Events

Retiro De Equipo (Recall) de Device Recall PadPro MiniInfant Multifunction Electrodes 2602 Series

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por ConMed Corporation.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    79337
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1177-2018
  • Fecha de inicio del evento
    2018-02-23
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162057
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Automated external defibrillators (non-wearable) - Product Code MKJ
  • Causa
    Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure.
  • Acción
    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
  • Modelo / Serial
    Lot Numbers:  Y013114-14 Y04191607 Y061413-09 Y081513-07 Y101212-03 Y020714-08 Y04201507 Y06151504 Y081712-39 Y101413-12 Y021413-09 Y042514-10 Y061914-14 Y082212-13 Y10231528 Y021712-01 Y042712-06 Y06261516 Y08281506 Y10231529 Y030113-12 Y05041703 Y071213-13 Y090313-12 Y110714-08 Y03041604 Y05081508 Y071814-11 Y091914-13 Y112414-04 Y031414-04 Y051414-07 Y07191604 Y09241503 Y112613-03 Y032513-03 Y052914-08 Y072712-03 Y092612-16 Y112912-13 Y032612-05 Y060412-05 Y07271508 Y100212-01 Y11301601 Y040314-07 Y060713-12 Y080113-05 Y100713-02 Y121714-09 Y040813-01 Y06071704 Y081114-05 Y10071602 Y121813-09 Y041712-02
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    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).
  • Descripción del producto
    MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Physio-Control¿ Quik-Combo" Connector, REF/Catalog Number 2602M || 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
  • Dirección del fabricante
    ConMed Corporation, 525 French Rd, Utica NY 13502-5945
  • Empresa matriz del fabricante (2017)
    CONMED Corp.
  • Source
    USFDA