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Recall Observatory FDA recall evidence

Device product

Baxter Spectrum IQ Infusion Pumps, Product code 3570009.

Z-0529-2022

December 29, 2021

Class I

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 89017
Status
Ongoing
Classification
Class I
Quantity
241,304 units
Official record key
device-enforcement:Z-0529-2022

Official wording

Reason: 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.

Code information: All serial numbers, GTIN 00085412610900.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.