BEUDAMED
    FDA Recall Terminated

    Fusion Omni-Tome, Rx Only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105.

    Recall: Z-1598-2009 · Initiated June 12, 2009

    Recall

    Recall Number
    Z-1598-2009
    Event Number
    52283
    Firm
    Cook Endoscopy
    FEI Number
    1037905
    Product Code
    KNS
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 12, 2009
    Posted
    July 21, 2009
    Terminated
    April 6, 2010
    Address
    5951 Grassy Creek Blvd, Winston Salem, NC, 27105-1206

    Description

    Fusion Omni-Tome, Rx Only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105.

    Reason

    The wire control port of these devices may be missing due to omission of a manufacturing activity.

    Action

    The distributor (Cook Ireland) was instructed to contact their customers and coordinate the return of all recall product to Cook Endoscopy. All devices returned as part of this recall initiative will be dispositioned to scrap and destroyed. Contact the Customer Quality Assurance Department at Cook Endoscopy for more information at [email protected] or 1-336-744-0157.

    Distribution

    International Distribution - Italy, Netherlands, Germany and Spain.

    Quantity

    20 units