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U.S. Department of Health and Human Services

Class 2 Device Recall Hospira Symbiq Infusion System with MedNet Software.

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 Class 2 Recall
Hospira Symbiq Infusion System with MedNet Software.
see related information
Date Posted February 27, 2009
Recall Status1 Open
Recall Number Z-0944-2009
Recall Event ID 50541
Premarket Notification
510(K) Number
K041550 
Product Classification Pump, Infusion - Product Code FRN
Product Symbiq One-Channel list number 16026-04 and Two-Channel list number 16027-04 Infusion System, a general purpose infuser, Distributed and Manufactured by Hospira Inc, Morgan Hill, CA. Is a general purpose infuser designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration. Intended primarily for use in the hospital setting and can be used in other acute and non-acute care areas, such as but not limited to Home Care, Nursing Homes, Mobile Intensive Care, Ambulatory Infusion Centers, Hospice, Subacute facilities, Outpatient/Surgical Centers, Long Term Care, Urgent Care, Transport and Physician Offices.
Code Information All products manufactured between 12/19/06 to 12/02/08 with list numbers 16026-04-01/03/04, 51/52, 79/80 and 81/82, or 16027-04-01/03/04, 51/52, 53/54, 79/80, and 81/82.
Recalling Firm/
Manufacturer
Hospira Inc
755 Jarvis Dr
Morgan Hill, California 95037-2810
Manufacturer Reason
for Recall
Hypersensitivity to normal motor friction/drag may cause malfunction errors and alarms that are designed to stop pump operations.
FDA Determined
Cause 2
DESIGN: Software Design (Manufacturing Process)
Action Recall initiated 12/03/2008. Consignees were notified of the issue via an Urgent: Device Field Correction letter, dated 12/3/2008, and were requested to respond appropriately to any alarm or warnings displayed by the device. The firm is making arrangements to screen each Symbiq pump in customer facilities and implement the appropriate enhancements.
Quantity in Commerce combined 11,840 units
Distribution Worldwide Distribution --- including USA and countries of Canada and Australia.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = ABBOTT LABORATORIES
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