BEUDAMED
    FDA Recall Terminated

    Esophageal Z-Stent Fully Coated or Uncoated Flanges, Endoprosthesis Systems with the Z Speed Introducer, Disposable Single Use Only, Rx Only, Sterile EO, Wilson-Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105

    Recall: Z-1410-04 · Initiated January 30, 2003

    Recall

    Recall Number
    Z-1410-04
    Event Number
    29853
    Firm
    Wilson-Cook Medical Inc
    FEI Number
    1037905
    Product Code
    ESW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 30, 2003
    Posted
    August 26, 2004
    Terminated
    March 4, 2005
    Address
    5951 Grassy Creek Blvd, Winston Salem, NC, 27105-1206

    Description

    Esophageal Z-Stent Fully Coated or Uncoated Flanges, Endoprosthesis Systems with the Z Speed Introducer, Disposable Single Use Only, Rx Only, Sterile EO, Wilson-Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105

    Reason

    Label contains the 'Sterile EO' symbol, however the device is provided non-sterile.

    Action

    Consignees were notified by visit by personal company representative to the user facility on January 30, 2003.

    Distribution

    CT, HI, LA, MO, PA

    Quantity

    5 units