AirLife Humidification Chamber, Heated Breathing Circuit Kits by Vyaire Medical: Class I Recall - Manufacturing Error

[Posted 01/31/2018]

AUDIENCE: Risk Manager, Critical Care Medicine, Nursing

ISSUE: Vyaire Medical recalled the AirLife Humidification Chamber and Heated Breathing Circuit Kits due to a manufacturing error that may cause parts of the chamber to split apart into layers, allowing water to overflow the chamber and to back up into the patient breathing circuit. If this occurs, an excessive amount of water could enter the airway or lungs of a ventilated patient and lead to serious adverse health consequences, including injury or death.

See the Recall Notice for a listing of affected model numbers.

• Lot Codes: AH290, AH132, AH265, AH202, and AH280
• Manufacturing Dates: May 18, 2017 to September, 28, 2017
• Distribution Dates: July 3, 2017 to November 10, 2017

BACKGROUND: The AirLife Humidification Chamber and Heated Breathing Circuit Kit are used with invasive and non-invasive ventilation systems to provide constant humidified breathing gasses for adults and children. The AirLife Humidification Chamber and Heated Breathing Circuit Kits are used in hospitals and other health care settings under the supervision of doctors and other trained health care providers.

RECOMMENDATION: Vyaire Medical sent an Urgent Recall Notification letter on November 29, 2017, instructing customers to:

• Inspect inventory on-hand and remove affected lots of the AirLife Humidification Chamber and Heated Breathing Circuit Kits;
• Destroy all affected product(s) in-stock in accordance with their facility's destruction protocol;
• Notify third party customers of the Urgent Recall Notification; and
• Complete the Customer Response Form and return to GMB-GLBALFieldActions@CareFusion.com

Customers wishing to receive credit for their in-stock products affected by this recall or to place an order for replacements can contact Vyaire Medical's Customer Service Department at 1-800-323-9088 (Option #1, followed by Option #1) Monday – Friday, 8:00 am to 5:00 pm, Central Standard Time.

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

[01/30/2018 - Recall Notice - FDA]