Events

Retiro De Equipo (Recall) de ARROW Pressure Injectable PICC Kit

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Teleflex Medical Australia Pty Ltd.

¿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
    RC-2017-RN-00986-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2017-08-07
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00986-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    As a precaution, arrow international has initiated a recall for this product because these finished good kits may potentially contain an incorrect component. this issue came to light through an internal inspection. a 4fr single lumen catheter was found in a 5fr double lumen kit. through investigation at the manufacturing facility it was determined that there is a potential that the reverse scenario could also have occurred, 5fr double lumen catheter ending up in a 4fr kit thus both product codes/lots are in scope of the action. zero complaints have been received for this issue (either scenario) furthermore no product has been found internally for 5fr catheter in a 4fr kit.
  • Acción
    Teleflex is requesting that customers: 1. Provide the customer letter to all who need to be aware of it within their organisation. 2. Inspect any stock on hand. The kit tray is transparent & does not need to be opened to determine the type of included catheter. 3. Lift the non-sterile pouch with the product information up to identify if the catheter has a single or double lumen. 4. Once all stock has been inspected, complete the Acknowledgement Form supplied with the customer letter with the details obtained during inspection. Note - include details of all stock implicated in this issue. 5. Return the completed & signed form to austcs@teleflex.com by 1 September 2017. If stock contains a 4FR Single lumen catheter – there is no impact and the stock can be used as normal. If stock contains a 5FR Double lumen catheter – this stock is impacted. In the event you have impacted stock a customer service team member will be in contact with you to arrange collection of the goods.

Device

ARROW Pressure Injectable PICC Kit
  • Modelo / Serial
    ARROW Pressure Injectable PICC KitProduct Code: PR-35041-HPHNMLot Numbers: 13F16A0089, 13F16A0180, 13F17B0290ARTG Number: 278735
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd