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
FDA Recall Z-2210-2026 · Posted 2026-05-18
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Recalling FirmICU Medical, Inc.
Recall StatusOpen, Classified
Product CodeONB
Date Initiated2026-03-24
Product Quantity20,506
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.
Firm Action
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 [email protected]
For further inquiries, please contact firm:
Global Complaint Management, [email protected], 1-866-216-8806.
Customer Service, [email protected], 1-800-258-5361.
Field Service Processing, [email protected]
Root Cause
Process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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