Events

Retiro De Equipo (Recall) de Device Recall BHM Reacher for Portable Ceiling Lifts

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 Arjo, 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
    36802
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0482-2007
  • Fecha de inicio del evento
    2006-11-13
  • Fecha de publicación del evento
    2007-01-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-01-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49378
  • 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
    patient lift accessory - Product Code FSA
  • Causa
    The carabineer may not be correctly attached to the reacher and the portable patient lift may drop.
  • Acción
    BHM sent recall letters to Arjo''s direct accounts on 11/13/06 via first class mail, informing them that fastening the carabineer to the exterior of the closed ring portion of the reacher is contrary to the manufacturer''s instructions and is an unsafe practice. The letters informed the users that Health Canada had received notification of an incident involving a reacher marketed by a competitor, and had conducted an investigation into all similar reachers available on the Canadian market. Enclosed with the letter was a copy of the BHM Reacher User''s Guide as well as a warning sticker that visually describes the safe method for connecting the carabineer to the reacher. The accounts were requested to place the warning stickers on their reachers, review the enclosed User''s Guide in detail, and ensure that all personnel using the reacher receive refresher training on its proper use and have access to the supplied User''s Guide. Once these measures have been completed, the account was requested to complete the enclosed response form and return it to BHM by fax, e-mail or mail.

Device

Device Recall BHM Reacher for Portable Ceiling Lifts
  • Modelo / Serial
    Part #700.08310 - 24'' handle length, and part #700.08320 - 36'' handle length, all reachers shipped between November 2003 through November 6, 2006.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide
  • Descripción del producto
    BHM Reacher for Portable Ceiling Lifts; a portable ceiling lift accessory used to connect the lift to the BHM Track or KwikTrak Trolley; Manufactured by BMH Medical Inc., 2001 Tanguay Street , Magog, Quebec, Canada J1X 5Y5. The reacher comes in two models: part #700.08310 - 24'' handle length, and part #700.08320 - 36'' handle length
  • Manufacturer
    Arjo, Inc.

Manufacturer

Arjo, Inc.
  • Dirección del fabricante
    Arjo, Inc., 50 Gary Ave Ste A, Roselle IL 60172-1684
  • Source
    USFDA