Official recall notice
FDA DeviceClass IINotable
FDA Recall: IV Sets with drip chambers
- Recall date
- 2026-09-23
- Brand
- ICU Medical, Inc.
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.
Product description
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.
Affected products
All products manufactured on or before 7/4/2026. UDI-DI: 20887787005831