Class 1 Recall: Vyaire Medical Recalls AirLife Resuscitation Devices and Broselow Convenience Kits Due to Risk of Malfunction Caused by Error in Product Design
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Mon May 14 2018
Recalled Product(s)
- Vyaire Medical AirLife Resuscitation Device & Broselow Convenience Kit
- Model/Item Numbers: See "Full List of Affected Devices"
- Lot Numbers: See "Full List of Affected Devices"
- Manufacturing Dates: January 2016 to January 2017
- Distribution Dates: March 2016 to January 2017
- Devices Recalled in the U.S.: 357,581
Device Use
The Vyaire Medical AirLife Resuscitation Device & Broselow Convenience Kit are manual resuscitation devices used together as one pair to provide constant ventilation to adults and children who are not breathing or cannot adequately breathe on their own following placement of an advanced airway device (tracheal or tracheostomy tube).
The AirLife Resuscitation Device & Broselow Convenience Kit are used in hospitals and other acute health care settings under the supervision of doctors and other trained health care providers.
Reason for Recall
Vyaire Medical is recalling the AirLife Resuscitation Device & Broselow Convenience Kit due to an error in its product design that may result in difficultly or the inability to disconnect the mask from the elbow of the resuscitator.
The AirLife Resuscitation Device & Broselow Convenience Kit comes fully assembled and ready to use with a cushioned mask, which can be removed to provide continuous ventilation after placement of an advanced airway device. However, the cushioned mask component has the possibility of sticking to the elbow of the resuscitator, making removal of the mask difficult, or unattainable. Difficulty disconnecting the mask from the resuscitator could result in a delay in or inability to provide necessary ventilation to the patient and potentially result in serious patient injury, such as hypoxia (inadequate oxygen supply), or death.
Who May be Affected
- Patients who may require manual resuscitation and ventilation after placement of an advanced airway device.
- Health care providers and first responders who use the AirLife Resuscitation Device & Broselow Convenience Kit to provide ventilation to patients after placement of an advanced airway device.
What to Do
Vyaire Medical sent an initial Urgent Recall Notification letter on April 27, 2017, and an updated letter on June 8, 2017 instructing customers to:
- Inspect inventory on-hand and remove affected lots of the AirLife Resuscitation Device & Broselow Convenience Kit;
- Destroy all affected product(s) in-stock in accordance with their facility's destruction protocol;
- Complete the enclosed Customer Response Form and return to GMB-GLB-VSFieldActions@CareFusion.com; and
- Contact Vyaire Medical Customer Support at (800)-323-9088 (Option #1), Monday-Friday, 8 AM 5 PM (CST) if they wish to obtain replacement devices.
Contact Information
Customers who have questions or need additional information or support regarding this recall should contact Lindy Schenning, Clinical Risk Coordinator, at (224)-706-6830 or Lindy.Schenning@CareFusion.com.
Date Recall Initiated
April 27, 2017
Full List of Affected Devices
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program. Health care professionals employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.