Events

Retiro De Equipo (Recall) de Expect Endoscopic Ultrasound Aspiration Needle

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 Boston Scientific 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
    59743
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-3215-2011
  • Fecha de inicio del evento
    2011-08-11
  • Fecha de publicación del evento
    2011-09-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-11-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103539
  • 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
    Kit needle biospy - Product Code FCG
  • Causa
    The firm has determined that a single lot of 25 ga expect eus/fna devices were mislabeled. the carton label incorrectly described the devices as 22 ga. the inner pouch label incorrectly describes the device as 25 ga.
  • Acción
    Boston Scientific Corporation sent a "URGENT MEDICAL DEVICE RECALL letter dated August 11, 2010, to all affected customers. The letter identified the product, the problem and the action needed to be taken by customer. Customers were instructed to immediately remove the affected lot of Recall products from your inventory ( whether in Labs, Central Supply, Shipping and Receiving or any other location). Also, segregate this product in a secure location for return to Boston Scientific. Complete and return the Reply Verification Tracking Form ( even if you do not have any product to return) following the directions on this page and Reply Verification Tracking Form. Fax the Form to (508) 683-5578. Further questions please call (508) 683-4678.

Device

Expect Endoscopic Ultrasound Aspiration Needle
  • Modelo / Serial
    Lot: 13615651C1; UPN M00550020
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including the states of VT, FL, SC, NC, WA, MA, and MN.
  • Descripción del producto
    Boston Scientific 25ga (0.52mm) Expect Endoscopic Ultrasound Aspiration Needle REF 5002 Use By 1999-12 LOT 13615651C1 STERILE EO || The Expect Needle is designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Dirección del fabricante
    Boston Scientific Corporation, 100 Boston Scientific Way, Marlborough MA 01752-1234
  • Empresa matriz del fabricante (2017)
    Boston Scientific
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA