Z-2210-2026 Class II Ongoing

Recalled by ICU Medical, Inc. — San Clemente, CA

Recall Details

Product Type
Devices
Report Date
May 27, 2026
Initiation Date
March 24, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
20,506

Product Description

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

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.

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.

Code Information

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