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FDA-Device2026-05-27Class IIPROCESSING DEFECT

ICU Medical ChemoLock oncology infusion sets recalled for potential leakage during therapy

ICU Medical
Nationwide distribution

ICU Medical ChemoLock oncology sets recalled for leak risk

ICU Medical oncology infusion kits with extension sets may develop leaks during chemotherapy administration. If a leak occurs during therapy, patients may receive less medication than intended, and healthcare workers or patients could be exposed to hazardous drugs.

  • If you use or administer this product, contact ICU Medical for guidance on the affected lot numbers (13919794, 14134777, 14196319).
  • Do not use affected kits if a leak is visible during setup.
  • Report any leaks or therapy interruptions to your healthcare provider immediately.
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.

Sold states
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.
Affected count
20,506
Manufactured in
951 Calle Amanecer, San Clemente, CA, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2210-2026

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