Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device container, i.v.
Regulation Description I.V. container.
Product CodeKPE
Regulation Number 880.5025
Device Class 2


Premarket Reviews
ManufacturerDecision
BEIJING L&Z MEDICAL TECHNOLOGY DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
EPIC MEDICAL PTE. , LTD.
  SUBSTANTIALLY EQUIVALENT 3
FRESENIUS KABI AG
  SUBSTANTIALLY EQUIVALENT 1
GILERO, LLC
  SUBSTANTIALLY EQUIVALENT 1
HAEMOTRONIC S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
ICU MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
TECHNOFLEX SAS.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 162 165
2022 112 113
2023 127 128
2024 158 158
2025 225 225
2026 118 118

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 241 242
Contamination /Decontamination Problem 192 192
Device Contamination with Chemical or Other Material 192 192
Detachment of Device or Device Component 46 46
Particulates 42 42
Leak/Splash 27 27
Contamination 23 23
Disconnection 23 23
Material Puncture/Hole 19 19
Break 18 20
Mechanical Problem 15 15
Material Split, Cut or Torn 13 13
Air/Gas in Device 13 13
Degraded 10 10
Contamination of Device Ingredient or Reagent 8 8
Material Separation 7 7
Crack 6 6
Component Missing 6 6
Failure to Disconnect 5 5
No Flow 5 5
Device Dislodged or Dislocated 5 6
Defective Component 5 5
Material Too Rigid or Stiff 4 4
Defective Device 4 4
Material Integrity Problem 3 3
Incomplete or Inadequate Connection 3 3
Material Rupture 3 3
Product Quality Problem 3 4
Device Difficult to Setup or Prepare 3 4
Fracture 3 3
Material Fragmentation 3 3
False Alarm 2 2
Labelling, Instructions for Use or Training Problem 2 2
Decrease in Pressure 2 2
Loose or Intermittent Connection 2 2
Microbial Contamination of Device 2 2
Failure to Eject 2 2
Unexpected Color 2 2
Fail-Safe Problem 2 2
Scratched Material 2 2
Material Perforation 2 2
Free or Unrestricted Flow 2 2
Improper Flow or Infusion 2 2
Infusion or Flow Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 3
Material Deformation 1 1
Device Markings/Labelling Problem 1 1
Difficult to Open or Close 1 1
Application Program Problem 1 2
Charging Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 845 850
Insufficient Information 48 48
No Patient Involvement 3 3
Air Embolism 2 2
Chemical Exposure 2 2
Hypoxia 2 2
No Consequences Or Impact To Patient 2 2
Awareness during Anaesthesia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
2 Microtek Medical Inc. II Aug-16-2024
3 ROi CPS LLC II Aug-16-2024
4 Stradis Healthcare II Jan-11-2023
5 The Metrix Company II Nov-08-2024
-
-