Events

Rappel de Two and three stage I.V. Poles (used as an optional accessory to a stretcher)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Stryker Australia 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-01123-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-11-17
  • 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-01123-1
  • 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
    It has been reported that some i.V. poles were retracting / lowering from an extended position to a low height unexpectedly. the i.V. latch housing has been identified as non-conforming, which has resulted in the suspended i.V. pole retracting.
  • Action
    Stryker is advising users to identify any of the stretcher models listed on which there may be an affected I.V. pole and place the pole at the lowest position. Stryker are supplying a sticker to be placed on the I.V. pole until the affected poles can be repaired. This action has been closed-out on 05/09/2016.

Device

Two and three stage I.V. Poles (used as an optional accessory to a stretcher)
  • Modèle / numéro de série
    Two and three stage I.V. Poles (used as an optional accessory to a stretcher)30” I.V. Pole, 2 Stage HE, PRCatalogue Number: 1105035368 Serial Number: 1403030970 26” I.V. Pole, 2 Stage HL Catalogue Number: 1105035638 Serial Number: 1402030027 Used on the following devices:Stretcher models: 1105, 1105E, 1105X, 1105XE, 1115, 1115E, 1115X, 115XE, 1125E, 1125X and 1125XEARTG Number: 167691
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    DHTGA