Events

Retiro De Equipo (Recall) de Device Recall VASCUGUARD Pheripheral Vascular Patch

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 Synovis Surgical Innovations, 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
    71191
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1637-2015
  • Fecha de inicio del evento
    2015-05-02
  • Fecha de publicación del evento
    2015-05-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-02-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136433
  • 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
    Patch, pledget and intracardiac, petp, ptfe, polypropylene - Product Code DXZ
  • Causa
    Baxter healthcare is recalling specific product codes of vascu-guard peripheral vascular patch due to complaints received for difficulty in distinguishing the smooth from rough surface.
  • Acción
    The firm, Baxter, sent an "Urgent Product Recall" letter dated 5/2/2015 via USPS overnight delivery to its customers. The letter identified the affected product, problem and actions to be taken. The customers were instructed to immediately discontinue use and segregate the affected product, locate and remove all affected product from your facility and to return it to Baxter. Customers are to contact Baxter Healthcare Center, 888-229-0001, for Service to arrange for return and credit. In addition, the customers were to complete and return the Customer Reply Form by faxing to 224-270-5457 or emailing to fca@baxter.com. If you have any questions, contact Director, Quality at 651-796-7543 or email: heidi_drafall@baxter.com.

Device

Device Recall VASCUGUARD Pheripheral Vascular Patch
  • Modelo / Serial
    all lot numbers
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1x6cm, product code 1504026, 0.8x8cm, product code 1504028, 1x10cm, product code 1504030, and 2x9cm, product code 1504032. VASCU-GUARD is packaged between two pieces of foam within a double sterile barrier pouch system. The contents of the unopened, undamaged package are sterile. VASCU-GUARD is intended for use in peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda, and tibial blood vessels and arteriovenous access revisions.
  • Manufacturer
    Synovis Surgical Innovations, Inc.

Manufacturer

Synovis Surgical Innovations, Inc.
  • Dirección del fabricante
    Synovis Surgical Innovations, Inc., 2575 University Ave W, Saint Paul MN 55114-1073
  • Empresa matriz del fabricante (2017)
    Baxter International
  • Source
    USFDA