Vyaire Medical AirLife Resuscitation Device & Broselow Convenience Kit by Vyaire Medical: Class I Recall - Due to Risk of Malfunction Caused by Error in Product Design

AUDIENCE: Emergency Medicine, Health Professional, Risk Manager, Patient, Pulmonology

ISSUE: 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.

• Model/Item Numbers: See "Full List of Affected Devices"
• Lot Numbers: See "Full List of Affected Devices"

BACKGROUND: 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.

RECOMMENDATION: 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 [email protected]
• 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.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the press release, at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm607494.htm