Events

Alerte De Sécurité sur CrystalR Metal Disposable Blades (Mac 3 and Mac 4)

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

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
    2011-09-23
  • 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_20110923.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
    Urgent field safety notice: penlon crystalr metal disposable blades (mac 3 and mac 4) medical device manufacturer, penlon ltd., has issued an urgent field safety notice concerning crystalr metal disposable blade (mac 3 and mac 4). penlon has been made aware of an incident where mac 3 blades have been incorrectly packaged in disposable bags labeled as mac 4 and then packed in a carton stating size mac 4. the affected batches have been identified and penlon has determined that this poses a low risk to the users, as users will recognise that the blade is not the size stated on the disposable bag prior to use or during pre-use check. the manufacturer further advised that all theatre staff and stores personnel should check their stock with expiry dates between august 2010 and august 2015 and ensure that the sizes etched on the blades, inner plastic bags, and the carton all match. according to penlon, the affected products have been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions.

Device

CrystalR Metal Disposable Blades (Mac 3 and Mac 4)
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Penlon CrystalR Metal Disposable Blades (Mac 3 and Mac 4)
  • Manufacturer
    Penlon Ltd.

Manufacturer

Penlon Ltd.