Vyaire Medical recalls 3100A Flexible Patient Circuits (REF 29028-003) distributed in the U.S. that were only approved for use outside the country. These circuits may pose safety risks when used with U.S. ventilators.
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.
Vyaire Medical is recalling certain Flexible Patient Circuits for the 3100A High Frequency Oscillatory Ventilator that were distributed in the U.S. but only approved for use outside the country. Using these circuits with U.S. ventilators could create safety risks.
The recalled circuits were only approved for use outside the U.S. and were distributed in the U.S. This means they may not meet U.S. safety standards when used with local ventilators, potentially causing risks.
Healthcare providers using the 3100A ventilator with the recalled circuits in the U.S. are most at risk. Patients using these circuits may face safety issues.
Check for the 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. The circuits are labeled as REF 29028-003 for the 3100A ventilator.
Look for the serial numbers listed in the recall notice: 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.
The recalled circuits were only approved for use outside the U.S. and were distributed in the U.S., which may create safety risks when used with local ventilators.
The recall notice does not specify a remedy, so check the serial numbers and contact Vyaire Medical for further instructions.
The recall states they were only approved for use outside the U.S., so they may not meet U.S. safety standards and could pose risks.
We’ve drafted a message you can send Vyaire Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0488-2024 — Vyaire Medical Vyaire Medical Hello, I own a Vyaire Medical that is covered by recall Z-0488-2024 from Vyaire Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
