Recall Z-2069-2015 ยท CAN Regulator, Pressure, Gas Cylinder
Western / Scott Fetzer Company
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.
| Date | Jul 20, 2015 (initiated Jan 31, 2015) |
| Status | Terminated |
| 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. |
| Root cause | Component design/selection |
| Action | Western/Scott Fetzer sent an Urgent Medical Device Recall Notice notification dated January 31, 2015 to their customers via U.S. mail. The notification identified the affected product, problem and actions to be taken. The OxyTOTE/oxyQuik/AirTOTE Distributors and Oxygen Service Providers were instructed to: 1) Notify and provide the letter to all accounts/customers to which any OxyTOTE/oxyQuik/AirTOTE products have been distributed. Alternately, please provide a list of customers who received affected product and Western/Scott Fetzer will notify them on your behalf. 2) Referring to the in |
| Quantity | 162,678 units |
| Distribution | Worldwide Distribution -- US, including the states of Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Ca |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.