Events

Alerte Ou Avis De Sécurité sur RUSCH Mackintosh laryngoscope disposable metallic 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 M.A. Arain & Brothers (PVT) 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/2012/032
  • Numéro de l'événement
    CON155659
  • Date
    2012-06-12
  • Date de publication de l'événement
    2012-06-12
  • 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/CON155659?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
    There is potential for the light to fail during intubation due to a loose connection between the battery and the battery cap.
  • Action
    Identify, quarantine and do not use devices from the affected batches. Contact Teleflex to arrange for devices to be exchanged or to confirm that you have none in stock. Follow the advice in the Teleflex Field Safety Notice (dated 29 May 2012).

Device

RUSCH Mackintosh laryngoscope disposable metallic kit
  • Modèle / numéro de série
  • Description du dispositif
    RUSCH Mackintosh laryngoscope disposable metallic kit (all sizes). Catalogue numbers: 670160-0000** (** relates to blade size). Batch numbers 041511 and 021512. Distributed in the UK by Teleflex (RUSCH). These laryngoscope handles are found in the RUSCH Mackintosh laryngoscope disposable metallic kit (all sizes) – ensure both components of the kit are returned to Teleflex. Teleflex issued a Field Safety Notice on 29 May 2012 regarding this product recall. M.A. Arain & Brothers (PVT) Ltd issued two of their own Field Safety Notices, published in April and May 2012.
  • Manufacturer
    M.A. Arain & Brothers (PVT) Ltd

Manufacturer

M.A. Arain & Brothers (PVT) Ltd