Agency classClass IIOur severity:High FDA (Devices)·Z-2210-2026·Announced 2026-05-27

Oncology Kit With Extension Sets May Leak During Infusion Therapy

ICU Medical is recalling Oncology Kits with extension sets due to potential leaks that could interrupt chemotherapy infusion and expose hazardous substances to patients, caregivers, and pharmacy technicians.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II recall involving a high-risk infusion device where leaks could result in therapy interruption and patient harm, including underdose of chemotherapy and hazardous substance exposure. No illnesses or injuries are reported in the source text, but the potential for serious harm is significant given the critical nature of oncology infusion therapy.

Plain-English summary

ICU Medical, Inc. is recalling an Oncology Kit with 60-inch (152 cm) Smallbore Extension Set with ChemoLock Port, Clamp, Anti-Siphon Valve, and Spiros; ChemoLock; and Syringe Transfer Set with MicroClave and ChemoLock Port (REF: CL3960). The recall affects 20,506 units distributed nationwide across multiple states.

The oncology sets and closed system transfer devices may leak. If a leak occurs during setup, it may delay therapy once noticed and corrected. If the leak occurs during active therapy, it may interrupt the infusion and result in the patient receiving less infusion solution than intended. Additionally, exposure of hazardous substances to the patient, caregiver, or pharmacy technician is possible.

Affected lot numbers are 13919794, 14134777, and 14196319 (UDI-DI: 10887709083278). Users of this product should check whether they have received affected units and contact ICU Medical or their healthcare facility for instructions on discontinuation and replacement.

The recalled product

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
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Infusion / Chemotherapy
Hazard: product-leak
therapy-interruption
hazardous-substance-exposure
Affected units: 20,506

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

UDI-DI: 10887709083278. Lots: 13919794
14134777
14196319

Distribution

Distributed nationwide across the United States.

The notice also names 26 states specifically:

Same manufacturer · ICU Medical, Inc.

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