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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device sterilant, medical devices
Product CodeMED
Regulation Number 880.6885
Device Class 2


Premarket Reviews
ManufacturerDecision
BEST SANITIZERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CIDEN TECHNOLOGIES LLC
  SUBSTANTIALLY EQUIVALENT 1
HEALTHPOINT, LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICROCHEM LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MINNTECH CORP.
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 17
STERIS CORPORATIONS
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 105 105
2015 110 110
2016 135 135
2017 74 74
2018 42 42
2019 35 35
2020 32 32
2021 31 31
2022 16 16
2023 9 9
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 105 105
Improper or Incorrect Procedure or Method 72 72
Leak/Splash 59 59
Adverse Event Without Identified Device or Use Problem 48 48
Device Disinfection Or Sterilization Issue 45 45
Chemical Problem 40 40
Use of Device Problem 27 27
Device Operates Differently Than Expected 23 23
Labelling, Instructions for Use or Training Problem 21 21
Device Rinsing Issue 19 19
Insufficient Information 19 19
Failure to Disinfect 13 13
Device Expiration Issue 12 12
Device Emits Odor 11 11
Problem with Sterilization 9 9
Inadequate or Insufficient Training 9 9
Patient-Device Incompatibility 9 9
Device Reprocessing Problem 9 9
Appropriate Term/Code Not Available 7 7
Chemical Spillage 7 7
Device Handling Problem 6 6
Break 6 6
Ventilation Problem in Device Environment 5 5
No Flow 4 4
Crack 4 4
Detachment Of Device Component 4 4
Shelf Life Exceeded 4 4
Off-Label Use 3 3
Contamination 3 3
Defective Device 3 3
Material Separation 3 3
Microbial Contamination of Device 3 3
Residue After Decontamination 3 3
Temperature Problem 3 3
Improper Chemical Reaction 3 3
Contamination of Device Ingredient or Reagent 2 2
Power Problem 2 2
Unintended Collision 2 2
Device Operational Issue 2 2
Difficult to Open or Close 2 2
Environmental Compatibility Problem 2 2
Disconnection 2 2
No Display/Image 1 1
Problem with Removal of Enzymatic Cleaner 1 1
Loose or Intermittent Connection 1 1
Mechanical Problem 1 1
Occlusion Within Device 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Material Too Rigid or Stiff 1 1
Material Rupture 1 1
Self-Activation or Keying 1 1
Shipping Damage or Problem 1 1
Device Slipped 1 1
Smoking 1 1
Failure to Cycle 1 1
Component Falling 1 1
Complete Blockage 1 1
Fail-Safe Design Failure 1 1
Filling Problem 1 1
Unintended Ejection 1 1
Fire 1 1
Flushing Problem 1 1
Fracture 1 1
Material Fragmentation 1 1
Environmental Particulates 1 1
Device Contamination with Chemical or Other Material 1 1
Human Factors Issue 1 1
Human-Device Interface Problem 1 1
Device Displays Incorrect Message 1 1
Out-Of-Box Failure 1 1
Ambient Temperature Problem 1 1
Deformation Due to Compressive Stress 1 1
Calibration Problem 1 1
Failure to Power Up 1 1
Unexpected Therapeutic Results 1 1
Insufficient Flow or Under Infusion 1 1
Fitting Problem 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1
Obstruction of Flow 1 1
Failure to Calibrate 1 1
Incorrect Or Inadequate Test Results 1 1
Expiration Date Error 1 1
Fumes or Vapors 1 1
Component Missing 1 1
Protective Measures Problem 1 1
Unintended Movement 1 1
Output Problem 1 1
Detachment of Device or Device Component 1 1
Device Contamination With Biological Material 1 1
Improper Device Output 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Markings/Labelling Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
No Apparent Adverse Event 1 1
Failure to Clean Adequately 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 257 257
No Consequences Or Impact To Patient 44 44
Chemical Exposure 35 35
No Clinical Signs, Symptoms or Conditions 33 33
Burning Sensation 30 30
Skin Discoloration 29 29
No Code Available 27 27
Irritation 26 26
Burn(s) 23 23
No Information 17 17
Skin Irritation 13 13
Anaphylactic Shock 11 11
Headache 8 8
Respiratory Distress 8 8
Complaint, Ill-Defined 7 7
Insufficient Information 7 7
Injury 6 6
Burn, Thermal 6 6
Caustic/Chemical Burns 6 6
Itching Sensation 6 6
Fever 6 6
Dyspnea 5 5
Erythema 5 5
Pain 5 5
Red Eye(s) 5 5
No Patient Involvement 5 5
Sore Throat 5 5
Dizziness 5 5
Reaction 4 4
Respiratory Tract Infection 4 4
Swelling 4 4
Unspecified Infection 4 4
Eye Injury 4 4
Asthma 4 4
Bacterial Infection 3 3
Low Blood Pressure/ Hypotension 3 3
Nausea 3 3
Rash 3 3
Chest Tightness/Pressure 3 3
Nasal Obstruction 3 3
Bronchospasm 3 3
Skin Burning Sensation 3 3
Skin Inflammation/ Irritation 2 2
Swelling/ Edema 2 2
Cough 2 2
Wheezing 2 2
Anaphylactoid 2 2
Tachycardia 2 2
Ulceration 2 2
Blurred Vision 2 2
Inflammation 2 2
Syncope 2 2
Corneal Abrasion 2 2
Unspecified Eye / Vision Problem 2 2
Dry Eye(s) 1 1
Chest Pain 1 1
Head Injury 1 1
Abdominal Pain 1 1
Airway Obstruction 1 1
Arrhythmia 1 1
Exposure to Body Fluids 1 1
Bronchitis 1 1
Bruise/Contusion 1 1
Laceration(s) 1 1
Miscarriage 1 1
Vomiting 1 1
Excessive Tear Production 1 1
Sneezing 1 1
Urticaria 1 1
Anxiety 1 1
Discomfort 1 1
Chills 1 1
Eye Burn 1 1
Malaise 1 1
Diaphoresis 1 1
Unspecified Respiratory Problem 1 1
Eye Pain 1 1
Syncope/Fainting 1 1
Hematuria 1 1
Decreased Sensitivity 1 1
Superficial (First Degree) Burn 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Advanced Sterilization Products II Sep-16-2015
2 Advanced Sterilization Products II Aug-25-2015
3 Advanced Sterilization Products II Aug-27-2012
4 Best Sanitizers Inc II Sep-02-2016
5 Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical II Jul-05-2019
6 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
7 Steris Corporation II Mar-16-2016
8 Steris Corporation II Jun-26-2013
9 Steris Corporation II Sep-07-2012
10 Steris Corporation II Aug-28-2012
11 Steris Corporation Hopkins Facility II Jan-25-2012
12 Steris Corporation Hopkins Facility II Apr-12-2011
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