FDAJune 21, 2018device

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), product code 35700BAX - Product Usage: The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These fluids may include pharmaceutical drugs, bloo...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

The flow rate test verification was not properly executed for certain Sigma Spectrum infusion pumps prior to release. The testing was performed for less than the required minimum run time. Improperly performed flow rate testing may not identify issues with pumps that could cause inaccuracies in flow rates which, in turn, could lead to over- or under- infusion. Potential risk to the patient depends on a number of factors including treatment and patient comorbidities. Depending on these factors, the patient could experience serious adverse health consequences.

What to do

FDA enforcement status: Terminated

Brands named

baxter healthcarebaxter

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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