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Resp-O2 M6 Oxygen B-Cylinder,1L With CGA870 Post Valve
Dynarex Corporation · Model 36393 · UDI-DI 00840117327511
10
510(k) clearances
99
Adverse events (8 deaths)
18
Recalls
17
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-28 | Ventec Life Systems, Inc. | Labeling; Oxygen Cylinders do not contain required medical gas labeling |
| 2026-07-28 | Ventec Life Systems, Inc. | Labeling; Oxygen Cylinders do not contain required medical gas labeling |
| 2026-07-28 | Ventec Life Systems, Inc. | Labeling; Oxygen Cylinders do not contain required medical gas labeling |
| 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 |
| 2019-08-15 | Western / Scott Fetzer Company | Limited access to flow settings as a result of the control knob having been rotated beyond its functional range |
| 2019-08-15 | Western / Scott Fetzer Company | Limited access to flow settings as a result of the control knob having been rotated beyond its functional range |
| 2019-08-15 | Western / Scott Fetzer Company | Limited access to flow settings as a result of the control knob having been rotated beyond its functional range |
| 2019-08-15 | Western / Scott Fetzer Company | Limited access to flow settings as a result of the control knob having been rotated beyond its functional range |
| 2019-08-15 | Western / Scott Fetzer Company | Limited access to flow settings as a result of the control knob having been rotated beyond its functional range |
| 2009-05-15 | Allied Healthcare Products Inc | Medical 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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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.