Reported Dec 6, 2023 · Ongoing
with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, an accessory to ventilator…
Breas Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Breas Medical, Inc. · 16 Esquire Rd · North Billerica, MA · 01862-2527
Is this the product you have?
- with Notch 22M/15F sold as part
- of Breas Medical MPV circuit 2 pc Kits006093, 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 codes and dates
- UDI-DI05030267120505 NIV Angled Mouthpiece with Notch 22M/15F; 07321820060931 MPV Kit 006093; 07321820066537 MPV
- Kit 006653 MPV mouthpiece Lot Numbers
3230444432305269 and 32306017
- Amount recalled
- 215 units
Where it was sold
- Nationwide
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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