with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, an accessory to ventilator de
Summary
The FDA issued a Class II for with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, by Breas Medical, Inc.. Reason: Produced with unintended open slits on the side of the mouthpiece body, may result in insufficient ventilation in spontaneous breathing patients using.
Details
Source
Device Recall
External ID
Z-0405-2024
Action Date
2023-12-06
Status
Ongoing
Category
device
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.
Lot/Code Info: 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
Quantity Affected: 215 units
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
Nationwide Foreign: Canada
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-13
Company
North Billerica, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 190 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Breas Medical, Inc. has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Breas Medical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Breas Medical, Inc. have FDA actions?
Breas Medical, Inc. has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0405-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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