Events

Rappel de Device Recall Vaxcel Implantable Vascular Access System

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 Corp.

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
    37427
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0746-2007
  • Date de mise en oeuvre de l'événement
    2006-06-13
  • Date de publication de l'événement
    2007-04-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2007-04-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50541
  • 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
    Implantable Vascular Access System - Product Code LJT
  • Cause
    Mispackaging: some kits of peelable sheaths/dilators may contain a 10f sheath instead of a 9f sheath--(recalling firm was notified by their supplier b. braun medical of the error).
  • Action
    Boston Scientific sent Urgent Medical Device Recall Notification- Immediate Action Required letters- (dated 6/13/06) to all 11 end users via Federal Express. The letters informed the end users that some of the peelable sheaths/dilators in the Vaxcel Implantable Vascular Access kits may incorrectly contain 10F sheaths instead of 9F sheaths which had been supplied by B. Braun Medical Inc. Improper sizing of the sheath for the catheter may result in difficulty /inability to insert the catheters. The letters instructed the end users to immediately remove the affected lots from inventory, segregate the recalled product, contact Boston Scientific at 1-800-862-1284 to obtain a Return Authorization (RGA) number, pack the product in an appropriate shipping carton, affix the shipping label to the outside of the shipping carton, write the RGA number on the outside of the shipping carton, and to return the recalled product to Boston Scientific''s Distribution Center Attn: QA Returns, 500 Commander Shea Blvd., Quincy, MA 02171. Accompanying each letter was a Reply Verification Tracking Form to be completed by the end user and mailed or faxed to Boston Scientific even if the user did not have the recalled lots on hand.

Device

Device Recall Vaxcel Implantable Vascular Access System
  • Modèle / numéro de série
    Lots 1109717 and 1120230
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    NY, CA, MD, WA, TN.
  • Description du dispositif
    Vaxcel Implantable Vascular Access System - Plastic Standard Port With 9F Polyurethane Catheter, Catalog/REF No. 45-360, UPN/Material No. M001453600, Single Use Only, STERILE, EO, Boston Scientific MEDI-TECH (617) 972-4000/(800) 225--3238, 480 Pleasant Street, Watertown, MA 02472 --- The port is provided as a kit, with various single use, disposable items necessary for achieving vascular access and implanting the port catheter. Each kit is provided in a plastic (PETG) tray with a heat-sealed tyvek lid. This inner tray is then placed in a second outer plastic (PETG) tray, along with the Directions for Use, and also sealed with a tyvek lid which is then labeled. The port kit is placed in a cardboard carton, with additional labels and sealed.
  • Manufacturer
    Boston Scientific Corp

Manufacturer

Boston Scientific Corp
  • Adresse du fabricant
    Boston Scientific Corp, 10 Glens Falls Tech Park, Glens Falls NY 12801-3864
  • Source
    USFDA