FDA Device Recall Z-2104-2023

Baxter Healthcare Corporation · Deerfield, IL

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009

Lot / serial / GTIN: UDI/DI 00085412610900, Software Version v9.02.01, All Serial Numbers

Quantity: 19861 units

Reason for recall

A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ Safety Software infusion pumps due to an increase in reported false upstream occlusion alarms following upgrades to software versions v8.01.01 and v9.02.01.

Recall record

Recall number: Z-2104-2023
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: US Nationwide distribution.
Recall initiated: 2023-06-15
Classified by FDA Center: 2023-07-13
FDA published: 2023-07-19
Recalling firm: Baxter Healthcare Corporation
Firm location: Deerfield, IL

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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