Events

Alerte De Sécurité sur Standard Rigid Tip Suction Wand

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

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
    2012-11-07
  • Date de publication de l'événement
    2012-11-07
  • 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_20121107.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: california medical laboratories standard rigid tip suction wand medical device manufacturer, california medical laboratories, inc. has initiated a field safety corrective action concerning the standard rigid tip suction wand (item no.: su-12202, lot no.: s111480 and s112462). due to insufficient adhesive application, the distal tip has the potential to come loose from the wand and fall into the patient's chest cavity. this would likely be identified during, or prior to, the procedure. if the issue goes unnoticed there is the possibility of risk to the patient should the clinician not remove the detached component and subsequently close the surgical site. the manufacturer is notifying the affected users not to use the affected products and to return any unused product and order replacements. according to conmed limited, the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 7 november 2012.

Device

Standard Rigid Tip Suction Wand
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: California Medical Laboratories Standard Rigid Tip Suction Wand
  • Manufacturer
    California Medical Laboratories

Manufacturer

California Medical Laboratories