Z-0405-2024Class II

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

Name: Z-0405-2024 with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, an accessory to...
Creator: Breas Medical, Inc.
Published: 2023-10-13
License: https://open.fda.gov/license/

Breas Medical AB / initiated 2023-10-13 / Open, Classified / root cause: manufacturing process

FDA source

Breas Medical, Inc. began a recall of 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... on 2023-10-13. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0405-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-13
Posted: 2023-11-27
Recalling firm: Breas Medical AB
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.
Product code: NOU Continuous, Ventilator, Home Use
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
Root cause tag: manufacturing process
FDA 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 NIV Angled Mouthpieces, we are asking customers to identify mouthpieces delivered from Breas since April 4, 2023 and complete the response form. We kindly ask you to acknowledge receipt of this Field Safety Notice together with your choice to remedy the issue using attached reply form NIV Angled Mouthpiece Field Safety Notice Distributor/Customer Reply Form. Contact Information Email: [email protected] Helpline: +1 (855) 436-8724 Postal Address 16 Esquire Road, N. Billerica, MA 01862 Web Portal: breas.com
Quantity in commerce: 215 units
Distribution: Nationwide Foreign: Canada
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0405-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0405-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-06	2023-11-27

Product code NOU

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)