TPLC - Total Product Life Cycle

show TPLC since

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

Premarket Reviews
Manufacturer	Decision
3M COMPANY
	GRANTED	1
	SUBSTANTIALLY EQUIVALENT	7
ADVANCED STERILIZATION PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ANDERSEN STERILIZERS, INC.
	SUBSTANTIALLY EQUIVALENT	1
CROSSTEX INTERNATIONAL, INC. (A CANTEL MEDICAL COMPANY)
	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 CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
STERIS
	SUBSTANTIALLY EQUIVALENT	6
1. K230558 Revital-Ox PAA High Level Disinfectant Chemical In ...
2. K240032 Celerity Chemical Indicator for enspire 3000 CLCSP ...
3. K243475 Chemical Indicator for enspire CLCSPS (LCC015)
STERIS CORPARATION
	SUBSTANTIALLY EQUIVALENT	1
STERIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
1. K230558 Revital-Ox PAA High Level Disinfectant Chemical In ...
2. K240032 Celerity Chemical Indicator for enspire 3000 CLCSP ...
3. K243475 Chemical Indicator for enspire CLCSPS (LCC015)
STERITEC PRODUCTS MFG CO INC
	SUBSTANTIALLY EQUIVALENT	1
STERITEC PRODUCTS MFG. (A GETINGE GROUP COMPANY)
	SUBSTANTIALLY EQUIVALENT	1
TERRAGENE SA
	SUBSTANTIALLY EQUIVALENT	1
TRUE INDICATING LLC
	SUBSTANTIALLY EQUIVALENT	2
TRUE INDICATING, LLC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Unexpected Color	23	23
Fluid/Blood Leak	13	13
Appropriate Term/Code Not Available	12	12
Material Integrity Problem	11	11
Leak/Splash	8	8
Material Discolored	7	7
Product Quality Problem	5	5
Contamination /Decontamination Problem	4	4
Problem with Sterilization	4	4
Use of Device Problem	4	4
Explosion	4	4
Insufficient Information	4	4
Defective Component	3	3
Improper Chemical Reaction	3	3
Device Reprocessing Problem	3	3
No Apparent Adverse Event	3	3
Output Problem	3	3
Burst Container or Vessel	2	2
Defective Device	2	2
Material Separation	2	2
Packaging Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Material Deformation	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Material Fragmentation	1	1
Device Slipped	1	1
Device Ingredient or Reagent Problem	1	1
Device Damaged Prior to Use	1	1
Protective Measures Problem	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Contamination	1	1
Material Rupture	1	1
Device Damaged by Another Device	1	1
Nonstandard Device	1	1
Missing Information	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Device Handling Problem	1	1
Activation, Positioning or Separation Problem	1	1
Peeled/Delaminated	1	1
Material Split, Cut or Torn	1	1
Optical Discoloration	1	1
Loss of or Failure to Bond	1	1
Illegible Information	1	1
Detachment of Device or Device Component	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	94	94
Insufficient Information	25	25
No Known Impact Or Consequence To Patient	2	2
Hemorrhage/Bleeding	1	1
Foreign Body In Patient	1	1
No Patient Involvement	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	Resource Optimization & Innovation LLC	II	Jul-24-2020
4	Steris Corporation Hopkins Facility	III	Sep-10-2022
5	TERRAGENE S.A.	II	Jan-26-2024
6	Young Dental Mfg Co I LLC	II	Feb-02-2022