Western Enterprises, Inc.
Westlake, OH, US
Western Enterprises, Inc. appears in FDA device records in Westlake, OH. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 18 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Western Enterprises, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Western a Scott Fetzer Corecall
- Western/Scott Fetzer Co.510(k), enforcement report, recall
510(k) clearance history
FDA records hold 1 510(k) clearance for Western Enterprises, Inc. in 2015.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2015 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1526809 | 1526809 | Western Enterprises, Inc. | 875 Bassett Rd, Westlake, OH 44145 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1376-2023 | Digital VIPR ROC-9839 Roberts Oxygen Ready to Use Digital VIPR (head only) ROC-9840, Roberts Oxygen Ready to Use Digital VIPR System (with E-size cylinder) MNDR-600, Western Oxytote DTE Digital VIPR (head only) MNDS-602, Western Oxytote DTE Digital VIPR System (with D-size cylinder) MNDS-603, Western Oxytote DTE Digital VIPR System (with E-size cylinder) | 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 without audible alarms, potentially leading to an out of oxygen event and no flow. | Class II | Open, Classified | |
| Z-0270-2022 | Western Oxytote DTE Digital VIPR System (with E-size cylinder) Model: MNDS-603 | VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke | Class II | Open, Classified | |
| Z-0269-2022 | Western Oxytote DTE Digital VIPR System (with D-size cylinder) Model: MNDS-602 | VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke | Class II | Open, Classified | |
| Z-0268-2022 | Western Oxytote DTE Digital VIPR (head only) Model: MNDR-600 | VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke | Class II | Open, Classified | |
| Z-0267-2022 | Roberts Digital VIPR System (with E-size cylinder) Model: ROC-9840 | VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke | Class II | Open, Classified | |
| Z-0343-2020 | Grab n Go Opti series VIPR system Model # PRX-9653 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use outside the 1,500 gauss (0.15 T) line during MR imaging for MRI systems up to 3.0 T. The device is intended for limited duration use, such as would be necessary during patient transports. | Limited access to flow settings as a result of the control knob having been rotated beyond its functional range | Class II | Terminated | |
| Z-0342-2020 | Grab n Go Opti series VIPR system Model # PRX-9646 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use outside the 1,500 gauss (0.15 T) line during MR imaging for MRI systems up to 3.0 T. The device is intended for limited duration use, such as would be necessary during patient transports. | Limited access to flow settings as a result of the control knob having been rotated beyond its functional range | Class II | Terminated | |
| Z-0341-2020 | Grab n Go Opti series VIPR system Model # PRX-9632 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use outside the 1,500 gauss (0.15 T) line during MR imaging for MRI systems up to 3.0 T. The device is intended for limited duration use, such as would be necessary during patient transports. | Limited access to flow settings as a result of the control knob having been rotated beyond its functional range | Class II | Terminated | |
| Z-0340-2020 | Grab n Go Opti series VIPR system Model # PRX-9627 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use outside the 1,500 gauss (0.15 T) line during MR imaging for MRI systems up to 3.0 T. The device is intended for limited duration use, such as would be necessary during patient transports. | Limited access to flow settings as a result of the control knob having been rotated beyond its functional range | Class II | Terminated | |
| Z-0339-2020 | Grab n Go Opti series VIPR system Model # PRX-9615 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use outside the 1,500 gauss (0.15 T) line during MR imaging for MRI systems up to 3.0 T. The device is intended for limited duration use, such as would be necessary during patient transports. | Limited access to flow settings as a result of the control knob having been rotated beyond its functional range | Class II | Terminated | |
| Z-2069-2015 | Various OxyTOTE Portable Oxygen System regulators, Valve Integrated Pressure Regulator, one unit per package. Product Usage: Used to dispense Oxygen at prescribed flow rates to patients for therapeutic purposes and is designed to provide mobility with a self-contained supply of Oxygen. | 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. | Class I | Terminated | |
| Z-1849-2014 | Model RG3000 and RG4000 Series Valve Integrated Pressure Regulator (VIPR) | Separation events have occurred, including the VIPR separating from the Aluminum cylinder. | Class II | Terminated | |
| Z-0060-2010 | Medical Gas Yoke Assembly. Airgas Portable 4-Cylinder Manifold Cart Model #AGI-2238. The device is a medical gas yoke assembly which is used to connect gas cylinder post valves to equipment used for anesthesia or respiratory therapy. | The yoke pins of the attached medical gas yoke assemblies could become displaced to such a degree that the yoke pin index safety system could become compromised and allow a post valve of one gas type to become interchangeable with a yoke connection of another gas type. | Terminated | ||
| Z-0061-2010 | Medical Gas Yoke Assembly. Airgas Portable 2-Cylinder Manifold Cart Model #AGI-2237. The device is a medical gas yoke assembly which is used to connect gas cylinder post valves to equipment used for anesthesia or respiratory therapy. | The yoke pins of the attached medical gas yoke assemblies could become displaced to such a degree that the yoke pin index safety system could become compromised and allow a post valve of one gas type to become interchangeable with a yoke connection of another gas type. | Terminated | ||
| Z-0059-2010 | Medical Gas Yoke Assembly. Generic 4-Cylinder Manifold Cart Model #8070. The device is a medical gas yoke assembly which is used to connect gas cylinder post valves to equipment used for anesthesia or respiratory therapy. | The yoke pins of the attached medical gas yoke assemblies could become displaced to such a degree that the yoke pin index safety system could become compromised and allow a post valve of one gas type to become interchangeable with a yoke connection of another gas type. | Terminated | ||
| Z-0056-04 | Western Medica OPC Portable Oxygen Conserving Regulator, Model MDL-7609, 1/2 - 5 LPM, packaged under the Medline label. | The demand valve is defective and does not function as intended in the 'Conservative Mode'. | Terminated | ||
| Z-0055-04 | Western Medica OPC Portable Oxygen Conserving Regulator, Model LIN-7005, 1/2 - 5 LPM, packaged under the Lincare label. | The demand valve is defective and does not function as intended in the 'Conservative Mode'. | Terminated | ||
| Z-0054-04 | Western Medica OPC Portable Oxygen Conserving Regulator, Model OPC-830, 1/2 - 5 LPM, packaged under the Western Medica label. | The demand valve is defective and does not function as intended in the 'Conservative Mode'. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain