BEUDAMED
    FDA Enforcement Class II Terminated

    Bard Caliber (CL3030) Inflation Device Product Usage: Inflation Device intended for use during cardiovascular to create and maintain, monitor pressure in the balloon catheter - balloon inflation device for angioplasty procedures

    Recall: Z-0876-2015 · Reported January 7, 2015

    Enforcement

    Recall Number
    Z-0876-2015
    Event ID
    69879
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    PEROUSE MEDICAL
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 7, 2015
    Initiation Date
    October 6, 2014
    Classification Date
    December 29, 2014
    Termination Date
    March 24, 2017
    Address
    ROUTE DU MANOIR, N/A, Ivry Le Temple, N/A, N/A, France

    Description

    Bard Caliber (CL3030) Inflation Device Product Usage: Inflation Device intended for use during cardiovascular to create and maintain, monitor pressure in the balloon catheter - balloon inflation device for angioplasty procedures

    Reason

    Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase may result in an incomplete inflation or delay in procedure

    Code Info

    All lot numbers beginning with Numbers: 1403,1404,1405,1406,1407

    Distribution

    US Nationwide Distribution in the states of AZ and CO.

    Quantity

    24821 units