Events

Retiro De Equipo (Recall) de Pilling Knife Handles

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-01280-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-10-09
  • 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-01280-1
  • 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
    Teleflex medical has identified that the slot depth of pilling knife handles are out of specification, so blades may not fit on the handles properly. if a blade does not fit properly, the user may struggle to connect the two pieces, causing them to slip and cut their hand. or, if the blade is not securely connected when the product is used in surgery, the blade could dislodge during use and fall into the body cavity. to date, teleflex medical has not received any reports of patient injuries or deaths relating to this issue.
  • Acción
    Teleflex is advising customers to quarantine all affected stock and discontinue use. Teleflex will arrange collection of affected product from impacted customers and apply credit to their accounts.

Device

Pilling Knife Handles
  • Modelo / Serial
    Pilling Knife HandlesKnife Handle 3 - Straight tip, Straight shaft, 3, 4 7/8" (12.5cm)Knife Handle 3L - Straight tip, Straight shaft, 3L, 8 3/8" (21cm)Knife Handle 3LA - Angled tip, Straight shaft, 3LA, 8 1/8" (20.5cm)Knife Handle 4 - Straight tip, Straight shaft, 4, 5 3/8" (13.5cm)Knife Handle 7 Scalpel - Straight tip, Straight shaft, 7 SCALPEL, 6 3/8" (16.5cm)Multiple Product Codes and Lot NumbersARTG: 94282
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd