Events

Alerte Ou Avis De Sécurité sur Syringe hypodermic safety product with needle attached 1ml syringe with 27G automatically retractable needle insulin

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par Medicina Ltd.

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
    Safety alert / Field Safety Notice
  • ID de l'événement
    MDA/2014/033
  • Numéro de l'événement
    CON448008
  • Date
    2014-08-20
  • Date de publication de l'événement
    2014-08-20
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON448008?tabName=allTabs
  • Notes / Alertes
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Notes supplémentaires dans les données
  • Cause
    The affected devices are unable to deliver fewer than 7 units of insulin. in addition, the safety and performance of these devices has not been properly evaluated and so the ce marking of all of these devices is invalid. medicina issued a field safety notice in june 2014 but has not had sufficient confirmation that customers have received and acted on these notices.
  • Action
    Do not use affected devices. Quarantine them and contact Medicina Ltd to arrange for their collection. Return the email / fax back form in the FSN to the manufacturer. Personnel involved in the purchase, supply and distribution of these devices.

Device

Syringe hypodermic safety product with needle attached 1ml syringe with 27G automatically retract...
  • Modèle / numéro de série
  • Description du dispositif
    Insulin syringe 1ml safety syringe 27G (for professional use). Product code: RN01/27i. All batches. If relevant to you, the NHS Supply Chain Code is as follows: Medicina product code NPC Product description RN01/27i FWD150 Syringe hypodermic safety product with needle attached 1ml syringe with 27G automatically retractable needle insulin
  • Manufacturer
    Medicina Ltd

Manufacturer

Medicina Ltd
  • Société-mère du fabricant (2017)
    Luan Srl
  • Source
    MHRA