BEUDAMED
    FDA Recall Terminated

    Latex-Free Primary Symbiq Pump Set, piggyback with backcheck valve, 2 CLAVE Y-sites, 105 inch, non-DEHP, 15 drops/mL; a sterile Rx single use device; Hospira Inc, Lake Forest, IL USA. Made in Costa Rica; product 160900428, list number 16090-28.

    Recall: Z-1058-2010 · Initiated November 24, 2009

    Recall

    Recall Number
    Z-1058-2010
    Event Number
    54080
    Firm
    Hospira Inc.
    FEI Number
    3013319212
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 24, 2009
    Posted
    March 9, 2010
    Terminated
    January 29, 2012
    Address
    375 N Field Dr, Lake Forest, IL, 60045-2513

    Description

    Latex-Free Primary Symbiq Pump Set, piggyback with backcheck valve, 2 CLAVE Y-sites, 105 inch, non-DEHP, 15 drops/mL; a sterile Rx single use device; Hospira Inc, Lake Forest, IL USA. Made in Costa Rica; product 160900428, list number 16090-28.

    Reason

    Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets.

    Action

    Hospira, Inc. issued an "Important Administration Set Information" letter dated November 24, 2009 to their direct accounts, informing them of the affected product. Consignees were instructed to return the defective product to the firm. For further information, contact Hospira Medical Communications at 1-800-615-0187.

    Distribution

    Worldwide Distribution -- United States, Australia, Canada, Costa Rica, India, Mexico, Netherlands, Philippines, Singapore and United Arab Emirates.

    Quantity

    1,118,821 sets