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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device multi-lumen hemodialysis catheterization kit
Regulation Description Blood access device and accessories.
Definition This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product CodePPO
Regulation Number 876.5540
Device Class 2

MDR Year MDR Reports MDR Events
2026 33 33

Device Problems MDRs with this Device Problem Events in those MDRs
Material Twisted/Bent 9 9
Fluid/Blood Leak 9 9
Crack 7 7
Difficult to Advance 3 3
Leak/Splash 2 2
Physical Resistance/Sticking 2 2
Incomplete or Inadequate Connection 2 2
Material Frayed 1 1
Unraveled Material 1 1
Material Deformation 1 1
Difficult or Delayed Separation 1 1
Partial Blockage 1 1
Material Separation 1 1
Material Too Soft/Flexible 1 1
Component Incompatible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 31 31
Thrombosis/Thrombus 1 1
Insufficient Information 1 1
Low Oxygen Saturation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ARROW INTERNATIONAL, LLC I Jun-13-2026
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