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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 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 4
SERIM RESEARCH CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
STERILUCENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPARATION
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
STERIS CORPORATIONS
  SUBSTANTIALLY EQUIVALENT 1
STERITEC PRODUCTS MFG CO INC
  SUBSTANTIALLY EQUIVALENT 1
TERRAGENE SA
  SUBSTANTIALLY EQUIVALENT 1
TRUE INDICATING LLC
  SUBSTANTIALLY EQUIVALENT 1
U&U MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 12 12
2019 8 8
2020 6 6
2021 26 26
2022 23 23

Device Problems MDRs with this Device Problem Events in those MDRs
Unexpected Color 20 20
Material Discolored 6 6
Product Quality Problem 4 4
Problem with Sterilization 4 4
Output Problem 4 4
Chemical Problem 4 4
Contamination /Decontamination Problem 3 3
Detachment of Device or Device Component 3 3
Use of Device Problem 3 3
Delivered as Unsterile Product 3 3
Device Reprocessing Problem 2 2
Shelf Life Exceeded 2 2
Improper or Incorrect Procedure or Method 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Device Operates Differently Than Expected 2 2
Expiration Date Error 2 2
Defective Device 2 2
Packaging Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
No Apparent Adverse Event 1 1
Appropriate Term/Code Not Available 1 1
Device Handling Problem 1 1
Non Reproducible Results 1 1
Missing Information 1 1
Protective Measures Problem 1 1
Activation, Positioning or Separation Problem 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
Nonstandard Device 1 1
Loss of or Failure to Bond 1 1
Burst Container or Vessel 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1
Device Slipped 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 37 37
Insufficient Information 13 13
No Known Impact Or Consequence To Patient 13 13
No Consequences Or Impact To Patient 7 7
No Patient Involvement 2 2
Foreign Body In Patient 1 1
Not Applicable 1 1
Hemorrhage/Bleeding 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Mckesson Medical-Surgical Inc. Corporate Office III Sep-26-2022
2 Resource Optimization & Innovation LLC II Jul-24-2020
3 Steris Corporation Hopkins Facility III Sep-10-2022
4 Young Dental Mfg Co I LLC II Feb-02-2022
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