Events

Retiro De Equipo (Recall) de Device Recall MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE

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
    65255
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1439-2013
  • Fecha de inicio del evento
    2013-05-24
  • Fecha de publicación del evento
    2013-05-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-05-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118384
  • 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
    Instrument, ent manual surgical - Product Code LRC
  • Causa
    Lack of sterility assurance.
  • Acción
    Cyrus ACMI notified their direct accounts of the recall by Priority Mail with delivery confirmation on May 24, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their inventory and immediately cease any further use of any affected product they may have, remove it from inventory, and quarantine it until they ship it back to the firm. For questions customers were instructed to contact their Olympus customer service representative at 1-800-848-9024 to obtain a Returned Goods Authorization so that they may return the product with no charge to them. Customers were asked to note on the enclosed questionnaire that they have received this information and fax it to 484-896-7128. For questions regarding this recall call 508-804-2739.

Device

Device Recall MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE
  • Modelo / Serial
    JC477666
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and countries of: Canada and United Kingdom.
  • Descripción del producto
    GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, Rx only, STERILE EO, GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104 || Disposable myringotomy knife intended to perforate the tympanic membrane to allow the placement of a bent tube or to directly provide ventilation or drainage of the middle ear.
  • 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