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MADA MEDICAL

MADA MEDICAL PRODUCTS, INC · Model 8250 · UDI-DI 00815160020665

NFB Prescription

510(k) clearances

Adverse events (4 deaths)

Recalls

Facilities

Description

A reduction valve designed to be attached through a gastight connector (e.g., a pin-index or bull-nosed screw thread connection) to the valve stem of an oxygen (O2) cylinder to lower high, variable gas pressure (e.g., 50 - 250 bar) to a lower, constant working pressure, typically 3 - 5 bar. It can be a single or a dual stage regulator, usually of a piston or diaphragm design. It will have a safety relief valve to avoid excessive pressure due to increased ambient temperatures, and it may have associated devices, usually a manometer or manometers, to display the available gas reserve of a gas cylinder and the working pressure

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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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.