BEUDAMED
    FDA Enforcement Class II Terminated

    Tubing Pack Convenience Kit, Product Code 65217 Product Usage: Intended for use only in the extracorporeal circuit of the cardiopulmonary bypass procedures for which the user designed it.

    Recall: Z-2550-2018 · Reported August 1, 2018

    Enforcement

    Recall Number
    Z-2550-2018
    Event ID
    80283
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Terumo Cardiovascular Systems Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    August 1, 2018
    Initiation Date
    May 12, 2017
    Classification Date
    July 26, 2018
    Termination Date
    October 26, 2018
    Address
    28 Howe St, N/A, Ashland, MA, 01721-1305, United States

    Description

    Tubing Pack Convenience Kit, Product Code 65217 Product Usage: Intended for use only in the extracorporeal circuit of the cardiopulmonary bypass procedures for which the user designed it.

    Reason

    Kit was labeled with the incorrect Expiration Date of April 30, 2019.

    Code Info

    Lot Number: VE17

    Distribution

    US state of FL

    Quantity

    30 cases/2 units (Total 60 units)