Recall Z-2210-2026 ยท ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
ICU Medical, Inc.
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
| Date | May 18, 2026 (initiated Mar 24, 2026) |
| Status | Open, Classified |
| Reason | 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 | 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 marketact |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131549 | CHEMOLOCK, CHEMOLOCK PORT Icu Medical, Inc., Jul 26, 2013 |