Official recall notice
FDA Recall: Oncology 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 that does not enter the fluid path, which if seen by a healthcare provider may lead to replacement of product before use, which could result in a delay in therapy.
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 that does not enter the fluid path, which if seen by a healthcare provider may lead to replacement of product before use, which could result in a delay in therapy.
Affected products
All products manufactured on or before 7/4/2026. UDI-DI: 10840619054486, 10887709091914