Baxter Healthcare Corporation recalls Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN 00085412091570); Model Numbers: 35700BAX

Recalled March 21, 2018 · FDA recall Z-0971-2018 · Baxter Healthcare

Hazard

Certain infusion pumps may exhibit excessive wear of the pumping mechanism caused by a lack of lubrication, this could affect the occlusion of the tubing and result in over- or under-infusion. · FDA Class II

Units

173,375

Sold at

Worldwide Distribution - US, including the District of Columbia, Puerto Rico, and Canada.

Description

Certain infusion pumps may exhibit excessive wear of the pumping mechanism caused by a lack of lubrication, this could affect the occlusion of the tubing and result in over- or under-infusion.

Product

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN 00085412091570); Model Numbers: 35700BAX and 35700ABB. Intended to be used for the controlled administration of fluids.

Manufacturer(s)

Baxter Healthcare Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →