Z-2095-2025Class I

Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX

Name: Z-2095-2025 Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX
Creator: Baxter Healthcare Corporation
Published: 2025-06-20
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2025-06-20 / Open, Classified / root cause: manufacturing process

FDA source

Baxter Healthcare Corporation began a recall of Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX on 2025-06-20. FDA classified it as Class I and gives the reason as "Certain Spectrum infusion pumps may have an incorrect version of software". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2095-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-06-20
Posted: 2025-07-17
Recalling firm: Baxter Healthcare Corporation
Product: Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX
Product code: PHC Infusion Safety Management Software
Reason for recall: Certain Spectrum infusion pumps may have an incorrect version of software.
Root cause tag: manufacturing process
FDA 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 in commerce: 14 units
Distribution: US States: CA, FL, IL, KS, MI, MS, NY, OH, OK, and VA.
Product codes and lots: UDI-DI: 00085412091570; Serial Numbers: 765100 , 772744 , 789742 , 841197 , 867753 , 920606 , 1024015 770164 788724 , 793079 , 842498 , 918342 , 962810 , 1027523

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2095-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2095-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-07-23	2025-07-17
Z-2096-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-07-23	2025-07-17

Product code PHC

K133801Class IIBaxter Sigma Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation / cleared 2014-05-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)