Recall Z-2055-2016 ยท FRN Pump, Infusion
Hospira Inc.
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.
| Date | Feb 4, 2013 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| 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. |
| Quantity | 20,311 |
| Distribution | Worldwide Distribution - USA (nationwide) |
| FDA record | Open on fda.gov |