Events

Rappel de General Laparoscopy Procedure Pack and Gynaecological Laparoscopy Procedure Pack containing CORE Suction Irrigation Handpiece (sterile) General Laparoscopy Procedure Pack

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-00882-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-07-01
  • 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-00882-1
  • 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
    This letter is to inform users that medline is recalling two procedure packs, the general laparoscopy and the gynecological laparoscopy, as they contain a conmed core suction irrigation handpiece. medline was informed by conmed that the core suction irrigation handpiece may contain creases in the packaging seal which sometimes results in an open channel. these channels may compromise sterility of the product. there have been no reports of injuries as a result of this issue.
  • Action
    Medline is advising users to check the procedure packs in stock, remove and retain the ConMed CORE suction Irrigation Handpiece for return. Medline will replace the affected handpieces with unaffected stock. This action has been closed-out on 20/01/2017.

Device

General Laparoscopy Procedure Pack and Gynaecological Laparoscopy Procedure Pack containing CORE ...
  • Modèle / numéro de série
    General Laparoscopy Procedure Pack and Gynaecological Laparoscopy Procedure Pack containing CORE Suction Irrigation Handpiece (sterile) General Laparoscopy Procedure PackProduct Codes: CSBABRMQ18A and CSBABRMQ18BGynecological Laparoscopy Procedure Pack Product Codes: CSMABRMQ10A and CSMABRMQ10BARTG Number: 137395
  • Manufacturer
    Medline International Two Australia Pty Ltd

Manufacturer

Medline International Two Australia Pty Ltd