BEUDAMED
    FDA Recall Terminated

    Thin-Flex Venous Return Cannulae, 33/43 Fr. x 39 cm, REF TF3343OA, Sterile EO, Edwards Lifesciences LLC, Irvine, CA 92614. Intended for cannula drainage of the superior and inferior vena cava during extracorporeal circulation for a duration of less than and equal to 6 hours.

    Recall: Z-2402-2008 · Initiated July 14, 2008

    Recall

    Recall Number
    Z-2402-2008
    Event Number
    49049
    Firm
    Edwards Lifesciences Research Medical, Inc.
    FEI Number
    1713910
    Product Code
    DWF
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 14, 2008
    Posted
    September 26, 2008
    Terminated
    December 23, 2008
    Address
    6864 South 300, West Midvale, UT, 84047

    Description

    Thin-Flex Venous Return Cannulae, 33/43 Fr. x 39 cm, REF TF3343OA, Sterile EO, Edwards Lifesciences LLC, Irvine, CA 92614. Intended for cannula drainage of the superior and inferior vena cava during extracorporeal circulation for a duration of less than and equal to 6 hours.

    Reason

    Reinforcement spring may detach from the cannula body resulting in reduced venous blood return flow.

    Action

    All domestic consignees were notified by a Product Recall letter on 07/15/2008 via FedEx. They were instructed to check their inventory for any affected product and return all unused product from their stock to Edwards. Customers are to contact Customer Service Organization to obtain a Returned Goods Authorization number and replacement product. Once inventory has been verified, the attached form needs to be completed and faxed to Edwards so that customer awareness can be confirmed. International accounts were notified on 07/14/2008.

    Distribution

    Worldwide Distribution --- USA including states of AL, CA, LA, MI, MN, MO, MS, NC, ND, SC, TX, and WA, and countries of Brazil, Israel, Japan, and Netherlands.

    Quantity

    690 units