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N/A
SALTER LABS · Model 4907-7-7 · UDI-DI 00607411891700
NFB
Prescription
1
510(k) clearances
55
Adverse events (4 deaths)
6
Recalls
16
Facilities
Description
Adult. Demand Nasal Cannula, for use with dual port demand valve.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-04-26 | Inovo, Inc | The pressure gauge (manometer) may dislodge from the threaded insertion/mount, creating a leak. |
| 2016-06-21 | Invacare Corporation | The rear gradation scale was screen printed upside down on the flowmeter gauge. |
| 2016-06-21 | Invacare Corporation | The rear gradation scale was screen printed upside down on the flowmeter gauge. |
| 2007-10-19 | Superior Products Inc | Leakage: Device was leaking oxygen |
| 2007-01-24 | Sunrise Medical | Cylinder could lose oxygen at high pressure after the filling process |
| 2007-01-24 | Sunrise Medical | Cylinder could lose oxygen at high pressure after the filling process |
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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.