Events

Retiro De Equipo (Recall) de Device Recall dynarex Specimen Containers

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 Dynarex Corporation.

¿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
    73584
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2057-2016
  • Fecha de inicio del evento
    2016-03-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144534
  • 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
    Container, specimen, non-sterile - Product Code NNI
  • Causa
    Exterior carton is mis-labeled as sterile. non-sterile, bulk specimen containers were packed in incorrect exterior carton.
  • Acción
    On March 2, 2016, dynarex Corporate Headquarters distributed Voluntary Device Recall notices and Recall Verification Forms to their customers via email. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to examine their stock immediately to determine if they have any of the lots listed on hand. If so, discontinue distributing and quarantine the product immediately. Promptly contact the Dynarex Credit & Return representative Avi Celnick (845-365-8200 Ext 6644) to arrange for product return. Customers account will be credited for all returned products. All customers are advised to complete the Voluntary Recall Verification Form and returm immediately via fax or e-mail to Vijay Sachdev (Fax 845-365-8238; v.sachdev@dynarex.com).

Device

Device Recall dynarex Specimen Containers
  • Modelo / Serial
    Lot Numbers: 31899, 32014, 32015, 32410 & 32411
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Nationwide in the states of AL, AR, FL, GA, MA, NC, NY, NJ, NH, PA, OH, TX & VA; International: Canada
  • Descripción del producto
    dynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal, Sterile, Single Use Only || Product Usage:containers for sample collection
  • Manufacturer
    Dynarex Corporation

Manufacturer

Dynarex Corporation
  • Dirección del fabricante
    Dynarex Corporation, 10 Glenshaw St, Orangeburg NY 10962-1207
  • Empresa matriz del fabricante (2017)
    Dynarex Corporation
  • Source
    USFDA