BEUDAMED
    FDA Recall Terminated

    Oscor Adelante Luer-Lock Peel Away Introducer Set, for introduction of diagnostic or therapeutic devices into the body.

    Recall: Z-0130-2009 · Initiated July 3, 2008

    Recall

    Recall Number
    Z-0130-2009
    Event Number
    49558
    Firm
    Oscor, Inc.
    FEI Number
    1035166
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    July 3, 2008
    Posted
    October 29, 2008
    Terminated
    December 9, 2008
    Address
    3816 Desoto Blvd, Palm Harbor, FL, 34683

    Description

    Oscor Adelante Luer-Lock Peel Away Introducer Set, for introduction of diagnostic or therapeutic devices into the body.

    Reason

    Difficulty breaking the sheath hub and subsequently to peel the sheath off for Introducer Set, Adelante size 7F.

    Action

    Oscor notified the Direct Account by letter on 07/03/2008. Direct account was asked to return all unused Introducers back to Oscor. All returned products should be labeled with the Return Goods Product number.

    Distribution

    Product was distributed to one direct account in MN.

    Quantity

    396