Events

Alerte De Sécurité sur Level 1® D/DI-60HL Normothermic IV Fluid Administration Sets, and HOTLINE® Blood and IV Fluid Warming Sets

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

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
    2011-12-23
  • 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_20111223.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
    Field safety notice: smiths medical voluntary recall for level 1® d/di-60hl normothermic iv fluid administration sets, and hotline® blood and iv fluid warming sets medical device manufacturer, smiths medical asd, inc., is conducting a product recall for the following products: a) level 1® d/di-60hl normothermic iv fluid administration sets, and b) hotline ® blood and iv fluid warming sets (product codes: l-70, l-70ni, l-80, l-270, and l-370). there was an increasing trend in reports of disconnections of the luer lock connector at the patient end of the tubing on certain sets of the above two products. based on the information provided by the manufacturer, if the luer lock connector disconnects during use, this could result in fluid/ blood loss and/ or a delay in therapy, which could result in patient injury, or while highly unlikely, death. the manufacturer has received no reports of serious injury or death related to the problem. according to the local supplier, the affected products have been distributed in hong kong. for details, please refer to the attached field safety notice (a) and field safety notice (b). if you are in possession of the affected products, please contact your supplier for further information and necessary actions.

Device

Level 1® D/DI-60HL Normothermic IV Fluid Administration Sets, and HOTLINE® Blood and IV Fluid War...
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Smiths Medical Voluntary Recall for Level 1® D/DI-60HL Normothermic IV Fluid Administration Sets, and HOTLINE® Blood and IV Fluid Warming Sets
  • Manufacturer
    Smiths Medical ASD

Manufacturer

Smiths Medical ASD