Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock

FDA device recall Z-2210-2026 · posted 2026-05-18 · Open, Classified

Recall details

Recalling firm

ICU Medical, Inc.

Reason for recall

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.

Action taken

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

Root cause

Process control

Status

Open, Classified

Product code

ONB

Quantity affected

20,506

Distribution

US Nationwide distribution in the states of GA, MA, OH, NC, CA, ND, MI, TX, FL, AR, CT, PA, WA, WI, CO, VT, NY, NH, KY, IA, KS, AL, NM, IL, MO, NJ.

Date initiated

2026-03-24

Date posted

2026-05-18

Location

San Clemente, CA

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