Events

Rappel de BioFlo PICC with ENDEXO and PASV Valve Technology with Nitinol Guidewire - Catheterisation kit, central venous Description:Bio-Stable 5F DL-55CM IR-145 Kit Valved with Nitinol GW PG

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

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-01597-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-01-03
  • 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-01597-1
  • 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
    Navilyst medical, inc., the manufacturer of the bioflo picc with pasv valve technology, is conducting a recall based on information received from greatbatch medical, who manufacturers the viapeel ptfe peelable introducer. navilyst medical has confirmed that the affected sheaths from a greatbatch medical recall of the peelable introducers (greatbatch model number 10890-006) have been included in packaged bioflo picc kits. these particular introducers have the potential for the handles to detach from the sheath during use. this may result in user dissatisfaction and/or prolonged procedure, or if both handles detach, the sheath tube could migrate into the patient leading to an unplanned surgical retrieval.. navilyst medical has received several complaints from users, but to date, there have been no reports of patient injuries as a result of this issue.
  • Action
    Emergo is advising users to immediately stop using and quarantine the affected lot of Bioflo PICC Kits. Affected product is to be returned to the distributor Florey Medical Pty Ltd. Replacement product or credit will be issued via the distributor.

Device

BioFlo PICC with ENDEXO and PASV Valve Technology with Nitinol Guidewire - Catheterisation kit, c...
  • Modèle / numéro de série
    BioFlo PICC with ENDEXO and PASV Valve Technology with Nitinol Guidewire - Catheterisation kit, central venousDescription:Bio-Stable 5F DL-55CM IR-145 Kit Valved with Nitinol GW PGItem Number: H965458830Catalogue Reference: 45-883Lot Number: 4908978Expiry: 30 June 2017 ARTG Number: 203831
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia