Events

Alerte Ou Avis De Sécurité sur Basin/bowl liner or equipment cover (drape)

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.

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/2014/034
  • Numéro de l'événement
    CON448388
  • Date
    2014-08-27
  • Date de publication de l'événement
    2014-08-27
  • 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/CON448388?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 manufacturer has found that some of these devices within the above product codes may have small cracks or holes. this could compromise the sterile field. the manufacturer issued a field safety notice (fsn) dated 14 july 2014 but hasn’t had enough confirmation that customers have received and acted on it.
  • Action
    Identify affected devices as described in the FSN. Remove and quarantine any affected stock and return to Microtek Medical. Complete the response form and return it to Microtek Medical.

Device

Basin/bowl liner or equipment cover (drape)
  • Modèle / numéro de série
  • Description du dispositif
    Basin/bowl liner or equipment cover (drape). Product codes: 17700, 16700A, 3109N, 3109NT, 3108N, 33099, 9386001, 3309N, TP1909A, TP1909B. All lot numbers. These products (a type of surgical drape) are manufactured by Microtek Medical, but may be distributed by other companies. These devices will have been supplied in procedure packs. See page 5 of the manufacturer’s FSN for full product descriptions. All devices manufactured since August 2009 are affected by this recall.
  • Manufacturer
    Microtek Medical

Manufacturer

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