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Completed

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

FDA Recall Z-0489-2024 · Posted 2023-12-05

Recalling FirmVyaire Medical
Recall StatusCompleted
Product CodeLSZ
Date Initiated2023-10-27
Product Quantity16 circuits

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.

Firm 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.

Root Cause

Process control

Distribution Pattern

US: Florida

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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