Events

Rappel de Device Recall Airway balloon catheter

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 Acclarent, Inc..

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
    61070
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1095-2012
  • Date de mise en oeuvre de l'événement
    2012-01-30
  • Date de publication de l'événement
    2012-03-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-08-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107235
  • 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
    Bronchoscope accessory - Product Code KTI
  • Cause
    Acclarent received reports of difficulty deflating the balloon during the procedure, which could potentially result in airway obstruction.
  • Action
    Acclarent sent an "Urgent Voluntary Product Recall" letter dated January 31, 2012 by US mail, return receipt requested to all affected customers. Additionally, customers known to have scheduled procedures using the affected product were notified by phone to advise them of the recall. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory immediately, discontinue use and return any remaining in stock per the instructions provided. The letter provides additional information and photographs illustrating how to identify the recalled product. Customers were advised to complete the enclosed Business Reply Card regardless of whether they have or do not have product subject to this recall in their possession and mail to Stericycle. Customers were instructed to distribute this information to all staff within their department who uses the affected product. For further questions call 1-866-781-1173 or contact your Acclarent Sales Representative.

Device

Device Recall Airway balloon catheter
  • Modèle / numéro de série
    Product code BC1840A, Size 18 x 40: Lot 110307E, Exp 3/2013; Lot 110429E, Exp 4/2013; Lot 110502B, Exp 5/2013; Lot 110506B, Exp 5/2013; Lot 110606B, Exp 6/2013; Lot 110614B, Exp 6/2013.
  • Classification du dispositif
    Ear, Nose, and Throat Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution (USA) only sixe 18 x 40 Worldwide distribution other sizes.Distirbution to France, Canada, Saudi Arabia
  • Description du dispositif
    Inspira AIR Balloon Dilation System, || size 18 x 40; || Manufactured by Acclarent, Inc. || 1525-G O'Brien Drive, Menlo Park, CA 94025 || Product Usage: Dilation of airway tree.
  • Manufacturer
    Acclarent, Inc.

Manufacturer

Acclarent, Inc.
  • Adresse du fabricant
    Acclarent, Inc., 1525b Obrien Dr, Menlo Park CA 94025-1463
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA