Events

Retiro De Equipo (Recall) de Device Recall ARROWgard Blue PLUS

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 Arrow International 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
    79528
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1152-2018
  • Fecha de inicio del evento
    2017-12-21
  • Fecha de publicación del evento
    2018-03-21
  • Estado del evento
    Open, Classified
  • 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=162585
  • 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
    Catheter,intravascular,therapeutic,short-term less than 30 days - Product Code FOZ
  • Causa
    Certain lots may be missing information at the bottom of the lid including the lot number, expiration date, and unique device identification (udi) information.
  • Acción
    Arrow International sent Notification letters to DISTRIBUTORS that include the following instructions: 1. Discontinue distribution and quarantine any affected products. 2. Inspect affected products to identify whether they have the lot number, expiration date, and UDI information. Products missing this information should be returned. 3. Using the provided Customer Letter and Acknowledgement Form templates, communicate this recall to any customers who have received affected products. Customers should return mislabeled products. Products that are properly labeled should not be returned. 4. Any customers with mislabeled products should return them with a completed Acknowledgement Form. 6. If you and customers have no affected stock please complete and return the Acknowledgment Form. Notification letters to RISK MANAGERS include the following instructions: 1. Discontinue use and quarantine any affected products. 2. Inspect affected products and identify whether they have the lot number, expiration date, and UDI information. Products missing this information should be returned to the Distributor. 3. Complete the Acknowledgement Form whether or not there is affected product that must be returned. For questions contact your local sales representative or Customer Service at 1-866-246-6990.

Device

Device Recall ARROWgard Blue PLUS
  • Modelo / Serial
    Lot Numbers: 23F16H0744, 23F16J0072, 23F17B0781
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    United States in the state of FL.
  • Descripción del producto
    ARROWg+ard Blue PLUS catheter, Catalog Number: ASK-45854-NG || Product Usage: || The ARROWg+ard Blue PLUS¿ catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins. The ARROWg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (> 30 days). Clinical effectiveness of the ARROWg+ard Blue PLUS¿ catheter in preventing CRBSIs compared to the original ARROWg+ard Blue¿ catheter has not been studied.
  • Manufacturer
    Arrow International Inc

Manufacturer

Arrow International Inc
  • Dirección del fabricante
    Arrow International Inc, 2400 Bernville Rd, Reading PA 19605-9607
  • Empresa matriz del fabricante (2017)
    Teleflex Incorporated
  • Source
    USFDA