BEUDAMED
    FDA Recall Terminated

    Boston Scientific/MEDI-TECH brand Fascial Dilator, 8 FR(2.7 mm), sterile, single use only, model M001481541; Catalog No. 48-154.

    Recall: Z-1104-04 · Initiated June 16, 2004

    Recall

    Recall Number
    Z-1104-04
    Event Number
    29476
    Firm
    Boston Scientific Corp
    FEI Number
    1828132
    Product Code
    DRE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 16, 2004
    Posted
    July 20, 2004
    Terminated
    February 11, 2005
    Address
    780 Brookside Dr, Spencer, IN, 47460-1080

    Description

    Boston Scientific/MEDI-TECH brand Fascial Dilator, 8 FR(2.7 mm), sterile, single use only, model M001481541; Catalog No. 48-154.

    Reason

    Labeling mix-up as to product size; 8FR may be labeled 10FR and vice versa.

    Action

    Recall letters dated June 16, 2004 were sent to consignees requesting product return.

    Distribution

    Nationwide and Netherlands.

    Quantity

    1840