Reported Apr 5, 2017 · Terminated
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code 35700BAX2
Baxter Healthcare Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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 · 711 Park Ave · Medina, NY · 14103-1036
Is this the product you have?
- Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code 35700BAX2
- Lot codes and dates
- 14,362 Serial Numbers (please contact CDRH for list of affected Serial Numbers).
- Amount recalled
- Domestic: 14,175 units; Canada: 187 units
Where it was sold
Why it was recalled
SIGMA Spectrum Infusion Pumps with Master Drug Library, Software V8.00.02 contains an anomaly that may cause a Sharp Watchdog Timeout error message. Specifically, the software anomaly causes the error message only under conditions in which a message is being written to the Spectrum Infusion Pumps Event History Log (EHL), and the length of that message exactly matches the size of the available memory at the end of a memory sector. For this reason, the issue is significantly more likely to manifest when poor network maintenance results in high volumes of messages being written to the EHL.
This product could cause temporary or reversible health problems — stop using it.
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