Events

Retiro De Equipo (Recall) de Device Recall Richard Wolf Medical Instrument Corporation

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
    68777
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0037-2015
  • Fecha de inicio del evento
    2014-07-09
  • Fecha de publicación del evento
    2014-11-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-04-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128639
  • 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
    Device, occlusion, tubal, contraceptive - Product Code KNH
  • Causa
    Richard wolf medical instrument corporation is recalling hulka clip tubal occluding device lot 51000232. the devices are being recalled as a part of an investigation into a biocompatibility test discrepancy where the recalled lot (lot 51000232) passed final release testing, but the subsequent lot failed biocompatibility testing on a component that was also used to manufacture lot 51000232.
  • Acción
    "Urgent: Medical Device Recall" letters dated July 9, 2014 were sent to all direct accounts (customers). The letters included instructions for customers to: 1) inspect their inventories for the recalled products; 2) contact Richard Wolf Medical Instruments at 800-323-9653 x 225 or 380 to notify Richard Wolf Medical Instruments if you have any devices in inventory; 3) review your records and report the number, if any, of Hulka Clips from lot 51000232 that were implanted in your patients on the Recall Response Form; 4) complete and return the Recall Response Form attached to the letter; and, 5) a RMA number will be provided to customers returning the recalled products and those customers will receive a credit. All returned product should be sent to the attention of Ms. Lisa Williams, Regulatory Specialist. Customers with questions can contact Richard Wolf Medical Instruments at 800-323-9653 x 225 or 380.

Device

Device Recall Richard Wolf Medical Instrument Corporation
  • Modelo / Serial
    Product Code: 4986.09;  Lot: 51000232
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution: US (Nationwide) including states of: (AK, AL, CO, CT, FL, GA, IA, IN, KY, LA, MI, MO, MS, NC, NY, OH, OR, PA, SC, TN, TX, VA, WA, WV; and country of: Germany.
  • Descripción del producto
    The Hulka Clip is a sterile packaged medical device that carries a two year expiration date. It is packaged two clips per procedural tray. Theses procedural trays are then sealed in a Tyvek/Mylar pouch and packaged in a cardboard shipping carton with ten pouches in each shipping carton.
  • 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