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U.S. Department of Health and Human Services

Class 2 Device Recall Breas NIV Angled Mouthpiece

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  Class 2 Device Recall Breas NIV Angled Mouthpiece see related information
Date Initiated by Firm October 13, 2023
Date Posted November 27, 2023
Recall Status1 Open3, Classified
Recall Number Z-0405-2024
Recall Event ID 93331
510(K)Number K193586  K233452  
Product Classification Continuous, ventilator, home use - Product Code NOU
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.
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
Recalling Firm/
Manufacturer		 Breas Medical, Inc.
16 Esquire Rd
North Billerica MA 01862-2527
For Additional Information Contact Chris Southerland
617-286-5509
Manufacturer 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
FDA Determined
Cause 2		 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: fsn@breas.com 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = NOU and Original Applicant = Breas Medical AB
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