FDA recall Z-1368-2026

Baxter Healthcare Corporation · Class II · device

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

Reason for recall

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

Distribution

States: Ohio Countries: United States

Key facts

Status: Ongoing
Initiation date: 2026-01-13
Report date: 2026-02-25
Voluntary/Mandated: Voluntary: Firm initiated
Location: Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1368-2026