AirLife Resuscitation, Replacement kit for outer shell, Broselow Product Usage: The AirLife Resuscitation devices are ma

FDA device recall Z-1579-2018 · posted 2018-05-10 · Terminated

Recall details

Recalling firm

Vyaire Medical

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.

Action taken

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.

Root cause

Component design/selection

Status

Terminated

Product code

OEV

Quantity affected

150 units

Distribution

Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.

Date initiated

2017-04-27

Date posted

2018-05-10

Date terminated

2019-05-09

Location

Vernon Hills, IL