BEUDAMED
    FDA Recall Terminated

    Boston Scientific brand One Step Button (percutaneous endoscopic gastrostomy tubes) Kit, 18/4.4 pull; catalog number 6848.

    Recall: Z-0969-05 · Initiated June 2, 2005

    Recall

    Recall Number
    Z-0969-05
    Event Number
    32383
    Firm
    Boston Scientific Corp
    FEI Number
    1828132
    Product Code
    KGC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 2, 2005
    Posted
    July 7, 2005
    Terminated
    December 13, 2006
    Address
    780 Brookside Dr, Spencer, IN, 47460-1080

    Description

    Boston Scientific brand One Step Button (percutaneous endoscopic gastrostomy tubes) Kit, 18/4.4 pull; catalog number 6848.

    Reason

    Two blades may be heat staked onto the stiletto instead of the expected one blade.

    Action

    Customers were notified by a recall letter dated 6/7/05 which instructed them to return any of the recalled products on hand.

    Distribution

    Nationwide and Panama.