BEUDAMED
    FDA Recall Terminated

    ESD-5, ESD Flexible Endoscopic Suturing Device, Flexible Sew Right Device: Flexible TI Knot Device: External Accessory Channel: 6mm./75 cm.; * Suture Quickload Units (2); TI Knot Quickload Units (2) * Disposable Single Use Only * Manufactured by: LSI Solutions * Sterile/EO * Rx Only * Wilson-Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105.

    Recall: Z-0698-05 · Initiated April 1, 2005

    Recall

    Recall Number
    Z-0698-05
    Event Number
    31553
    Firm
    Wilson-Cook Medical Inc
    FEI Number
    1037905
    Product Code
    GCJ
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    April 1, 2005
    Posted
    April 8, 2005
    Terminated
    July 8, 2005
    Address
    5951 Grassy Creek Blvd, Winston Salem, NC, 27105-1206

    Description

    ESD-5, ESD Flexible Endoscopic Suturing Device, Flexible Sew Right Device: Flexible TI Knot Device: External Accessory Channel: 6mm./75 cm.; * Suture Quickload Units (2); TI Knot Quickload Units (2) * Disposable Single Use Only * Manufactured by: LSI Solutions * Sterile/EO * Rx Only * Wilson-Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105.

    Reason

    The expiration date listed on the product label is greater than the vendor recommended expiration date.

    Action

    Consignees were notified by certified mail on 04/01/2005.

    Distribution

    Nationwide, Brazil, Canada, Hong Kong, Ireland & Pakistan

    Quantity

    167 units