Class 2 Device Recall vyaire

• Date Initiated by Firm: October 27, 2023
• Date Posted: December 05, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0488-2024
• Recall Event ID: 93332
• PMA Number: P890057
• Product Classification: Ventilator, high frequency - Product Code LSZ
• Product: vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
• Code Information: UDI/DI 10190752159747: Lot/serial numbers: 4060467, 4165459, 4167324, 4180598, 4180599, 4180604, 4180609, 4180610, 4180611, 4182155, 4182156, 4182157, 4182158, 4182159, 4182160, 4182161, 4182162, 4182163, 4182164, 4183410, 4183411, 4188658, 4190144, 4253788, 4253789, 4180603
• 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: 188 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.

• PMA Database: PMAs with Product Code = LSZ