Events

Retiro De Equipo (Recall) de Device Recall Access Tray

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
    79512
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1332-2018
  • Fecha de inicio del evento
    2017-12-22
  • 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=162551
  • 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, percutaneous - Product Code DQY
  • Causa
    Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
  • Acción
    The notification letter includes the following instructions for CUSTOMERS: 1. Discontinue use and quarantine any affected products. 2. Complete and return the Recall Acknowledgement Form to start return process. 3. Complete the Recall Acknowledgment Form if there is no product on hand. Instructions for DISTRIBUTORS: 1.Discontinue distribution and quarantine any affected products. 2. Communicate this recall to any customers with affected product. 3. Have the customers return any affected product to you with a completed Recall Acknowledgement Form. 4. Return affected products from inventory using the Recall Acknowledgement Form. 5. Once you have returned recalled products from your own inventory, and collected the recalled products from your customers, please check the box on the enclosed Recall Acknowledgment Form that indicates that you have completed the recall and return the form.

Device

Device Recall Access Tray
  • Modelo / Serial
    Lot Numbers: (1) 13F17E0546; (2) 13F16L0177, 13F17E0449, 13F17E0873, 13F17F0295; (3) 13F17E0677, 13F17F0477; (4) 13F17A0318, 13F17F0083; (5) 13F16M0272, 13F17E0648; (6) 13F17B0122, 13F17F0512; (7) 13F17A0320, 13F17F0528
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.
  • Descripción del producto
    (1) Access Tray, Part Number (PN): ASK-04001-MS; Arrow Multi-Lumen CVC Kit (2) PN: CDC-12703-1A; (3) PN: CDC-15703-1A; (4) PN: CDC-15703-B1A; Arrow Two-Lumen CVC Kit (5) PN: CDC-12802-1A; (6) PN: CDC-15802-1A; (7) PN: CDC-17702-1A
  • 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