Events

Rappel de Encore 26 Inflation Device Single Pack

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Boston Scientific Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2017-RN-00795-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-06-21
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00795-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Notes supplémentaires dans les données
  • Cause
    Boston scientific has received reports of cracking with specific lots of encore 26 inflation device single packs. the device trays from these lots have the potential to crack under certain handling conditions, such as impact during shipment. this issue has been attributed to a change in the material used in the packaging process. use of an encore device with a cracked device tray during a procedure could result in patient infection if used within the sterile field. to date, no reports of patient harm have been received.
  • Action
    Boston Scientific is requesting that Customers: 1. Immediately check inventory and identify whether there are products with UPNs and lot numbers listed in Attachment 1 of the customer letter; 2. Inspect the device tray in the area highlighted above. If you identify any units with a cracked tray in your supply, immediately discontinue use and segregate affected units in a secure location; and 3. Complete the Reply Verification Tracking Form detailing identified affected units.

Device

Encore 26 Inflation Device Single Pack
  • Modèle / numéro de série
    Encore 26 Inflation Device Single PackUPN: H74904526011, M001151050, M00566670 and M0067101140 Multiple Lot NumbersARTG Number: 137086
  • Manufacturer
    Boston Scientific Pty Ltd

Manufacturer

Boston Scientific Pty Ltd
  • 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
    DHTGA