Events

Retiro De Equipo (Recall) de Device Recall Inrad sample master aspiration biopsy needle

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 Inrad, 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
    57531
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1063-2011
  • Fecha de inicio del evento
    2010-12-20
  • Fecha de publicación del evento
    2011-02-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-02-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96475
  • 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
    Needle, aspiration and injection, disposable - Product Code GAA
  • Causa
    This lot of product has the wrong expiration date on the carton label. the pouches contained the correct expiration date.
  • Acción
    The firm, Inrad Inc., sent an "URGENT FIELD CORRECTION" notice dated December 20, 2010 to its customers. The notice described the product, problem and actions to be taken by the customers. The customers were instructed to immediately examine their inventory for the affected product. If the recalled product was in stock, the customers were told to removed the affected product from the carton and dispose of carton; to disregard carton label expiration date and reference the expiration date appearing on the pouch label only, and to complete, sign and return the attached "Carton Expiration Date" INFORMATION FORM via fax to 616-301-779 or mail to Inrad Inc., ATTN: Director RA/QA, 4375 Donker Court SE, Kentwood, MI 49512. If you have any additional questions about this action, please call 800-558-4647 extension 102.

Device

Device Recall Inrad sample master aspiration biopsy needle
  • Modelo / Serial
    6100-7001.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution: USA including states of: FL, GA, KY, NH, NJ, NM, PA , SC, WA, and WI.
  • Descripción del producto
    Inrad sample master aspiration biopsy needle with hiliter sharp bevel needle, 22 ga x 2 3/8'' (6 cm), model 41222, Inrad, Inc. Kentwood, MI. || The device is intended for use during percutaneous biopsy and drainage procedures to obtain tissues or fluid specimens.
  • Manufacturer
    Inrad, Inc

Manufacturer

Inrad, Inc
  • Dirección del fabricante
    Inrad, Inc, 4375 Donkers Ct Se, Kentwood MI 49512-4054
  • Empresa matriz del fabricante (2017)
    Inrad Inc.
  • Source
    USFDA