Events

Rappel de Sureclip and Sureclip Plus Haemostasis Clips (Gastrointestinal endotherapy clip applier) Hemoclip 90 degree/5mm/12mm(max) rotatable/relocatable (x10/box) Hemoclip 90 degree/8mm/17mm(max) rotatable/relocatable (x10/box)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par CK Surgitech 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-00181-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-02-15
  • 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-00181-1
  • 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
    Ck surgitech has been notified of an incident concerning one of the above products. the device proved hard to fire, and upon deployment, detached a 10cm piece of wire that was removed through the scope with biopsy forceps. there is a risk of tissue puncture as a result of the issue.As a result, ck surgitech is recalling both the standard sureclip and the sureclip plus until investigations have been undertaken.
  • Action
    CK Surgitech is advising users to inspect stock and quarantine affected units. Affected stock will be replaced or an alternative product supplied.

Device

Sureclip and Sureclip Plus Haemostasis Clips (Gastrointestinal endotherapy clip applier) Hemoclip...
  • Modèle / numéro de série
    Sureclip and Sureclip Plus Haemostasis Clips (Gastrointestinal endotherapy clip applier)Hemoclip 90 degree/5mm/12mm(max) rotatable/relocatable (x10/box)Product Code: ROCC-D-26-230-CLot Number: 150625231Expiry Date: 24/06/2018Hemoclip 90 degree/8mm/17mm(max) rotatable/relocatable (x10/box)Product Code: ROCC-F-26-230-CLot Number: 151115231Expiry Date: 15/11/2018ARTG Number: 261692
  • Manufacturer
    CK Surgitech Pty Ltd

Manufacturer

CK Surgitech Pty Ltd