BEUDAMED
    FDA Recall Terminated

    Boston Scientific/Microvasive brand Biliary Stent Kit, 7 FR x 5 cm, sterile, single use only; Ref 3101.

    Recall: Z-1102-04 · Initiated June 18, 2004

    Recall

    Recall Number
    Z-1102-04
    Event Number
    29418
    Firm
    Boston Scientific Corp
    FEI Number
    1828132
    Product Code
    FGE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 18, 2004
    Posted
    July 20, 2004
    Terminated
    December 14, 2004
    Address
    780 Brookside Dr, Spencer, IN, 47460-1080

    Description

    Boston Scientific/Microvasive brand Biliary Stent Kit, 7 FR x 5 cm, sterile, single use only; Ref 3101.

    Reason

    Mislabeled as to length; 10 cm length labeled as 5 cm.

    Action

    Consignees were notified via recall letter dated June 18, 2004. Consignees were instructed to call the firm if they had any product in stock.

    Distribution

    California, Hawaii, Kentucky, New Jersey and Oregon.