARK CORP.
  SUBSTANTIALLY EQUIVALENT 7
MILTON E PEDRAZZI D.D.S., INC.
  SUBSTANTIALLY EQUIVALENT 1
PRIMUS STERILIZER CO., INC.
  SUBSTANTIALLY EQUIVALENT 4
SAUTER AG
  SUBSTANTIALLY EQUIVALENT 5
SCICAN LTD.
  SUBSTANTIALLY EQUIVALENT 3
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 13
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
TUTTNAUER CO. LTD.
  SUBSTANTIALLY EQUIVALENT 6

Device Problems
Other (for use when an appropriate device code cannot be identified) 6
Device operates differently than expected 4
Loose 4
Improper or incorrect procedure or method 3
Dislodged or dislocated 2
Device Issue 2
Tipover 2
Misapplication 2
Normal 2
Unstable 2
Failure to Adhere or Bond 2
Detachment of device component 2
Component falling 2
Dislodged 1
Electrical issue 1
Fluid leak 1
Leak 1
Break 1
Device Cleaning Issue 1
Air leak 1
Device alarm system issue 1
Use of Device Issue 1
Water softener process, failure of 1
Slippage of device or device component 1
Failure to sterilize 1
Misassembled 1
Mechanical issue 1
Locking mechanism failure 1
Malfunction 1
Unknown (for use when the device problem is not known) 1
Valve(s), defective 1
Component missing 1
Environmental Particulates 1
No Information 1
Total Device Problems 56

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

Recalls
Manufacturer Recall Class Date Posted
1 Midmark Corportation II Jan-11-2012
2 Steris Corp II Sep-17-2008
3 Steris Corp II Aug-23-2007
4 Steris Corporation III Nov-04-2015
5 Steris Corporation II Apr-30-2015
6 Steris Corporation II Dec-11-2013
7 Steris Corporation II Mar-06-2013
8 Steris Corporation II May-11-2012

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