Recalls / —

—#214421

Product

Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2

FDA product code

PHC — Infusion Safety Management Software

Device class

Class 2

Medical specialty

General Hospital

510(k) numbers

K230022

Affected lot / code info

UDI-DI: 00085412498683; Serial Numbers: 2006307 , 2052091 , 2093765 , 2095360 , 2104302 , 2119236 , 2141815 , 2025925 , 2067699 , 2094483 , 2095541 , 2105238 , 2119436 , 2143406 , 2034297 , 2074097 , 2094580 , 2096351 , 2105769 , 2135482 , 2143684 , 2051591 , 2090658 , 2095202 , 2096856 , 2118940 , 2137976 , 2156201

Why it was recalled

Certain Spectrum infusion pumps may have an incorrect version of software.

Root cause (FDA determination)

Employee error

Action the firm took

An URGENT MEDICAL DEVICE RECALL notification letter dated 6/20/25 was sent to customers. Actions to be Taken by Customers 1. Immediately locate Spectrum pumps with the affected serial numbers and remove them from service. The product code and serial number can be found on the bottom of the infusion pump. 2. Check and record the software version installed on the pump. The software on a V6 pump should begin with the number 6 and the software on a V8 pump should begin with the number 8. The software version is located on the startup screen upon powering up the pump as pictured on the next page. Additionally, the software version is indicated in the pump menu which can be accessed by following the steps. For V6: From the Pump Information screen, press the sw info soft key to display the software version screen. For V8: From the Select Care Area screen, press the options menu soft key. Select User Options and press OK. Select View Information and press OK. Select Pump Information and press OK to display the Pump Info screen. 3. Contact Baxter to confirm the software version on the affected pumps and to schedule service if required. Baxter Global Technical Services can be reached at 800-843-7867 (select option 1, then option 2), Monday through Friday, between 7:00 am and 7:00 pm Eastern Time. 4. If you received this communication directly from Baxter, acknowledge receipt of this notification by following the instructions on the enclosed reply instruction sheet, even if you have no remaining inventory. Acknowledging receipt will prevent you from receiving repeat notices. If you do not complete the acknowledgement, you will receive a phone call from OnProcess Technology on behalf of Baxter to confirm your receipt of this notification. 5. If you purchased this product from a distributor or wholesaler, please note that responding on the Baxter customer portal is not applicable. If a response is requested by your distributor or wholesaler, please respond to them

Recalling firm

Firm

Baxter Healthcare Corporation

Address

1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern

US States: CA, FL, IL, KS, MI, MS, NY, OH, OK, and VA.

Timeline

Recall initiated

2025-06-20

Posted by FDA

2025-07-17

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #214421. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.