Z-1368-2026Class II

Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A...

Name: Z-1368-2026 Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A...
Creator: Baxter Healthcare Corporation
Published: 2026-01-13
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2026-01-13 / Open, Classified / root cause: manufacturing process

FDA source

Baxter Healthcare Corporation began a recall of Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Description: Infusion Pump, one unit per carton... on 2026-01-13. FDA classified it as Class II and gives the reason as "Pumps were released without full testing being performed, including occlusion alarm testing". 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-1368-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-01-13
Posted: 2026-02-13
Recalling firm: Baxter Healthcare Corporation
Product: Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Description: Infusion Pump, one unit per carton Component: N/A
Product code: FRN Pump, Infusion
Reason for recall: Pumps were released without full testing being performed, including occlusion alarm testing.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Firm notified the single customer on 1/13/26 via phone call. Customer was asked to work with on-site service technician to coordinate return of affected product.
Quantity in commerce: 5
Distribution: States: Ohio Countries: United States
Product codes and lots: Lot Code: GTIN 00085412610900, Serial Numbers 3815663, 3823468, 3824743, 3825234, and 3825599

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1368-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1368-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-25	2026-02-13

Product code FRN

K251636Class IISpectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare Corporation / cleared 2025-07-28

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)