Baxter Healthcare Corporation recalls Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 So…

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

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.

• FDA enforcement recordOfficial FDA database entry for Z-1368-2026
• FDA 510(k) clearance · K251636The device's official FDA premarket clearance record
• FDA device classification · FRNOfficial FDA classification for this device type
• CFR regulation · 21 CFR 880.5725The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Baxter Healthcare CorporationSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.