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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
Regulation Description Sterilization process indicator.
Product CodeJOJ
Regulation Number 880.2800
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 10
ANDERSEN STERILIZERS, INC.
  SUBSTANTIALLY EQUIVALENT 2
CANADIAN TECHNICAL TAPE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
INTERTAPE POLYMER INC..
  SUBSTANTIALLY EQUIVALENT 1
KEM MEDICAL PRODUCTS CORP.
  SUBSTANTIALLY EQUIVALENT 1
SERIM RESEARCH CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
STERILUCENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 10
TERRAGENE SA
  SUBSTANTIALLY EQUIVALENT 1
U&U MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 11 11
2017 35 35
2018 12 12
2019 8 8
2020 6 6
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Chemical Problem 31 31
Device Operates Differently Than Expected 31 31
Shelf Life Exceeded 6 6
Material Discolored 4 4
Improper or Incorrect Procedure or Method 3 3
Delivered as Unsterile Product 3 3
Contamination /Decontamination Problem 3 3
Device Handling Problem 3 3
Device Disinfection Or Sterilization Issue 3 3
Appropriate Term/Code Not Available 2 2
Output Problem 2 2
Test Strip 2 2
Detachment of Device or Device Component 2 2
Incorrect, Inadequate or Imprecise Resultor Readings 2 2
Expiration Date Error 2 2
Leak/Splash 2 2
Melted 1 1
Migration or Expulsion of Device 1 1
Product Quality Problem 1 1
Device Rinsing Issue 1 1
Problem with Sterilization 1 1
Device Expiration Issue 1 1
Fluid Leak 1 1
Fracture 1 1
Guidewire 1 1
Integrator 1 1
Break 1 1
Burst Container or Vessel 1 1
Device Packaging Compromised 1 1
Device Contamination with Chemical or Other Material 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Optical Discoloration 1 1
No Apparent Adverse Event 1 1
Therapeutic or Diagnostic Output Failure 1 1
Adhesive 1 1
Non Reproducible Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 28 28
No Patient Involvement 25 25
No Consequences Or Impact To Patient 11 11
No Information 3 3
No Clinical Signs, Symptoms or Conditions 2 2
Partial thickness (Second Degree) Burn 1 1
Insufficient Information 1 1
Irritation 1 1
Skin Discoloration 1 1
Foreign Body In Patient 1 1
Not Applicable 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Resource Optimization & Innovation LLC II Jul-24-2020
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