BEUDAMED
    FDA Recall Terminated

    Gold Probe 7FR Working Length: 350 cm, Probe Tip O.D. 2.3 mm (7Fr), Rx Only. Electrical Connector: Standard. Single Use Only. Legal Manufacturer, Boston Scientific Corporation, One Boston Scientific Place Natick, MA 01760-1537 USA. Made in USA: 8600 N.W. 41st Street Miami, FL 33166-6202 USA. The device is indicated for use in transendoscopic electrocautery of visible bleeding and nonbleeding sites in the gastrointestinal tract including the esophagus, stomach, duodenum, and colon.

    Recall: Z-0979-2009 · Initiated December 24, 2008

    Recall

    Recall Number
    Z-0979-2009
    Event Number
    50697
    Firm
    Boston Scientific Corporation
    FEI Number
    1051710
    Product Code
    KNS
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    December 24, 2008
    Posted
    February 13, 2009
    Terminated
    May 11, 2010
    Address
    8600 Nw 41st St, Miami, FL, 33166-6202

    Description

    Gold Probe 7FR Working Length: 350 cm, Probe Tip O.D. 2.3 mm (7Fr), Rx Only. Electrical Connector: Standard. Single Use Only. Legal Manufacturer, Boston Scientific Corporation, One Boston Scientific Place Natick, MA 01760-1537 USA. Made in USA: 8600 N.W. 41st Street Miami, FL 33166-6202 USA. The device is indicated for use in transendoscopic electrocautery of visible bleeding and nonbleeding sites in the gastrointestinal tract including the esophagus, stomach, duodenum, and colon.

    Reason

    Packaging tray for the Gold Probe Single-Use BiPolar Electrohemostasis Catheters may have a crack. Cracks in the tray or damage to the tray of the Gold Probe device may lead to a compromised sterile barrier.

    Action

    A notification letter (dated December 24, 2008) was issued to customers. The letter identified the issue. Consignees are instructed to: 1) Discontinue use and segregate affected product, 2) Complete a Reply Verification Tracking Form and fax to the Boston Scientific Corporation (BSC) at 508-683-5578 and 3) Package and ship recalled product as instructed in the letter. If affected product is found, customers are instructed to call BSC Customer Service at 1-866-868-4004 between 8:30 a.m. through 6:00 p.m. (Eastern Standard Time). Please direct questions about the recall to your local Sales Representative.

    Distribution

    Worldwide Distribution.

    Quantity

    10,841