Reported Oct 28, 2020 · Terminated

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)

Baxter Healthcare Corporation

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Baxter Healthcare Corporation · 1 Baxter Pkwy · Deerfield, IL · 60015-4625

Is this the product you have?

  • Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
Lot codes and dates
  • Product Code
    • 35700BAX
    • All Serial Numbers
    • GTIN 00085412091570
Amount recalled
310,969 units

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

Why it was recalled

Stop using this product now

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

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 29, 2024 · Data as of Sep 19, 4:57 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.