FDA-Device2016-11-02Class II
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.
Hospira Inc.
Hazard
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.
Sold states
Worldwide Distribution - USA (nationwide) and Canada
Affected count
35,596 devices in total
Manufactured in
275 N. Field Dr., Lake Forest, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0306-2017Don't want to check this manually?
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