Events

Recall of Device Recall PadPro MiniInfant Multifunction Electrodes 2602 Series

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

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
    79337
  • Event Risk Class
    Class 2
  • Event Number
    Z-1175-2018
  • Event Initiated Date
    2018-02-23
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162054
  • 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
    Automated external defibrillators (non-wearable) - Product Code MKJ
  • Reason
    Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure.
  • Action
    The firm, ConMed,issued an "URGENT: DEVICE RECALL" notice dated 2/28/2018 and business reply forms to customers on 2/28/2018 via courier service. The notice described the product, problem and actions to be taken. The Customers were instructed to do the following: Step 1: Review your inventory for any of the devices with the lot codes listed on the notice. Customers are encouraged to contact all of those departments within your facility and any other facilities within your organization that may have received affected products. It is imperative that all end users of these devices receive this notice and respond immediately. Step 2a: If you HAVE inventory of any of the devices with the lot codes listed on the notice, complete the business reply form and return it with the devices to: CONMED Corporation 525 French Road Utica, NY 13502 USA Attn: Ed Kovac Step 2b: If you DO NOT HAVE any affected devices to return, please complete the business reply form, indicating you have no devices and return by one of the means listed below: 1. Email to: padpro2602@conmed.com 2. Fax to: Field Action Support Team at 315-624-3225. 3. US mail, using enclosed postage-paid envelope, to: CONMED, 525 French Road, Utica, NY 13502; Attn: Field Action Support Team If you have any questions or requests, please don't hesitate to contact the Field Action Support Team at 1-800-448-6506, fax to 315-624-3225, or email padpro2602@conmed.com.

Device

Device Recall PadPro MiniInfant Multifunction Electrodes 2602 Series
  • Model / Serial
    Lot Numbers: Y01221601, Y03241702, Y10121501, Y020713-17, Y04071501, & Y12021501.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (Nationwide) and countries of: New Zealand, Saudi Arabia, Switzerland, United Arab Emirates Uruguay & Republic of Macedonia (The former Yugoslav Republic of Macedonia).
  • Product Description
    MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog Number 2602H || Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.).
  • Manufacturer
    ConMed Corporation

Manufacturer

ConMed Corporation
  • Manufacturer Address
    ConMed Corporation, 525 French Rd, Utica NY 13502-5945
  • Manufacturer Parent Company (2017)
    CONMED Corp.
  • Source
    USFDA