BEUDAMED
    FDA Recall Terminated

    Boston Scientific Vesica Sling Kits with Drill-In Anchor System sterile, for single use only; Ref/Catalog No. 820-100, UPN Product No. (M0068201000).

    Recall: Z-1308-06 · Initiated June 2, 2006

    Recall

    Recall Number
    Z-1308-06
    Event Number
    35724
    Firm
    Boston Scientific Corp
    FEI Number
    1828132
    Product Code
    JDR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 2, 2006
    Posted
    August 2, 2006
    Terminated
    April 17, 2007
    Address
    780 Brookside Dr, Spencer, IN, 47460-1080

    Description

    Boston Scientific Vesica Sling Kits with Drill-In Anchor System sterile, for single use only; Ref/Catalog No. 820-100, UPN Product No. (M0068201000).

    Reason

    The packages are labeled sterile, but the product was not sterilized.

    Action

    Consignees were notified by letters dated 6/2/06 and sent via Federal Express and requesting return of the products.

    Distribution

    Nationwide, including California, Florida, Kansas, North Carolina, Oklahoma, South Dakota, Tennessee, West Virginia and Wisconsin.

    Quantity

    22 kits.