Events

Alerte De Sécurité sur SUREFLUX 25UX LC GA

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

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
    2015-08-04
  • 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_20150804_b.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: nipro europe nv sureflux 25ux lc ga medicines and healthcare products regulatory agency (mhra), united kingdom, has posted a field safety notice concerning sureflux 25ux lc ga [lot numbers: 14i29f, 14l29f, 15b23f, 14i29f], a dialyzer manufactured by nipro europe v. the manufacturer received complaints from the japanese market regarding a housing body crack of dialyzer and a leakage of the saline or dialyzer solution. the position of the crack is near its header position. the manufacturer found that the housings were misaligned because auxiliaries were bumped unintentionally into auxiliary removing device set before roughly-cutting process. due to this, misaligned housings were contacted by holding jig at the next process and cracks were generated around the dialysate ports. according to the manufacturer, there was no adverse event or health injury related to this problem having been reported so far. the manufacturer is recalling the affected product and users are advised not to use the affected lots. if you are in possession of the affected products, please contact your supplier for necessary actions.

Device

SUREFLUX 25UX LC GA
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Nipro Europe NV SUREFLUX 25UX LC GA
  • Manufacturer
    Nipro Europe V

Manufacturer

Nipro Europe V