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U.S. Department of Health and Human Services

Class 2 Device Recall Hospira Phoenix Infusion System with MedNet Software, One Channel Infusion System

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 Class 2 Device Recall Hospira Phoenix Infusion System with MedNet Software, One Channel Infusion Systemsee related information
Date Initiated by FirmMarch 31, 2009
Date PostedAugust 11, 2009
Recall Status1 Terminated 3 on December 18, 2010
Recall NumberZ-1815-2009
Recall Event ID 52523
510(K)NumberK041550 
Product Classification Pump, infusion - Product Code frn
ProductHospira Phoenix Infusion System with MedNet Software, Symbiq One-Channel Infusion System, Software versions v2.1 & v3.0, Manufactured by Hospira Inc., Morgan Hill, CA.
Code Information List number 16026-04-83/84 and 87/88, software versions 2.1 and 3.0 only.
FEI Number 2921482
Recalling Firm/
Manufacturer		 Hospira Inc
755 Jarvis Dr
Morgan Hill CA 95037-2810
For Additional Information Contact
408-782-3200
Manufacturer Reason
for Recall		Potential delay/underinfusion of critical therapy-- Devices experience increased frequency of alarms that result in temporary pump stoppage.
FDA Determined
Cause 2		Software design
ActionHospira, 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.
DistributionProduct was distributed to 59 consignees to all 50 States.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = frn
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