BEUDAMED
    FDA Enforcement Class II Terminated

    Edwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/Lung Perfusion Packs.

    Recall: Z-1985-2013 · Reported August 28, 2013

    Enforcement

    Recall Number
    Z-1985-2013
    Event ID
    65869
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sorin Group USA, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 28, 2013
    Initiation Date
    July 8, 2013
    Classification Date
    August 20, 2013
    Termination Date
    January 28, 2014
    Address
    14401 W 65th Way, N/A, Arvada, CO, 80004-3503, United States

    Description

    Edwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/Lung Perfusion Packs.

    Reason

    Sorin Group is recalling certain lots of Edwards Lifesciences Suction Wand Model S099B due to presence of plastic particles inside the pouch.

    Code Info

    Model S099B

    Distribution

    Nationwide Distribution

    Quantity

    18,927 packs