Recall Z-0405-2024 ยท NOU Continuous, Ventilator, Home Use
Breas Medical, Inc.
with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, an accessory to ventilator device, Vivo 45LS. intended for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system.
| Date | Nov 27, 2023 (initiated Oct 13, 2023) |
| Status | Open, Classified |
| Reason | Produced with unintended open slits on the side of the mouthpiece body, may result in insufficient ventilation in spontaneous breathing patients using MPV-VCV and MPV-PCV modes of ventilation |
| Root cause | Process control |
| Action | Breas Medical contacted customers via telephone followed by email on 10/13/23. Letter (Breas reference: SCAR-330) states reason for recall, health risk and action to take: Breas Medical recommends that all those potentially affected by this notice inspect existing inventory and identify mouthpieces which have been set up with the Vivo 45 LS for patient use. All defective mouthpieces shall be discarded. Breas Medical will provide replacement NIV Angled Mouthpieces, article number 008234, for all defective inventory and for devices in patient possession, where applicable. To obtain replacement N |
| Quantity | 215 units |
| Distribution | Nationwide Foreign: Canada |
| FDA record | Open on fda.gov |