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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
BELIMED AG
  SUBSTANTIALLY EQUIVALENT 2
CEFLA S.C.
  SUBSTANTIALLY EQUIVALENT 2
MAQUET GMBH
  SUBSTANTIALLY EQUIVALENT 1
MAQUET, INC.
  SUBSTANTIALLY EQUIVALENT 1
MIDMARK CORP.
  SUBSTANTIALLY EQUIVALENT 1
MIDMARK CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MILTON E PEDRAZZI D.D.S., INC.
  SUBSTANTIALLY EQUIVALENT 1
REVOLUTIONARY SCIENCE
  SUBSTANTIALLY EQUIVALENT 1
SAUTER AG
  SUBSTANTIALLY EQUIVALENT 1
SCICAN LTD.
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
STURDY INDUSTRIAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
TUTTNAUER CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
TUTTNAUER USA CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
W&H STERILIZATION S.R.L.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Leak / Splash 12
Failure To Adhere Or Bond 12
Device Operates Differently Than Expected 6
Seal 3
Improper or Incorrect Procedure or Method 2
Residue After Decontamination 2
Device Contamination with Chemical or Other Material 2
Human Factors Issue 2
Device Disinfection Or Sterilization Issue 2
Device Handling Problem 2
Use of Device Problem 2
Gas Leak 2
Moisture or Humidity Problem 1
Missing Value Reason 1
Device Issue 1
Component Falling 1
Material Erosion 1
Device Dislodged or Dislocated 1
Unintended Movement 1
Device Reprocessing Problem 1
Device Contaminated during manufacture or shipping 1
Crack 1
Fluid Leak 1
Pressure Problem 1
Loose or Intermittent Connection 1
Problem with Sterilization 1
Sparking 1
Material Split, Cut or Torn 1
Overheating of Device 1
Unstable 1
Scratched Material 1
Total Device Problems 68

Recalls
Manufacturer Recall Class Date Posted
1 Fort Defiance Industries, LLC II Jul-10-2018
2 Skytron, Div. The KMW Group, Inc II Jun-13-2019
3 Steris Corporation II Dec-05-2019
4 Steris Corporation II Nov-29-2019
5 Steris Corporation II Feb-13-2019
6 Steris Corporation III Nov-04-2015
7 Steris Corporation II Apr-30-2015

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