Reported Apr 30, 2014 · Terminated
SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product Usage: Sigma Spectrum Volumetric Infusion…
Baxter Healthcare Corp.
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 Corp. · 1 Baxter Pkwy · Deerfield, IL · 60015-4625
Is this the product you have?
- SIGMA SPECTRUM Volumetric Infusion Pump
- with Master Drug Library Product UsageSigma Spectrum Volumetric Infusion Pumps with Master Drug Library are intended to be used for the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy
- Lot codes and dates
- Product Codes
35700BAX35700ABB
- Product Codes
- Amount recalled
- 277,096 units (revised)
Where it was sold
- Nationwide
- PR
Why it was recalled
Stop using this product now
Baxter Healthcare Corporation has issued an Urgent Device Correction for the SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library due to repeated System Error 322 occurrences.
Using this product could cause serious injury, illness or death — stop using it now.
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