Recall Z-1815-2009 ยท FRN Pump, Infusion
Hospira Inc
Hospira Phoenix Infusion System with MedNet Software, Symbiq One-Channel Infusion System, Software versions v2.1 & v3.0, Manufactured by Hospira Inc., Morgan Hill, CA.
| Date | Aug 11, 2009 (initiated Mar 31, 2009) |
| Status | Terminated |
| Reason | Potential delay/underinfusion of critical therapy-- Devices experience increased frequency of alarms that result in temporary pump stoppage. |
| Root cause | Software design |
| Action | Hospira, Inc. issued an "Urgent: Device Field Correction" dated March 31, 2009 via Federal Express to Healthcare Professionals and Valued Hospira Customers. Consignees were informed of the affected devices and will be contacted by a Hospira representative to arrange necessary device upgrades. For further questions, contact Hospira Global Product Safety and Complaints at 1-800-441-4100. |
| Distribution | Product was distributed to 59 consignees to all 50 States. |
| 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 |