Class 1 Recall: Vyaire Medical Recalls AirLife Humidification Chamber & Heated Breathing Circuit Kits Due to Manufacturing Error
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.
Tue Jan 30 2018
Recalled Product(s)
- Recalled Product(s): Air Life Humidification Chamber & Heated Breathing Circuit Kits
- Model/Item Numbers:See complete list
- 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
- Devices Recalled in the U.S.: 16,670 units nationwide
Device Use:
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.
Reason for Recall
Vyaire Medical is recalling 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.
Who May be Affected
- All patient groups who may be given breathing support with ventilators using these devices
- Health care providers using ventilators with the AirLife Humidification Chamber and Heated Breathing Circuit Kits
What to Do
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
Contact Information
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.
Date Recall Initiated
November 29, 2017
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experience using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.