BEUDAMED
    FDA Enforcement Class II Terminated

    Lipofilter 3000, model ASP-CAN-2, labeled in part ***MicroAire, 1641 Edlich Drive, Charlottesville, VA 22911, USA*** Product Usage: A fat collection canister intended for use during liposuction procedures.

    Recall: Z-1792-2012 · Reported June 20, 2012

    Enforcement

    Recall Number
    Z-1792-2012
    Event ID
    61853
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    MicroAire Surgical Instruments, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 20, 2012
    Initiation Date
    April 26, 2012
    Classification Date
    June 8, 2012
    Termination Date
    November 21, 2012
    Address
    1641 Edlich Dr, Charlottesville, VA, 22911-5839, United States

    Description

    Lipofilter 3000, model ASP-CAN-2, labeled in part ***MicroAire, 1641 Edlich Drive, Charlottesville, VA 22911, USA*** Product Usage: A fat collection canister intended for use during liposuction procedures.

    Reason

    Medical device was not manufactured under Good Manufacturing Procedures and a user may be unable to sterilize the device according to procedures.

    Code Info

    Lot Number: 0312200152

    Distribution

    US Nationwide Distribution including the states of CA, OH and NY.

    Quantity

    15 devices