Events

Rappel de Device Recall Boston Scientific

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Boston Scientific Corporation.

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
    44736
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0117-2008
  • Date de mise en oeuvre de l'événement
    2007-08-28
  • Date de publication de l'événement
    2007-10-31
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-07-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64330
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Biopsy Forceps - Product Code FFF
  • Cause
    Device lacked manufacturing finishing process resulting in endoscope damage.
  • Action
    Boston Scientific notified accounts by letter on 8/28/07 by Federal Express Priority mail. Accounts are requested to remove product from inventory and return product.

Device

Device Recall Boston Scientific
  • Modèle / numéro de série
    Lot Numbers: 8984691, 9005322, 9005726, 9005727
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide, including USA, Sweden, and South Africa.
  • Description du dispositif
    Boston Scientific Radial Jaw Large Capacity Biopsy Forceps with Needle, Sterile, 240 mm. Box of 20 || UPN Number: M00513331 || REF: 1333-20
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Adresse du fabricant
    Boston Scientific Corporation, 100 Boston Scientific Way, Marlborough MA 01752-1234
  • 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
    USFDA