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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 4
STERIS CORPARATION
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
STERIS CORPORATIONS
  SUBSTANTIALLY EQUIVALENT 1
STERITEC PRODUCTS MFG CO INC
  SUBSTANTIALLY EQUIVALENT 1
TERRAGENE SA
  SUBSTANTIALLY EQUIVALENT 1
TRUE INDICATING LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
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 7 7
Leak/Splash 5 5
Product Quality Problem 5 5
Problem with Sterilization 5 5
Output Problem 4 4
Contamination /Decontamination Problem 4 4
Explosion 4 4
Detachment of Device or Device Component 3 3
No Apparent Adverse Event 3 3
Insufficient Information 3 3
Use of Device Problem 3 3
Defective Component 3 3
Burst Container or Vessel 3 3
Device Reprocessing Problem 3 3
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Material Separation 2 2
Packaging Problem 2 2
Defective Device 2 2
Therapeutic or Diagnostic Output Failure 2 2
Improper Chemical Reaction 2 2
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
Device Ingredient or Reagent Problem 1 1
Device Damaged by Another Device 1 1
Activation, Positioning or Separation Problem 1 1
Protective Measures Problem 1 1
Device Handling Problem 1 1
Device Slipped 1 1
Material Rupture 1 1
Expiration Date Error 1 1
Device Damaged Prior to Use 1 1
Contamination 1 1
Loss of or Failure to Bond 1 1
Nonstandard Device 1 1
Peeled/Delaminated 1 1
Material Split, Cut or Torn 1 1
Non Reproducible Results 1 1
Illegible Information 1 1
Missing Information 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 8 8
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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