Events

Alerte De Sécurité sur Multi-Med Single Lumen Catheters

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

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
    2016-12-12
  • Date de publication de l'événement
    2016-12-12
  • 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_20161212a.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: centurion multi-med single lumen catheters the united states food and drug administration (fda) has issued medical device safety alerts concerning multi-med single lumen catheters manufactured by centurion. the affected devices are identified as follows:- product code: foz centurion kit codes: ecvc1680, ecvc4785, m11620hkic, m11620hkicnl, m11620hs, m11620kc, m11620kcnl, m12013k, m12013knl lot numbers: 2016062150, 2016062950, 2016070650, 2016081550, 2016051050 2016053150, 2016060750, 2016061550, 2016063050, 2016072050, 2016080250, 2016091950, 2016060750, 2016072650, 2016093050, 2016101050, 2016052050, 2016062850, 2016082350, 2016082650, 2016090250, 2016050950, 2016053150, 2016060750, 2016071250, 2016080350, 2016082950, 2016060850, 2016061650, 2016062050, 2016070550, 2016071950, 2016080250, 2016090750, 2016071350, 2016072050, 2016092650, 2016100650, 2016072950, 2016082450 distribution date: 23 may 2016 to 18 oct 2016 the manufacturer is recalling the centurion convenience kits containing multi-med single lumen catheters. the catheters have a potential for excess material to remain at the tip of the catheter from the manufacturing process. if this occurs, the excess material may separate from the catheter during use and could enter the patient’s bloodstream. this can result in serious adverse health consequences such as the development of blood clots, embolism of the excess material to vital organs, or death. customers are asked to identify and stop using the affected products in their inventory. for details, please refer to the fda website: medwatch: http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm532629.Htm medical device recalls:http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm532576.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 12 december 2016.

Device

Multi-Med Single Lumen Catheters

Manufacturer

Centurion