Events

Rappel de Moog Infusion System Administration Sets 340-4114 Non DEHP Microbore Admin Set with Non-Vented Spike Packaged Assy, STERILE340-4166 Non DEHP Microbore Administration Set with Non-Vented Spike ASV Packaged Assy, STERILE340-4134 Non-DEHP Microbore Admin Set with Non-Vented Spike and Y-Site with Check Valve, Packaged Assy, STERILE

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Fresenius Kabi 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-2018-RN-00053-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2018-01-17
  • 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-2018-RN-00053-1
  • 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
    Fresenius kabi australia has received notice from the manufacturer, moog medical group, that they have initiated a recall in the usa for certain non-filtered moog iv administration sets manufactured between 9th june 2015 and 6th july 2016. the manufacturer received 7 complaints regarding particulate found on the tip of non-filtered moog iv spike sets manufactured between 9th june 2015 and 6th july 2016. during that period, 1,390,720 non-filtered spike administration sets were manufactured. when found, the loose particulate is located on the external edge of the non-vented spike and can potentially enter into the fluid path. introducing foreign material into the body can cause a range of side effects depending on the particle size and the type of line being used. no complaints have been received in australia to date.
  • Action
    Fresenius Kabi is advising customers to check inventory and quarantine affected stock. Fresenius Kabi will contact affected users to arrange return of stock.

Device

Moog Infusion System Administration Sets 340-4114 Non DEHP Microbore Admin Set with Non-Vented Sp...
  • Modèle / numéro de série
    Moog Infusion System Administration Sets 340-4114 Non DEHP Microbore Admin Set with Non-Vented Spike Packaged Assy, STERILE340-4166 Non DEHP Microbore Administration Set with Non-Vented Spike ASV Packaged Assy, STERILE340-4134 Non-DEHP Microbore Admin Set with Non-Vented Spike and Y-Site with Check Valve, Packaged Assy, STERILEMultiple Affected Part and Lot NumbersARTG Number: 225965 (Fresenius Kabi Australia Pty Limited - Infusion administration set, infusion pump)
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Manufacturer
    Fresenius Kabi Australia Pty Ltd

Manufacturer

Fresenius Kabi Australia Pty Ltd