Events

Retiro De Equipo (Recall) de Device Recall ARROWgard Blue

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
    79339
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1002-2018
  • Fecha de inicio del evento
    2017-11-27
  • 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=162067
  • 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
    Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and unique device identification (udi) information.
  • Acción
    On November 29, 2017 an Urgent Medical Device Correction notice was issued to customers stating the following: Our records indicate that you have received products that are subject to this action. We are now notifying our distributors to take the following actions: 1. Immediately discontinue distribution and quarantine any products with the product codes and lot numbers listed above. 2. Inspect affected products within your control to identify whether they have the sticker with the lot number, expiration date, and UDI information. Products missing this sticker should be returned to Arrow International so they are not distributed to health care providers in error. Products which are properly labeled should not be returned. 3. Using the provided Customer Letter and Acknowledgement Form templates, communicate this correction to any of your customers who have received products included within the scope of the correction. Customers should return mislabeled products. Products that are properly labeled should not be returned. 4. If any of your customers have mislabeled products to return, have them return the affected products to you, together with a completed Acknowledgement Form, for consolidation and return to Arrow International. In the event that an alternative approach is needed, contact Customer Service for more information at 1-866-246-6990. 5. To return products to Arrow International, complete the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email it to recalls@teleflex.com. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Arrow International. 6. If you and your customers have no affected stock or if the products in your stock are properly labeled, please complete the enclosed Acknowledgment Form and fax it to 1-855-419

Device

Device Recall ARROWgard Blue
  • Modelo / Serial
    CDA-29803-1A 13F16M0122 13F17C0267 13F17E0385 13F17G0192
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US in the states of OH, FL, SC, TX, KY, NJ, MI
  • Descripción del producto
    ARROWg+ard Blue || Product Usage: || The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values frequent blood sampling or blood/blood component infusions infusion of incompatible medications central venous pressure monitoring lack of usable peripheral IV sites replacement of multiple peripheral sites for IV access injection of contrast media When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with pressure injectable CVC may not exceed 400 PSI.
  • 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