FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corporation: Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2
- Recall number
- Z-2096-2025
- Recalling firm
- Baxter Healthcare Corporation
- Product
- Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2
- Status
- Open, Classified
- Initiated
- 2025-06-20
- Posted
- 2025-07-17
- Terminated
- not on file
- Reason
- Certain Spectrum infusion pumps may have an incorrect version of software.
- Root cause
- Employee error
- Action
- 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
- Quantity
- 28 units
- Distribution
- US States: CA, FL, IL, KS, MI, MS, NY, OH, OK, and VA.
- Lot, serial or model codes
- 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
- 510(k) numbers
- K230022
- PMA numbers
- not on file
- Product code
- PHC
- 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