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GENTEC®
GENTEC(SHANGHAI)CORPORATION · Model FM197A-3L · UDI-DI 06970966664506
10
510(k) clearances
157
Adverse events (15 deaths)
1
Recalls
45
Facilities
Description
Flowmeter, 3L Series, Oxygen or Air, Aluminum
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2008-08-26 | Porter Instrument Co Inc | inverted check value on the bag tee assembly which can cause leaking of mixed N2O/O2 gas |
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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.