Z-0123-2021Class I

Spectrum IQ Infusion System with Dose IQ Safety Software

Name: Z-0123-2021 Spectrum IQ Infusion System with Dose IQ Safety Software
Creator: Baxter Healthcare Corporation
Published: 2020-06-30
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2020-06-30 / Terminated / root cause: labeling and UDI

FDA source

Baxter Healthcare Corporation began a recall of Spectrum IQ Infusion System with Dose IQ Safety Software on 2020-06-30. FDA classified it as Class I and gives the reason as "Baxter is updating the device IFU for safety communication regarding cleaning practices". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0123-2021
Classification: Class I
Status: Terminated
Initiated: 2020-06-30
Posted: 2020-10-22
Terminated: 2024-04-29
Recalling firm: Baxter Healthcare Corporation
Product: Spectrum IQ Infusion System with Dose IQ Safety Software
Product code: FRN Pump, Infusion
Reason for recall: Baxter is updating the device IFU for safety communication regarding cleaning practices.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: A Safety Alert communication was sent to affected customers on 04/01/2020 via USPS First Class Mail. A follow-up Urgent Device Correction communication was sent to all affected customers on 8/28/2020 via USPS first class mail. The customer communications reiterate instructions for use listed in the Operator's Manual. Baxter is asking customers to: 1) Operators may continue to safely use the infusion pumps while following the instructions for cleaning provided in the Operator's Manual. An electronic copy of the Operator's Manual can be accessed at https://service.baxter.com. In addition, a full list of approved cleaning agents can be accessed at www.spectrumIQ.com/resources.html. 2) Inspect all pumps at their facility to assess the electrical pins on the pump rear case and the battery electrical contacts for residue buildup or corrosion. If corrosion or residue buildup is identified, please contact Baxter to service the device. 3) Baxter will be updating the Instructions for Use to recommend a routine inspection process for the electrical pins on the pump rear case and the battery electrical contacts. Once the updated Instructions for Use are made available, Baxter will issue a written notification to inform customers of the availability of the updated IFU. The updated IFU may be accessed online at the Baxter Global Technical E Service Center at URL: https://service.baxter.com. 4) Clinicians should ensure backup devices are readily available when infusing critical medications where interruptions could cause serious injury or death. 5) To maintain the battery properly, please ensure the pumps are plugged into AC power when possible to prevent battery depletion. 6) Complete the enclosed customer reply form and return it to Baxter by email. On 9/22/2021, the firm issued an Urgent Device Correction letter dated 9/22/2021 in follow-up to their communication of the 4/1/2020 safety alert and 8/28/2020 Urgent Device Correction. This was issued via first class USPS ma
Quantity in commerce: 146,224 units
Distribution: Distribution throughout the United States, St. Thomas USVI, and Puerto Rico. Foreign distribution including Canada, Caribbean (Barbados, Trinidad and Tobago, Jamaica, Bahamas, Bermuda, and Guyana)
Product codes and lots: Product Code: 3570009, All Serial Numbers; GTIN 00085412610900

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0123-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0120-2021	Class I	Terminated	Voluntary: Firm initiated	2020-10-28	2020-10-22
Z-0121-2021	Class I	Terminated	Voluntary: Firm initiated	2020-10-28	2020-10-22
Z-0122-2021	Class I	Terminated	Voluntary: Firm initiated	2020-10-28	2020-10-22
Z-0123-2021	Class I	Terminated	Voluntary: Firm initiated	2020-10-28	2020-10-22

Product code FRN

K173084Class IISpectrum IQ Infusion System, Dose IQ Safety SoftwareBaxter Healthcare Corporation / cleared 2018-05-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)