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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = frn
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