Events

Alerte De Sécurité sur Ultraxx Nephrostomy Balloon Set and Ascend AQ Ureteral Dilation Balloon Catheter Set

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

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
    2016-02-03
  • Date de publication de l'événement
    2016-02-03
  • 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_20160203.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: cook medical ultraxx nephrostomy balloon set and ascend aq ureteral dilation balloon catheter set medical device manufacturer, cook medical, has issued a medical device safety alert concerning its ultraxx nephrostomy balloon set and the ascend aq ureteral dilation balloon catheter set [catalogue number: unbs-10-15-cs (lot number: 5082013) and aubs-6-4 (lot number: 5083854)]. the affected products were distributed between 22 july 2014 and 6 august 2014. the manufacturer has received reports of packages labeled as ultraxx nephrostomy balloon set actually containing the ascend aq ureteral dilation balloon catheter set and vice versa. according to the manufacturer, this event is not likely to lead to an adverse patient/user outcome and is obvious to the user. this nonconformity is detectable, making it less likely that an incorrect device would be used or misused during a procedure. product recall is on-going. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 3 february 2016.

Device

Ultraxx Nephrostomy Balloon Set and Ascend AQ Ureteral Dilation Balloon Catheter Set
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Cook Medical Ultraxx Nephrostomy Balloon Set and Ascend AQ Ureteral Dilation Balloon Catheter Set
  • Manufacturer
    Cook Medical

Manufacturer

Cook Medical