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OHIO MEDICAL, LLC · Model FI-T03UO-CN-E · UDI-DI 00628101616632

CAX Prescription
10
510(k) clearances
156
Adverse events (15 deaths)
1
Recalls
45
Facilities

Description

UNPCKD IFM 3.5LPM T US OXY CF*N TYP E

Recalls

DateFirmReason
2008-08-26Porter Instrument Co Incinverted check value on the bag tee assembly which can cause leaking of mixed N2O/O2 gas

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.