Events

Rappel de Waratah Private General Packs and Waratah Private Knee/Shoulder Arthro Pack(Surgical procedure packs)

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-2015-RN-00712-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-08-04
  • 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-2015-RN-00712-1
  • 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
    Following notification from component supplier, convatec ltd concerning the 3m suction tube contained in some procedure packs, mölnlycke is issuing this recall for product correction notice for packs containing this suction tubing. convatec conducted an internal assessment of product complaints that they had received and has identified that the suction tubes are not meeting their manufacturer's specifications. specifically, the connector part for application to the suction devices in the lots affected by the recall, has failed to meet its required reliability. the connector parts of the specified lots have a higher probability to crack once applied to suction devices outlets.
  • Action
    Customers are advised to isolate all affected, unused packs at their facility and contact Mölnlycke representative for alternative single packed sterile suction tubing. At the point of use, it is recommended that the users remove the ConvaTec 3m Suction Tube and dispose of the product, replacing it with a single packed sterile version. If customers or users have any issues with the above recommendation, please send the affected packs back to Mölnlycke for a full refund. This action has been closed-out on 15/08/2016.

Device

Waratah Private General Packs and Waratah Private Knee/Shoulder Arthro Pack(Surgical procedure pa...
  • Modèle / numéro de série
    Waratah Private General Packs and Waratah Private Knee/Shoulder Arthro Pack(Surgical procedure packs)Waratah Private General PackCatalogue number (SKU) : 97035035-05Batch numbers: 15030983, 15038366, 15077945, 15100388Waratah Private Knee/Shoulder Arthro PackCatalogue number (SKU): 97067575-00Batch number: 15035436ARTG Number: 133565
  • Manufacturer
    Molnlycke Health Care Pty Ltd

Manufacturer

Molnlycke Health Care Pty Ltd