Recall Z-0300-04 ยท MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
Bio-Med Devices, Inc.
MVP-10 Pediatric/ Neonatal Volume Ventilator
| Date | Jan 6, 2004 (initiated Nov 7, 2003) |
| Status | Terminated |
| Reason | Two way relief valve may fail to activate at the low negative pressure of -3cm H2O. |
| Root cause | Other |
| Action | Bio Med Devices notified accounts by telephone on 11/7/03, to return the device for replacement and correction. |
| Quantity | 3 units |
| Distribution | ID, PA, TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.