Medical device recalls Moderate risk

Hospira Inc. recalls Symbiq Two 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-0306-2017
FDA classification
Class II
Brand / firm
Hospira Inc.
Sold / distributed
Worldwide Distribution - USA (nationwide) and Canada

Why it was recalled

Symbiq Infusers have the potential to experience a white screen during titration of a Keep Vein Open (KVO) delivery. This can allow the clinician to select the "NEXT" button prior to completion of the programming. If this error occurs, a delay in therapy could occur and potentially result in significant injury.

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 Two 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.

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