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Recall Observatory FDA recall evidence

Device 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.

Z-0405-2024

October 13, 2023

Class II

Product summary

Firm
Breas Medical, Inc.
Event
Event 93331
Status
Ongoing
Classification
Class II
Quantity
215 units
Official record key
device-enforcement:Z-0405-2024

Official wording

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

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

Distribution pattern: Nationwide Foreign: Canada

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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