Vyaire Medical recalls 3100A Flexible Patient Circuits with serial numbers 4022993-4253792 that were distributed in the U.S. despite being approved only for non-U.S. use. This poses a risk of improper use.
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 specific flexible patient circuits for their 3100A ventilator that were distributed in the U.S. even though they were only approved for use outside the country. This could lead to improper use if used in the U.S. without proper approval.
These patient 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, potentially causing improper use if used without proper approval.
Healthcare providers using the 3100A ventilator in the U.S. may be affected. Patients using these circuits could face improper use risks if the circuits are not properly approved for U.S. use.
Check for the serial numbers: 4022993, 4160569, 4160570, 4163199, 4163200, 4165472, 4166359, 4231715, 4243198, 4253792. The circuits are intended for the 3100A High Frequency Oscillatory Ventilator.
Look for the serial numbers: 4022993, 4160569, 4160570, 4163199, 4163200, 4165472, 4166359, 4231715, 4243198, 4253792.
The recall states that these circuits were distributed in the U.S. despite being only approved for use outside the country.
Check the serial numbers listed and contact Vyaire Medical for further instructions.
No, these circuits were only approved for use outside the U.S. and may not meet U.S. safety standards.
We’ve drafted a message you can send Vyaire Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0489-2024 — Vyaire Medical Vyaire Medical Hello, I own a Vyaire Medical that is covered by recall Z-0489-2024 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.
