Early Alert: IV Tubing Set Issue from ICU Medical

Published: 05/28/2026

Sources:
  • Food and Drug Administration
Relevant To:
  • Ambulatory Surgical Centers,
  • Rural Emergency Hospitals,
  • Urgent Care,
  • Dialysis Facilities,
  • Medical Office,
  • Critical Access Hospitals,
  • Home Health,
  • Hospitals,
  • Long Term Care,
  • Ambulatory Care,
  • Inpatient Rehabilitation Facility,
  • Behavioral Health - Inpatient,
  • Hospice,
  • Rural Health Clinics

The FDA is aware that ICU Medical has issued a customer communication recommending certain IV tubing sets be removed from where they are used or sold.

ICU Medical has received reports of black specks and discoloration observed on the inner wall of drip chambers, as well as particulate matter found within the drip chambers in certain IV tubing sets. ICU Medical is investigating these findings to determine if there is biological contamination, or if the reported material could enter the fluid p…

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