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. Exclusively Distributed in the U.S. Market by: Progressive Medical, Inc., St. Louis, MO, Made in China. 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-0276-2013 · Reported November 21, 2012

    Enforcement

    Recall Number
    Z-0276-2013
    Event ID
    63445
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Progressive Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    November 21, 2012
    Initiation Date
    December 9, 2011
    Classification Date
    November 14, 2012
    Termination Date
    November 14, 2012
    Address
    11085 Gravois Industrial Ct, 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. Exclusively Distributed in the U.S. Market by: Progressive Medical, Inc., St. Louis, MO, Made in China. 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

    Some of the sterile packages had broken seals.

    Code Info

    Lot 1108-01

    Distribution

    USA (nationwide) including the states of CO, IN, KS, MA, MN, MO, NE, OH, SC, TN, TX, VA, and WI.

    Quantity

    70 boxes