Events

Alerte De Sécurité sur Medset CM Breast Pump Kit

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Medela AG.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2018-05-09
  • Date de publication de l'événement
    2018-05-09
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180509b.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: medset cm breast pump kit the medicines and healthcare products regulatory agency (mhra) of united kingdom, has posted a medical device safety alert concerning medset cm breast pump kit, manufactured by medela ag [product code: 001.0112 medset cm; all lots] an internal review performed by the manufacturer found that the labelling documentation for the medset cm breast pump kit is incomplete. additionally, although all product is sterile, the manufacturer cannot demonstrate full compliance with the quality standard for sterilisation. according to the manufacturer, no other sterile breast pump kit is affected by this issue. it can confirm that, to date, there have not been any complaints received which are associated with this issue. however, the manufacturing of this product has been discontinued. a replacement product is immediately available. the affected users are advised to: immediately check their internal inventory and storage areas for subject devices; transfer any subject devices which are found to quarantine area, pending destruction; destroy all subject devices by removing from packaging and disposing in waste in accordance with any local or environmental regulations; and notify the manufacturer immediately of any complaints associated with this issue. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 9 may 2018.

Device

Medset CM Breast Pump Kit
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Medset CM Breast Pump Kit
  • Manufacturer
    Medela AG

Manufacturer

Medela AG