Events

Retiro De Equipo (Recall) de Device Recall Vaxcel Implantable Vascular Access 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 Boston Scientific 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
    37427
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0745-2007
  • Fecha de inicio del evento
    2006-06-13
  • Fecha de publicación del evento
    2007-04-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-04-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50537
  • 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
    Implantable Vascular Access System - Product Code LJT
  • Causa
    Mispackaging: some kits of peelable sheaths/dilators may contain a 10f sheath instead of a 9f sheath--(recalling firm was notified by supplier b. braun medical of the error).
  • Acción
    Boston Scientific sent Urgent Medical Device Recall Notification- Immediate Action Required letters- (dated 6/13/06) to all 11 end users via Federal Express. The letters informed the end users that some of the peelable sheaths/dilators in the Vaxcel Implantable Vascular Access kits may incorrectly contain 10F sheaths instead of 9F sheaths which had been supplied by B. Braun Medical Inc. Improper sizing of the sheath for the catheter may result in difficulty /inability to insert the catheters. The letters instructed the end users to immediately remove the affected lots from inventory, segregate the recalled product, contact Boston Scientific at 1-800-862-1284 to obtain a Return Authorization (RGA) number, pack the product in an appropriate shipping carton, affix the shipping label to the outside of the shipping carton, write the RGA number on the outside of the shipping carton, and to return the recalled product to Boston Scientific''s Distribution Center Attn: QA Returns, 500 Commander Shea Blvd., Quincy, MA 02171. Accompanying each letter was a Reply Verification Tracking Form to be completed by the end user and mailed or faxed to Boston Scientific even if the user did not have the recalled lots on hand.

Device

Device Recall Vaxcel Implantable Vascular Access System
  • Modelo / Serial
    Lots 1103350 and 1113798
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    NY, CA, MD, WA, TN.
  • Descripción del producto
    Vaxcel Implantable Vascular Access System -Titanium Standard Port With 9F Polyurethane Catheter, Catalog/REF No. 45-315, UPN/Material No. M001453150, Single Use Only, STERILE, EO. Boston Scientific MEDI-TECH, (617) 972-4000/(800) 225-3238, 480 Pleasant Street, Watertown, MA 02472 --- The port is provided as a kit, with various single use, disposable items necessary for achieving vascular access and implanting the port catheter. Each kit is provided in a plastic (PETG) tray with a heat-sealed tyvek lid. This inner tray is then placed in a second outer plastic (PETG) tray, along with the Directions for Use, and also sealed with a tyvek lid which is then labeled. The port kit is placed in a cardboard carton, with additional labels and sealed.
  • Manufacturer
    Boston Scientific Corp

Manufacturer

Boston Scientific Corp
  • Dirección del fabricante
    Boston Scientific Corp, 10 Glens Falls Tech Park, Glens Falls NY 12801-3864
  • Source
    USFDA