BEUDAMED
    FDA Enforcement Class II Terminated

    Edwards Lifesciences Suction Wand, models S099 and S0998B Suction wands are intended for hand held use and pericardial sumps are intended for stationary use in removing excess fluid from the surgical field.

    Recall: Z-1749-2013 · Reported July 24, 2013

    Enforcement

    Recall Number
    Z-1749-2013
    Event ID
    65492
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Edwards Lifesciences, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 24, 2013
    Initiation Date
    June 19, 2013
    Classification Date
    July 17, 2013
    Termination Date
    November 4, 2014
    Address
    12050 Lone Peak Pkwy, N/A, Draper, UT, 84020-9414, United States

    Description

    Edwards Lifesciences Suction Wand, models S099 and S0998B Suction wands are intended for hand held use and pericardial sumps are intended for stationary use in removing excess fluid from the surgical field.

    Reason

    Edwards is recalling certain lots of Rigid Suction Wands because they discovered plastic particulate inside the sterile pouch and within the internal diam ether of the wand.

    Code Info

    Models S099 and S099B

    Distribution

    Worldwide Distribution - USA (nationwide) and Canada.

    Quantity

    S099: 171,587 units and S099B: 505,107 units