Events

Rappel de Medline Cardiac Pack (which includes Edwards LifeSciences Suction Wand)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Medline International Two 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-2013-RN-00706-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-07-11
  • 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-00706-1
  • 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
    Edwards lifesciences has notified medline that they are conducting a recall of certain lot numbers of the edwards lifescience suction wand, which is included in medline's cardiac pack. edwards discovered plastic particulate inside the sterile pouch and within the internal diameter of the rigid suction wands. the particulate ranged from 0.26 to 0.41 (6.6 to 10.4mm) in size. particulate not detected during the preparation of the device may pose a risk as it may enter into the pericardium and could cause abrasions to the surface of the heart.
  • Action
    Customers are asked to inspect all inventory and return affected packs to Medline.

Device

Medline Cardiac Pack (which includes Edwards LifeSciences Suction Wand)
  • Modèle / numéro de série
    Medline Cardiac Pack (which includes Edwards LifeSciences Suction Wand) Product Code: SCVPEMO01H (which includes Suction Wand Model Code: S099)Lot Numbers: CS1273342, CS1274530, CS1275921, CS1276983, CS1277145, CS1279180, CS1279527, CS1381863, CS1381982, CS1383487, CS1384082, CS1384586 and CS1385127ARTG Number: 136870
  • Manufacturer
    Medline International Two Australia Pty Ltd

Manufacturer

Medline International Two Australia Pty Ltd