Events

Retiro De Equipo (Recall) de VNVD Veronikis Neo Vaginal Dilator Tip/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 Marina Medical Instruments 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
    53501
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1208-2010
  • Fecha de inicio del evento
    2009-04-09
  • Fecha de publicación del evento
    2010-03-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-09-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85660
  • 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
    Dilator, Cervical, Fixed Size - Product Code HDQ
  • Causa
    Marina medical, sunrise, fl initiated recall of 46 products of 350 series devices and 47 products of 270 series products because the material used to manufacture the products was not proven to be biocompatible, resulting in risk of temporary skin or tissue irritation.
  • Acción
    A "PRODUCT RECALL NOTICE" letter dated April 8, 2009, was sent to the customers. The letter describes the product, problem and the action to be taken by the customers. The customers are asked to identify the subject part in their instrument inventory and quarantine it. The Quality Control team at Marina Medical will contact the customer with instructions to return the part. When contacted, the customer should report any incidents of adverse reactions that have been observed at their institution. If you have any questions, please call 1-800-697-1119 ore (954) 924-4418.

Device

VNVD Veronikis Neo Vaginal Dilator Tip/Set
  • Modelo / Serial
    Product No.: 270-100, 270-115, 270-125, 270-135, 270-145, 270-155, 270-165, 270-175, 270-185, 270-195, 270-199.
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution.
  • Descripción del producto
    VNVD Veronikis Neo Vaginal Dilator - Complete Set Catalog No. 270-100, || VNVD Veronikis Neo Vaginal Dilator - 1.5cm Tip:Width:0.625in Catalog No. 270-115 (sold individually), || VNVD Veronikis Neo Vaginal Dilator - 2.5cm Tip:Width:0.625in Catalog No. 270-125 (sold individually), || VNVD Veronikis Neo Vaginal Dilator - 3.5cm Tip:Width:0.625in Catalog No. 270-135 (sold individually), || VNVD Veronikis Neo Vaginal Dilator - 4.5cm Tip:Width:0.625in Catalog No. 270-145 (sold individually), || VNVD Veronikis Neo Vaginal Dilator - 5.5cm Tip:Width:0.625in Catalog No. 270-155 (sold individually), || VNVD Veronikis Neo Vaginal Dilator - Partial Taper Couple: Width:0.625in - 1in Catalog No. 270-165 (sold individually), || VNVD Veronikis Neo Vaginal Dilator - Full Taper Couple: Width:0.625in - 1in Catalog No. 270-175 (sold individually), || VNVD Veronikis Neo Vaginal Dilator - Coupler 3cm Length: Width: 1in Catalog No. 270-185 (sold individually), || VNVD Veronikis Neo Vaginal Dilator - Small Base, Screw Length 2cm Tip: Width: 1in Catalog No. 270-195 (sold individually), || VNVD Veronikis Neo Vaginal Dilator - 1.5cn Tip: Width:0.625in Catalog No. 270-199 (sold individually). || For use in securing open the opening during examination of the vaginal body cavity. For the Non-Surgical Neo Vagina.
  • Manufacturer
    Marina Medical Instruments Inc.

Manufacturer

Marina Medical Instruments Inc.
  • Dirección del fabricante
    Marina Medical Instruments Inc., 955 Shotgun Rd, Sunrise FL 33326-1964
  • Empresa matriz del fabricante (2017)
    Marina Medical Instruments Inc.
  • Source
    USFDA