Breas Medical Ventilator Mouthpiece Recall: Unintended Slits May Reduce Ventilation
Breas Medical is recalling 215 mouthpiece units due to manufacturing defects with unintended slits that may result in insufficient ventilation in mechanical ventilation patients.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm medical device where serious injury (inadequate ventilation in a ventilator patient) has not yet been reported. No hospitalizations or deaths are documented in the source, and the hazard is stated as theoretical ('may result'). Class II device recall with potential safety impact but no actual harm reported fits the 'High' severity category.
Plain-English summary
Breas Medical, Inc. is recalling the NIV Angled Mouthpiece with Notch 22M/15F, a respiratory accessory used with the Vivo 45LS ventilator. The device is intended for partial insertion into a patient's mouth to facilitate respiratory access. The recall affects 215 units distributed nationwide and in Canada, with lot numbers 32304444, 32305269, and 32306017.
The mouthpiece units were produced with unintended open slits on the side of the mouthpiece body. This manufacturing defect may result in insufficient ventilation in patients using the device in spontaneous breathing modes (MPV-VCV and MPV-PCV ventilation).
Patients and healthcare providers should cease use of affected units and contact Breas Medical or their equipment supplier for replacement or corrective action.
The recalled product
- 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.
- Manufacturer
- Breas Medical, Inc.
- Affected units
- 215
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- 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
Distributed nationwide across the United States.
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