Reported Jul 19, 2023 · Ongoing
SIGMA Spectrum Infusion Pump, Product Code 35700BAX2
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?
- SIGMA Spectrum Infusion Pump, Product Code 35700BAX2
- Lot codes and dates
GTIN 00085412498683Software version v8.01.01Serial Numbers
- Amount recalled
- 3306 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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