TPLC - Total Product Life Cycle

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Device	indicator, biological sterilization process
Regulation Description	Sterilization process indicator.
Product Code	FRC
Regulation Number	880.2800
Device Class	2

Premarket Reviews
Manufacturer	Decision
3M
	SUBSTANTIALLY EQUIVALENT	1
3M COMPANY
	SUBSTANTIALLY EQUIVALENT	14
3M COMPLANY
	SUBSTANTIALLY EQUIVALENT	1
ADVANCED STERILIZATION PRODUCTS (ASP)
	SUBSTANTIALLY EQUIVALENT	1
ANDERSEN STERILIZERS, INC.
	SUBSTANTIALLY EQUIVALENT	3
PLASMAPP CO,.LTD.
	SUBSTANTIALLY EQUIVALENT	1
PLASMAPP CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
STERIS
	SUBSTANTIALLY EQUIVALENT	2
STERIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	10
TERRAGENE
	SUBSTANTIALLY EQUIVALENT	1
TERRAGENE S.A.
	SUBSTANTIALLY EQUIVALENT	1
TERRAGENE SA
	SUBSTANTIALLY EQUIVALENT	2
TRUE INDICATING LLC
	SUBSTANTIALLY EQUIVALENT	1
TSO3 INC., NOW A PART OF STRYKER
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Appropriate Term/Code Not Available	54	54
Leak/Splash	6	6
Insufficient Information	4	4
Use of Device Problem	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Break	2	2
Contamination /Decontamination Problem	2	6
Component Missing	2	2
Chemical Problem	1	1
Defective Device	1	1
Therapeutic or Diagnostic Output Failure	1	1
Problem with Sterilization	1	1
No Apparent Adverse Event	1	1
Device Reprocessing Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	51	51
No Consequences Or Impact To Patient	14	14
Insufficient Information	5	5
No Known Impact Or Consequence To Patient	3	7
Burn(s)	3	3
Laceration(s)	2	2
Skin Discoloration	1	1
Discomfort	1	1
Eye Injury	1	1
Eye Pain	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	3M Company - Health Care Business	II	Sep-26-2023
2	HF Acquisition Co LLC	II	Feb-11-2025
3	Mckesson Medical-Surgical Inc. Corporate Office	III	Sep-26-2022
4	Steris Corporation	II	Jan-03-2023
5	TERRAGENE S.A.	II	Feb-27-2025
6	TERRAGENE S.A.	II	Jan-26-2024