Events

Retiro De Equipo (Recall) de SANDEL Weighted Safety Scalpels

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Ansell Ltd T/A Ansell Healthcare.

¿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-2015-RN-00167-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-02-26
  • 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-2015-RN-00167-1
  • 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
    In november of 2013 ansell limited undertook a recall of a number of specific batches of some of the product codes for the above product. tga recall rc-2013-rn-01152-1 refers. this recall was closed out by the tga on 13 february 2015.As an interim corrective action, both the overseas manufacturer and ansell limited in california implemented a 100% visual inspection of all product prior to shipping from our warehouse to prevent recurrence of the problem of the safety shield moving and the blade tip being exposed.Subsequently, one customer complaint has been received of a user receiving an injury from an exposed blade tip while picking up the scalpel from the dispenser pack. this was a scalpel not originating from any identified lot of product from the original recall.Upon inspecting warehouse stock, we have further identified a small number of scalpels where the blade tip has become exposed. these were all found before the product was shipped to distributors or customers.
  • Acción
    Ansell is requesting users to quarantine affected lots and return to Ansell for replacement or credit. This action has been closed-out on 1/06/2016.

Device

SANDEL Weighted Safety Scalpels
  • Modelo / Serial
    SANDEL Weighted Safety ScalpelsCatalogue numbers: 2210-N, 2211-N, 2215-N, 2220-N, 2210-L, 2211-L & 2215-LARTG number: 196914
  • Manufacturer
    Ansell Ltd T/A Ansell Healthcare

Manufacturer

Ansell Ltd T/A Ansell Healthcare