Home › Device types › CAN
Regulator, Pressure, Gas Cylinder
FDA product code CAN · Class 1 · Anesthesiology
1,399
Registered devices
724
Adverse events
17
Recalls
55
510(k) clearances
Devices with this code
Varimed+ — GCE, s.r.o.Protekt Regulator — PROACTIVE MEDICAL PRODUCTS, LLCMediSelect II — GCE, s.r.o.Ohio — OHIO MEDICAL, LLCMVA2 Viproxy 1 Touch — CAVAGNA GROUP SPAOhio — OHIO MEDICAL, LLCWestern/Scott Fetzer — Western EnterprisesCramer Decker Medical — Cramer-Decker IndustriesLIFE®Regulator — Mv Life LLCOhio — OHIO MEDICAL, LLCMedSource Tank Regulator — MEDSOURCE INTERNATIONAL LLCPC — Allied Medical, LLCCo2mmander® ELITE — Angioadvancements, LLCSINYA — Danyang Xinya Valve Co., Ltd.Ohio — OHIO MEDICAL, LLCOhio — OHIO MEDICAL, LLCCramer Decker Medical — Cramer-Decker IndustriesResponsive Respiratory, Inc. — RESPONSIVE RESPIRATORY, INC.NA — Control Devices, LLCOhio — OHIO MEDICAL, LLCPC — Allied Medical, LLCEM — Allied Medical, LLCOhio — OHIO MEDICAL, LLCRegulators/Conservers — SUNSET HEALTHCARE SOLUTIONS, INC.
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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