- Recalling firm
- Baxter Healthcare Corporation
- Reason for recall
- A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.
- Affected products (lot / model / serial)
- UDI-DI 00197886002300, all serial numbers
- Units affected
- 4 units
- Distribution pattern
- US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.
- Firm location
- Deerfield, IL, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3066-2026
- Recall initiated
- August 11, 2026
- FDA classification date
- August 31, 2026
- FDA report date
- September 9, 2026
- FDA event ID
- 99557
- Last updated on HTM Vibe
- September 15, 2026