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Recall Observatory FDA recall evidence

Device product

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

Z-0489-2024

October 27, 2023

Class II

Product summary

Firm
Vyaire Medical
Event
Event 93332
Status
Completed
Classification
Class II
Quantity
16 circuits
Official record key
device-enforcement:Z-0489-2024

Official wording

Reason: 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.

Code information: UDI/DI 10190752155251: Lot/serial numbers: 4022993, 4160569, 4160570, 4163199, 4163200, 4165472, 4166359, 4231715, 4243198, 4253792

Distribution pattern: US: Florida

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.