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Regulator, Pressure, Gas Cylinder
FDA product code CAN · Class 1 · Anesthesiology
1,394
Registered devices
646
Adverse events
17
Recalls
55
510(k) clearances
Devices with this code
Ohio — OHIO MEDICAL, LLCSINYA — Danyang Xinya Valve Co., Ltd.Western/Scott Fetzer — Western EnterprisesFRU, Int'l O2 Regulator, 2-4 Cyl — ACCUTRON, INC.NA — Control Devices, LLCBF — Allied Medical, LLCWestern/Scott Fetzer — Western EnterprisesResp-O2 Mini Oxygen Regulator, CGA 870 Style — Dynarex CorporationOhio — OHIO MEDICAL, LLCOhio — OHIO MEDICAL, LLCWestern/Scott Fetzer — Western EnterprisesVarimed+ — GCE, s.r.o.Cavagna — CAVAGNA NORTH AMERICA INCControl Devices — Control Devices, LLCDRIVEMEDICAL — Drive Devilbiss HealthcareMediReg II — GCE, s.r.o.MVA2 Viproxy 1 Touch — CAVAGNA GROUP SPAWestern/Scott Fetzer — Western EnterprisesMADA MEDICAL PRODUCTS, INC. — MADA MEDICAL PRODUCTS, INCEMSREG8725-B2D — Meret USA LLCWestern/Scott Fetzer — Western EnterprisesOxygen Regulator — Dynarex CorporationMediReg II — GCE, s.r.o.Western/Scott Fetzer — Western Enterprises
Recent 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 |
| 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 actual |
| 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 deat |
| 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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