Recalled Ventlab AirFlow manual resuscitators with integrated manometers have a backwards leak allowing CO2 rebreathing. Affected models include Adult, Child, Infant, Pediatric, and Small Adult Resuscitators with specific reference numbers. Stop using immediately to prevent potential CO2 buildup.
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Ventlab's AirFlow manual resuscitators with integrated manometers have a backwards leak that allows CO2 rebreathing. This hazard could lead to dangerous CO2 buildup in the patient's lungs during use. Affected models include various adult, child, infant, and pediatric resuscitators with specific reference numbers listed in the recall.
The integrated manometer in the patient valve has a backwards leak that allows carbon dioxide (CO2) to be rebreathed by the patient. This can cause dangerous CO2 buildup in the lungs, potentially leading to respiratory distress or other complications during emergency resuscitation.
Healthcare professionals and emergency responders who use Ventlab AirFlow resuscitators are most at risk. Patients using these devices could experience CO2 buildup if the leak occurs during resuscitation attempts.
Check the reference numbers listed in the recall. Affected models include Adult, Child, Infant, Pediatric, and Small Adult Resuscitators with specific reference numbers provided in the recall document. All units manufactured from September 21, 2018, to present are affected.
Discontinue use of the affected Ventlab AirFlow resuscitators to prevent potential CO2 buildup in the patient's lungs.
Affected models include Adult, Child, Infant, Pediatric, and Small Adult Resuscitators with specific reference numbers listed in the recall. All units manufactured from September 21, 2018, to present are affected.
The recall does not mention a fix or remedy; affected units must be stopped using immediately.
Check the reference numbers listed in the recall. Affected models include various resuscitators with specific reference numbers provided in the document. All units manufactured from September 21, 2018, to present are affected.
We’ve drafted a message you can send Ventlab to request your refund or repair — edit it as you like.
Subject: Recall Z-0361-2024 — Ventlab Ventlab Hello, I own a Ventlab that is covered by recall Z-0361-2024 from Ventlab. 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.
