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Recall Observatory FDA recall evidence

Device product

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.

Z-1697-2025

April 10, 2025

Class I

Product summary

Firm
Vyaire Medical
Event
Event 96664
Status
Ongoing
Classification
Class I
Quantity
1895
Official record key
device-enforcement:Z-1697-2025

Official wording

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.

Code information: 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

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Germany, Poland, Belgium, Spain, Romania, UK, Italy, Netherlands, India, Slovenia, Qatar, and Saudi Arabia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.

Field note

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