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 Services L.P..

¿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
    59861
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1614-2012
  • Fecha de inicio del evento
    2011-07-28
  • Fecha de publicación del evento
    2012-05-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103883
  • 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
    The recall is being conducted as a precautionary measure due to out of specification results observed at the 24 months time point (out of 24-month licensed shelf life to expiration) during a coseal stability study. the parameter that is out specification is an indicator of possible failure for the product to gel appropriately . coseal's failure to gel does not represent risk for the patient's life.
  • Acción
    Baxter Healthcare sent an"URGENT PRODUCT RECALL" letter dated July 27, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to immediately stop the usage/distribution of the affected product and to quarantine any units that are in inventory. Instructions for obtaining replacement product were attached to the letter. Contact the firm at 1-800-423-2090 for questions concerning this recall.

Device

Device Recall Coseal Surgical Sealant.
  • Modelo / Serial
    Lot numbers: (2mL) HA100143, HA091236. (4mL) HA090950, HA090944, HA090843, HA090749, HA090947. (8mL) HA100132, HA100142
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    Coseal Surgical Sealant. || Coseal is an adjunctive surgical sealant.
  • Manufacturer
    Baxter Healthcare Services L.P.

Manufacturer

Baxter Healthcare Services L.P.
  • Dirección del fabricante
    Baxter Healthcare Services L.P., 1 Baxter Pkwy, Building 3, Deerfield IL 60015-4625
  • Empresa matriz del fabricante (2017)
    Baxter International
  • Source
    USFDA