Recall Z-1697-2025 ยท BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Vyaire Medical
Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH165 Software Version: N/A Product Description: AirLife Infant Heated Wire Circuit dual-limb, dual-heat, high-flow circuit (>4 L/min) Component: No. a conduit for respiratory gas between the patient and a ventilator.
| Date | May 9, 2025 (initiated Apr 10, 2025) |
| Status | Open, Classified |
| Reason | Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, including hypoxia, hypercapnia, and organ failure. |
| Root cause | Component design/selection |
| Action | On April 10, 2025, the firm notified customers via emailed letters titled URGENT: MEDICAL DEVICE RECALL. Customers are instructed to examine their inventory for the affected lots of product. Product in inventory should be quarantined. For in-use product - 1) For affected product in use that is utilizing the adaptor connection, immediately stop use of the product. 2) For affected product in use that is not utilizing the adaptor connection, ventilator circuit may continue to be utilized. Customers were provided with additional precautions to take to ensure proper function. Customers can c |
| Quantity | 1895 |
| Distribution | Worldwide distribution - US Nationwide and the countries of Germany, Poland, Belgium, Spain, Romania, UK, Italy, Netherlands, India, Slovenia, Qatar, and Saudi Arabia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151303 | AirLife Infant Heated Wire Circuit Care Fusion, Jan 21, 2016 |