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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
Regulation Description Liquid chemical sterilants/high level disinfectants.
Product CodeMED
Regulation Number 880.6885
Device Class 2


Premarket Reviews
ManufacturerDecision
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 5

MDR Year MDR Reports MDR Events
2020 32 32
2021 31 31
2022 16 16
2023 9 9
2024 8 8
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Improper or Incorrect Procedure or Method 24 24
Use of Device Problem 14 14
Fluid/Blood Leak 14 14
Leak/Splash 10 10
Problem with Sterilization 9 9
Adverse Event Without Identified Device or Use Problem 7 7
Chemical Problem 5 5
Insufficient Information 5 5
Break 4 4
Device Handling Problem 3 3
Failure to Disinfect 3 3
Fire 1 1
Device Markings/Labelling Problem 1 1
Unintended Movement 1 1
Defective Device 1 1
Contamination 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Shipping Damage or Problem 1 1
Material Too Rigid or Stiff 1 1
Insufficient Flow or Under Infusion 1 1
Device Emits Odor 1 1
Device Contamination with Chemical or Other Material 1 1
No Apparent Adverse Event 1 1
Explosion 1 1
Power Problem 1 1
Deformation Due to Compressive Stress 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 37 37
Burning Sensation 21 21
Skin Discoloration 16 16
Insufficient Information 7 7
Skin Irritation 5 5
Burn(s) 5 5
Anaphylactic Shock 5 5
Chemical Exposure 4 4
No Known Impact Or Consequence To Patient 3 3
Irritation 3 3
Nasal Obstruction 3 3
Caustic/Chemical Burns 3 3
No Consequences Or Impact To Patient 3 3
Skin Burning Sensation 3 3
Wheezing 2 2
Skin Inflammation/ Irritation 2 2
Eye Burn 2 2
Unspecified Eye / Vision Problem 2 2
Dyspnea 2 2
Bronchospasm 2 2
Cough 2 2
Swelling/ Edema 2 2
Blurred Vision 2 2
Headache 2 2
Low Blood Pressure/ Hypotension 2 2
Superficial (First Degree) Burn 1 1
Syncope/Fainting 1 1
Decreased Sensitivity 1 1
Red Eye(s) 1 1
Corneal Abrasion 1 1
Asthma 1 1
Erythema 1 1
Pain 1 1
Unspecified Respiratory Problem 1 1
Sore Throat 1 1
Eye Pain 1 1
Excessive Tear Production 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
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