Retiro De Equipo (Recall) de Device Recall Posey

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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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 - Product Code FMQ
  • Causa
    Failure to restrain: this recall was initiated after a complaint was received by the firm regarding a posey 2217sl unit indicating that a patient was able to pull the rivet or washer through the synthetic leather allowing the patient to have freedom of arm movement. a second complaint was received indicating that a patient was able to tear the strap at the adjustment notch on a posey 221 7sl unit.
  • Acción
    On July 29, 2008 Posey sent a Recall Letter to all affected customers. The recall letters were sent by certified mail with return receipt signature. The recall letter instructed the customers not to distribute or use the affected products. Any existing inventory subject to this recall was requested to be returned to Posey Company. Also, if they were a distributor, they were asked to please additionally forward a copy of the recall notice and reply form to each of their customers to whom you have further distributed the subject product. A Recall Fax Back form was provided with the recall letter for the affected facilities to fax back to inform Posey of their existing inventory. An RMA number was issured to each facility and a return UPS label was provided for any product that will be returned to Posey. Additionally, the sales representatives for each of the customers will be contacted by Posey Customer Service.


  • Modelo / Serial
    Catalog Numbers: 2217SL and 2217B ; Note: All 22l7SL and 2217B units are affected by this recall.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide, USA, Australia, Canada, France & The Netherlands.
  • Descripción del producto
    Posey Synthetic Leather and Biothane Waist and Wrist Restraints, Catalog Numbers: 2217SL and 2217B
  • Manufacturer


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