MADA MEDICAL PRODUCTS, INC.
MADA MEDICAL PRODUCTS, INC · Model 1300BM · UDI-DI 00815160020009
Description
A container designed as a refillable cylinder(FILLED) with an integrated pressure regulator used to hold compressed medical oxygen (O2) under safe conditions at high pressure (e.g., 50 - 200 Bar). It is typically filled with O2 when delivered from the gas supplier and includes a built-in pressure regulator that, when activated, releases the O2 at the correct working pressure. It is available in some cylinder sizes (capacity) and color-coded to denote O2 content. The cylinder may be made of steel, aluminum (Al) or other ferrous or non-ferrous materials. O2 is used as an essential life support gas, for anesthesia, and for therapeutic purposes. Includes a 1319A carry bag.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-01-03 | Western/Scott Fetzer Company | Gauge malfunction: Digital gauge displays an incorrect tank pressure - displays pressure higher than actual tank pressure. This may lead to tank running out of oxygen during use wi |
| 2021-10-16 | Western/Scott Fetzer Company | VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke |
| 2021-10-16 | Western/Scott Fetzer Company | VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke |
| 2021-10-16 | Western/Scott Fetzer Company | VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke |
| 2018-05-08 | Dynarex Corporation | The device is equipped with a dial that has an inaccurate flow rate indicator. |
| 2015-10-08 | Precision Medical, Inc. | These lots of Oxygen Dial Regulators could have the settings label off by one position. When the indicator arrow points to OFF position, the regulator is actually on the half liter |
| 2015-01-31 | Western / Scott Fetzer Company | The firm has become aware of the possibility of ignition and rupture (explosion) of a compressed gas oxygen cylinder, which can cause serious injury and/or death. |
| 2014-04-07 | Western / Scott Fetzer Company | Separation events have occurred, including the VIPR separating from the Aluminum cylinder. |
| 2013-03-08 | Linde Gas North America Llc | A number of MEDICYL-e Portable Oxygen Systems may have misapplied valve flow knobs. |
| 2012-11-16 | Praxair Inc. | Isolated incidents of ignition inside Grab n' Go cylinders that had been knocked over or otherwise subject to significant physical impact. |
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