Recall Z-0944-2009 ยท FRN Pump, Infusion
Hospira Inc
Symbiq One-Channel list number 16026-04 and Two-Channel list number 16027-04 Infusion System, a general purpose infuser, Distributed and Manufactured by Hospira Inc, Morgan Hill, CA. Is a general purpose infuser designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidur
| Date | Feb 27, 2009 (initiated Dec 3, 2008) |
| Status | Terminated |
| Reason | Hypersensitivity to normal motor friction/drag may cause malfunction errors and alarms that are designed to stop pump operations. |
| Root cause | Software design |
| Action | Recall initiated 12/03/2008. Consignees were notified of the issue via an Urgent: Device Field Correction letter, dated 12/3/2008, and were requested to respond appropriately to any alarm or warnings displayed by the device. The firm is making arrangements to screen each Symbiq pump in customer facilities and implement the appropriate enhancements. |
| Quantity | combined 11,840 units |
| Distribution | Worldwide Distribution --- including USA and countries of Canada and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041550 | HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE Abbott Laboratories, Jun 30, 2004 |