Events

Alerte De Sécurité sur custom procedural trays or kits containing 1% Lidocaine HCl Injection

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

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
    2014-02-27
  • Date de publication de l'événement
    2014-02-27
  • 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_20140227.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: merit medical systems custom procedural trays or kits containing 1% lidocaine hcl injection the u.S. food and drug administration (fda) posted a medical device safety alert concerning custom procedural trays or kits containing 1% lidocaine hcl injection, usp, 10 mg/ml, lot 25-090-dk. the products were recalled because there was one confirmed customer report where visible particulate were found in the primary product container in the form of dark red/black particles. the particular matter may dislodge through the tissue and could possibly cause a pneumothorax or haemothorax. for details, please refer to the fda website http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-product-tabs.Cfm?action=select&recall_number=z-0980-2014&w=02262014&lang=eng if you are in possession of the product, please contact your supplier for necessary actions. posted on 27 february 2014.

Device

custom procedural trays or kits containing 1% Lidocaine HCl Injection

Manufacturer

Merit Medical Systems