Events

Retiro De Equipo (Recall) de Device Recall Medline Industries Inc.

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 Medline Industries 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
    71720
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2433-2015
  • Fecha de inicio del evento
    2015-07-08
  • Fecha de publicación del evento
    2015-08-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-11-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138826
  • 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
    Razor, surgical - Product Code LWK
  • Causa
    Charging base of surgical clippers overheats and smokes.
  • Acción
    Medline Industries sent a " Urgent Remedial Action Destruction Form " letter via first class dated July 9, 2015, to all affected customers.The letter identified the product the problem and the action needed to be taken by the customer. ***URGENT RECALL IMMEDIATE ACTION REQUIRED SURGICAL CLIPPER CHARGER BASE DYND70800 *** Medline Industries, Inc. is recalling specific lots of the Medline Surgical Clippers Charger Base (base only). This recall is being conducted due to a potential defective component on the circuit board causing the charger base to overheat which could result in a charger base malfunction. These lots were distributed October 2013 through March 2015. After further investigation we have determined the root cause to be a defective circuit board. This defect has since been corrected. REQUIRED ACTION: 1. Immediately check your stock for item number DYND70800 and the affected lots listed on the destruction form, dispose of the affected charger base only (do not dispose of the clipper). 2. Please return the completed enclosed destruction form listing the quantity of affected charger base(s) you destroyed. Even if you do not have any affected product please complete and return the form, as indicated on the destruction form. When we receive your completed destruction form we will send you replacement charger base(s). 3. If you are a distributor, promptly notify any of your customers that may have received affected product. If you have any questions, please contact 866-359-1704. As the distributor of this product, we sincerely regret the inconvenience. We, like you, place the health and safety of your patients first and foremost. This recall is being made with the knowledge of the U.S. Food and Drug Administration.

Device

Device Recall Medline Industries Inc.
  • Modelo / Serial
    Product item number: DYND70800 with Lot Numbers: 13F1, 13KD, 14A1, 14C1, and Lot 1.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) Distribution including Puerto Rico and to the countries of : United Arab Emirates, Barbados, Bahamas, Chile, Costa Rica, Italy, Lebanon, and Singapore.
  • Descripción del producto
    Medline Electrical Clipper with Charging base || The Electrical Surgical Clipper is intended for the removal of body hair from patients as required prior to surgery or other minor procedures.
  • Manufacturer
    Medline Industries Inc

Manufacturer

Medline Industries Inc
  • Dirección del fabricante
    Medline Industries Inc, 1 Medline Pl, Mundelein IL 60060-4485
  • Empresa matriz del fabricante (2017)
    Medline Industries Inc.
  • Source
    USFDA