Important Safety Alerts

The United States Food and Drug Administration (FDA) is issuing a medical device safety alert regarding the

Air Life Humidification Chamber & Heated Breathing Circuit Kits, manufactured by Vyaire Medical. The affected devices are identified as the following: -

• Air Life Humidification Chamber & Heated Breathing Circuit Kits
  • Lot Codes: AH290, AH132, AH265, AH202, and AH280
  • Manufacturing Dates: 18 May 2017 to 28 September 2017
  • Distribution Dates: 3 July 2017 to 10 November 2017

According to the FDA, the manufacturer 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.

The manufacturer sent an Urgent Recall Notification letter instructing affected users 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

For details, please refer to the FDA website:
https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm594566.htm

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 31 January 2018