Events

Retiro De Equipo (Recall) de Device Recall PremierEdge MICROSURGICAL KNIFE 2.53.0mm Clear Cornea Knife Trapezoid

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 Oasis Medical Inc.

¿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
    45870
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0500-2008
  • Fecha de inicio del evento
    2007-07-18
  • Fecha de publicación del evento
    2008-01-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-09-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66349
  • 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
    Ophthalmic Knife - Product Code HNN
  • Causa
    Sterility (package integrity) compromised: the device is puncturing the packing during handling. once the packaging is damaged, the product is no longer sterile as labeled. this is an expansion of a previous recall.
  • Acción
    A recall notification, Urgent Medical Device Recall Expansion Letter, dated 7.18.2007, was sent to customers advising the letter is to inform them of a voluntary product recall expansion involving the OASIS Medical Premier Edge Knives. A product label for ease in identifying the product is included. The letter further advises this voluntary recall has been expanded due to the product puncturing the packing during rough handling. Once the packaging is damaged, the product is no longer sterile as labeled. The letter instructs customers to immediately examine their inventory and quarantine product subject to recall. Once the product has been identified, product is to be returned by FedEx to OASIS Medical. The letter further instructs that if the customer has further distributed this product, to identify their customers and notify them at once of this product recall. This recall should be carried out to the user level.

Device

Device Recall PremierEdge MICROSURGICAL KNIFE 2.53.0mm Clear Cornea Knife Trapezoid
  • Modelo / Serial
    Lot No: DK0307AJ
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide: USA, Kuwait, Lebanon, Lithuania, Mexico, Netherlands, Norway, South Africa, Saudi Arabia, Slovakia, Spain, Sweden, Switzwerland, Turkey, United Kingdom, Ecuador, Finland, France, Germany, Greece, Italy, Denmark, Columbia, Chile, Brazil, Belgium, and Australia
  • Descripción del producto
    PremierEdge MICROSURGICAL KNIFE , 2.5-3.0mm Clear Cornea Knife - Trapezoid, Item Code/REF: PE 3302, OASIS Glendora, CA 91741
  • Manufacturer
    Oasis Medical Inc

Manufacturer

Oasis Medical Inc
  • Dirección del fabricante
    Oasis Medical Inc, 514 S Vermont Ave Bldg 510-528, Glendora CA 91741-6205
  • Empresa matriz del fabricante (2017)
    Oasis Medical Inc.
  • Source
    USFDA