Recall Z-2069-2015— Western / Scott Fetzer Company
Class I · Terminated
Class I FDA medical device recall by Western / Scott Fetzer Company, initiated 2015-01-31, terminated 2018-01-18. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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..
- Recalling firm
- Western / Scott Fetzer Company
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2015-01-31
- Terminated
- 2018-01-18
- Firm location
- Westlake, OH, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.