BEUDAMED
    FDA Recall Terminated

    Boston Scientific Contour VL Injection Stent with Hydro Plus Coating, 6 FR (2.0 mm) x 22-30 cm (220-300mm), sterile, UPN: M0061856300. Ureteral stent.

    Recall: Z-1238-06 · Initiated May 10, 2006

    Recall

    Recall Number
    Z-1238-06
    Event Number
    35494
    Firm
    Boston Scientific Corp
    FEI Number
    1828132
    Product Code
    FAD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 10, 2006
    Posted
    July 13, 2006
    Terminated
    November 1, 2006
    Address
    780 Brookside Dr, Spencer, IN, 47460-1080

    Description

    Boston Scientific Contour VL Injection Stent with Hydro Plus Coating, 6 FR (2.0 mm) x 22-30 cm (220-300mm), sterile, UPN: M0061856300. Ureteral stent.

    Reason

    Instructions on how to inject are not included in the package.

    Action

    A letter dated 5/10/06 was sent to each consignee requesting that they discontinue use of, and return, the product.

    Distribution

    New York and Pennsylvania.

    Quantity

    29