Events

Rappel de Device Recall AirLife Nebulizer Heater

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 Carefusion 211 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
    59376
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-3016-2011
  • Date de mise en oeuvre de l'événement
    2011-07-13
  • Date de publication de l'événement
    2011-08-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-04-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102439
  • 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
    nebulizer (direct patient interface) - Product Code CAF
  • Cause
    The recall was initiated because carefusion's investigation has confirmed the nebulizer heater can, over time, develop a failure mode that results in an internal electrical short. the short can result in smoke and sparks being emitted from the device. in the presence of oxygen enriched environments and a fuel source, this failure represents a potential risk of flame. carefusion is voluntarily rec.
  • Action
    Carefusion sent a URGENT PRODUCT RECALL letter dated July 15, 2011, to all affected customers. The letter identified the product, the problem, and the action needed to be taken by the customer. Customers were instructed to examine their inventory for the affected product as indicated on the sample shown in the enclosed Attachment A-1 and remove any affected heaters present in their facility. Confirm the total number of affected units in their possession and enter the quantity and respective serial number on the enclosed Customer Response Card (Attachment A-2). Customers were instructed to contact CareFusion's Technical Support Department at 800-554-8933, (6:30 am to 5:00 pm PDST), to obtain an RMA (returned materials authorization) number for the return of the affected product. Upon receipt of their response, CareFusion will ship to their customers new replacement Nebulizer Heaters in exchange for the affected units. Customers were instructed to acknowledge receipt of this communication by completing the enclosed Customer Response Card and faxing or sending a copy by return mail to the address indicated on the Customer Response Card, (Attachment A-2).

Device

Device Recall AirLife Nebulizer Heater
  • Modèle / numéro de série
    identified by with serial number logic of TXXXXX or SXXXXX.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    AirLife Nebulizer Heater, Catalog Code 2M8021 || The AirLife Nebulizer Heater is part of the heated nebulizer system intended to provide warm bland aerosol therapy to respiratory patients. The system is used in conjunction with a standard oxygen flowmeter, which by providing pressurized oxygen powers the nebulizer creating ultra-fine particles in the therapeutic aerosol. The heater warms the solution before it reaches the aerosol jet in the nebulizer and heats the dilution air before it is entrained into the aerosol stream. An aluminum heat exchanger on the nebulizer cap transfers the thermal energy to a nebulizer solution bottle warming the solution prior to aerosolizing.
  • Manufacturer
    Carefusion 211 Inc

Manufacturer

Carefusion 211 Inc
  • Adresse du fabricant
    Carefusion 211 Inc, 22745 Savi Ranch Pkwy, Yorba Linda CA 92887-4668
  • Source
    USFDA