BEUDAMED
    FDA Recall 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 · Initiated April 12, 2013

    Recall

    Recall Number
    Z-1364-2013
    Event Number
    64931
    Firm
    Progressive Medical Inc
    FEI Number
    3000236238
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Manufacturing material removal
    Initiated
    April 12, 2013
    Posted
    May 22, 2013
    Terminated
    May 7, 2014
    Address
    997 Horan Dr, Fenton, MO, 63026-2401

    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.

    Action

    Progressive Medical Inc. sent an Urgent Medical Device Recall letter dated April 12, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and segregate the affected units prior to return to Progressive Medical, Inc. If product was further distributed customers should notify their accounts of ther ecall and return the products. Customers were asked to complete and return the attached form by fax to 314-961-4535, even if they had no inventory remaining. Customers with questions were instructed to call 1-800-969-6331. For questions regarding this recall call 314-961-5786.

    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.