Events

Rappel de Device Recall Concha Therm Neptune Heated Humidifier

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 Telefelx Medical.

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
    54232
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1040-2010
  • Date de mise en oeuvre de l'événement
    2010-01-12
  • Date de publication de l'événement
    2010-03-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-04-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87913
  • 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
    humidifier - Product Code BTT
  • Cause
    When turned on, the neptune heater may cause an artifact on the patient's heart monitor.
  • Action
    Teleflex consignees were notified via Urgent Medical Device Recall letter via next day delivery on/about 01/12/2010. They were asked to return all of the affected product. Each consignee that is a distributor was instructed to forward the letter to their consignees to retrieve relevant product from those locations. A second mailing to non-responders on the consignee list will be made approximately four to six weeks after the first mailing. A third mailing to non-responding customers on the consignee list will be made approximately four to six weeks after the second mailing or as an alternative, they may be contacted by phone, e-mail or fax. A record of these contacts will be maintained. Affected products received by Teleflex Medical will be reworked with software upgrade and placed back into distribution. Consignees will either receive a software upgrade on site by a third party or replacement product with the software upgrade. Records will be maintained accordingly.

Device

Device Recall Concha Therm Neptune Heated Humidifier
  • Modèle / numéro de série
    Product numbers: 425-00, 425-10 and 525-30, All lot and serial numbers.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    U.S. Canada, India, Japan, Puerto Rico, Germany, France, Italy and Ireland.
  • Description du dispositif
    Teleflex Medical, Hudson RCI, Concha Therm Neptune, Heated Humidifier. Product numbers: 425-00, 425-10 and 525-30.
  • Manufacturer
    Telefelx Medical

Manufacturer

Telefelx Medical
  • Adresse du fabricant
    Telefelx Medical, 2917 Weck Drive, Durham NC 27709
  • Société-mère du fabricant (2017)
    Teleflex Incorporated
  • Source
    USFDA