Z-1775-2024Class II

Baxter Spectrum IQ Infusion Pump, Product Code 3570009

Name: Z-1775-2024 Baxter Spectrum IQ Infusion Pump, Product Code 3570009
Creator: Baxter Healthcare Corporation
Published: 2024-03-20
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2024-03-20 / Open, Classified / root cause: manufacturing process

FDA source

Baxter Healthcare Corporation began a recall of Baxter Spectrum IQ Infusion Pump, Product Code 3570009 on 2024-03-20. FDA classified it as Class II and gives the reason as "One device was improperly performed testing prior to release from a Service Center". 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-1775-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-20
Posted: 2024-05-03
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Spectrum IQ Infusion Pump, Product Code 3570009
Product code: FRN Pump, Infusion
Reason for recall: One device was improperly performed testing prior to release from a Service Center.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The affected customer was contacted via on-site visit on March 20, 2024, and by phone call on March 22, 2024. Baxter has asked the customer to locate the affected pump at their facility and return the device to Baxter for testing.
Quantity in commerce: 1 pump
Distribution: US Nationwide distribution in the state of Massachusetts.
Product codes and lots: UDI/DI 00085412610900, Serial Number 3540772

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1775-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1775-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-15	2024-05-03

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)