Retiro De Equipo (Recall) de Device Recall Bovie Precise 360 Handpiece

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 Bovie Medical Corporation.

¿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
    74790
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2647-2016
  • Fecha de inicio del evento
    2016-07-18
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2016-12-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Causa
    The adhesive may be inadequately applied or the assembly may be manipulated after application of the adhesive resulting in an incomplete bond to the angled tip.
  • Acción
    Consignees were notified by written recall notice sent via certified mail or courier on July 18, 2016 to quarantine their inventory of the Precise 360 Handpiece, identify and contact their customers that have received the affected product and provide the a copy of the attached field safety notice. Customers are requested to return affected product, and return all affected product currently in their possession. All customer inventory should be reviewed, discontinue use, and return all Bovie Precise 360 handpieces to: Quality Assurance Department, Bovie Medical Corporation, 5115 Ulmerton Road, Clearwater, Florida 33760, Attn: Precise 360 Recall. Also, please write the authorization number RMA XXXX on the outside of the shipping container and use UPS account number 342562 and return via ground shipping and Fax or email the attached recall return response form to the email or fax indicated on the form as soon as possible and include a copy with the shipment. A completed recall return response form is required even if the customer has no product to return. If you have any questions about this recall or the product affected by the recall, call 727-803-8617.

Device

  • Modelo / Serial
    Lot 0316D and 0516B.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the states of: MD, GA, MO and FL and the country of Finland.
  • Descripción del producto
    BVX-330NR Bovie Precise 360 Handpiece 33cm, needle || Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Bovie Medical Corporation, 5115 Ulmerton Rd, Clearwater FL 33760-4004
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA