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-2017-RN-00490-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-04-19
  • 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-00490-1
  • 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 an investigation of the reported customer complaints, the manufacturer has identified that there is a potential for some circuits of the affected batches to operate incorrectly. the 10mm female connector was slightly oversized during its manufacturing and therefore the device could become loose from the fisher & paykel neopuff’s 10mm male connector under certain conditions and would therefore not deliver the required pressure to the patient.
  • Action
    Affected Lots are being recalled from Hospitals. Users are requested to note this is an expanded recall from December 2016 where this issue was first identified and Batch Number: TB2000-0141 was recalled.

Device

TB2000 Disposable t-piece infant resuscitation circuit with adjustable PEEP
  • Modèle / numéro de série
    TB2000 Disposable t-piece infant resuscitation circuit with adjustable PEEPThis Recall:- Batch / Lot Number: TB2000-0146, TB2000-0149 and TB2000-0151Previous Recall from December 2016:- Batch / Lot Number: TB2000-0141ARTG Number: 188097
  • Manufacturer
    Swirl Technologies Pty Ltd T/A Parker Healthcare

Manufacturer

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