Recall Z-1368-2026

Baxter Healthcare Corporation · initiated January 13, 2026

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

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

Codes / lots: Lot Code: GTIN 00085412610900, Serial Numbers 3815663, 3823468, 3824743, 3825234, and 3825599

Reason for recall

Pumps were released without full testing being performed, including occlusion alarm testing.

FDA-determined cause: Employee error

Action taken

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.

Details

Recall number
Z-1368-2026
Initiated
January 13, 2026
Posted by FDA
February 13, 2026
Product code
FRN – Pump, Infusion
Quantity
5
Distribution
States: Ohio Countries: United States
Recalling firm
Baxter Healthcare Corporation, Deerfield, IL

Official FDA recall record