Reported Dec 13, 2023 · Completed
vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory…
Vyaire Medical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Vyaire Medical · 26125 N Riverwoods Blvd · Mettawa, IL · 60045-3420
Is this the product you have?
- vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
- Lot codes and dates
- UDI/DI 10190752159747Lot/serial
- numbers
40604674165459416732441805984180599418060441806094180610418061141821554182156418215741821584182159418216041821614182162418216341821644183410418341141886584190144425378842537894180603
- Amount recalled
- 188 circuits
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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