Events

Alerte De Sécurité sur ACME Monaco Guidewire

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

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
    2014-02-26
  • Date de publication de l'événement
    2014-02-26
  • 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_20140226c.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: medline acme monaco guidewire the united states food and drug administration (fda) has issued a medical device safety alert concerning acme monaco guidewire .035x150 3mmj tcfc item 88241[product codes and lot numbers: 054372-1-1a; 054372-1-1b; 054372-1-2a]. the affected products, manufactured by medline industries, inc, were distributed from march 2013 through august 2013.. the acme monaco guidewire .035x150 3mmj tcfc item number 88241 is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel. various convenience kits containing acme monaco guidewire .035x150 3 mmj tcfc, item number 88241, have a potential for the coating to flake off of the wire which may result in serious adverse health consequences. according to the fda, affected users should examine their inventory. the affected guidewires should be removed from the kit and returned to the manufacturer. the rest of the kit may be used and the affected guidewire may be replaced with a sterile product from supply. for details, please refer to fda websites: http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm387123.Htm http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm387097.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 26 february 2014.

Device

ACME Monaco Guidewire
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Medline ACME Monaco Guidewire
  • Manufacturer
    Medline Industries

Manufacturer

Medline Industries