- Recalling firm
- ICU Medical, Inc.
- 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.
- Affected products (lot / model / serial)
- UDI-DI: 10887709083278. Lots: 13919794, 14134777, 14196319
- Units affected
- 20,506
- Distribution pattern
- 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.
- Firm location
- San Clemente, CA, United States
- Recall type
- Voluntary: Firm initiated
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2210-2026
- Recall initiated
- March 24, 2026
- FDA classification date
- May 18, 2026
- FDA report date
- May 27, 2026
- FDA event ID
- 98622
- Last updated on HTM Vibe
- July 24, 2026