Events

Rappel de Medline Procedure Packs containing ConvaTec Unomedical Brand Frazier Suction Handle

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Medline International Two 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
    RC-2016-RN-00971-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-07-21
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00971-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    Medline is issuing an instruction’s for use (ifu) for the convatec unomedical brand frazier suction handle. this action is being taken in response to complaints received by convatec in relation to breaking of the instrument at the junction of the handle and the metal tubing when pressure is applied at the tip. if the issue were to occur, it would result in a loss of suction and loss of visibility in the surgical field. there is a low risk of tissue damage or the potential for debris to remain in the surgical field as a result of the device breaking. there have been no injuries reported as a result of this issue.
  • Action
    The manufacturer has decided to issue an IFU to instruct the users on how to use the product appropriately to avoid any breakage of the instrument. Medline is providing hospitals with the IFU along with the customer letter. This action has been closed-out on 22/02/2017.

Device

Medline Procedure Packs containing ConvaTec Unomedical Brand Frazier Suction Handle
  • Modèle / numéro de série
    Medline Procedure Packs containing ConvaTec Unomedical Brand Frazier Suction HandleMultiple Product Codes and Procedure Packs affectedARTG Numbers: 137394, 137395, 136870, 140054, 140055, 140057, 140058, 140059, 140387, 161683, 161684, 161685
  • Manufacturer
    Medline International Two Australia Pty Ltd

Manufacturer

Medline International Two Australia Pty Ltd