Baxter Spectrum IQ Infusion Pumps, Product code 3570009.
FDA Recall #Z-0529-2022 — Class I — December 29, 2021
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.
Recalling Firm
Baxter Healthcare Corporation — Deerfield, IL
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
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.
Code Information
All serial numbers, GTIN 00085412610900.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated