Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH165 Software Version: N/A Product Description:…
Vyaire Medical · Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, i…
Open FDA's page for this record- Cfres ID
- 213370
- Product res number
- Z-1697-2025
- Event date initiated
- 2025-04-10
- Event date posted
- 2025-05-09
- Recall status
- Open, Classified
- Res event number
- 96664
- Product code
- BZE
- Firm FEI number
- 3013421741
- Recalling firm
- Vyaire Medical
- Address 1
- 26125 N Riverwoods Blvd
- City
- Mettawa
- State
- IL
- Postal code
- 60045-3420
- Root cause description
- Component design/selection
- Product quantity
- 1895
- Product description
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.
- Code info
Lot Code: Lot/Serial Number(s): 0004240347 0004240348 0004252021 0004253194 0004253470 0004255176 0004260100 0004262183 0004262987 0004263371 0004292077 0004300092 0004301668 UDI-DI AirLife Label Each: 10889483595862 Case: 30889483595866 Vyaire Label Each: 10190752145139 Case: 50190752145137
- 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.
- 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 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.
- Distribution pattern
Worldwide distribution - US Nationwide and the countries of Germany, Poland, Belgium, Spain, Romania, UK, Italy, Netherlands, India, Slovenia, Qatar, and Saudi Arabia.
- K numbers
- K151303
- Harmonized identifiers (openFDA)
- Device name
- Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
- Medical specialty description
- Anesthesiology
- Regulation number
- 868.5270
- Device class
- 2
- K number
- K770984, K034026, K860941, K241268, K880769, K881625, K873179, K201418, K110398, K253322, K151959, K122432, K915226, K761295, K173280, K894654, K842597, K153234, K914994, K140424, K222822, K103767, K234032, K952267, K092129, K781530, K243244, K801101, K844005, K851245, K150900, K160540, K780630, K170378, K821735, K881231, K100104, K252066, K881137, K881451 +6 more
- Registration number
- 3004050971, 3049808762, 3011137372, 1000604079, 9611451, 2085602, 3001421318, 3001400310, 3000126629, 3017520736, 3029706818, 3016723884, 3023272766, 3008331339, 3029906224, 3021039857, 8030673, 3007709321, 9611500, 3029227324, 3003898360, 3008264065, 3011120183, 3002797442, 2518422, 1314417, 8022265, 3020460367, 3013095415, 2028807, 3015084765, 3030149975, 1225492, 8021995, 3014766741, 3002807267, 3008342612, 3006061749, 3007220521, 3015928685 +10 more
- FEI number
- 3004050971, 3049808762, 1000604079, 3001421318, 1000374126, 3001400310, 3000126629, 3017520736, 3016723884, 3023272766, 3008331339, 3029906224, 3002861325, 3021039857, 3007709321, 3029227324, 3003898360, 3002806988, 3008264065, 3011120183, 3002797442, 2518422, 3000210616, 1314417, 3004213967, 3020460367, 3013095415, 3015084765, 3030149975, 3005747797, 3003949221, 3002807293, 3014766741, 3002807267, 3008342612, 3003080079, 3006061749, 3007220521, 3015928685, 3018783526 +10 more