Events

Alerte Ou Avis De Sécurité sur TransRadial artery access kit

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 Arrow International.

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/2013/083
  • Numéro de l'événement
    CON354193
  • Date
    2013-12-13
  • Date de publication de l'événement
    2013-12-13
  • 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/CON354193?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
    Risk of delay to patient treatment. arrow international are recalling certain models and lot numbers of their transradial artery access kits because the introducer needles packaged within the kits can be partially or fully occluded. arrow international issued a field safety notice (fsn) dated 9 october 2013. the fsn lists the part and lot numbers that are affected. the manufacturer has not received sufficient confirmation that this fsn had been received and acted upon.
  • Action
    Identify and quarantine affected kits pending return to Teleflex Medical. Ensure that all users are aware of the advice given in the Arrow International FSN for identifying and returning affected stock. Fill in the acknowledgement form in the FSN and return it to Teleflex Medical.

Device

TransRadial artery access kit
  • Modèle / numéro de série
  • Description du dispositif
    TransRadial artery access kit. (a division of Teleflex Medical). Specific part numbers and lot numbers.
  • Manufacturer
    Arrow International

Manufacturer

Arrow International