Cylinder, Compressed Gas, And Valve
Anesthesiology · 21 CFR 868.2700
Recent MDR events
96 adverse event reports on file
- Intelli-OX+ Medical Oxygen CylinderJul 22, 2026InjuryAirgas Usa, Llc25904140
- INTELLI-OXJul 17, 2026MalfunctionAirgas Usa3003764448-2026-00001
- GRAB N' GOApr 27, 2026InjuryLinde Gas & Equipment3012160128-2026-00005
- INTELLI-OX PORTABLE OXYGEN TANKFeb 25, 2026MalfunctionAirgas UsaMW5184415
- ISPAN C3F8 INTRAOCULAR GASNov 19, 2025InjuryBausch + Lomb0001920664-2025-00119
- WALK-O2-BOUT+ COMPRESSED OXYGENNov 3, 2023MalfunctionAirgas Therapeutics Llc18064380
- INTELLIOX PLUSSep 18, 2023MalfunctionRotarex3003764448-2023-00002
- INTELLI-OXAug 18, 2023InjuryAirgas Usa Llc / Air Liquide Healthcare America CorporationMW5144785
- LIV (LINDE INTEGRATED VALVE)Mar 22, 2022MalfunctionLinde Gas & Equipment Inc.13844674
- CRYO TANKNov 9, 2021MalfunctionPraxair Distribution, Inc.12778516
Event type breakdown
Recalls
15 recall events for this product code
- Intermed Gas Products CorporationTerminatedSep 11, 2009
Post Medical Valves VO870A-Y and VO870-A-Y-T PSI 2015, PSI 2015, CGA 870, Inlet .750 STDS, Gas services (Oxygen), PSI 2015, Aluminum Cylinders, InterMed Gas P
Firm received reports from customers that valves malfunctioned when installation and/or filling process. Customers forwarded pictures of the defect where the top portion of the packing nut broke off from the threaded portion of the net; which may cause the valve to fail and result in uncontrolled release of oxygen when the valve is in the open position.
Z-2011-2009 · View FDA record ↗ - Allied Healthcare Products IncTerminatedSep 10, 2009
Empty M9 aluminum oxygen cylinders packaged in shipping containers (1 per container) labeled as: Product #0022-57P, Desc: CYL 02 ALUM 240 LITER, Catalog #31-10-
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.
Z-2031-2009 · View FDA record ↗ - Allied Healthcare Products IncTerminatedSep 10, 2009
Empty D aluminum oxygen cylinders packaged in shipping containers labeled as: Product #0022-44P, CYL 02 ALUM 400 LITER, Catalog #31-10-0014. The brand and firm
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.
Z-2032-2009 · View FDA record ↗ - Allied Healthcare Products IncTerminatedSep 10, 2009
Empty D aluminum oxygen cylinders packaged in shipping containers labeled as: Product #0022-58 P, Desc CYL 02 ALUM 400 LITER, Catalog #31-10-2014. The brand
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.
Z-2033-2009 · View FDA record ↗ - Allied Healthcare Products IncTerminatedSep 10, 2009
Empty Jumbo D aluminum oxygen cylinders, 72 cylinders per skid labeled as: Product #0022-96D, Desc: CYL 02, JUMBO D, A VLV, 72/SKID, Catalog #31-10-0117. The b
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.
Z-2034-2009 · View FDA record ↗ - Allied Healthcare Products IncTerminatedSep 10, 2009
Empty Jumbo D aluminum oxygen cylinders packaged in shipping containers labeled as: Product #0022-96P, Desc CYL 02, JUMBO D, W/TYPE B POST, Catalog #31-10-2017.
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.
Z-2035-2009 · View FDA record ↗ - Allied Healthcare Products IncTerminatedSep 10, 2009
Empty Jumbo D aluminum oxygen cylinders packaged in shipping containers labeled as: Product 0022-96, Desc CYL 02 ASSY., 637.2 LITER, Catalog #31-10-0017. The
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.
Z-2036-2009 · View FDA record ↗ - Allied Healthcare Products IncTerminatedSep 10, 2009
Empty D aluminum oxygen cylinders packaged in shipping containers labeled as: Product #65261-E, Desc D PORTABLE W STRAIGHT POS, Catalog #65261-E. The brand and
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.
Z-2037-2009 · View FDA record ↗ - Allied Healthcare Products IncTerminatedSep 10, 2009
First Responder Kit containing a 240-liter aluminum oxygen cylinder with individually packaged regulator, cannula, and bag mask resuscitator, all packaged in a
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.
Z-2038-2009 · View FDA record ↗ - Western/Scott Fetzer CompanyOpen, ClassifiedUnknown
Roberts Digital VIPR System (with E-size cylinder)
VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke
Z-0267-2022 · View FDA record ↗
Registered firms
18 firms currently registered for this product code
Jiangsu Mcare Medical Co.,ltd.
Danyang Jiangsu, CN
Yuyao Jiahua Medical Appliance, Co., Ltd.
Yuyao Zhejiang, CN
Jiangsu Jumao X-care Medical Equipment Co., Ltd
Danyang Jiangsu, CN
Life Corporation
Orlando, FL, US
Danyang Xinya Valve Co., Ltd.
Danyang Jiangsu, CN
Hangzhou Rollmed Co.,ltd.
Hangzhou Zhejiang, CN
Control Devices - Carr Lane
Saint Louis, MO, US
Responsive Respiratory Inc.
Saint Louis, MO, US
Danyang Airtech Co.,ltd
danyang Jiangsu, CN
Kemp Llc
Charlotte, NC, US
Pro-med (wuxi)imp.& Exp.co.,ltd.
Wuxi Jiangsu, CN
Ceodeux S.a.
LINTGEN Luxembourg, LU
Shanghai Tianhai Composite Cylinders Co., Ltd.
Shanghai, CN
Airgas Usa
Houston, TX, US
Zjg Royaltrust Med Co., Ltd.
Zhangjiagang City Jiangsu, CN
Greens Surgicals Private Limited
Vadodara Gujarat, IN
510(k) clearances
13 clearances for this product code
- Air Liquide Healthcare America CorporationApr 13, 2017
K161179 · Intelli-Ox
- Essex Industries, Inc.Nov 18, 2016
K161472 · Walk-O2-Bout
- Praxair Distribution, Incorporated.Jun 3, 2016
K153518 · Medipure Oxygen-LC System
- Air Liquide HealthcareMay 21, 2015
K143060 · Intelli-Ox
- Western/Scott Fetzer Co.Apr 17, 2015
K142149 · OXYTOTE INFINITY SERIES VIPR SYSTEMS
- Praxair Healthcare ServicesJul 7, 2014
K132778 · GRAB 'N GO PLUS, GRAB 'N GO DIGITAL
- Air Liquide Healthcare AmericaMar 14, 2014
K131386 · EZ-OX PLUS GENERATION II
- Linde Gas North America, LLCMar 18, 2011
K101792 · LIV LINDE INTERGRATED VALVE-PORTABLE OXYGEN SYSTEM, MODEL M706