BEUDAMED
    FDA Enforcement Class II Terminated

    Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamaged pouch, Cotton Tip - X-Ray Detectable, 1 Pc/Pouch, 10 Pouches/Box, 20 boxes/case. Product Usage: The product is used for pushing tissue from the incision or wound during medical procedures. Per the IFU, the indications for use are for gynecological laparoscopy, laparoscopic cholecystectomy, and other laparoscopic procedures.

    Recall: Z-0159-2013 · Reported November 7, 2012

    Enforcement

    Recall Number
    Z-0159-2013
    Event ID
    62386
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Progressive Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 7, 2012
    Initiation Date
    October 28, 2011
    Classification Date
    October 26, 2012
    Termination Date
    October 26, 2012
    Address
    11085 Gravois Industrial Ct, N/A, Saint Louis, MO, 63128-2012, United States

    Description

    Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamaged pouch, Cotton Tip - X-Ray Detectable, 1 Pc/Pouch, 10 Pouches/Box, 20 boxes/case. Product Usage: The product is used for pushing tissue from the incision or wound during medical procedures. Per the IFU, the indications for use are for gynecological laparoscopy, laparoscopic cholecystectomy, and other laparoscopic procedures.

    Reason

    The tip of the product could come loose or unravel.

    Code Info

    Lot 1104-01

    Distribution

    US Nationwide Distribution in the states of: CO, IL, IN, KS, LA, MA, MN, MO, NE, OH, OK, TN, TX, VA, and WI.

    Quantity

    124 boxes