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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
  1.  K210737  SYSTEM 1E Liquid Chemical Sterilant Processing Sys ...
  2.  K211607  SYSTEM 1E Liquid Chemical Sterilant Processing Sys ...
  3.  K222615  SYSTEM 1E Liquid Chemical Sterilant Processing Sys ...
  4.  K230582  SYSTEM 1 endo Liquid Chemical Sterilant Processing ...
  5.  K232914  SYSTEM 1E Liquid Chemical Sterilant Processing Sys ...

MDR Year MDR Reports MDR Events
2020 32 32
2021 31 31
2022 16 16
2023 9 9
2024 8 8
2025 2 2

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 8 8
Chemical Problem 5 5
Insufficient Information 5 5
Break 4 4
Device Handling Problem 3 3
Failure to Disinfect 3 3
Fire 1 1
Mechanical Problem 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
Swelling/ Edema 2 2
Bronchospasm 2 2
Cough 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
Hypersensitivity/Allergic reaction 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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