FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corporation: Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL
- Recall number
- Z-3066-2026
- Recalling firm
- Baxter Healthcare Corporation
- Product
- Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL
- Status
- Open, Classified
- Initiated
- 2026-08-11
- Posted
- 2026-08-31
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Software design
- Action
- On August 11, 2026, firm began sending customers Urgent Medical Device Correction delivered via email and USPS first class mail. Customers were advised to use the same compatible syringe model (brand/size) for all syringes required within a Multi-Syringe VOT workflow. Customers were provided with additional instructions for situations where the syringe does not support the intended flow rate and the user receives a prompt to confirm continuation of the infusion at the maximum or minimum supported flow rate for that syringe after a syringe change.
- Quantity
- 4 units
- Distribution
- 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.
- Lot, serial or model codes
- UDI-DI 00197886002300, all serial numbers
- 510(k) numbers
- ["K242390"]
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 1417572
- Firm city
- Deerfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28