Events

Alerte De Sécurité sur StoneBreaker Pneumatic Lithotripter and associated accessories

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
    2018-03-15
  • Date de publication de l'événement
    2018-03-15
  • 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_20180315.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 stonebreaker pneumatic lithotripter and associated accessories medical device manufacturer, cook medical, has issued a medical device safety alert concerning its stonebreaker pneumatic lithotripter and associated accessories. the products are listed below: product brand name: a) stonebreaker pneumatic lithotripter: b) stonebreaker exhaust cap; c) stonebreaker exhaust line; d) stonebreaker probe cap; e) stonebreaker sterilization cap; f) stonebreaker co2 cartridge; g) stonebreaker single use probe. catalog identifier: a) sbl-kit1; b) sba-ec; c) sba-el; d) sba-pc; e) sba-sc; f) sba-10; g) sbp-010500, sbp-010605, sbp-016500, sbp-016605, sbp-020425. lot number: all the manufacturer is initiating a voluntary recall of the affected products, which are intended for reprocessing at the user’s facility. the manufacturer has identified that the interior of the products may not be sterilized to the appropriate sterility assurance level when following the reprocessing instructions provided in the instruction for use (ifu). according to the manufacturer, the potentially adverse events may occur include urinary tract infection, pyelonephritis, and urosepsis. the users are advised to examine inventory immediately to determine if they have affected products and quarantine affected products. products recall is on-going. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of any affected units, please contact your supplier for necessary actions. posted on 15 march 2018.

Device

StoneBreaker Pneumatic Lithotripter and associated accessories
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Cook Medical StoneBreaker Pneumatic Lithotripter and associated accessories
  • Manufacturer
    Cook Medical

Manufacturer

Cook Medical