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Ceodeux S.A - Meditec

CEODEUX S.A. · Model 1151641 · UDI-DI 05400992008643

ECX
10
510(k) clearances
96
Adverse events (8 deaths)
15
Recalls
16
Facilities

Recalls

DateFirmReason
2021-10-16Western/Scott Fetzer CompanyVIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke
2019-08-15Western / Scott Fetzer CompanyLimited access to flow settings as a result of the control knob having been rotated beyond its functional range
2019-08-15Western / Scott Fetzer CompanyLimited access to flow settings as a result of the control knob having been rotated beyond its functional range
2019-08-15Western / Scott Fetzer CompanyLimited access to flow settings as a result of the control knob having been rotated beyond its functional range
2019-08-15Western / Scott Fetzer CompanyLimited access to flow settings as a result of the control knob having been rotated beyond its functional range
2019-08-15Western / Scott Fetzer CompanyLimited access to flow settings as a result of the control knob having been rotated beyond its functional range
2009-05-15Allied Healthcare Products IncMedical valves do not meet quality specifications which may cause the valve to fail and result in uncontrolled release of oxygen when the valve is in the open position.
2009-05-15Allied Healthcare Products IncMedical valves do not meet quality specifications which may cause the valve to fail and result in uncontrolled release of oxygen when the valve is in the open position.
2009-05-15Allied Healthcare Products IncMedical valves do not meet quality specifications which may cause the valve to fail and result in uncontrolled release of oxygen when the valve is in the open position.
2009-05-15Allied Healthcare Products IncMedical valves do not meet quality specifications which may cause the valve to fail and result in uncontrolled release of oxygen when the valve is in the open position.

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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.