Home / Recalls / Breas Medical, Inc. / Z-0405-2024

Z-0405-2024 Class II Ongoing

Recalled by Breas Medical, Inc. — North Billerica, MA

Recall Details

Product Type
Devices
Report Date
December 6, 2023
Initiation Date
October 13, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product 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

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 by Breas Medical, Inc.

  • Z-2690-2024 Class I — Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or i (July 25, 2024)
  • Z-1382-2022 Class II — Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory (June 2, 2022)
  • Z-0943-2022 Class II — Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models (March 21, 2022)
  • Z-1352-2020 Class II — Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344. It is an acc (January 28, 2020)
  • Z-2094-2015 Class II — Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care (November 7, 2014)