with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, an acce...

FDA Device Recall #Z-0405-2024 — Class II — October 13, 2023

Recall Summary

Recall Number Z-0405-2024
Classification Class II — Moderate risk
Date Initiated October 13, 2023
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Breas Medical, Inc.
Location North Billerica, MA
Product Type Devices
Quantity 215 units

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

Distribution Pattern

Nationwide Foreign: Canada

Lot / Code Information

UDI-DI: 05030267120505 NIV Angled Mouthpiece with Notch 22M/15F; 07321820060931 MPV Kit 006093; 07321820066537 MPV Kit 006653 MPV mouthpiece Lot Numbers: 32304444, 32305269 and 32306017

Other Recalls from Breas Medical, Inc.

Recall # Classification Product Date
Z-2690-2024 Class I Vivo 45 LS, pressure and volume ventilator capa... Jul 25, 2024
Z-1382-2022 Class II Vivo 45LS Ventilator- intended to provide conti... Jun 2, 2022
Z-0943-2022 Class II Breas Ventilator Trolley with the Vivo 50/60/65... Mar 21, 2022
Z-1352-2020 Class II Protective Cover Vivo 55/65 (Used for Vivo 50/6... Jan 28, 2020

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.