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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 System see related information
Date Initiated by Firm March 31, 2009
Date Posted August 11, 2009
Recall Status1 Terminated 3 on December 18, 2010
Recall Number Z-1815-2009
Recall Event ID 52523
510(K)Number K041550  
Product Classification Pump, infusion - Product Code frn
Product 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.
Code Information List number 16026-04-83/84 and 87/88, software versions 2.1 and 3.0 only.
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
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.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = frn and Original Applicant = ABBOTT LABORATORIES
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