Events

Rappel de KimVent Microcuff Subglottic Suctioning Endotracheal Tube, 7.0 mm, 7.5 mm, 8.0 mm, 8.5 mm & 9.0 mm

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Kimberly Clark Aust 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-2014-RN-01242-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-11-26
  • 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-2014-RN-01242-1
  • 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
    Halyard australia pty ltd on behalf of kimberly-clark australia pty ltd, is recalling certain kimvent* microcuff* subglottic suctioning endotracheal tubes following advice that the referenced product codes and lot numbers may have the inflation line detach from the endotracheal tube during use (i.E. if pulled, tugged or excess tube/patient movement occurs). the potential harms associated with the pilot balloon inflation line disconnecting from the ett lumen include the need to re-intubate the patient to re-establish an adequate cuff seal and maintain appropriate ventilation of the patient. if the inflation line detachment and resulting cuff deflation are not detected and connected in time the patient may initially lose positive end expiratory pressure and get a reduction in tidal volumes.
  • Action
    Kimberly-Clark is requesting their customers to inspect their stocks and quarantine all units of the above lot numbers. Customer Service Team Leader Halyard Australia can be contacted to arrange for a return goods authorisation and credit note to be issued. This action has been closed-out on 01/03/2016.

Device

KimVent Microcuff Subglottic Suctioning Endotracheal Tube, 7.0 mm, 7.5 mm, 8.0 mm, 8.5 mm & 9.0 mm
  • Modèle / numéro de série
    KimVent Microcuff Subglottic Suctioning Endotracheal Tube, 7.0 mm, 7.5 mm, 8.0 mm, 8.5 mm & 9.0 mmProduct Codes: 13220, 13221, 13222, 13223 & 13224Multiple Lot NumbersARTG number: 215983
  • Classification du dispositif
    Anesthesiology Devices
  • Manufacturer
    Kimberly Clark Aust Pty Ltd

Manufacturer

Kimberly Clark Aust Pty Ltd