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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device kit, repair, catheter, hemodialysis
Definition Hemodialysis Tray
Product CodeNFK
Regulation Number 876.5540
Device Class 2

MDR Year MDR Reports MDR Events
2019 5 5
2020 1 1
2022 18 18
2023 4 4
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Break 15 15
Crack 12 12
Fluid/Blood Leak 2 2
Leak/Splash 2 2
Gas/Air Leak 2 2
Fitting Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 27 27
No Consequences Or Impact To Patient 5 5

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc II Aug-13-2020
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