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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 5
ADVANCED STERILIZATION PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CROSSTEX INTERNATIONAL, INC. (A CANTEL MEDICAL COMPANY)
  SUBSTANTIALLY EQUIVALENT 1
INTERTAPE POLYMER GROUP
  SUBSTANTIALLY EQUIVALENT 1
JIANGMEN NEW ERA EXTERNAL USE DRUG CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KEM MEDICAL PRODUCTS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PROPPER MANUFACTURING CO., INC.
  SUBSTANTIALLY EQUIVALENT 5
SERIM RESEARCH
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN SAFESECURE MEDICAL INFECTION CONTROL TECH CO. , LTD.
  SUBSTANTIALLY EQUIVALENT 1
STERIS
  SUBSTANTIALLY EQUIVALENT 6
STERIS CORPARATION
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
STERITEC PRODUCTS MFG. (A GETINGE GROUP COMPANY)
  SUBSTANTIALLY EQUIVALENT 1
STERITEC PRODUCTS, INC. (A GETINGE COMPANY)
  SUBSTANTIALLY EQUIVALENT 1
TRUE INDICATING, LLC
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2021 29 55
2022 23 25
2023 39 42
2024 25 25
2025 12 12
2026 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Unexpected Color 23 27
Appropriate Device Problem Term/Code Not Available 11 11
Insufficient Device Problem Information 6 6
Leak/Splash 5 5
Use of Device Problem 4 4
Improper Chemical Reaction 3 3
No Apparent Adverse Event 3 3
Defective Component 3 6
Device Ingredient or Reagent Problem 3 4
Defective Device 2 2
Unclear Information 2 2
Activation Failure 2 2
Illegible Information 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Component Missing 1 1
Material Fragmentation 1 1
Material Discolored 1 1
Loss of or Failure to Bond 1 1
Explosion 1 1
Device Handling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 119 125
Insufficient Information 24 49
Hemorrhage/Blood Loss/Bleeding 1 1
Bone Cement Implantation Syndrome 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 Steris Corporation Hopkins Facility III Sep-10-2022
4 TERRAGENE S.A. II Jan-26-2024
5 Young Dental Mfg Co I LLC II Feb-02-2022
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