Events

Retiro De Equipo (Recall) de Device Recall LeMaitre Vascular AnastoClip AC Closure System

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 LeMaitre Vascular, 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
    74563
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2284-2016
  • Fecha de inicio del evento
    2016-06-22
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147906
  • 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
    Clip, implantable - Product Code FZP
  • Causa
    Us marketing brochure for the anastoclip ac closure system states that the anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use.
  • Acción
    The firm, LeMaitre Vascular, Inc., sent an "URGENT: Medical Device Correction" letter dated June 20, 2016 to its distributors and hospitals via Priority mail. The letter describes the product, problem and actions to be taken. The customers were informed of the intended use of the devices and the correct catalog numbers to order for the dura application. The customers were instructed to return unused devices for an exchange or refund; destroy any Anastoclip related marketing materials that you have received from Lemaitre between October 25- 2015 and June 15, 2016, and complete and return the reply form for reconciliation of this recall via fax at 781-221-2223, email: CSUS@LEMAITRE.COM or by mail. LeMaitre Vascular, Inc. will replace any affected device with a new device labeled for dura closure or issue a credit per request. Questions concerning this safety notice, please contact me at 781-221-2266 ext. 183.

Device

Device Recall LeMaitre Vascular AnastoClip AC Closure System
  • Modelo / Serial
    Lot Numbers: ANC1549¿ ANC1612¿ ANC1678¿ ANC1679¿ ANC1682¿ ANC2001¿ ANC2008¿ ANC2009¿ ANC2013¿ ANC2015¿ ANC2016¿ ANC2017¿ ANC2018¿ ANC2019¿ ANC2020¿ ANC2021¿
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    AnastoClip AC 8cm 35 Clips (1 Each} Large || REF # 4000-07 || The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an accessory to the Anastoclip AC Clip Applier.
  • Manufacturer
    LeMaitre Vascular, Inc.

Manufacturer

LeMaitre Vascular, Inc.
  • Dirección del fabricante
    LeMaitre Vascular, Inc., 63 2nd Ave, Burlington MA 01803-4413
  • Empresa matriz del fabricante (2017)
    LeMaitre Vascular, Inc.
  • Source
    USFDA