Events

Retiro De Equipo (Recall) de Hulka Clip

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 Richard Wolf Medical Instruments Corp..

¿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
    53586
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0272-2010
  • Fecha de inicio del evento
    2009-10-16
  • Fecha de publicación del evento
    2009-11-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-03-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85917
  • 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
    tubal occlusion device - Product Code HGB
  • Causa
    The sterile pouch seal may fail to remain intact during handling rendering the hulka clip non-sterile.
  • Acción
    Richard Wolfe sent recall letters dated October 16, 2009 to the direct accounts via certified mail on the same date. The accounts were informed that the lot of Hulka clips did not meet their sterile seal burst test requirements, and that the sterile seal may fail to remain intact during handling, resulting in the clips becoming contaminated or non-sterile. They were instructed to inspect their inventory for the affected lot, quarantine any product found and call Richard Wolf at 800-323-9653, ext 225 or 380 to arrange for the return of the affected product for replacement. The accounts were also requested to complete and return the enclosed response form to Richard Wolf, even if they do not have any of the affected lot in stock.

Device

Hulka Clip
  • Modelo / Serial
    lot number 1391, expiry date 02.2010
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Nationwide
  • Descripción del producto
    Richard Wolf Hulka Clip; for single patient use only; a sterile tubal occluding device; 2 clips per procedure tray/pouch, 10 pouches per shipping carton; Richard Wolf Medical Instruments Corp., Vernon Hills, IL 60061; item 4986.90. || Indicated for use for female sterilization (permanent contraception) by occluding the fallopian tubes
  • Manufacturer
    Richard Wolf Medical Instruments Corp.

Manufacturer

Richard Wolf Medical Instruments Corp.
  • Dirección del fabricante
    Richard Wolf Medical Instruments Corp., 353 Corporate Woods Pkwy, Vernon Hills IL 60061-3110
  • Empresa matriz del fabricante (2017)
    Richard Und Annemarie Wolf Stiftung
  • Source
    USFDA