Events

Retiro De Equipo (Recall) de RochesterPean Hemostatic Forceps 61/4, Curved, Sterile.

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 Integra York PA, 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
    75710
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0751-2017
  • Fecha de inicio del evento
    2016-10-28
  • Fecha de publicación del evento
    2016-12-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-04-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151083
  • 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
    Forceps, general & plastic surgery - Product Code GEN
  • Causa
    The chevron seals of 6x10 tyvek peel pouch used to package the sterile instruments may separate causing the packages to open and compromise sterility of the instrument.
  • Acción
    The firm, Integra, mailed an "URGENT MEDICAL DEVICE RECALL NOTICE" dated October 26, 2016 to customers affected by the recall to notify them of the issue. The notice described the product, problem and actions to be taken. The customers were instructed to immediately review their inventory to determine if they had any of the recalled product on hand and to discontinue distributing the product; review your customer traceability records for shipment of the product and forward a copy of this Recall Notice to any of your customers that purchased the affected lots; complete and return the Acknowledgement Form that accompanied the notice (even if you do not have any product(s)) by email to: FCA3@integralife.com or fax to: 1-609-750-4220. Should you have any questions regarding these instructions, please contact Customer Service at 1-866-854-8300.

Device

RochesterPean Hemostatic Forceps 61/4, Curved, Sterile.
  • Modelo / Serial
    Catalog # ST7-138; lot# 352
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution in NC and TX.
  • Descripción del producto
    Rochester-Pean Hemostatic Forceps 61/4, Curved, Sterile. || The Rochester-Pean Hemostatic Forceps 61/4 Curved are single-use sterile surgical instruments intended for cutting and grasping tissue in general surgical procedures.
  • Manufacturer
    Integra York PA, Inc

Manufacturer

Integra York PA, Inc