Breas Medical recalls Protective Cover Vivo 55/65 (for Vivo 50/65 ventilators) due to risk of exhalation valve obstruction. This accessory may cause breathing issues if the outlet hole becomes blocked during use.
The outlet hole of the exhalation valve control pressure tube on the ventilator may become obstructed by the protective cover.
Breas Medical is recalling protective covers for Vivo 50 and Vivo 65 ventilators because the exhalation valve outlet hole might get blocked by the cover. This could interfere with the ventilator's ability to properly deliver air to patients, potentially causing breathing difficulties.
The protective cover's outlet hole may become obstructed by the cover itself, blocking the exhalation valve. This could prevent the ventilator from properly delivering air to patients, potentially causing breathing difficulties or other complications.
Healthcare providers using the Vivo 50 or Vivo 65 ventilators with this protective cover are most at risk. Patients using these ventilators in home or hospital settings could be affected if the cover becomes obstructed.
Look for the Protective Cover Vivo 55/65 (used for Vivo 50/65 ventilators) with part number 006344. These covers were distributed between January 11, 2018, and December 17, 2019.
Inspect the outlet hole of the exhalation valve control pressure tube for obstructions.
If the outlet hole is blocked, remove the cover immediately to prevent breathing issues.
The cover can be used while the ventilator is operating, but it must not be placed in warm areas like direct sunlight or near radiators to prevent obstruction.
If the outlet hole becomes obstructed, remove the cover immediately to prevent breathing difficulties.
These covers were distributed between January 11, 2018, and December 17, 2019.
We’ve drafted a message you can send Breas Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1352-2020 — Breas Medical Breas Medical Hello, I own a Breas Medical that is covered by recall Z-1352-2020 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.
