Recall Z-0361-2017 ยท FRN Pump, Infusion
Hospira Inc.
Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids. List number 16026. Note that Hospira retired this pump June 30, 2015. The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood, and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural,
| Date | Mar 16, 2011 |
| Status | Terminated |
| Reason | May go to a white screen due to a problem with the SOM2 module. A white screen is a diagnostic screen displayed to the user as part of the safety shutdown procedure of the device. The infusion and the processor stop, sound a 3 minute audible alarm from the backup buzzer and deactivate the couch screen and the automated loading/unloading of cassettes. Delay or interruption of therapy. |
| Root cause | Device Design |
| Action | Hospira sent an Urgent Device Recall Letters, dated February 5, 2013, to all affected customers. Customers were directed to notify their consignees if they further distributed the product and confirm they have done so by return of the reply form. Healthcare professionals were to contact Stericycle. Hospira discontinued support of these devices as of June 30, 2015. Customers with questions were instructed to call 1-800-201-9064. For questions regarding this recall call 224-212-4892. |
| Quantity | 10,337 |
| Distribution | Worldwide Distribution - US (nationwide) and Canada |
| FDA record | Open on fda.gov |