Events

Rappel de Medline Custom Procedure Kit, incorporating Unomedical suction tubing

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Medline Assembly Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    18830
  • Date de mise en oeuvre de l'événement
    2015-07-08
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Recalling Organisation: REM Systems Limited, 69 Elizabeth Knox Place, Glen Innes, AUCKLAND
  • Cause
    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.
  • Action
    Manufacturer to issue advice regarding use

Device

Medline Custom Procedure Kit, incorporating Unomedical suction tubing
  • Modèle / numéro de série
    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