BEUDAMED
    FDA Recall Terminated

    Boston Scientific EndoVive 20Fr (6.7 mm) Safety PEG Kit, Push Method, latex free, sterile, Boston Scientific Corp., Natick, MA; Cat. no./REF 6653, inner pouch UPN M00566530 and outer carton UPN M00566531. The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means.

    Recall: Z-0913-2009 · Initiated December 30, 2008

    Recall

    Recall Number
    Z-0913-2009
    Event Number
    50749
    Firm
    Boston Scientific Corp
    FEI Number
    1828132
    Product Code
    KNT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 30, 2008
    Posted
    January 28, 2009
    Terminated
    October 30, 2009
    Address
    780 Brookside Dr, Spencer, IN, 47460-1080

    Description

    Boston Scientific EndoVive 20Fr (6.7 mm) Safety PEG Kit, Push Method, latex free, sterile, Boston Scientific Corp., Natick, MA; Cat. no./REF 6653, inner pouch UPN M00566530 and outer carton UPN M00566531. The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means.

    Reason

    The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device.

    Action

    Consignees were notified by "Urgent Medical Device Recall" letter dated 12/30/08. The letter described the problem with the product, instructed customers to determine whether they store these products in the outer carton or the inner pouch at their facility, to locate all affected products, and to return them to the firm. For additional information, contact Boston Scientific Corporation at 1-508-683-4678.

    Distribution

    Nationwide.

    Quantity

    2460 of all products