Events

Retiro De Equipo (Recall) de AngioSeal Evolution

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 Terumo Medical 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
    80242
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2337-2018
  • Fecha de inicio del evento
    2018-04-09
  • 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=164942
  • 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
    Device, hemostasis, vascular - Product Code MGB
  • Causa
    Two lots of product were released for distribution prior to the completion of all required validation and lot acceptance activities. although sterile, products from these lots may not function as intended and therefore should not be used.
  • Acción
    On April 9, 2018, the firm sent Urgent Voluntary Medical Device Recall letters and Inventory Confirmation Forms to customers via FedEx. The letter described the product issue. Customers were asked to: 1. Review your Angio-Seal Evolution inventory immediately to identify and isolate affected inventory in order to prevent future use. 2. Your Terumo Territory Manager will visit your facility to confirm product inventory and assist you in completing the enclosed Recall Acknowledgement/ Inventory Confirmation Form. This required documentation, along with the enclosed Fed-Ex product shipment labels will facilitate your return of affected Angio-Seal Evolution product to Terumo Medical Corporation.

Device

AngioSeal Evolution
  • Modelo / Serial
    5980075, 5980077
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Distributed to accounts in AL, CA, FL, IA, IN, MI, MO, NC, NY, SD, TN, and TX.
  • Descripción del producto
    Angio-Seal Evolution Vascular Closure Device, Cat. No. C610135
  • Manufacturer
    Terumo Medical Corp

Manufacturer

Terumo Medical Corp
  • Dirección del fabricante
    Terumo Medical Corp, 2101 Cottontail Ln, Somerset NJ 08873-1277
  • Empresa matriz del fabricante (2017)
    Terumo Corp.
  • Source
    USFDA