BEUDAMED
    FDA Enforcement Class II Terminated

    Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and monitor pressure in the balloon catheter.

    Recall: Z-2089-2014 · Reported July 30, 2014

    Enforcement

    Recall Number
    Z-2089-2014
    Event ID
    68795
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Perouse Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 30, 2014
    Initiation Date
    May 10, 2012
    Classification Date
    July 22, 2014
    Termination Date
    September 9, 2014
    Address
    135, Route Neuve, Irigny, N/A, France

    Description

    Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and monitor pressure in the balloon catheter.

    Reason

    Perouse Medical in France initiated a voluntary recall of certain batches of Perouse FLAMINGO Inflations Devices due to a potential water-tightness default. The potential default could cause an air entry when the plunger is positioned around 20 mL.

    Code Info

    Model 0218TA and 0218TB. Manufacturing Lot Numbers: 12031275 and 12031242. EXP.: 02/2017. Batches: 12031526, 12031249, 12031527, 12031248, 12041183, 12041186, 12031244, 12031461, 12031460, 12021404, 12031462, 12031245, 12021405, 12031405, 12031246, 12021401, 12041344, 12031237, 12031241, 12021403, 12041345, 12041184, 12031497, 12031240, 12021194, 12031524, 12031480, 12041181, 12031275, 12031242, 12021450, 12021449, 12041185, 12031525, 12031247, 12021402, 12021448.

    Distribution

    US.

    Quantity

    2,496 units