PlainRecalls
FDA Devices Critical Class I Ongoing

Baxter Spectrum IQ Infusion Pumps, Product code 3570009.

Reported: February 9, 2022 Initiated: December 29, 2021 #Z-0529-2022

Product Description

Baxter Spectrum IQ Infusion Pumps, Product code 3570009.

Reason for Recall

There is the potential for reduced or non-delivery of medication, in some cases without alerting the user via pump alarm. This may occur as a result of incorrect administration set setup and/or incomplete resolution of upstream occlusion alarms when using Spectrum V8 and Spectrum IQ infusion pumps.

Details

Units Affected
241,304 units
Distribution
Worldwide Distribution. US nationwide Puerto Rico and St. Thomas. There was government/military distribution. Countries of Canada, Bahamas, Barbados, Bermuda, Guyana, Jamaica, and Trinidad and Tobago.
Location
Deerfield, IL

Frequently Asked Questions

What product was recalled?
Baxter Spectrum IQ Infusion Pumps, Product code 3570009.. Recalled by Baxter Healthcare Corporation. Units affected: 241,304 units.
Why was this product recalled?
There is the potential for reduced or non-delivery of medication, in some cases without alerting the user via pump alarm. This may occur as a result of incorrect administration set setup and/or incomplete resolution of upstream occlusion alarms when using Spectrum V8 and Spectrum IQ infusion pumps.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 9, 2022. Severity: Critical. Recall number: Z-0529-2022.