Events

Recall of Device Recall AirLife Nebulizer Heater

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Carefusion 211 Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    59376
  • Event Risk Class
    Class 2
  • Event Number
    Z-3016-2011
  • Event Initiated Date
    2011-07-13
  • Event Date Posted
    2011-08-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102439
  • Notes / Alerts
    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.
  • Extra notes in the data
    nebulizer (direct patient interface) - Product Code CAF
  • Reason
    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
  • Model / Serial
    identified by with serial number logic of TXXXXX or SXXXXX.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    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
  • Manufacturer Address
    Carefusion 211 Inc, 22745 Savi Ranch Pkwy, Yorba Linda CA 92887-4668
  • Source
    USFDA