Breas Medical recalls specific MPV circuit mouthpieces with unintended slits that may cause insufficient ventilation in spontaneous breathing patients. Affected units include model 006093 and 006653 sold with Vivo 45LS ventilators.
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
Breas Medical is recalling two specific mouthpiece kits that have unintended slits on the side. These slits could cause insufficient ventilation for patients breathing on their own during certain ventilator modes. This is a safety issue that requires immediate attention.
The mouthpieces have unintended slits that can reduce airflow during spontaneous breathing. This may lead to insufficient ventilation when the patient is breathing on their own, potentially causing breathing difficulties or other complications.
Patients using the Breas MPV ventilator with these specific mouthpieces for spontaneous breathing may be at risk. The most vulnerable are those with respiratory conditions requiring ventilator support.
Check for mouthpieces labeled 'Notch 22M/15F' sold with Breas MPV circuit kits numbered 006093 or 006653. These were sold with Vivo 45LS ventilators and have lot numbers 32304444, 32305269, or 32306017.
Inspect the mouthpiece for unintended slits on the side of the mouthpiece body.
If slits are present, stop using the mouthpiece immediately and contact Breas Medical for a replacement.
The recalled mouthpieces are model 006093 and 006653 sold with Breas MPV circuit kits.
The recall record does not specify a return process, but you should stop using it if slits are found and contact Breas Medical for a replacement.
The mouthpieces were sold with Breas Vivo 45LS ventilators.
We’ve drafted a message you can send Breas Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0405-2024 — Breas Medical Breas Medical Hello, I own a Breas Medical that is covered by recall Z-0405-2024 from Breas Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
