Events

Retiro De Equipo (Recall) de Pleatman Sac Tissue Removal System

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 Gyrus Acmi, Incorporated.

¿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
    56626
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2436-2010
  • Fecha de inicio del evento
    2010-08-03
  • Fecha de publicación del evento
    2010-09-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-08-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94140
  • 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
    Laparoscope, General & Plastic Surgery - Product Code GCJ
  • Causa
    Gyrus medical, inc. has issued a urgent medical device recall for the gyrus acmi product 004942-903 - pleatman sac¿ tissue removal system, sold as lot 186540fc with an expiration date of 06/2015. as a result of a manufacturing error in the production of the trays used in this lot, it is possible that a crack could form that would compromise the package integrity, and possibly the sterility of th.
  • Acción
    Gyrus Medical, Inc. of Maple Grove, MN issued an Urgent Medical Device Recall drawing attention to a possible package integrity compromise that could affect the product sterility. USA consignees were contacted via telephone on 8/3/10. The firm directed consignees to inspect their stock to confirm if any of the affected lot of product remains in their possession. Use of remaining affected product should cease immediately. Affected products should be return to Gyrus ACMI. For questions or concerns, consignees should contact the firm at (888) 524-7266.

Device

Pleatman Sac Tissue Removal System
  • Modelo / Serial
    lot 186540FC
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    UT, PA, Canada
  • Descripción del producto
    The Gyrus ACMI Pleatman Sac Tissue Removal System facilitates removal of specimens while minimizing contamination of the abdominal cavity or wound tract. The system contains one (1) Sac and one (1) obturator in a sterile, ready -to -use, single- use procedure tray.
  • Manufacturer
    Gyrus Acmi, Incorporated

Manufacturer

Gyrus Acmi, Incorporated
  • Dirección del fabricante
    Gyrus Acmi, Incorporated, 136 Turnpike Road, Southborough MA 01772-2118
  • Empresa matriz del fabricante (2017)
    Olympus Corporation
  • Source
    USFDA