Z-2210-2026Class II

Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve...

Name: Z-2210-2026 Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve...
Creator: ICU Medical, Inc.
Published: 2026-03-24
License: https://open.fda.gov/license/

Abbott Medical / initiated 2026-03-24 / Open, Classified / root cause: manufacturing process

FDA source

ICU Medical, Inc. began a recall of 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... on 2026-03-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2210-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-24
Posted: 2026-05-18
Recalling firm: Abbott Medical
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
Product code: ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 3/24/2026, correction notices were emailed to customers who were asked to do the following: 1) Discontinue use. Destroy all affected products following your institution's process for destruction. If destroying is not immediately possible at your facility, then the product should be quarantined until disposal. 2) Share this notification with all potential users of the device, to ensure they are aware of this notification. If the devices are used at another location, please ensure this communication is delivered there. 3) Complete and return the attached Customer Response Form to [email protected] For further inquiries, please contact firm: Global Complaint Management, [email protected], 1-866-216-8806. Customer Service, [email protected], 1-800-258-5361. Field Service Processing, [email protected]
Quantity in commerce: 20,506
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.
Product codes and lots: UDI-DI: 10887709083278. Lots: 13919794, 14134777, 14196319

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2210-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2210-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-27	2026-05-18

Product code ONB

K131549Class IIChemolock, Chemolock PortIcu Medical, Inc. / cleared 2013-07-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)