Events

Retiro De Equipo (Recall) de Gyrus ACMI Disposable FalopeRing Band Applicator Kits

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
    69584
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0419-2015
  • Fecha de inicio del evento
    2014-10-21
  • Fecha de publicación del evento
    2015-06-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130993
  • 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
    Device, occlusion, tubal, contraceptive - Product Code KNH
  • Causa
    All packages of falope ring band applicator kits are being recalled due to compromises in sterile packaging that could be associated with bacterial contamination that might lead to patient infection.
  • Acción
    Olympus sent an Urgent Medical Device Recall letter dated October 21, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Olympus requires you to take the following action: I. Immediately cease any further use of any affected product you have, remove it from your inventory and quarantine it until it is shipped back to us. 2. Call your Olympus customer service representative at 1-888-524-7266 to obtain a Returned Goods Authorization so that you may return the product with no charge to you. Olympus will issue a credit t or replacement to your facility y for any returned product. 3. Please note on the enclosed questionnaire that you have received this information. 4. Fax the completed questionnaire to 484-896-7128 regardless of whether you have any affected inventory at your facility. ln addition, if you may have further distributed this product, please identify your customers, notify them at once of this product recall, and appropriately document your notification process. Your notification to your customers may be enhanced by including a copy of this recall notification letter.

Device

Gyrus ACMI Disposable FalopeRing Band Applicator Kits
  • Modelo / Serial
    All lots
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution. US Nationwide, Canada, Vietnam, and Europe
  • Descripción del producto
    Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Single Use Only. The disposable Falope-Ring Band Applicator is a sterile, two-band, dual-incision instrument. The two-band applicator enables the physician to occlude both Fallopian tubes without removing the applicator from the abdominal cavity. The Falope-Ring Band and Applicator Kits are indicated for use for female sterilization (permanent contraception).
  • 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