TPLC - Total Product Life Cycle

• 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
1.  K183209  3M Comply Hydrogen Peroxide Indicator Tape
2.  K183211  3M Comply Hydrogen Peroxide Chemical Indicator
3.  K191236  3M™ Attest™ Steam Chemical Integrators
4.  K192673  3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228
5.  K192937  3M Comply Hydrogen Peroxide Chemical Indicator
6.  K193254  3M Attest Steam Chemical Integrator
7.  K203285  3M Comply Hydrogen Peroxide Indicator Tape 1228
8.  K203458  3M Comply Hydrogen Peroxide Chemical Indicator 124 ...
9.  K212081  3M(TM) Comply(TM) Hydrogen Peroxide Indicator Tape ...
10.  K220564  3M Comply Lead Free Steam Indicator Tape 1322, 3M ...
11.  K220942  3M Attest Steam Chemical Integrators (1243A, 1243B ...
12.  K222152  3M™ Attest™ Hydrogen Peroxide Indicator Tape 1228
13.  K222508  3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1 ...
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
	SUBSTANTIALLY EQUIVALENT	4
STERIS CORPARATION
	SUBSTANTIALLY EQUIVALENT	1
STERIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	4
STERIS CORPORATIONS
	SUBSTANTIALLY EQUIVALENT	1
STERITEC PRODUCTS MFG CO INC
	SUBSTANTIALLY EQUIVALENT	1
TERRAGENE SA
	SUBSTANTIALLY EQUIVALENT	1
TRUE INDICATING LLC
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2019	8	8
2020	6	6
2021	29	29
2022	23	23
2023	39	39
2024	13	13

Device Problems	MDRs with this Device Problem	Events in those MDRs
Unexpected Color	23	23
Fluid/Blood Leak	13	13
Material Integrity Problem	11	11
Appropriate Term/Code Not Available	10	10
Material Discolored	7	7
Leak/Splash	5	5
Product Quality Problem	5	5
Problem with Sterilization	5	5
Output Problem	4	4
Contamination /Decontamination Problem	4	4
Explosion	4	4
Detachment of Device or Device Component	3	3
Improper Chemical Reaction	3	3
No Apparent Adverse Event	3	3
Insufficient Information	3	3
Use of Device Problem	3	3
Defective Component	3	3
Burst Container or Vessel	3	3
Device Reprocessing Problem	3	3
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Material Separation	2	2
Packaging Problem	2	2
Defective Device	2	2
Therapeutic or Diagnostic Output Failure	2	2
Protective Measures Problem	1	1
Device Handling Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Material Deformation	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Optical Discoloration	1	1
Device Ingredient or Reagent Problem	1	1
Device Damaged by Another Device	1	1
Activation, Positioning or Separation Problem	1	1
Device Slipped	1	1
Material Rupture	1	1
Expiration Date Error	1	1
Device Damaged Prior to Use	1	1
Contamination	1	1
Loss of or Failure to Bond	1	1
Nonstandard Device	1	1
Peeled/Delaminated	1	1
Material Split, Cut or Torn	1	1
Non Reproducible Results	1	1
Illegible Information	1	1
Missing Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	81	81
Insufficient Information	23	23
No Known Impact Or Consequence To Patient	8	8
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	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