Events

Rappel de SAFETY Blood Collection Sets with:Luer Adaptor, 21g X 30cm, Sterile Single PackItem Code: 450065Lot Number: 12I20Holder, 23g X 19cm, Sterile Single PackItem Code: 450086Lot Number: 12H26Luer Adaptor, 21gx30cm, Sterile Single PackItem Code: 450095Lot Number: 12I22Luer Adaptor, 25gx30cm, Sterile Single PackItem Code: 450099Lot Number: 12H26Luer Adaptor, 23gx30cm, Sterile Single PackItem Code: 450159Lot Number: 12I14ARTG number: 150062

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Interpath Services 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-2013-RN-00290-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-04-17
  • 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-2013-RN-00290-1
  • 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, greiner bio-one, has advised that safety blood collection sets may have a small crack in the luer connector. this may cause minor leakage (small droplets) of blood or infusion liquid at the luer connector side. additionally evacuated blood collection tubes would only fill with a few droplets or would not fill at all.
  • Action
    Interpath is recalling affected units and replacing them with unaffected stock.

Device

SAFETY Blood Collection Sets with:Luer Adaptor, 21g X 30cm, Sterile Single PackItem Code: 450065L...
  • Modèle / numéro de série
    SAFETY Blood Collection Sets with:Luer Adaptor, 21g X 30cm, Sterile Single PackItem Code: 450065Lot Number: 12I20Holder, 23g X 19cm, Sterile Single PackItem Code: 450086Lot Number: 12H26Luer Adaptor, 21gx30cm, Sterile Single PackItem Code: 450095Lot Number: 12I22Luer Adaptor, 25gx30cm, Sterile Single PackItem Code: 450099Lot Number: 12H26Luer Adaptor, 23gx30cm, Sterile Single PackItem Code: 450159Lot Number: 12I14ARTG number: 150062
  • Manufacturer
    Interpath Services Pty Ltd

Manufacturer

Interpath Services Pty Ltd
  • Société-mère du fabricant (2017)
    Bunzl Plc
  • Source
    DHTGA