Events

Alerte De Sécurité sur Merit 1mL Medallion Syringes

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
    2018-03-05
  • Date de publication de l'événement
    2018-03-05
  • 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_20180305.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 1ml medallion syringes medical device manufacturer, merit medical systems, inc., has issued a medical device safety alert concerning its 1ml medallion syringes. the affected products are identified as below: catalog numbers: a) k01-05526p; b) k01-07427; c) k01-07477p; d) k01-07930p; e) k02-00565c; f) k02-01260b; g) k02-01331a; h) k04-00748; i) k12-03636; j) mss011; k) mss011-dg; l) mss011-lg; m) mss011-pr; n) mss011-r; o) mss011-y; p) mss011-yp. lot numbers: a) h1258821; b) h1263015; c) h1242962, h1246807; d) h1246733; e) h1258361; f) h1258575, h1265248; g) h1252652; h) h1258488, h1264381; i) h1258530; j) h1242750, h1246807, h1255504; k) h1246809; l) h1246810; m) h1242752; n) h1242752, h1255507; o) h1246811; p) h1242927. the manufacturer is voluntarily conducting a recall of specific lots of 1 ml medallion syringes due to a supplier manufacturing defect with the syringe plunger tip. according to the manufacturer, prior to use and during prep, when fluid is drawn into the syringe, air may enter the barrel and/or fluid may leak out the back of the barrel. this may result in a minor delay in procedure and user dissatisfaction. it has not received any reports of patient harm or injury as a result of this issue. the manufacturer has chosen to remove the units from the market. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 5 march 2018.

Device

Merit 1mL Medallion Syringes
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Merit 1mL Medallion Syringes
  • Manufacturer
    Merit Medical Systems

Manufacturer

Merit Medical Systems