Date Initiated by Firm | April 27, 2017 |
Date Posted | May 10, 2018 |
Recall Status1 |
Terminated 3 on May 09, 2019 |
Recall Number | Z-1568-2018 |
Recall Event ID |
78412 |
Product Classification |
Cardiopulmonary resuscitation aid kit - Product Code OEV
|
Product | AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, 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: 2K8035. Lots: 001022606, 0001034508, 0001034509 |
Recalling Firm/ Manufacturer |
Vyaire Medical 75 N Fairway Dr Vernon Hills IL 60061-1845
|
For Additional Information Contact | Lindy 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 |
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. |
Quantity in Commerce | 3.600 units |
Distribution | Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe. |
Total Product Life Cycle | TPLC Device Report |
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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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