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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device warmer, thermal, infusion fluid
Regulation Description Infusion pump.
Product CodeLGZ
Regulation Number 880.5725
Device Class 2


Premarket Reviews
ManufacturerDecision
BARKEY GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
MEQU A/S
  SUBSTANTIALLY EQUIVALENT 1
QUALITY IN FLOW , LTD.
  SUBSTANTIALLY EQUIVALENT 1
SMISSON-CARTLEDGE BIOMEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
THE SURGICAL COMPANY INTERNATIONAL B.V.
  SUBSTANTIALLY EQUIVALENT 2
THE SURGICAL COMPANY INTERNATIONAL BV (AS TSC LIFE)
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 885 939
2022 1548 1575
2023 1033 1035
2024 862 863
2025 380 380
2026 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 1105 1122
Device Alarm System 375 377
Leak/Splash 315 315
Temperature Problem 281 285
Display or Visual Feedback Problem 209 213
Insufficient Heating 197 200
Break 185 186
Crack 160 160
Defective Alarm 158 160
Overheating of Device 147 149
No Audible Alarm 125 129
Mechanical Problem 118 118
Power Problem 117 117
Failure to Pump 110 113
Fracture 106 107
Defective Component 97 98
Excessive Heating 89 92
Electrical /Electronic Property Problem 82 84
Failure to Power Up 81 82
Noise, Audible 80 82
No Display/Image 79 85
False Alarm 71 73
Pumping Problem 64 65
Connection Problem 58 58
Failure to Calibrate 54 57
Defective Device 46 46
Device Sensing Problem 46 47
Key or Button Unresponsive/not Working 45 45
Circuit Failure 41 41
Failure to Sense 37 37
Detachment of Device or Device Component 36 38
Material Separation 36 36
Component Missing 32 32
Audible Prompt/Feedback Problem 32 32
Device Damaged Prior to Use 31 32
Incorrect, Inadequate or Imprecise Result or Readings 31 31
Patient Device Interaction Problem 30 30
Failure to Deliver 29 29
Air/Gas in Device 29 32
Display Difficult to Read 29 30
Alarm Not Visible 27 27
Calibration Problem 27 28
No Flow 27 27
Insufficient Information 25 25
Smoking 24 24
Infusion or Flow Problem 24 24
Corroded 21 21
Contamination 19 19
Improper Flow or Infusion 18 18
Device Displays Incorrect Message 15 15

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3570 3652
Insufficient Information 1246 1264
No Information 98 98
No Patient Involvement 54 54
No Consequences Or Impact To Patient 24 24
Thrombosis/Thrombus 5 5
Exsanguination 3 3
Urethral Stenosis/Stricture 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Electric Shock 2 2
Ischemia 2 3
Hypothermia 2 2
Aneurysm 2 2
Ruptured Aneurysm 2 2
Hemorrhage/Bleeding 2 2
Hypovolemia 2 2
Hypovolemic Shock 1 1
Death 1 1
Respiratory Arrest 1 1
Skin Inflammation/ Irritation 1 1
Adhesion(s) 1 1
Abrasion 1 1
Obstruction/Occlusion 1 1
Anaphylactoid 1 1
No Known Impact Or Consequence To Patient 1 1
Cardiac Arrest 1 1
Burn(s) 1 1
Exposure to Body Fluids 1 1
Loss of consciousness 1 1
Hemothorax 1 1
Low Blood Pressure/ Hypotension 1 1
Bruise/Contusion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 3M Company II Aug-01-2025
2 Belmont Instrument LLC II Apr-25-2025
3 Belmont Instrument LLC II Apr-25-2025
4 Eight Medical International BV I Jul-23-2021
5 RanD S.r.l. II Jul-09-2021
6 Smisson-Cartledge Biomedical, LLC I Mar-26-2021
7 Smiths Medical ASD Inc. I Sep-03-2021
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