FDA Recall Terminated

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.

Recall: Z-2056-2016 · Initiated February 4, 2013

Recall

Recall Number
Z-2056-2016
Event Number
63990
Firm
Hospira Inc.
FEI Number
3013319212
Product Code
FRN
Status
Terminated
Root Cause
Software design
Initiated
February 4, 2013
Terminated
September 12, 2016
Address
275 N Field Dr, Lake Forest, IL, 60045-2579

Description

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.

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.

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.

Distribution

Worldwide Distribution - USA (nationwide)

Quantity

15,285