Class 2 Device Recall vyaire

• Date Initiated by Firm: October 27, 2023
• Date Posted: December 05, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0489-2024
• Recall Event ID: 93332
• Product Classification: Ventilator, high frequency - Product Code LSZ
• Product: vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
• Code Information: UDI/DI 10190752155251: Lot/serial numbers: 4022993, 4160569, 4160570, 4163199, 4163200, 4165472, 4166359, 4231715, 4243198, 4253792
• Recalling Firm/ Manufacturer: Vyaire Medical; 26125 N Riverwoods Blvd; Mettawa IL 60045-3420
• Manufacturer Reason for Recall: Two patient circuits, 29028-003 and 29028-004, for the 3100 High Frequency Oscillatory ventilator that are only approved for use outside the U.S. were distributed in the U.S.
• FDA Determined Cause: Process control
• Action: Vyaire issued a Customer Notification to its consignees on 10/27/2023 via email. The notice explained the issue and how to identify the affected products. The firm is seeking the return of the circuits.
• Quantity in Commerce: 16 circuits
• Distribution: US: Florida
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.