Recall Z-0405-2024— Breas Medical, Inc.

Name: FDA recall Z-0405-2024
Creator: U.S. Food and Drug Administration
Published: 2023-10-13

Class II · Ongoing

Class II FDA medical device recall by Breas Medical, Inc., initiated 2023-10-13. It names 2 FDA 510(k) clearances: K233452, K193586. Product: 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.. 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.

Recalling firm: Breas Medical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-10-13
Firm location: North Billerica, MA, United States

510(k) clearances named in this recall

2 on FDA's record

K233452 — Vivo 45 LSBreas Medical AB·cleared 2025-01-13
K193586 — Vivo 45 LSBreas Medical AB·cleared 2021-01-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.