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.
This recall has been terminated (originally issued August 11, 2009).
- Company
- Hospira Inc
- Recall Initiated
- March 31, 2009
- Posted
- August 11, 2009
- Terminated
- December 18, 2010
- Recall Number
- Z-1815-2009
- Firm Location
- Morgan Hill, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Potential delay/underinfusion of critical therapy-- Devices experience increased frequency of alarms that result in temporary pump stoppage.
Distribution
Product was distributed to 59 consignees to all 50 States.
Lot / Code Info
List number 16026-04-83/84 and 87/88, software versions 2.1 and 3.0 only.
Root Cause
Software design
Action Taken
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.