Events

Retiro De Equipo (Recall) de Posey Connected TwiceAs Tough Cuffs

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 J T Posey Company.

¿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
    52711
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2268-2009
  • Fecha de inicio del evento
    2009-04-20
  • Fecha de publicación del evento
    2009-09-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83735
  • 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
    Restraint, protective - Product Code FMQ
  • Causa
    Posey has initiated a recall on certain posey product units which were manufactured using an incorrect key lock buckle. the intended use of these products is to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others.
  • Acción
    JT Posey Company issued an "Urgent Medical Device Recall (Removal)" letter dated May 14, 2009 informing customers of the affected products. Any used and/or existing inventory subject to this recall is requested to be returned to Posey including the Recall Reply Fax-Back Form. For further questions, contact your local sales representative or JT Posey Company at 1-800-447-6739 extension 111.

Device

Posey Connected TwiceAs Tough Cuffs
  • Modelo / Serial
    All Product with Catalog Number 2794 manufactured between Ferbruary 2009 and April 2009.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Class II Recall - Worldwide Distribution -- United States, Canada, France, Belgium and the Netherlands.
  • Descripción del producto
    Posey Connected Twice-As Tough Cuffs, Wrists (for use on bed) (2794). || Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others.
  • Manufacturer
    J T Posey Company

Manufacturer

J T Posey Company
  • Dirección del fabricante
    J T Posey Company, 5635 Peck Rd, Arcadia CA 91006
  • Empresa matriz del fabricante (2017)
    Tidi Products Llc
  • Source
    USFDA