Events

Rappel de Leongatha Delivery Pack containing umbilical clamps

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-2016-RN-01043-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-08-09
  • 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-01043-1
  • 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
    Mölnlycke health care has become aware of situations where the umbilical clamp included in the procedurepak kits and trays may have been incorrectly used due to a lack of adequate instructions for use. if the clamp is used incorrectly i.E. both hooks in the clamp are not engaged, the clamp may reopen. if the clamp is not in place correctly when the umbilical cord has been cut, this can potentially lead to blood loss for the baby if not monitored regularly.The ifu will be improved to include further instruction to ensure correct usage of the clamps.
  • Action
    Mölnlycke Health Care is providing users with the correct instructions for the umbilical clamp. To ensure correct usage: - Rotate the umbilical cord clamp with the open side of the lock towards you, so that you can see the locking hooks. - Place the (thick) umbilical cord towards the ring end. - Both hooks must be correctly positioned, check carefully that both hooks are securely clicked into place. Incorrect engagement of the hooks can cause the clamp to open. This action has been closed-out on 17/02/2017.

Device

Leongatha Delivery Pack containing umbilical clamps
  • Modèle / numéro de série
    Leongatha Delivery Pack containing umbilical clampsProduct number: 97047649-01Umbilical clamps ref.: IFKR21 and 2305123-00All batches are affectedARTG Number: 133562
  • Manufacturer
    Molnlycke Health Care Pty Ltd

Manufacturer

Molnlycke Health Care Pty Ltd