FDA Medical devices recall ·
Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock… recall
- Recall number
- Z-2210-2026
- Date
- (initiated March 24, 2026)
- Company / brand
- ICU Medical, Inc.
951 Calle Amanecer, San Clemente, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 20,506
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 10887709083278. Lots: 13919794, 14134777, 14196319
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.
States: 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
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2210-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.