Events

Alerte Ou Avis De Sécurité sur Various Arrow Critical Care devices

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 Teleflex.

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
  • Date
    2018-05-31
  • Date de publication de l'événement
    2018-05-31
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://www.gov.uk//drug-device-alerts/various-arrow-critical-care-devices-recall-due-to-incomplete-packaging-seals
  • 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
    Manufactured by teleflex – various critical care devices manufactured from january to december 2017 inclusive have been placed on the market with incomplete packaging seals potentially leading to infection.
  • Action
    Refer to the manufacturer’s FSN for a list of affected products Identify, cease using and quarantine these devices Contact Arrow International to return the devices

Device

Various Arrow Critical Care devices
  • Modèle / numéro de série
  • Description du dispositif
    Please refer to the FSN and related Appendix for a complete list of affected products. Note that Devices marked as non-CE marked are not on the EU market.In addition to the Field Safety Notice which details affected product, please refer to the spreadsheet which accompanies this MDA for additional unique device identification information.
  • Manufacturer
    Teleflex

Manufacturer

Teleflex
  • Adresse du fabricant
    Ken Oshanksy Arrow International Inc. 4024 Stirrup Creek Drive NC 27703 Durham USA Tel: +1 919-433-4940Email: internationalFCA@teleflex.comCliodhna Coffey UK Customer Service Fax: +44 (0) 1494 524650 Tel: +44 (0) 1494 532761Email: orders.uk@teleflex.com
  • Société-mère du fabricant (2017)
    Teleflex Incorporated
  • Source
    MHRA