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.
FDA Recall Z-2056-2016 · Posted None
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Recalling FirmHospira Inc.
Recall StatusTerminated
Product CodeFRN
Date Initiated2013-02-04
Date Terminated2016-09-12
Product Quantity15,285
Reason for Recall
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.
Firm Action
Hospira sent letters on May 2, 2013, to customers informing them of the discontinuation of sales, service, and support for the Symbiq pump were sent via traceable mailing to all affected customers. For questions regarding this recall call 224-212-4892.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution - USA (nationwide)
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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