Events

Retiro De Equipo (Recall) de Device Recall Universal Quick Adjust

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 Medical Depot Inc..

¿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
    73918
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2104-2016
  • Fecha de inicio del evento
    2016-02-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-06-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145416
  • 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
    Tips and pads, cane, crutch and walker - Product Code INP
  • Causa
    Tip crutch failure involving the bottom of the metal portion which comes in contact with ground.
  • Acción
    On February 17, 2016, drive DeVilbiss Healthcare issued a preliminary notice their customers informing them of the situation via courier service. Secondly, On February 25, 2016, drive DeVilbiss Healthcare distributed another notice informing customers that the potential issue was confirmed to a limited number of lots. Customers were advised to quarantine all products in inventory as replacement products will be provided. The company notified customers that they will commence shipping orders for the product on Monday, February 29, 2016. Customers were also advised that a substantial inventory of replacement crutch tips for distribution will begin on or about March 7, 2016. On March 11, 2016, drive DeVilbiss distributed a third notice to their customers via courier service advising them of customer reimbursement for time and labor costs associated with this action. Drive Devilbiss Healthcare will reimburse based on the total number of tips requested to be shipped. Lastly, on May 12, 2016, drive DeVilbiss distributed a fourth Urgent Medical Device notice and response form to their customers via email. drive DeVilbiss advised customers to: 1) quarantine any stock that has not been inspected already and compare serial numbers of stocks to list provided, 2) any product received after 3/7/16 has been fully inspected and has an approved crutch tip that is free of defect, 3) if products were further distributed, contact those customers who received product between 7/2015 to 12/2015 and determine if items are still being used, 4) If the customer is still using this item, contact your sales representative so the return and replacement of this product can be processed and 5) complete and return the response form vial email. Customers with questions can contact by telephone 516-998-4600 ext. 4422.

Device

Device Recall Universal Quick Adjust
  • Modelo / Serial
    Item #: 1) RTL 10400, 2) RTL 10402
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Universal Quick Adjust under the following labels: 1) Aluminum crutch, adult, 1 pair per case, 2) Aluminum crutch, tall adult, 1 pair per case || Aid the user in walking while relieving weight from one foot or leg.
  • Manufacturer
    Medical Depot Inc.

Manufacturer

Medical Depot Inc.
  • Dirección del fabricante
    Medical Depot Inc., 99 Seaview Blvd Fl 2, Port Washington NY 11050-4606
  • Empresa matriz del fabricante (2017)
    Medical Depot Inc.
  • Source
    USFDA