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U.S. Department of Health and Human Services

Class 1 Device Recall AirLife Resuscitation

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 Class 1 Device Recall AirLife Resuscitationsee related information
Date Initiated by FirmApril 27, 2017
Date PostedMay 10, 2018
Recall Status1 Terminated 3 on May 09, 2019
Recall NumberZ-1569-2018
Recall Event ID 78412
Product Classification Cardiopulmonary resuscitation aid kit - Product Code OEV
ProductAirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector, PEEP valve 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.
Code Information Part Number: 2K8035C2. Lots: 0001022607, 0001029750, 0001034507
Recalling Firm/
Manufacturer		 Vyaire Medical
75 N Fairway Dr
Vernon Hills IL 60061-1845
For Additional Information ContactLindy Schenning
872-757-0109
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Component design/selection
ActionThe 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.
Quantity in Commerce2,982 units
DistributionWorldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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