Events

Recall of AirLife Resuscitation

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

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
    78412
  • Event Risk Class
    Class 1
  • Event Number
    Z-1558-2018
  • Event Initiated Date
    2017-04-27
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163361
  • 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
    Cardiopulmonary resuscitation aid kit - Product Code OEV
  • Reason
    The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.
  • Action
    The firm, Vyaire Medical, sent an "URGENT RECALL NOTICE" letter on 04/27/2017 and again on 06/08/2017 for the expansion of the recall to its Customers. The letter described the product, problem and actions to be taken. The customers were instructed to inspect current inventory on-hand and immediately perform a 1OO% physical inventory of the product to identify and be removed; complete and return the Customer Response Form by Fax to: (312) 949.0972 or email to:GMB-GLB-VSFieldActions@CareFusion.com.; destroy all affected product in accordance with your facility's destruction protocol; and for replacements, contact your distributor Armstrong Medical direct at (800)323.4220 x129. For any additional questions and support concerning this voluntary recall, please contact Customer Advocacy Analyst at (224) 706.6829 or email: Kristina.Scheppa@CareFusion.com.

Device

AirLife Resuscitation
  • Model / Serial
    Part Number: 2K8008C2M. Lots: 0001022614, 0001035872
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.
  • Product Description
    AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, CO2 monitor, monometer || Product Usage: || The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
  • Manufacturer
    Vyaire Medical

Manufacturer

Vyaire Medical
  • Manufacturer Address
    Vyaire Medical, 75 N Fairway Dr, Vernon Hills IL 60061-1845
  • Manufacturer Parent Company (2017)
    Vyaire Holding Company
  • Source
    USFDA