Events

Alerte De Sécurité sur BioGlue Surgical Adhesive 5mL

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

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
    2014-06-13
  • Date de publication de l'événement
    2014-06-13
  • 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_20140613a.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: cryolife bioglue surgical adhesive 5ml medical device manufacturer, cryolife has issued a field safety notice concerning its bioglue surgical adhesive 5ml (product code: bg3515-5). at the request of the united states food and drug administration, the manufacturer has changed the expiration dating for the product from 24 months to 18 months due to the fact that the serum albumin component monomer failed to meet the manufacturer’s internally established end of shelf-life specification. based on the manufacturer’s health risk assessment, serum albumin monomer content below specification does not impose any change in patient risk to the delivered product. the manufacturer has advised users in the united states to either return or re-label the affected products. according to the local supplier, integmed ltd., the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 13 june 2014.

Device

BioGlue Surgical Adhesive 5mL
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: CryoLife BioGlue Surgical Adhesive 5mL
  • Manufacturer
    CryoLife

Manufacturer

CryoLife