BEUDAMED
    FDA Recall Terminated

    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

    Recall: Z-0127-2011 · Initiated February 22, 2010

    Recall

    Recall Number
    Z-0127-2011
    Event Number
    56462
    Firm
    Hospira Inc
    FEI Number
    2921482
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 22, 2010
    Posted
    October 22, 2010
    Terminated
    December 3, 2013
    Address
    755 Jarvis Dr, Morgan Hill, CA, 95037-2810

    Description

    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

    Reason

    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.

    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.