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O-Two
O-Two Medical Technologies Inc · Model 01FCO125D · UDI-DI 07540195050075
CCN
Prescription
9
510(k) clearances
51
Adverse events (4 deaths)
1
Recalls
15
Facilities
Description
FLOW CONTROL 0-25 LPM O2 DISS. The O-Two Adjustable Oxygen Therapy Flow Controller is a calibrated, 12-position, fixed orifice, non-gravity sensitive flow controller.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2009-05-29 | Amvex Corporation | The affected flowmeters may have a damaged o-ring which may cause the flowmeter to deliver higher amounts of gas and or not be able to shut off fully. |
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Get your free API keyRead the docsData 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.