TPLC - Total Product Life Cycle

show TPLC since

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

Premarket Reviews
Manufacturer	Decision
3M
	SUBSTANTIALLY EQUIVALENT	1
3M COMPANY
	SUBSTANTIALLY EQUIVALENT	15
3M COMPLANY
	SUBSTANTIALLY EQUIVALENT	1
ADVANCED STERILIZATION PRODUCTS (ASP)
	SUBSTANTIALLY EQUIVALENT	2
ANDERSEN STERILIZERS, INC.
	SUBSTANTIALLY EQUIVALENT	3
CROSSTEX/SPSMEDICAL, A DIVISION OF CANTEL MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
PLASMAPP CO,.LTD.
	SUBSTANTIALLY EQUIVALENT	1
PLASMAPP CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SPSMEDICAL SUPPLY CORP. A DIVISION OF CANTEL MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
STERILUCENT, INC.
	SUBSTANTIALLY EQUIVALENT	1
STERIS
	SUBSTANTIALLY EQUIVALENT	1
STERIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	18
STERIS CORPORATIONS
	SUBSTANTIALLY EQUIVALENT	3
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	96	96
Leak/Splash	6	6
Chemical Problem	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Use of Device Problem	4	4
Contamination /Decontamination Problem	2	2
Break	2	2
Insufficient Information	2	2
Device Reprocessing Problem	1	1
Device Disinfection Or Sterilization Issue	1	1
Improper or Incorrect Procedure or Method	1	1
Defective Device	1	1
Device Operates Differently Than Expected	1	1
Improper Chemical Reaction	1	1
Material Fragmentation	1	1
No Apparent Adverse Event	1	1
Problem with Sterilization	1	1
Therapeutic or Diagnostic Output Failure	1	1
Off-Label Use	1	1
Component Missing	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	48	48
No Known Impact Or Consequence To Patient	45	45
No Consequences Or Impact To Patient	22	22
Burn(s)	3	3
Insufficient Information	2	2
Patient Problem/Medical Problem	1	1
Eye Injury	1	1
Abrasion	1	1
Fever	1	1
Chemical Exposure	1	1
Eye Pain	1	1
Skin Discoloration	1	1
Laceration(s)	1	1
Discomfort	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	3M Company - Health Care Business	II	Sep-26-2023
2	Mckesson Medical-Surgical Inc. Corporate Office	III	Sep-26-2022
3	Mesa Laboratories Bozeman Manufacturing Facility	II	Mar-29-2018
4	Steris Corporation	II	Jan-03-2023
5	TERRAGENE S.A.	II	Jan-26-2024