Events

Alerte Ou Avis De Sécurité sur Adaptors for Shelfpak humidifier and Aquapak sterile water

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 Medical.

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/2014/023
  • Numéro de l'événement
    CON426887
  • Date
    2014-06-17
  • Date de publication de l'événement
    2014-06-17
  • 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/CON426887?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 packaging of these devices might not be sealed properly. however, the adaptors are used as part of a non-sterile system, so there is limited risk to patients. teleflex published a field safety notice recalling affected products in april 2014 but has not had sufficient confirmation from users that they have received and acted upon this information.
  • Action
    Identify the affected devices using the FSN and quarantine them. Return affected devices and arrange for replacements from Teleflex. Return the acknowledgement form to the manufacturer. Action by: All staff who use these devices.

Device

Adaptors for Shelfpak humidifier and Aquapak sterile water
  • Modèle / numéro de série
  • Description du dispositif
    Adaptors for Shelfpak humidifier and Aquapak sterile water. Specific product and lot numbers. The adaptors may be sold separately or with the Aquapak sterile water.
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical