Events

Rappel de SURGICAL GOWN UL HP L (Molnlycke Health Care Pty Ltd - Gown, operating room, single use)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Molnlycke Health Care 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-01433-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-11-23
  • 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-01433-1
  • 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
    During internal rigorous quality checking, mölnlycke has self-identified a quality issue with specific batches of gowns released between october 6th till october 16th 2017. the issue is regarding foreign particles (loose threads) being identified on the products.No complaints or reports of patient harm related to this issue have been received as of november 2017.
  • Action
    Customers are requested to; 1. Identify and isolate all affected, BARRIER Ultimate Surgical Gown at your facility; 2. Complete the confirmation form supplied with the customer letter and e-mail/fax back per its instructions. Even if you no longer have any concerned BARRIER Ultimate Surgical Gown, Mölnlycke needs to be sure all customers are aware of the situation; 3. Mölnlycke will contact you and arrange for collection of the product(s) from your facility, as soon as you return the confirmation form. Mölnlycke will organize to issue a credit for the goods returned; and 4. If you have forwarded any affected products to other healthcare institutions, send them a copy of the customer letter together and make sure they act accordingly.

Device

SURGICAL GOWN UL HP L (Molnlycke Health Care Pty Ltd - Gown, operating room, single use)
  • Modèle / numéro de série
    SURGICAL GOWN UL HP L (Molnlycke Health Care Pty Ltd - Gown, operating room, single use)Product number: 6901021-01Batch number: 17357759ARTG number: 138941
  • Manufacturer
    Molnlycke Health Care Pty Ltd

Manufacturer

Molnlycke Health Care Pty Ltd