Events

Retiro De Equipo (Recall) de Device Recall Re Turn

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 Handicare USA, 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
    70995
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1613-2015
  • Fecha de inicio del evento
    2015-03-26
  • Fecha de publicación del evento
    2015-05-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-08-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135822
  • 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
    Aid, transfer - Product Code IKX
  • Causa
    Complaints were received that the heat-welded seam on the wipeable belt's strap tore when force was applied.
  • Acción
    Handicare sent an Voluntary Product Recall Notification letter dated April 2, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were requested to quarantine any remaining stock and to contact customers if product was further distributed and to return the affected product for a replacement and/or full refund. Also, enclosed is a response form. Please complete and return the form even if you do not have any product to return. Your Sales representative can assist you in completing this form. This information is essential in order to maintain recall effectiveness information (required by FDA). Thank you for your support. We are committed to re-releasing the wipeable ReTurn belt as soon as we believe that it meets the quality standards that you expect from Handicare. Please contact our Customer Experience team at 1-866-276-5438 if you have any questions regarding the recall or would like assistance with the recall. We regret any inconvenience that this action may cause, but we appreciate your understanding as we take action to ensure patient and customer satisfaction.

Device

Device Recall Re Turn
  • Modelo / Serial
    All affected product in the U.S are from the same LOT #1402S, Model #s 6133-6136
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution to the states of : FL, CA, NJ, NC and MD.
  • Descripción del producto
    ReTurn belt, wipeable, sizes Small through Extra Large, Plastic pouch, 1 item per pouch. Patient transfer aid.
  • Manufacturer
    Handicare USA, Inc.

Manufacturer

Handicare USA, Inc.
  • Dirección del fabricante
    Handicare USA, Inc., 2201 Hangar Pl, Ste 200, Allentown PA 18109-9342
  • Empresa matriz del fabricante (2017)
    Handicare Group Ab
  • Source
    USFDA