BEUDAMED
    FDA Enforcement Class II Terminated

    Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it.

    Recall: Z-1828-2015 · Reported July 1, 2015

    Enforcement

    Recall Number
    Z-1828-2015
    Event ID
    71196
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Terumo Cardiovascular Systems Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    July 1, 2015
    Initiation Date
    May 6, 2015
    Classification Date
    June 22, 2015
    Termination Date
    July 27, 2015
    Address
    28 Howe St, Ashland, MA, 01721-1305, United States

    Description

    Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it.

    Reason

    The Overpressure Safety Valve is not cleared with an indication for use on the arterial side of the extracoporeal bypass circuit. It is intended for use only on the venous side. There is a remote possibility of minimal blood loss, fluid weeping, or dripping on the user.

    Code Info

    Part Number: 66086-01: Lot Numbers: RG09, RM20 and Part Number: 70700-03: Lot Numbers: QL09, RH07, RL15, QG17, RD03

    Distribution

    Distributed to the states of MO and FL.

    Quantity

    163 devices