BEUDAMED
    FDA Recall 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 · Initiated June 19, 2013

    Recall

    Recall Number
    Z-1749-2013
    Event Number
    65492
    Firm
    Edwards Lifesciences, LLC
    FEI Number
    1713910
    Product Code
    DWF
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    June 19, 2013
    Posted
    July 17, 2013
    Terminated
    November 4, 2014
    Address
    12050 Lone Peak Pkwy, Draper, UT, 84020-9414

    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.

    Action

    Edwards sent an Urgent Field Safety Notice Product Recall letter, dated June 19, 2013, via FedEx to all affected customers. Two additional attempts will be made to notify customers to return products. The letter idenditifed the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory for any affected device in their inventory, quarantine all affected product from their inventory and return all devices to Edwards. Customers were instructed to acknowledge that they have reviewed the Recall Notice and confirm that they have taken appropriate action by completing, sign and dating the enclosed Recall Response Form and returning the form to Edwards by fax to Edwards Customer Service at 800-422-9329. Customers should contact Customer Service at 800-424-3278 to obtain a Returned Goods Authorization number to return their current product to and receive replacement product. Customers with questions were instructed to call Edwards Customer Service at 800-424-3278.

    Distribution

    Worldwide Distribution - USA (nationwide) and Canada.

    Quantity

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