Events

Retiro De Equipo (Recall) de Medline Cardiac Pack (which includes Edwards LifeSciences Suction Wand)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Medline International Two 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-2013-RN-00706-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-07-11
  • 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-2013-RN-00706-1
  • 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
    Edwards lifesciences has notified medline that they are conducting a recall of certain lot numbers of the edwards lifescience suction wand, which is included in medline's cardiac pack. edwards discovered plastic particulate inside the sterile pouch and within the internal diameter of the rigid suction wands. the particulate ranged from 0.26 to 0.41 (6.6 to 10.4mm) in size. particulate not detected during the preparation of the device may pose a risk as it may enter into the pericardium and could cause abrasions to the surface of the heart.
  • Acción
    Customers are asked to inspect all inventory and return affected packs to Medline.

Device

Medline Cardiac Pack (which includes Edwards LifeSciences Suction Wand)
  • Modelo / Serial
    Medline Cardiac Pack (which includes Edwards LifeSciences Suction Wand) Product Code: SCVPEMO01H (which includes Suction Wand Model Code: S099)Lot Numbers: CS1273342, CS1274530, CS1275921, CS1276983, CS1277145, CS1279180, CS1279527, CS1381863, CS1381982, CS1383487, CS1384082, CS1384586 and CS1385127ARTG Number: 136870
  • Manufacturer
    Medline International Two Australia Pty Ltd

Manufacturer

Medline International Two Australia Pty Ltd