BEUDAMED
    FDA Enforcement Class II Terminated

    Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Push Button Pencil With PTFE Blade and Holster, Product number P0035H Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Rx Only Electrodes used in Electrosurgeries

    Recall: Z-1364-2013 · Reported May 29, 2013

    Enforcement

    Recall Number
    Z-1364-2013
    Event ID
    64931
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Progressive Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 29, 2013
    Initiation Date
    April 12, 2013
    Classification Date
    May 22, 2013
    Termination Date
    May 7, 2014
    Address
    997 Horan Dr, N/A, Fenton, MO, 63026-2401, United States

    Description

    Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Push Button Pencil With PTFE Blade and Holster, Product number P0035H Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Rx Only Electrodes used in Electrosurgeries

    Reason

    Product coatings require 510K approval.

    Code Info

    Lot number 082712-12

    Distribution

    Nationwide Distribution including AR, AZ, CA, CO, FL, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, NE, OH, OK, OR, TN, TX, WA, and WI.

    Quantity

    11 boxes with 25 units each.