FDA-Device2026-02-25Class IIPROCESSING DEFECT

Baxter Spectrum IQ infusion pump recalled for incomplete safety testing

OTHEROH

Check your Baxter Spectrum IQ infusion pump

Baxter Healthcare released 5 Spectrum IQ infusion pumps (model 3570009) without completing required safety tests, including tests of the occlusion alarm that alerts users to blockages. The pumps were distributed in Ohio. No injuries have been reported.

  • If you use or operate a Baxter Spectrum IQ infusion pump, check the serial number: 3815663, 3823468, 3824743, 3825234, or 3825599
  • If your pump matches, contact Baxter Healthcare immediately for instructions
  • Do not discard the pump without guidance from Baxter or your healthcare provider
Hazard

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

Sold states
States: Ohio Countries: United States
Affected count
5
Manufactured in
1 Baxter Pkwy, Deerfield, IL, United States
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

Official notice

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

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