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U.S. Department of Health and Human Services

Class 2 Device Recall vyaire

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  Class 2 Device Recall vyaire see related information
Date Initiated by Firm October 27, 2023
Date Posted December 05, 2023
Recall Status1 Open3, 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 2		 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.
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