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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
  SUBSTANTIALLY EQUIVALENT 3
STERIS CORPARATION
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 7
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 29 29
2022 23 23
2023 39 39
2024 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Unexpected Color 23 23
Fluid/Blood Leak 13 13
Material Integrity Problem 11 11
Appropriate Term/Code Not Available 10 10
Material Discolored 8 8
Contamination /Decontamination Problem 7 7
Leak/Splash 5 5
Product Quality Problem 5 5
Problem with Sterilization 5 5
Output Problem 4 4
Chemical Problem 4 4
Explosion 4 4
No Apparent Adverse Event 3 3
Insufficient Information 3 3
Defective Component 3 3
Detachment of Device or Device Component 3 3
Use of Device Problem 3 3
Delivered as Unsterile Product 3 3
Burst Container or Vessel 3 3
Device Reprocessing Problem 3 3
Improper or Incorrect Procedure or Method 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Material Separation 2 2
Shelf Life Exceeded 2 2
Device Operates Differently Than Expected 2 2
Expiration Date Error 2 2
Defective Device 2 2
Therapeutic or Diagnostic Output Failure 2 2
Packaging Problem 2 2
Improper Chemical Reaction 2 2
Device Handling Problem 2 2
Material Split, Cut or Torn 1 1
Non Reproducible Results 1 1
Illegible Information 1 1
Missing Information 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Optical Discoloration 1 1
Protective Measures Problem 1 1
Activation, Positioning or Separation Problem 1 1
Device Damaged by Another Device 1 1
Device Ingredient or Reagent Problem 1 1
Device Slipped 1 1
Material Rupture 1 1
Device Damaged Prior to Use 1 1
Contamination 1 1
Loss of or Failure to Bond 1 1
Peeled/Delaminated 1 1
Nonstandard Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 80 80
Insufficient Information 23 23
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 3M Company - Health Care Business II May-18-2023
2 Mckesson Medical-Surgical Inc. Corporate Office III Sep-26-2022
3 Resource Optimization & Innovation LLC II Jul-24-2020
4 Steris Corporation Hopkins Facility III Sep-10-2022
5 TERRAGENE S.A. II Jan-26-2024
6 Young Dental Mfg Co I LLC II Feb-02-2022
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