BEUDAMED
    FDA Recall Terminated

    SGD-12-70 Savary-Gilliard Dilator - Diameter: 12MM./36 FR. Length: 70 CM Reusable

    Recall: Z-0441-06 · Initiated January 5, 2006

    Recall

    Recall Number
    Z-0441-06
    Event Number
    34326
    Firm
    Cook Endoscopy
    FEI Number
    1037905
    Product Code
    KNQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 5, 2006
    Posted
    January 25, 2006
    Terminated
    April 4, 2006
    Address
    5951 Grassy Creek Blvd, Winston Salem, NC, 27105-1206

    Description

    SGD-12-70 Savary-Gilliard Dilator - Diameter: 12MM./36 FR. Length: 70 CM Reusable

    Reason

    The dilator size does not match the label on the product and product packaging.

    Action

    A recall letter was issued to the consignees on 1/5/06 requesting return of the product. The letter also requested a sub-recall if the product had been further distributed.

    Distribution

    Canada and Australia