Events

Alerte De Sécurité sur RIGIFLEX II Single Use Achalasia Balloon Dilator

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

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
    2013-05-31
  • Date de publication de l'événement
    2013-05-31
  • 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_20130531b.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: boston scientific rigiflex ii single use achalasia balloon dilator medical device manufacturer, boston scientific, has issued a field safety notice concerning rigiflex ii single use achalasia balloon dilator with: material no.: m00554510 catalogue no.: 5451 lot/batch no.: 091541 expiration date: 2013-12 boston scientific has become aware that the pouch label expiration date on a single lot/batch of rigiflex ii single use achalasia balloon dilators is labeled with the incorrect expiration date, 0213-12. boston scientific has confirmed that the correct expiration date is 2013-12 (in the year-month format, yyyy-mm). the product is not expired and there is no patient risk related to the labeling issue if the product is used prior to 2013-12. the manufacturer advises users to immediately discontinue use of and segregate affected products, and to return the affected product. according to the local supplier, affected products were not distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 31 may 2013.

Device

RIGIFLEX II Single Use Achalasia Balloon Dilator
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Boston Scientific RIGIFLEX II Single Use Achalasia Balloon Dilator
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • Société-mère du fabricant (2017)
    Boston Scientific
  • Commentaire du fabricant
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DH