Events

Retiro De Equipo (Recall) de LeMaitre

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
    72534
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0379-2016
  • Fecha de inicio del evento
    2015-10-21
  • Fecha de publicación del evento
    2015-12-04
  • 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=141776
  • 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
    Catheter, embolectomy - Product Code DXE
  • Causa
    Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
  • Acción
    Consignees were notified of the recall on October 21, 2015 via letter. Consignees were asked to do the following: Identify all catheters with the affected LOT and model numbers in inventory; quarantine all unused catheters from the affected LOTs and record this action in the attached form; send the form via mail, email or fax to Customer Service who will then issue an RMA-number (Return Merchandise Authorization number) for the return shipment and replacement of the products; pass this notice on to all those who need to be aware within your organization and to any organization to which the potentially affected devices have been transferred. For questions concerning this safety notice, please contact Salva Kozin, Quality Assurance Engineer, at 781-221-2266 ext. 183.

Device

LeMaitre
  • Modelo / Serial
    Lot Numbers: OTW3080 OTW3080¿ OTW3081¿ OTW3083¿ OTW3100¿
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution. US nationwide including PUERTO RICO, and Australia, AUSTRIA, BELGIUM, COLOMBIA, COSTA RICA, Czech Republic, DENMARK, EGYPT, FRANCE, GERMANY, ICELAND, Italy, JAPAN, JORDAN, Latvia, LUXEMBOURG, MOROCCO, NETHERLANDS, Norway, Oman, PERU, PORTUGAL, Poland, Slovenia, Spain, Switzerland, Sweden, THAILAND, United Kingdom, United Arab Emirates, and VIETNAM.
  • Descripción del producto
    LeMaitre Over-the-Wire Embolectomy Catheter 3F, 80cm, Model 1651-38. || Indicated for the removal of arterial emboli and thrombi.
  • 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