BEUDAMED
    FDA Enforcement Class II Terminated

    CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device Model: CC3-01

    Recall: Z-1513-2015 · Reported April 29, 2015

    Enforcement

    Recall Number
    Z-1513-2015
    Event ID
    70851
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CSA Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 29, 2015
    Initiation Date
    March 25, 2015
    Classification Date
    April 23, 2015
    Termination Date
    August 21, 2015
    Address
    91 Hartwell Ave, Lexington, MA, 02421-3137, United States

    Description

    CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device Model: CC3-01

    Reason

    TruFreeze Console caused a higher rate of liquid nitrogen (cryogen) to be delivered and may cause: stricture,scarring, bradycardia, or pneumothorax

    Code Info

    Serial Numbers: 01-00106 through 01-00201

    Distribution

    Nationwide

    Quantity

    82 units