FDAFDA · Food and drugs·Recall number Z-2210-2026
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
Published May 27, 2026 · Recall initiated: March 24, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- ICU Medical, Inc.
- Distributor
- 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.
- Lot
- UDI-DI: 10887709083278. Lots: 13919794, 14134777, 14196319
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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