FDA recall, , Moderate risk
ICU Medical ChemoLock Oncology Kits and Transfer Sets
Oncology sets may leak, causing therapy interruption and possible exposure to hazardous substances.
Summary by Recall Canary from the FDA notice
What happened
ICU Medical, Inc. of San Clemente, California, is recalling Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros and ChemoLock Syringe Transfer Set w/MicroClave, ChemoLock Port, REF: CL3960.
The oncology sets and closed system transfer devices may leak, which can delay therapy if noticed and corrected during setup, or cause therapy interruption with the potential for the patient to receive less infusion solution than intended if the leak occurs during therapy. Exposure of hazardous substances to the patient, caregiver, or pharmacy technician is possible.
The company began the recall on March 24, 2026, and the FDA added it to the Enforcement Report on May 18, 2026. The products were distributed nationwide in states including 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, and NJ.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
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
- UDI-DI
- 10887709083278
- 13919794
- 14134777
- 14196319
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Georgia, Massachusetts, Ohio, North Carolina, California, North Dakota, Michigan, Texas, Florida, Arkansas, Connecticut, Pennsylvania, Washington, Wisconsin, Colorado, Vermont, New York, New Hampshire, Kentucky, Iowa, Kansas, Alabama, New Mexico, Illinois, Missouri, New Jersey.
- Company
- ICU Medical, Inc.San Clemente, California
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98622
- Recall number
- Z-2210-2026
All recalls from ICU Medical, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
