BEUDAMED
    FDA Recall Terminated

    LifeShield Latex-free Primary I.V. Set, convertible P.P. yellow key slide clamp, backcheck valve, 4 Clave ports, piggyback with Option-Loc, attached extension set, 122 inch, 15 drops/mL; an Rx sterile single use fluid path way for administration of I.V. fluids; 48 sets per case; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; list number 19689-01

    Recall: Z-0809-2010 · Initiated January 8, 2010

    Recall

    Recall Number
    Z-0809-2010
    Event Number
    54195
    Firm
    Hospira Inc.
    FEI Number
    3013319212
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 8, 2010
    Posted
    February 22, 2010
    Terminated
    July 20, 2011
    Address
    375 N Field Dr, Lake Forest, IL, 60045-2513

    Description

    LifeShield Latex-free Primary I.V. Set, convertible P.P. yellow key slide clamp, backcheck valve, 4 Clave ports, piggyback with Option-Loc, attached extension set, 122 inch, 15 drops/mL; an Rx sterile single use fluid path way for administration of I.V. fluids; 48 sets per case; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; list number 19689-01

    Reason

    There is a potential for fluid to leak from the backcheck valve which could result in inaccurate delivery and occupational exposure.

    Action

    Hospira Medical issued an "Urgent Device Recall" notification dated January 8, 2010 informing consignees of the affected product. The accounts were instructed to examine their inventory and quarantine affected product immediately and arrange for its return. Users were also requested to complete the enclosed reply form and return it to the firm. For further information, contact Hospira Medical Communications at 1-800-615-0187.

    Distribution

    Minnesota and Utah

    Quantity

    1,536 sets