Breas Medical, Inc. is recalling 215 units of its NIV Angled Mouthpieces and MPV Kits because they were manufactured with unintended open slits on the side of the mouthpiece. These mouthpieces are used as accessories for the Vivo 45LS ventilator device. If you are using these devices in specific ventilation modes (MPV-VCV or MPV-PCV), the slits can prevent you from receiving the full amount of air or pressure needed for breathing. Consumers should contact their healthcare provider or the manufacturer to determine if their equipment is affected and to receive further instructions.
The unintended slits on the mouthpiece body create an air leak during use, which can result in the patient receiving insufficient ventilation. For patients who rely on these devices for spontaneous breathing, this defect poses a serious risk of respiratory distress or inadequate oxygenation.
manufacturer or healthcare provider Consultation
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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