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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 vyairesee related information
Date Initiated by FirmOctober 27, 2023
Date PostedDecember 05, 2023
Recall Status1 Completed
Recall NumberZ-0488-2024
Recall Event ID 93332
PMA NumberP890057 
Product Classification Ventilator, high frequency - Product Code LSZ
Productvyaire 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
FEI Number 3013421741
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
ActionVyaire 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 Commerce188 circuits
DistributionUS: Florida
Total Product Life CycleTPLC 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.
PMA DatabasePMAs with Product Code = LSZ
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