Hospira Inc. recalls Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpo…

Recall date

February 4, 2013

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2055-2016

FDA classification

Class II

Brand / firm

Hospira Inc.

Sold / distributed

Worldwide Distribution - USA (nationwide)

Why it was recalled

Frequent Proximal Occlusion Alarms (POAs) occurring on Symbiq devices with list numbers 16026 and 16027. When there are false alarms, the pump will continue to alarm even though there is no occlusion present. False POAs could result in a delay/interruption in therapy, and require the clinician to reset the alarm multiple times or to replace the pump.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral administration; and various solution through enteral, intravenous, intra-arterial, subcutaneous, and pathways.