BEUDAMED
    FDA Recall Terminated

    Boston Scientific brand Zero Tip Nitinol Stone Retrieval Basket, 12 mm, 90 cm, 1.9 Fr., sterile, latex free; Catalog no. 390-104.

    Recall: Z-0510-06 · Initiated December 20, 2005

    Recall

    Recall Number
    Z-0510-06
    Event Number
    34300
    Firm
    Boston Scientific Corp
    FEI Number
    1828132
    Product Code
    FFL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 20, 2005
    Posted
    February 8, 2006
    Terminated
    May 1, 2007
    Address
    780 Brookside Dr, Spencer, IN, 47460-1080

    Description

    Boston Scientific brand Zero Tip Nitinol Stone Retrieval Basket, 12 mm, 90 cm, 1.9 Fr., sterile, latex free; Catalog no. 390-104.

    Reason

    The basket wire assembly may detach from the drive wire while in the patient.

    Action

    U.S. and foreign consignees were notified via letter dated 12/20/05 and requested to return stocks on hand. Distributors were requested to notify their customers.

    Distribution

    Nationwide, Argentina, Australia, Belgium, Brazil, Canada, Chile, Denmark, Dominican Republic, Finland, France, Germany, Great Britain, Greece, Hong Kong, Ireland, Italy, Malaysia, Morocco, Netherlands, New Zealand, Norway, Poland, South Korea, Singapore, South Africa, Spain and Sweden.

    Quantity

    2076