Events

Retiro De Equipo (Recall) de Device Recall INSTAT

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 Integra LifeSciences Corporation.

¿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
    64778
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1288-2013
  • Fecha de inicio del evento
    2013-03-28
  • Fecha de publicación del evento
    2013-05-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-06-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117045
  • 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
    Agent, absorbable hemostatic, collagen based - Product Code LMF
  • Causa
    Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
  • Acción
    The firm, Integra, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated April 9, 2013, to all US, Canada, and non-EU Integra consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to verify if they have any lots of the listed product, if so, STOP using that product; remove the product from service; and promptly complete and return the PRODUCT RECALL RETURN ACKNOWLEDGMENT FORM via Email: FCA@integralife.com or FAX to : 1-609-275-9445. Customer Service department will contact you to return and replace the product. "However, if you have already implanted or used collagen sponge products affected by this recall, we recommend you monitor the patient for a fever in the immediate postoperative period according to the standard hospital or clinician protocol." For assistance or any other questions that you may have, please contact Customer Service at 1-855-532-1723.

Device

Device Recall INSTAT
  • Modelo / Serial
    1105177, 1105178 1110143, 1110227 1110228, 1110229 1110230, 1110233 1110786, 1110787 1111356, 1105179 111023 1, 1110232 1110785
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.
  • Descripción del producto
    INSTAT - Agent, Absorbable Hemostatic, Collagen Based || INSTAT MCH is recommended for use in surgical procedures (other than Urological and Ophthalmological surgery) as an adjunct to hemostatis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
  • Manufacturer
    Integra LifeSciences Corporation

Manufacturer

Integra LifeSciences Corporation