BEUDAMED
    FDA Enforcement Class II Terminated

    Progel Pleural Air Leak Sealant, Model #: PGPS002 Lot #: 111202-002 Product Usage: The Progel Pleural Air Leak Sealant is indicated for application to visceral pleura during an open thoracotomy after standard visceral pleural closure with, for example, sutures or staples, of visible air leaks (;::2mm) incurred during open resection of lung parenchyma.

    Recall: Z-2454-2012 · Reported October 3, 2012

    Enforcement

    Recall Number
    Z-2454-2012
    Event ID
    63156
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Neomend Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 3, 2012
    Initiation Date
    August 13, 2012
    Classification Date
    September 25, 2012
    Termination Date
    September 25, 2012
    Address
    60 Technology Dr, N/A, Irvine, CA, 92618-2301, United States

    Description

    Progel Pleural Air Leak Sealant, Model #: PGPS002 Lot #: 111202-002 Product Usage: The Progel Pleural Air Leak Sealant is indicated for application to visceral pleura during an open thoracotomy after standard visceral pleural closure with, for example, sutures or staples, of visible air leaks (;::2mm) incurred during open resection of lung parenchyma.

    Reason

    Product was distributed with an incorrect expiration date. Product was labeled with an expiration date of 2013-04 and should have been labeled with 2012-09.

    Code Info

    Model #: PGPS002 Lot #: 111202-002

    Distribution

    US Nationwide Distribution

    Quantity

    95 units