CLASS II Device recall · Reported 24 Oct 2018 · FDA Enforcement Report

Spectrum Iq Infusion System With Dose Iq Safety recalled

Baxter Healthcare is recalling Spectrum Iq Infusion System With Dose Iq Safety, distributed in New Jersey. The recall was initiated on 18 Sep 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI 00085412610900 All Serial Numbers distributed prior to 07/09/2018

Quantity recalled354 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0107-2019
FDA event ID: 81158
Recalling firm: Baxter Healthcare, Medina, NY
Classification: Class II
Status: Terminated
Recall initiated: 18 Sep 2018
FDA classified: 12 Oct 2018
Reported: 24 Oct 2018
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Medical Software

Timeline

18 Sep 2018	Recall initiated by company
12 Oct 2018	Classified by FDA	+24 days
24 Oct 2018	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

If an operator attempts to manually program a Basic Infusion for a drug that is not included in the Drug Library using the Basic-Dose Mode, the operator will receive a false hard limit exceeded error, preventing him or her from programming the infusion.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009

Where it was distributed

New Jersey

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI 00085412610900 All Serial Numbers distributed prior to 07/09/2018

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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