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Recall Observatory FDA recall evidence

Device product

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

Z-2210-2026

March 24, 2026

Class II

Product summary

Firm
ICU Medical, Inc.
Event
Event 98622
Status
Ongoing
Classification
Class II
Quantity
20,506
Official record key
device-enforcement:Z-2210-2026

Official wording

Reason: 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.

Code information: UDI-DI: 10887709083278. Lots: 13919794, 14134777, 14196319

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.