ICU Medical ChemoLock oncology infusion sets recalled for potential leakage during therapy
What this means
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.
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2210-2026More ICU Medical recalls
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