BEUDAMED
    FDA Recall Terminated

    MED-RX Single Use REF 54-3680R, 8 FR. x 36" (91CM) Polyurethane Feeding Tube For Pediatric Use with Orange Radiopaque Stripe and Enteral Connector, Made in Canada, Benton, Oakville, Ontario, Canada

    Recall: Z-0595-2016 · Initiated December 11, 2015

    Recall

    Recall Number
    Z-0595-2016
    Event Number
    72851
    Firm
    Benlan, Inc.
    FEI Number
    3932
    Product Code
    FPD
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    December 11, 2015
    Terminated
    October 31, 2016
    Address
    2760 Brighton Road, Oakville Canada

    Description

    MED-RX Single Use REF 54-3680R, 8 FR. x 36" (91CM) Polyurethane Feeding Tube For Pediatric Use with Orange Radiopaque Stripe and Enteral Connector, Made in Canada, Benton, Oakville, Ontario, Canada

    Reason

    The product may be packaged with a 5 or 6.5FR tube instead of an 8FR size.

    Action

    Benlan, Inc. sent a Product Recall Notification letter dated December 11, 2015, to all affected customers. Customers were asked to examine their stock and to discontinue/use of the product and return product. The letter included a response form which was to be returned via fax to 905-825-9600. Customers with questions were instructed to call 905-825-9300.

    Distribution

    Worldwide Distribution - US including GA & Internationally to Canada.

    Quantity

    120 units