Oncology Kit w/60" recall (ICU Medical, Inc.)
Medical deviceClass IIOngoing
Summary: ICU Medical, Inc. is recalling 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.
What is being recalled
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
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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. (states named: Alabama, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Kansas, Kentucky, Massachusetts, Michigan, Missouri, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Texas, Vermont, Washington, Wisconsin)
How to tell if yours is affected
UDI-DI: 10887709083278. Lots: 13919794, 14134777, 14196319
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2210-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | March 24, 2026 |
| Reported | May 27, 2026 |
| Company | ICU Medical, Inc. |
| Company location | San Clemente, CA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 20,506 |
More recalls from ICU Medical, Inc. · all medical device recalls · recalls from March 2026