Recall Z-1698-2025
Vyaire Medical · initiated April 10, 2025
Class I – dangerous or defective products that could cause serious health problems or death
Product
Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH265 Software Version: N/A Product Description: AirLife Infant Heated Wire Circuit Kit Dual-limb, Dual-heat, high-flow circuit (>4 L/min) Contains AH165 Circuit, AH290 Chamber Component: No. a conduit for respiratory gas between the patient and a ventilator.
Codes / lots: Lot Code: Lot/Serial Number(s): 0004247924 0004247925 0004252940 0004252941 0004256292 0004256293 0004256294 0004256295 0004272325 0004272868 0004278978 0004279156 0004280036 0004285304 0004288036 0004289514 UDI-DI: AirLife Label Each: 10889483595909 Case: 30889483595903 Vyaire Label: Each: 10190752145160 Case: 50190752145168
Reason for recall
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.
FDA-determined cause: Component design/selection
Action taken
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 choose between returning or destroying affected product. Firm will provide replacement product. If you have any questions regarding this field action, please call AirLife at 1-800-433-2797, or e-mail at productquality@myairlife.com.
Details
- Recall number
- Z-1698-2025
- Initiated
- April 10, 2025
- Posted by FDA
- May 9, 2025
- Product code
- BZE – Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
- Quantity
- 3053
- Distribution
- Worldwide distribution - US Nationwide and the countries of Germany, Poland, Belgium, Spain, Romania, UK, Italy, Netherlands, India, Slovenia, Qatar, and Saudi Arabia.
- Recalling firm
- Vyaire Medical, Mettawa, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1697-2025 Class I | Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog…Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any… | 04/10/2025Open, Classified |