Z-2530-2024Class II

Baxter SIGMA Spectrum Infusion Pump

Name: Z-2530-2024 Baxter SIGMA Spectrum Infusion Pump
Creator: Baxter Healthcare Corporation
Published: 2024-06-14
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2024-06-14 / Open, Classified

FDA source

Baxter Healthcare Corporation began a recall of Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2 on 2024-06-14. FDA classified it as Class II and gives the reason as "Improperly performed testing prior to release". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2530-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-06-14
Posted: 2024-08-07
Recalling firm: Baxter Healthcare Corporation
Product: Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2
Product code: FRN Pump, Infusion
Reason for recall: Improperly performed testing prior to release
FDA root cause: Under Investigation by firm
Action: The impacted customer was contacted via phone call on 6/14/2024. Baxter has asked the customer to locate the affected pump at their facility and return the device to Baxter to be serviced.
Quantity in commerce: 1 unit
Distribution: US Nationwide distribution in the state of Florida.
Product codes and lots: Product Code: 35700BAX2. Serial Number: 2158913.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2530-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2530-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-14	2024-08-07

Product code FRN

K230022Class IIBaxter SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation / cleared 2023-03-31

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)