Z-0348-2025Class II

Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009

Name: Z-0348-2025 Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
Creator: Baxter Healthcare Corporation
Published: 2024-10-02
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2024-10-02 / Open, Classified / root cause: manufacturing process

FDA source

Baxter Healthcare Corporation began a recall of Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009 on 2024-10-02. FDA classified it as Class II and gives the reason as "The door on the Spectrum IQ Infusion pump may not be able to fully close". 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-0348-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-02
Posted: 2024-11-08
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
Product code: FRN Pump, Infusion
Reason for recall: The door on the Spectrum IQ Infusion pump may not be able to fully close.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Baxter Healthcare notified its consignees on 10/03 and 04/2024 via telephone. The call included information regarding the problem with the device, risk to health, and requested the affected units be removed from service pending inspection. On-site inspections to assess for impact and offer replacement, were scheduled.
Quantity in commerce: 8 units
Distribution: GA, ID
Product codes and lots: 00085412610900, Serial Numbers: 3796578, 3797382, 3797464, 3797578, 3797728, 3797733, 3798019, 3798200

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0348-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0348-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-08

Product code FRN

K230041Class IISpectrum IQ Infusion System with Dose IQ Safety SoftwareBaxter 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)