RecallRadar

FDA Device recall Z-0529-2022

Baxter Spectrum IQ Infusion Pumps, Product code 3570009

On 2022-02-09 the FDA classified a Class I recall of Baxter Spectrum IQ Infusion Pumps, Product code 3570009 by Baxter Healthcare, citing 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 se….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0529-2022
ClassificationClass I
Statusongoing
Initiated2021-12-29
Published2022-02-09
Last updated2026-09-13 11:56 UTC
CompanyBaxter Healthcare
DistributionUS

Product

Baxter Spectrum IQ Infusion Pumps, Product code 3570009.

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.

Identifiers

code_infoAll serial numbers, GTIN 00085412610900.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0529-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.