BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-0944-2009 · Initiated December 3, 2008

    Recall

    Recall Number
    Z-0944-2009
    Event Number
    50541
    Firm
    Hospira Inc
    FEI Number
    2921482
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 3, 2008
    Posted
    February 27, 2009
    Terminated
    April 3, 2012
    Address
    755 Jarvis Dr, Morgan Hill, CA, 95037-2810

    Description

    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.

    Reason

    Hypersensitivity to normal motor friction/drag may cause malfunction errors and alarms that are designed to stop pump operations.

    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.

    Distribution

    Worldwide Distribution --- including USA and countries of Canada and Australia.

    Quantity

    combined 11,840 units