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
This recall has been terminated (originally issued October 22, 2010).
- Company
- Hospira Inc
- Recall Initiated
- February 22, 2010
- Posted
- October 22, 2010
- Terminated
- December 3, 2013
- Recall Number
- Z-0127-2011
- Firm Location
- Morgan Hill, CA
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution: USA and the coutnries of Australia, Canada, Colombia, Costa Rica, Malaysia, Mexico, Puerto Rico, Singapore and the UAE.
Lot / Code Info
All units of these List Numbers.
Root Cause
Device Design
Action Taken
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.