Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon V...
FDA Device Recall #Z-2210-2026 - Class II, March 24, 2026
Recall Summary
| Recall Number | Z-2210-2026 |
| Classification | Class II - Moderate risk |
| Date Initiated | March 24, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | ICU Medical, Inc. |
| Location | San Clemente, CA |
| Product Type | Devices |
| 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.
Lot / Code Information
UDI-DI: 10887709083278. Lots: 13919794, 14134777, 14196319
Other Recalls from ICU Medical, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2724-2026 | Class II | ICU Medical Plum Solo Precision IV Pump, v1.0.3... | Jun 10, 2026 |
| Z-2723-2026 | Class II | ICU Medical Plum Duo Infusion Pump, v1.2.3: 1)... | Jun 10, 2026 |
| Z-2311-2026 | Class II | Plum Solo Precision IV Pump, 40001-0401 | Apr 29, 2026 |
| Z-2312-2026 | Class II | Plum Duo Infusion Pump, 40002-0401 | Apr 29, 2026 |
| Z-2313-2026 | Class II | Plum Duo Precision IV Pump, 40002-0403 | Apr 29, 2026 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.