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 Bioscience.

¿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
    55825
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1948-2010
  • Fecha de inicio del evento
    2010-01-14
  • Fecha de publicación del evento
    2010-07-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-12-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91968
  • 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
    Polymerizing Sealant - Product Code NBE
  • Causa
    The recall is being conducted as a precautionary measure due to out of specification results at the 18 month and 21 month time points (out of the 24 month licensed shelf life to expiration) for the percent thiol substitution during a coseal stability study. the parameter that is out of specification is an indicator of possible failure for the product to gel appropriately.
  • Acción
    The recall notification was initiated on January 14, 2010 with the firm sending a Product Recall letter and attached Customer Reply Form to the affected consignees. The recall letter informed the consignees of the reason for recall and requested them to immediately stop the usage/distribution of the lots noted above and to quarantine any units you may still have in your inventory. The letter provided instruction for product return. The letter also requested the consignees to please forward the recall information as appropriate to other services/facilities/departments that they may have provided this product to. Consignees were instructed to complete the Customer Reply Form, and fax it as soon as possible to 888-345-4261. Consignees with questions were instructed to contact Stericycle at 877-870-4486.

Device

Device Recall Coseal Surgical Sealant
  • Modelo / Serial
    Lot Numbers: HA080828, HA080841, HA081101, HA081216,  HA081217, HA090113, HA090225, HA090226, & HA090427.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Coseal Surgical Sealant 2mL, Product Codes: 934070 & 934073. || Indicated for use in vascular reconstructions to achieve adjunctive hemostasis.
  • Manufacturer
    Baxter Bioscience

Manufacturer

Baxter Bioscience
  • Dirección del fabricante
    Baxter Bioscience, 1 Baxter Way, Westlake Village CA 91362-3811
  • Empresa matriz del fabricante (2017)
    Baxter International
  • Source
    USFDA