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Open, Classified

Baxter Spectrum IQ Infusion Pump, Product Code 3570009

FDA Recall Z-1775-2024 · Posted 2024-05-03

Recalling FirmBaxter Healthcare Corporation
Recall StatusOpen, Classified
Product CodeFRN
Date Initiated2024-03-20
Product Quantity1 pump

Reason for Recall

One device was improperly performed testing prior to release from a Service Center.

Firm Action

The affected customer was contacted via on-site visit on March 20, 2024, and by phone call on March 22, 2024. Baxter has asked the customer to locate the affected pump at their facility and return the device to Baxter for testing.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US Nationwide distribution in the state of Massachusetts.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K230041Spectrum IQ Infusion System with Dose IQ Safety SoftwareBaxter Healthcare Corporation · 2023-03-31

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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