Events

Rappel de TB2000 Disposable t-piece infant resuscitation circuit with adjustable PEEP

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Swirl Technologies Pty Ltd T/A Parker Healthcare.

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-01577-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-12-06
  • 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-01577-1
  • 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
    During investigation of the reported complaints from the field, the manufacturer has identified that there is a potential for some circuits of the affected batch to operate incorrectly. the 10 mmf connector of the circuits was slightly oversized during its manufacturing and therefore the device could become loose from the fisher & paykel neopuff’s 10 mmm connector under certain pressure and would not deliver the required pressure to the patient.
  • Action
    All remaining TB2000 circuits from the affected Batch TB2000-0141 will be replaced with unaffected batches without any additional costs to the customer. Customers are advised to isolate the affected units and contact Parker Healthcare Customer Service Department or their sales representative to organise the return of the recalled stock and to get replacement stock. This action has been closed-out on 26/05/2017.

Device

TB2000 Disposable t-piece infant resuscitation circuit with adjustable PEEP

Manufacturer

Swirl Technologies Pty Ltd T/A Parker Healthcare
  • Source
    DHTGA