Events

Avis De Sécurité sur Ezy Dose Baby Care Kits, Ezy Dose Pacifier Syringe Nursers, Ezy Dose Medicine Spoons* & Flents Paediatric Urine Collectors * Includes ‘Duffy Dog’ and ‘Kyle Crocodile’ Medicine Spoons

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

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
    SN2011(15)
  • Date
    2011-06-17
  • 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=/ezy-dose-baby-care-kits-ezy-dose-pacifier-syringe-nursers-ezy-dose-medicine-spoons-flents-paediatric-urine-collectors-includes-duffy-dog-and-kyle-crocodile-medicine-spoons&id=8397f825-9782-6eee-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 ezy dose baby care kits, ezy dose pacifier syringe nursers, ezy dose medicine spoons and flents paediatric urine collectors have been provided to pharmacy outlets in ireland. these dosage products are not ce marked.
  • Action
    Advice for Pharmacies  Pharmacies should examine their stock to determine if they have any Ezy Dose Baby Care Kits, Ezy Dose Pacifier Syringe Nursers, Ezy Dose Medicine Spoons and Flents Paediatric Urine Collectors.  If you find that you have these products, cease sale of these products immediately and quarantine all stock and contact Apothecary Products Inc. immediately to obtain further instruction and guidance.  Please advise the IMB should you discover any other similar brands of dosage spoons, dosage droppers or medicines feeders that:  (a) Do not carry the CE mark  (b) Carries a CE mark but the CE mark is not accompanied by a four digit Notified Body number  Advice for Consumers  Consumers should check their medicine feeders to determine if their device is branded Ezy Dose Baby Care Kits, Ezy Dose Pacifier Syringe Nursers, Ezy Dose Medicine Spoons and Flents Paediatric Urine Collectors.  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

Ezy Dose Baby Care Kits, Ezy Dose Pacifier Syringe Nursers, Ezy Dose Medicine Spoons* & Flents Pa...
  • Modèle / numéro de série
  • Description du dispositif
    Ezy Dose Baby Care Kits, Ezy Dose Pacifier Syringe Nursers, Ezy Dose Medicine Spoons* & Flents Paediatric Urine Collectors * Includes ‘Duffy Dog’ and ‘Kyle Crocodile’ Medicine Spoons
  • Manufacturer
    Apothecary Products

Manufacturer

Apothecary Products