Events

Alerte De Sécurité sur Angiodynamics Soft Vu Omni Flush Angiographic Catheter

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

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
    2016-07-25
  • Date de publication de l'événement
    2016-07-25
  • 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_20160725c.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: stryker sustainability solutions (formerly ascent healthcare solutions) angiodynamics soft vu omni flush angiographic catheter the food and drug administration (fda) of the united states has issued a medical device safety alert concerning angiodynamics soft vu omni flush angiographic catheter, manufactured by stryker sustainability solutions (formerly ascent healthcare solutions). the affected devices are identified as follows:- lot numbers: 8248u, 119965u, 158623u, 175183u, 179688u, 191185u, 210813u,225911u, 225918u, 225919u, 253202u, 277726u, 302844u, 309329u, 325680u, 343908u, 352756u, 352761u, 359352u, 363987u, 366572u, 369818u, 375883u, 772102u, 773196u, 773216u, 775985u, 7710750u manufacturing dates: november 7, 2003 to october 18, 2008 distribution dates: january 5, 2004 to december 3, 2008 according to the fda, the manufacturer is recalling angiodynamics soft vu omni flush angiographic catheters due to reports of separation of the tip of the catheter from the main body. tip separation leads to loss of device function, possible surgical intervention to retrieve a separated segment, or other complications such as blocking blood flow to bodily organs. tip separation can also lead to internal organ injury and cause stroke, kidney failure, and intestinal failure among other serious adverse health consequences, including death. the manufacturer sent a customer notification letter to affected customers informing them of the high possibility of tip separation during use and customers are advised to discontinue use of the affected lots of the recalled products. according to the local supplier, the affected products are not distributed in hong kong. for details, please refer to the fda websites: http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm512644.Htm http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm512633.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 25 july 2016.

Device

Angiodynamics Soft Vu Omni Flush Angiographic Catheter
  • Modèle / numéro de série
  • Classification du dispositif
    Cardiovascular Devices
  • Description du dispositif
    Medical Device Safety Alert: Stryker Sustainability Solutions (formerly Ascent Healthcare Solutions) Angiodynamics Soft Vu Omni Flush Angiographic Catheter
  • Manufacturer
    Stryker Sustainability Solutions

Manufacturer

Stryker Sustainability Solutions
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    DH