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Baxter Healthcare Corp. recalls sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum Infusion Pump, Product Code 35700BAX and 3
Recalled December 7, 2016 · FDA recall Z-0670-2017 · Baxter Healthcare
Hazard
A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library in order to replace speakers installed in pumps or included in spare part rear case assemblies that have an increased potential to fail prematurely. · FDA Class II
Units
5,976 units (US: 5972, Canada: 4)
Sold at
Nationwide Distribution, Puerto Rico and Canada
Description
A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library in order to replace speakers installed in pumps or included in spare part rear case assemblies that have an increased potential to fail prematurely.
Product
sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum Infusion Pump, Product Code 35700BAX and 35700BAXR, Unique Device Identifier GTIN 00085412091570, Rx ONLY -- Sigma, LLC Medina, NY 14103 --- NOTE: The speakers are a part of the rear case assembly located in the back of the infusion pump. The speaker is intended to generate audible tones during each keystroke, and during alarm conditions. However, some speakers have a variation in their internal wiring that increases the potential for the speaker to fail prematurely. Spectrum Infusion Pumps with non-functional speakers will continue to display visual alarm indications, and will otherwise continue to operate as intended.
Manufacturer(s)
Baxter Healthcare Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →