Events

Rappel de Pivot, Pivot Hygiene, Pivot Hammock and Tony Pringle clip style sling with the keyhole clip fastening

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Active Medical Supplies 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-00522-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-06-26
  • 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-2017-RN-00522-1
  • 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
    The manufacturer nortec medical have advised that the keyhole clips on pivot, pivot hygiene, pivot hammock and tony pringle clip style sling may break. there have been four recorded cases of failure of the keyhole clip that attaches a sling to a pivot framed hoist. these keyhole clips are the black plastic component which is attached to the sling by means of a webbing strap threaded through a slot. the affected clips have all broken at the slot.If the clip on the sling were to fail under load (whilst a patient is being transferred), the patient will fall from the hoist.
  • Action
    Active Medical requests that all recalled sling/s must be removed from service and disposed of. Users are requested to return a completed Urgent Medical Device Recall Notification form (provided with the Customer letter) and return it to Active Medical Supplies at recalls@activemedicalsupplies.com.au or fax to (07) 3899 8825 or post to Active Medical Supplies – Quality Assurance PO BOX 3392 TINGALPA QLD 4173. Replacement slings will be made available to affected customers.

Device

Pivot, Pivot Hygiene, Pivot Hammock and Tony Pringle clip style sling with the keyhole clip faste...
  • Modèle / numéro de série
    Pivot, Pivot Hygiene, Pivot Hammock and Tony Pringle clip style sling with the keyhole clip fasteningARTG Number: 146792
  • Manufacturer
    Active Medical Supplies Pty Ltd

Manufacturer

Active Medical Supplies Pty Ltd