Events

Retiro De Equipo (Recall) de Medline Custom Procedure Kit, incorporating Unomedical suction tubing

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Medline Assembly 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
    18830
  • Fecha de inicio del evento
    2015-07-08
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: REM Systems Limited, 69 Elizabeth Knox Place, Glen Innes, AUCKLAND
  • Causa
    Medline is recalling specified lots of the unomedical suction tubing. this tubing is a component in the medline procedure pack product code sotnzah04b., an internal assessment of convatec's product complaints confirmed that these devices were not meeting customer expectations. the connector parts for application to the suction device in these lots have failed to meet their required reliability. the connector parts of the specified lots have a higher probability to crack once applied to suction device outlets. cracking may result in loss of suction during an operation. this could result in reduced surgical site visibility (due to poor removal of fluid) and may make stemming of bleeding more difficult.
  • Acción
    Manufacturer to issue advice regarding use

Device

Medline Custom Procedure Kit, incorporating Unomedical suction tubing
  • Modelo / Serial
    Model: SOTNZAH04B, Affected: CS1405587, CS1417569, CS1418438, CS1418710, CS1419278, CS1420864, CS1422092, CS1423500, CS1423501, CS1423955, CS1527665, CS1528112, CS1528978, CS1529680, CS1529789, CS1531866
  • Manufacturer
    Medline Assembly Australia Pty Ltd

Manufacturer

Medline Assembly Australia Pty Ltd