ICU Medical, Inc. recalls Oncology Kit w/60" (152 cm) Appx 2.2 ml

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.

On 3/24/2026, correction notices were emailed to customers who were asked to do the following: 1) Discontinue use. Destroy all affected products following your institution's process for destruction. If destroying is not immediately possible at your facility, then the product should be quarantined until disposal. 2) Share this notification with all potential users of the device, to ensure they are aware of this notification. If the devices are used at another location, please ensure this communication is delivered there. 3) Complete and return the attached Customer Response Form to marketaction@mailac.custhelp.com For further inquiries, please contact firm: Global Complaint Management, globalcomplaints@icumed.com, 1-866-216-8806. Customer Service, customerservice@icumed.com, 1-800-258-5361. Field Service Processing, marketaction@mailac.custhelp.com

• FDA enforcement recordOfficial FDA database entry for Z-2210-2026
• FDA 510(k) clearance · K131549The device's official FDA premarket clearance record
• FDA device classification · ONBOfficial FDA classification for this device type
• CFR regulation · 21 CFR 880.5440The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find ICU Medical, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.