Recall Z-1550-2018 · OEV Cardiopulmonary Resuscitation Aid Kit

Vyaire Medical

AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, filter 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.

Date	May 10, 2018 (initiated Apr 27, 2017)
Status	Terminated
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.
Root cause	Component design/selection
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
Quantity	1,260 units
Distribution	Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.
FDA record	Open on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.