—#83445

Product

Hospira Phoenix Infusion System with MedNet Software, Symbiq Two-Channel Infusion System, Software versions v2.1 & v3.0, Manufactured by Hospira Inc., Morgan Hill, CA

FDA product code: frn
510(k) numbers: K041550
Affected lot / code info: List number 16027-04-83/84 and 87/88, software versions 2.1 and 3.0 only.

Why it was recalled

Potential delay/underinfusion of critical therapy-- Devices experience increased frequency of alarms that result in temporary pump stoppage.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Hospira Inc
Address: 755 Jarvis Dr, Morgan Hill, California 95037-2810

Distribution

Distribution pattern: Product was distributed to 59 consignees to all 50 States.

Timeline

Recall initiated: 2009-03-31
Posted by FDA: 2009-08-11
Terminated: 2010-12-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #83445. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.