Events

Alerte Ou Avis De Sécurité sur Suction catheters, gastro-enteral tubes, intermittent urology catheters and sterile urine drainage bags

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 ConvaTec Limited.

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
    2018-11-14
  • Date de publication de l'événement
    2018-11-14
  • 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/suction-catheters-gastro-enteral-tubes-intermittent-urology-catheters-and-sterile-urine-drainage-bags-potential-breach-in-sterile-barrier-packaging-mda-2018-034
  • 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 convatec limited – use of affected devices may increase risk of patients getting infections.
  • Action
    Refer to the manufacturer’s Field Safety Notice FSN for a list of affected product codes and affected lots. Stop using and quarantine affected devices as directed in the manufacturer’s FSN. Complete the ‘Recall Response Form for END USERS’ in the FSN and return to convatecproductrecall@stericycle.com to arrange return of affected device(s). Report any incidents or complaints involving this product to unomedical-uk.customerservice@convatec.com.

Device

Suction catheters, gastro-enteral tubes, intermittent urology catheters and sterile urine drainag...
  • Modèle / numéro de série
  • Description du dispositif
    Affected devices can only be identified by comparing product code and manufacture date stated on the packaging to the product list in the manufacturer’s FSN. The breach in the packaging is not visible.In addition to the FSN, which details the affected products, please refer to the spreadsheet which accompanies this MDA for additional unique device identification information and national supply chain codes (where available).
  • Manufacturer
    ConvaTec Limited

Manufacturer

ConvaTec Limited
  • Adresse du fabricant
    ConvaTec Limited Tel: 01244 832206 Email: convatecproductrecall@stericycle.com, unomedical-uk.customerservice@convatec.com.
  • Société-mère du fabricant (2017)
    Triona Holding Sa
  • Source
    MHRA