Events

Avis De Sécurité sur ‘First Steps’ Medicine Feeder

Selon Health Products Regulatory Authority, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Ireland qui a été fabriqué par RSW International Limited.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Numéro de l'événement
    SN2009(05)
  • Date
    2009-06-18
  • Pays de l'événement
    Ireland
  • Source de l'événement
    HPRA
  • URL de la source de l'événement
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/first-steps-medicine-feeder&id=4c99f825-9782-6eee-9b55-ff00008c97d0
  • Notes / Alertes
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
  • Notes supplémentaires dans les données
  • Cause
    Non-compliant ‘first steps’ medicine feeders have been provided to retail outlets in ireland by rsw international limited. these medicine feeders are not appropriately ce marked.
  • Action
    Advice for Pharmacies, Retailers and Wholesalers Pharmacies, retailers and wholesalers should examine their stock to determine if they have any medical devices from the ‘First Steps’ medicine feeder range.  If you find that you have these products, cease sale of these products immediately and quarantine all stock. Contact the IMB immediately to obtain further instruction and guidance.  Also, should you discover any other similar brands of medicine feeders that do not carry the CE mark, please advise the IMB. Advice for Consumers  Consumers should check their medicine feeders to determine if their device is branded ‘First Steps’ medicine feeder range.  If you find that you have one of these devices, discontinue use immediately and seek an alternative. Consumers with health concerns should consult with their general practitioner.

Device

‘First Steps’ Medicine Feeder
  • Modèle / numéro de série
  • Description du dispositif
    ‘First Steps’ Medicine Feeder
  • Manufacturer
    RSW International Limited

Manufacturer

RSW International Limited