Events

Rappel de ISOMed Arterial Embolectomy Catheters – Single Lumen (2F & 3F)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Medical Specialties 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-2017-RN-00091-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-01-18
  • 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-2017-RN-00091-1
  • 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
    The manufacturer (isomed) has advised that for procedures requiring embolectomy/thrombectomy of arteriovenous (av) fistulas, the catheter used should have the tensile strength to withstand at least 9n of resistance. after extensive testing, it was determined that the maximum resistances of the isomed 2f, 3f & 4f single lumen arterial embolectomy catheters are: 3n, 5n & 9n respectively. to minimise the risk of vessel damage, balloon rupture or tip detachment in av fistula procedures, it is recommended that single lumen arterial embolectomy catheters of less than 4f (i.E. 2f & 3f) should not be used for these procedures. the “warnings” section of the ifu has been updated to include this information.
  • Action
    Medical Specialties Australia is advising users to immediately inspect their stock for affected products. IFUs in the affected stock are to be discarded and replaced with a copy of the updated IFU. This action has been closed-out on 26/05/2017.

Device

ISOMed Arterial Embolectomy Catheters – Single Lumen (2F & 3F)
  • Modèle / numéro de série
    ISOMed Arterial Embolectomy Catheters – Single Lumen (2F & 3F)Product/Catalogue Numbers (2F): 300240, 300260, 300280, 300240T, 300260T, 300280TProduct/Catalogue Numbers (3F): 300340, 300360, 300380, 300340T, 300360T, 300380TAll Lots/Batches affectedARTG Number: 168959
  • Manufacturer
    Medical Specialties Australia Pty Ltd

Manufacturer

Medical Specialties Australia Pty Ltd
  • Source
    DHTGA