Baxter Healthcare Recalls Spectrum IQ Infusion Pumps Due to Missing Safety Testing

What Happened

Baxter Healthcare Corporation has initiated a voluntary Class II recall of specific Spectrum IQ Infusion Pumps. The recall was triggered because these units were released into distribution without undergoing full safety testing, specifically missing the required occlusion alarm testing. This failure to test means the devices may not properly alert healthcare providers if an infusion line becomes blocked.

Which Products Are Affected

This recall is limited to five (5) units distributed in the state of Ohio. The affected products are identified by the following details:

• Brand Name: Spectrum IQ
• Product Name: Infusion Pump
• Model/Catalog Number: 3570009
• GTIN: 00085412610900
• Serial Numbers: 3815663, 3823468, 3824743, 3825234, and 3825599
• Recall Number: Z-1368-2026

What You Should Do

Healthcare facilities and providers in Ohio should immediately check their inventory for the serial numbers listed above. Baxter Healthcare Corporation initiated the notification process via telephone. Owners of the affected devices should contact the firm at 1 Baxter Pkwy, Deerfield, IL 60015, to arrange for the return or proper testing of the units.

Why This Matters

Occlusion alarms are critical safety features that ensure patients receive the correct dosage of medication without interruption. If a pump fails to detect a blockage, it could lead to a delay in treatment or the delivery of an incorrect dose, posing a serious risk to patient health.

Source

Information provided by the FDA. Recall Event ID: 98306.