BEUDAMED
    FDA Enforcement Class II 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 · Reported January 13, 2016

    Enforcement

    Recall Number
    Z-0595-2016
    Event ID
    72851
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Benlan, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 13, 2016
    Initiation Date
    December 11, 2015
    Classification Date
    January 6, 2016
    Termination Date
    October 31, 2016
    Address
    2760 Brighton Road, N/A, Oakville, N/A, N/A, 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.

    Code Info

    Lots 114842, 116433 & 118251

    Distribution

    Worldwide Distribution - US including GA & Internationally to Canada.

    Quantity

    120 units