BEUDAMED
    FDA Recall Terminated

    LifeShield Primary Plumset, CLAVE port, CLAVE Y-Site, 104 inch, 15 drops/mL, 48 sets per case; a sterile Rx device; Hospira Inc, Lake Forest, IL USA. Made in Costa Rica; product 120300412, list number 12030-12. Product Usage: For administration of I.V. fluids.

    Recall: Z-1491-2012 · Initiated April 25, 2012

    Recall

    Recall Number
    Z-1491-2012
    Event Number
    61680
    Firm
    Hospira Inc.
    FEI Number
    3013319212
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 25, 2012
    Posted
    May 4, 2012
    Terminated
    December 15, 2016
    Address
    275 N Field Dr, Lake Forest, IL, 60045-2579

    Description

    LifeShield Primary Plumset, CLAVE port, CLAVE Y-Site, 104 inch, 15 drops/mL, 48 sets per case; a sterile Rx device; Hospira Inc, Lake Forest, IL USA. Made in Costa Rica; product 120300412, list number 12030-12. Product Usage: For administration of I.V. fluids.

    Reason

    The Lifeshield Primary Plumsets may cause a cassette test failure alarm when the set is loaded onto the infusion pump. A set which results in a cassette test failure alarm may result in delay in therapy, requiring medical intervention.

    Action

    Hospira, sent an "URGENT DEVICE RECALL" letter dated April 25, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The customers were instructed to check their inventory and immediately quarantine any affected product to return for credit. A Reply Form was enclosed for customers to complete and return via fax to 1-888-386-2073 or e-mail to: [email protected]. Contact Hospira Customer Care at 1-877-946-7747 for information regarding product availability.

    Distribution

    Worldwide Distribution - USA (nationwide) including the states of: Alabama, Colorado, Georgia, Illinois, Indiana, Iowa, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Oklahoma, Pennsylvania, Wisconsin and the country of Australia.

    Quantity

    145,875 sets