ICU Medical, Inc. recalls Oncology Kit w/60"
- Recalling company
- ICU Medical, Inc.
- 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
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Mar 24, 2026
- Reported
- May 27, 2026
- Distribution
- 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.
- Status
- Ongoing
- Quantity
- 20,506
- Lot / codes
- UDI-DI: 10887709083278. Lots: 13919794, 14134777, 14196319
- Company location
- San Clemente, CA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2210-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2210-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.