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Vyaire Medical Recall 93332

Description: vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)

Vyaire Medical Recall 93332 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0489-2024
Event ID93332
Event Descriptionvyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
Product TypeDevices
DistributionUS: Florida
Quantity16 circuits
Recall ReasonTwo 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.
Device Classification20231213
Device Code InfoUDI/DI 10190752155251: Lot/serial numbers: 4022993, 4160569, 4160570, 4163199, 4163200, 4165472, 4166359, 4231715, 4243198, 4253792
Center Classification Date20231205
Recall Initiation Date20231027
Recalling FirmVyaire Medical
Initial Notification E-Mail
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