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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device indicator, physical/chemical sterilization process
Product CodeJOJ
Regulation Number 880.2800
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 13
ANDERSEN STERILIZERS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ANDERSEN STERILIZERS,INC.
  SUBSTANTIALLY EQUIVALENT 1
CROSSTEX INTERNATIONAL, INC. (A CANTEL MEDICAL COMPANY)
  SUBSTANTIALLY EQUIVALENT 1
INTERTAPE POLYMER INC.
  SUBSTANTIALLY EQUIVALENT 1
KEM MEDICAL PRODUCTS CORP.
  SUBSTANTIALLY EQUIVALENT 1
PROPPER MANUFACTURING CO., INC.
  SUBSTANTIALLY EQUIVALENT 3
SERIM RESEARCH CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
STERILUCENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPARATION
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 9
STERIS CORPORATIONS
  SUBSTANTIALLY EQUIVALENT 1
STERITEC PRODUCTS MFG CO INC
  SUBSTANTIALLY EQUIVALENT 1
TERRAGENE SA
  SUBSTANTIALLY EQUIVALENT 1
U&U MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 35 35
2018 12 12
2019 8 8
2020 6 6
2021 25 25
2022 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Chemical Problem 31 31
Device Operates Differently Than Expected 29 29
Unexpected Color 19 19
Material Discolored 6 6
Shelf Life Exceeded 6 6
Problem with Sterilization 4 4
Product Quality Problem 4 4
Output Problem 4 4
Contamination /Decontamination Problem 3 3
Detachment of Device or Device Component 3 3
Improper or Incorrect Procedure or Method 3 3
Delivered as Unsterile Product 3 3
Expiration Date Error 2 2
Defective Device 2 2
Use of Device Problem 2 2
Incorrect, Inadequate or Imprecise Resultor Readings 2 2
Packaging Problem 2 2
Appropriate Term/Code Not Available 2 2
Device Handling Problem 2 2
Non Reproducible Results 1 1
Missing Information 1 1
Therapeutic or Diagnostic Output Failure 1 1
No Apparent Adverse Event 1 1
Device Disinfection Or Sterilization Issue 1 1
Activation, Positioning or SeparationProblem 1 1
Device Damaged by Another Device 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Optical Discoloration 1 1
Material Rupture 1 1
Material Separation 1 1
Device Expiration Issue 1 1
Nonstandard Device 1 1
Loss of or Failure to Bond 1 1
Burst Container or Vessel 1 1
Device Reprocessing Problem 1 1
Device Slipped 1 1
Device Damaged Prior to Use 1 1
Device Rinsing Issue 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 33 33
No Patient Involvement 24 24
No Known Impact Or Consequence To Patient 22 22
Insufficient Information 13 13
No Consequences Or Impact To Patient 11 11
Partial thickness (Second Degree) Burn 1 1
Not Applicable 1 1
Foreign Body In Patient 1 1
Hemorrhage/Bleeding 1 1
Skin Discoloration 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Resource Optimization & Innovation LLC II Jul-24-2020
2 Young Dental Mfg Co I LLC II Feb-02-2022
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