TPLC - Total Product Life Cycle

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Device	indicator, physical/chemical sterilization process
Product Code	JOJ
Regulation Number	880.2800
Device Class	2

Premarket Reviews
Manufacturer	Decision
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 CORPARATION
	SUBSTANTIALLY EQUIVALENT	1
STERIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	6
STERIS CORPORATIONS
	SUBSTANTIALLY EQUIVALENT	1
STERITEC PRODUCTS MFG CO INC
	SUBSTANTIALLY EQUIVALENT	1
TERRAGENE SA
	SUBSTANTIALLY EQUIVALENT	1
TRUE INDICATING LLC
	SUBSTANTIALLY EQUIVALENT	1
U&U MEDICAL TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Unexpected Color	20	20
Material Discolored	6	6
Product Quality Problem	4	4
Problem with Sterilization	4	4
Output Problem	4	4
Chemical Problem	4	4
Contamination /Decontamination Problem	3	3
Detachment of Device or Device Component	3	3
Use of Device Problem	3	3
Delivered as Unsterile Product	3	3
Device Reprocessing Problem	2	2
Shelf Life Exceeded	2	2
Improper or Incorrect Procedure or Method	2	2
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Device Operates Differently Than Expected	2	2
Expiration Date Error	2	2
Defective Device	2	2
Packaging Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
No Apparent Adverse Event	1	1
Appropriate Term/Code Not Available	1	1
Device Handling Problem	1	1
Non Reproducible Results	1	1
Missing Information	1	1
Protective Measures Problem	1	1
Activation, Positioning or Separation Problem	1	1
Device Damaged by Another Device	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Optical Discoloration	1	1
Material Rupture	1	1
Material Separation	1	1
Nonstandard Device	1	1
Loss of or Failure to Bond	1	1
Burst Container or Vessel	1	1
Device Damaged Prior to Use	1	1
Defective Component	1	1
Device Slipped	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	37	37
Insufficient Information	13	13
No Known Impact Or Consequence To Patient	13	13
No Consequences Or Impact To Patient	7	7
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	Mckesson Medical-Surgical Inc. Corporate Office	III	Sep-26-2022
2	Resource Optimization & Innovation LLC	II	Jul-24-2020
3	Steris Corporation Hopkins Facility	III	Sep-10-2022
4	Young Dental Mfg Co I LLC	II	Feb-02-2022