RecallRadar

FDA Device recall Z-0123-2021

Spectrum IQ Infusion System with Dose IQ Safety Software

On 2020-10-28 the FDA classified a Class I recall of Spectrum IQ Infusion System with Dose IQ Safety Software by Baxter Healthcare, citing baxter is updating the device IFU for safety communication regarding cleaning practices.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0123-2021
ClassificationClass I
Statusterminated
Initiated2020-06-30
Published2020-10-28
Last updated2026-09-13 11:55 UTC
CompanyBaxter Healthcare
DistributionUS

Product

Spectrum IQ Infusion System with Dose IQ Safety Software

Reason

Baxter is updating the device IFU for safety communication regarding cleaning practices.

Identifiers

code_infoProduct Code: 3570009, All Serial Numbers; GTIN 00085412610900

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0123-2021%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.