Events

Retiro De Equipo (Recall) de Disposable Bimanual Irrigation and Aspiration Handpiece Set

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
    38120
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0741-2007
  • Fecha de inicio del evento
    2007-04-09
  • Fecha de publicación del evento
    2007-06-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-10-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53023
  • 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 irrigation and aspiration - Product Code KYG
  • Causa
    Plastic shavings are coming from the product handle during irrigation. use of this product may leave plastic shavings in the patient's eyes.
  • Acción
    An April 9, 2007, notification of the recall will be sent to distributors and users. They are requested to notify down to the user (physician) level. Included in the Recall Notification Letter are instructions: "In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by induding a copy of this recall notification letter. This recall should be carried out to the user level. Your assistance is appreciated and necessary to prevent any inconvenience."

Device

Disposable Bimanual Irrigation and Aspiration Handpiece Set
  • Modelo / Serial
    ltem #1720 Bimanual Irrigation/Aspiration Set 20 Gauge: DB0105B, DB0l06A, DB0605F, DB0705J, DB0705J, DB0804B, DB0804B, DB1005A, DB1104H, DB1104I; Item #1720-A Disposable Bimanual Aspiration Handpiece 20g: DB1004I; ltem # 1720-I Disposable Bimanual Irrigation Handpiece 20g: DB0105D, DB0305A, DB0305A, DB0705B, DB0705I, DB1004H; Item #1720-S Disp Bimanual l/A Set 20g Dual Port Smooth: DB0505B, DB0505B, DB0605G, DB0705K, DB1205C
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide, including USA, United Kingdom, Canada, Spain, Turkey, Kuwait, Colombia, Italy, Greece, Australia, Switzerland, South Africa, Germany, Portugal, and France.
  • Descripción del producto
    Disposable Bimanuals Irrigation and Aspiration Handpiece Set: Item #1720 Disposable Bimanuals Irrigation/Aspiration Set 20 Gauge, Dual Port; Item #1720-A - Disposable Bimanual Aspiration Handpiece 20g; Item #1720-I Disposable Bimanuals Irrigation/Aspiration Set 20g, Open End; Item #1720-S Disposable Bimanuals Irrigation/Aspiration Set, 20g, Dual Port, Smooth. For use in cataract surgical procedures.
  • Manufacturer
    Oasis Medical Inc

Manufacturer

Oasis Medical Inc
  • Dirección del fabricante
    Oasis Medical Inc, 510-528 South Vermont Ave, Glendora CA 91741
  • Source
    USFDA