Home/Recalls/FDA-Z-1368-2026
FDA DevicesClass II

Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570...

Published: February 25, 2026Recall ID: Z-1368-2026Category: devicesCountry: US

Reason for Recall / Hazard

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

Product Description & Identification

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

Affected Products

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

Additional Source Details

FieldValue
CityDeerfield
StateIL
Event id98306
Address 11 Baxter Pkwy
Code infoLot Code: GTIN 00085412610900, Serial Numbers 3815663, 3823468, 3824743, 3825234, and 3825599
Postal code60015-4625
Report date20260225
Product typeDevices
Product quantity5
Reason for recallPumps were released without full testing being performed, including occlusion alarm testing.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260113
Initial firm notificationTelephone
Center classification date20260213

Overview

  • Recalling FirmBaxter Healthcare Corporation
  • StatusOngoing
  • Risk LevelClass II
  • DistributionStates: Ohio Countries: United States
Official Agency Alert