Events

Recall of Progressive Medical Laparoscopic Electrode PTFE Coated J Hook

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Progressive Medical Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    64931
  • Event Risk Class
    Class 2
  • Event Number
    Z-1360-2013
  • Event Initiated Date
    2013-04-12
  • Event Date Posted
    2013-05-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-05-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117482
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • 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.

Device

Progressive Medical Laparoscopic Electrode PTFE Coated J Hook
  • Model / Serial
    Lot number 082712-09
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated J Hook 33cm Length, Product number P0021, Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. || Electrodes used in Electrosurgeries
  • Manufacturer
    Progressive Medical Inc

Manufacturer

Progressive Medical Inc
  • Manufacturer Address
    Progressive Medical Inc, 997 Horan Dr, Fenton MO 63026-2401
  • Manufacturer Parent Company (2017)
    Progressive Medical Inc
  • Source
    USFDA