Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set… recallZ-2210-2026 · ICU Medical, Inc. · initiated Mar 24, 2026

Why it was 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.

FDA root cause category: Process control

What the company is doing

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]

Recall details

Recall number

Z-2210-2026

Status

Open, Classified

Initiated by the company

Mar 24, 2026

Posted by the FDA

May 18, 2026

Recalling firm

ICU Medical, Inc.

Quantity

20,506

Product code

ONB

FDA submissions

K131549

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 description

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• ICU Medical CL3960

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  2 recalls26 reports

Other devices under the same FDA submission

90 devices cleared under K131549 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• ICU Medical CL3011

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  3 recalls26 reports
• ICU Medical CL3511

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  3 recalls6 reports
• ICU Medical CL4136

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  3 recalls1 report
• ICU Medical CL-80

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  3 recalls0 reports
• ICU Medical CL3900

  Icu Medical, Inc. · Set, administration, intravascular
  3 recalls0 reports
• ICU Medical CL4130

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  2 recalls6 reports
• ICU Medical CL4131

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  2 recalls6 reports
• ICU Medical CL-80S

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  2 recalls5 reports
• ICU Medical CL-82

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  2 recalls3 reports
• ICU Medical CL-80S-5

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  2 recalls2 reports
• ICU Medical CL-72

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  2 recalls1 report
• ICU Medical CL-70S

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  2 recalls1 report