Events

Retiro De Equipo (Recall) de Device Recall COSEAL Surgical Sealant

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 Baxter Healthcare 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
    74139
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1840-2016
  • Fecha de inicio del evento
    2016-05-12
  • Fecha de publicación del evento
    2016-05-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146453
  • 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
    Sealant,polymerizing - Product Code NBE
  • Causa
    Potential for incomplete dissolution of the polyethylene glycol (peg) component during the reconstitution of the product, which may affect the consistency of the hydrogel formation during use.
  • Acción
    An Urgent Product Recall letter dated 5/13/16 was sent to customers to inform them that Baxter Healthcare Corporation is issuing a voluntary product recall for the product codes and lots listed below due to the potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of the hydrogel formation during use. The letter provides the customers with the list of affected products, hazards involved, and actions to be taken. Customers with questions regarding the recall communication, are instructed to contact Baxter Product Surveillance at (800) 437-5176, 8-5pm, Monday-Friday.

Device

Device Recall COSEAL Surgical Sealant
  • Modelo / Serial
    HA151038, HA151220, HA151037, HA151028, HA160114, HA160115, HA160222
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Distributed US (nationwide) including Puerto Rico and in the Bahamas, Canada, and Singapore.
  • Descripción del producto
    COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
  • Manufacturer
    Baxter Healthcare Corp

Manufacturer

Baxter Healthcare Corp
  • Dirección del fabricante
    Baxter Healthcare Corp, 21026 Alexander Ct, Hayward CA 94545-1234
  • Empresa matriz del fabricante (2017)
    Baxter International
  • Source
    USFDA