Events

Alerte Ou Avis De Sécurité sur Burr hole probe cover with gel

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 Microtek Medical Europe.

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/2013/076
  • Numéro de l'événement
    CON329263
  • Date
    2013-10-24
  • Date de publication de l'événement
    2013-10-24
  • 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/CON329263?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 exposure to endotoxin levels above acceptable limits if the ultrasound probe cover comes into contact with the central nervous system. the manufacturer has identified that the affected ultrasound probe covers have not undergone adequate endotoxin testing. microtek medical europe issued a field safety notice (fsn) dated 10 july 2013 but has not received sufficient confirmation from users that they have received and acted on this information.
  • Action
    Ensure that relevant staff are aware of this Field Safety Notice. Identify all affected batches of these ultrasound probe covers. Quarantine all affected batches. Complete the recall response form and return it to Microtek Medical Europe as soon as possible. Follow the manufacturer’s instructions for returning the affected devices. Action by: Operating theatre staff and surgical staff Neurosurgery departments Spinal surgery departments Radiology departments Supplies departments

Device

Burr hole probe cover with gel
  • Modèle / numéro de série
  • Description du dispositif
    Ultrasound probe cover: Burr hole probe cover with gel. These ultrasound probe covers are disposable, single-use drapes. They are used as a cover for ultrasound probe scan heads and power cords, used for various surgical procedures, to provide a barrier over the equipment. Product reference (SKU number): 3688UK, PC3688, PC3688EU. Affected batch numbers are listed in the Field Safety Notice (FSN). Note that product ref (SKU number) 3688 is listed in the FSN but it is not for sale in the UK.
  • Manufacturer
    Microtek Medical Europe

Manufacturer

Microtek Medical Europe
  • Société-mère du fabricant (2017)
    Ecolab Inc
  • Source
    MHRA