ICU Medical Oncology Extension Set
ICU Medical is recalling Oncology Extension Set REF: CL3960 due to a potential leak that could cause therapy interruption or hazardous exposure.
Immediately stop using the affected Oncology Kit (REF: CL3960) and contact ICU Medical for further instructions regarding product return and replacement.
Why it was recalled
Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy this may result in therapy interruption with the potential for the patient to receive less infusion solution than intended. Exposure of hazardous substances to the patient, caregiver, or pharmacy technician is possible.
How to identify it
UPC 10887709083278 13919794 14134777 14196319
Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock; Syringe Transfer Set w/MicroClave, ChemoLock Port, REF: CL3960
Where it was sold
Distributed in US.
Official source
Editorial summary by Recall Canary · last updated 2026-05-19 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification