BEUDAMED
    FDA Recall Terminated

    Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 30 mm cut wire, proximal balloon, sterile, single use only, material number M00535210; catalog number 3521.

    Recall: Z-1114-06 · Initiated May 19, 2006

    Recall

    Recall Number
    Z-1114-06
    Event Number
    35535
    Firm
    Boston Scientific Corp
    FEI Number
    1828132
    Product Code
    LQR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 19, 2006
    Posted
    June 27, 2006
    Terminated
    June 20, 2007
    Address
    780 Brookside Dr, Spencer, IN, 47460-1080

    Description

    Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 30 mm cut wire, proximal balloon, sterile, single use only, material number M00535210; catalog number 3521.

    Reason

    Lack of assurance of sterility, as the sterile barrier may fail.

    Action

    Consignees were notified to cease using, and to return, the products via recall letter dated May 19, 2006. International customers were also notified.

    Distribution

    Nationwide, Arab Emirate, Australia, Austria, Belgium, Canada, Denmark, Finland, France, germany, Great Britain, Hong Kong, Israel, Italy, Japan, Libya, Mexico, Netherlands, New Zealand, Portugal, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Turkey, Taiwan, Venezuela and Viet Nam.