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U.S. Department of Health and Human Services

Class 1 Device Recall Hospira brand Symbiq OneChannel Infuser

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  Class 1 Device Recall Hospira brand Symbiq OneChannel Infuser see related information
Date Initiated by Firm February 22, 2010
Date Posted October 22, 2010
Recall Status1 Terminated 3 on December 03, 2013
Recall Number Z-0127-2011
Recall Event ID 56462
510(K)Number K041550  
Product Classification Pump, infusion - Product Code FRN
Product Hospira brand Symbiq One-Channel Infuser
LIST No. 16026 Symbiq One-Channel Infuser,
List Number Configurations:
16026-04-01/03/04,51/52, 53/54, 79/80, 81/82, 83/84, 87/88 and 89/90,
16026-13-25/26, 53/54,
Distributed by: Hospira, Inc. Morgan Hill, CA

Code Information All units of these List Numbers.
Recalling Firm/
Manufacturer		 Hospira Inc
755 Jarvis Dr
Morgan Hill CA 95037-2810
For Additional Information Contact
408-782-3200
Manufacturer Reason
for Recall		 Hospira has identified motor encoder failures in the Symbiq pumping mechanism that causes the infuser to cease operation during infusion therapy, resulting in delay or interruption of infusion therapy.
FDA Determined
Cause 2		 Device Design
Action Hospira issued a Recall Notification letter dated October 4, 2010, updating the Urgent Device Field Correction letter dated February 22, 2010, ideentifying the affected products, the issue prompting the recall, and actions to be taken by customers. Customers are to examine their inventory to determine if they have any of the affected products, and recommended to remove them from service in critical care areas, and contact Hospira to schedule removal and replacement of the motor. Replace affected devices with a loaner or corrected back-up pump if available. Custoemrs can contacvtd Hospira Global Product Safety and Complaints at 1-800-441-4100, and Technical Support Operations at 1-800-241-4002.
Distribution Worldwide Distribution: USA and the coutnries of Australia, Canada, Colombia, Costa Rica, Malaysia, Mexico, Puerto Rico, Singapore and the UAE.
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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