BEUDAMED
    FDA Recall Terminated

    Hospira brand Symbiq One-Channel Infuser; List Number: 16026; Distributed by: Hospira, Inc. Morgan Hill, CA and Manufactured by: Hospira Inc, La Aurora, Heredia, Costa Rica. Intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural or irrigation routes of administration.

    Recall: Z-1894-2010 · Initiated April 9, 2010

    Recall

    Recall Number
    Z-1894-2010
    Event Number
    55854
    Firm
    Hospira Inc
    FEI Number
    2921482
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 9, 2010
    Posted
    July 2, 2010
    Terminated
    December 3, 2013
    Address
    755 Jarvis Dr, Morgan Hill, CA, 95037-2810

    Description

    Hospira brand Symbiq One-Channel Infuser; List Number: 16026; Distributed by: Hospira, Inc. Morgan Hill, CA and Manufactured by: Hospira Inc, La Aurora, Heredia, Costa Rica. Intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural or irrigation routes of administration.

    Reason

    Hospira has received numerous customer complaints of the Symbiq infusion pump's failure to detect air-in-line conditions during operation.

    Action

    Hospira issued a "Urgent: Medical Device Recall Notification" dated June 11, 2010 to update a previously issued Clinical Bulletin. Customers were informed of the issue and instructed on proper mitigation steps to further avoid the issue associated with the affected product. Consignees were asked to complete and return the Reply Form. For further information, contact Hospira Technical Support Operations at 1-800-332-4002, 6AM to 4PM PST, Monday through Friday.

    Distribution

    Worldwide Distribution -- United States (AL, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NY, OH, OK, PA, SC, SD, TN, TX, VA and WA), and Australia, Canada, Colombia, Costa Rica, Malaysia, Mexico, Puerto Rico, Singapore and United Arab Emirates.

    Quantity

    28,485 total