Recall Z-0268-2022 ยท CAN Regulator, Pressure, Gas Cylinder
Western/Scott Fetzer Company
Western Oxytote DTE Digital VIPR (head only) Model: MNDR-600
| Date | Oct 16, 2021 |
| Status | Open, Classified |
| Reason | VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke |
| Root cause | Device Design |
| Action | Western / Scott Fetzer Co. issued Urgent Medical device Recall letter, dated 10/15/21 distributed via USPS to consignees on 10/16/21, and emailed to the same consignees on 10/18/21. Letter states reason for recall , health risk and action to take: Fill facility employees are asked to verify the functionality of each unit through the observation of information on the digital display. Note that this direction and expectation is already clearly indicated in the product Operating Instructions and Inspection Guidelines. If the digital display shows the expected information as depicted in the Operat |
| Quantity | 4974 units |
| Distribution | CT, MD, MT, OH |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.