CLASS II ONGOING Device recall · Reported 27 May 2026 · FDA Enforcement Report
Oncology Kit w/60" Appx, Smallbore Ext Set w/ChemoLock Port recalled
ICU Medical is recalling Oncology Kit w/60" Appx, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, distributed nationwide in the US. The recall was initiated on 24 Mar 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2210-2026
- FDA event ID
- 98622
- Recalling firm
- ICU Medical, San Clemente, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Mar 2026
- FDA classified
- 18 May 2026
- Reported
- 27 May 2026
- Type
- Voluntary: Firm initiated
- Reason category
- Packaging Defects
- Device type
- Syringes & Needles
Timeline
| 24 Mar 2026 | Recall initiated by company | |
| 18 May 2026 | Classified by FDA | +55 days |
| 27 May 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
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.
Nationwide AlabamaArkansasCaliforniaColoradoConnecticutFloridaGeorgiaIowaIllinoisKansasKentuckyMassachusettsMichiganMissouriNorth CarolinaNorth DakotaNew HampshireNew JerseyNew MexicoNew York
Questions about this recall
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.
Which lots are affected?
UDI-DI: 10887709083278. Lots: 13919794, 14134777, 14196319
Where was it 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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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