Ventlab BreathTech manual resuscitators with integrated manometers risk CO2 rebreathing due to a backwards leak. Affected models include adult, child, infant and pediatric resuscitators with specific reference numbers and production dates.
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
SunMed Holdings, LLC recalls Ventlab BreathTech manual resuscitators with integrated manometers because a backwards leak allows CO2 rebreathing. This could cause dangerous buildup of carbon dioxide in the patient's lungs during resuscitation attempts.
The integrated manometer in the patient valve has a backwards leak that allows carbon dioxide to be rebreathed by the patient. This can cause dangerous buildup of carbon dioxide in the lungs during resuscitation attempts, potentially leading to respiratory distress or other complications.
Healthcare professionals using these resuscitators for emergency medical care are most at risk. Patients receiving treatment with these devices could experience carbon dioxide buildup.
Check for specific reference numbers listed in the recall: adult models include BT5107F and BT5104P; child models include BT3030, BT3034, BT3025; infant models include multiple BT2000 series numbers; pediatric models include BT4000 series numbers. All units manufactured from September 21, 2018, to present are affected.
Identify your device's reference number from the list provided in the recall notice.
Reach out to Ventlab for guidance on next steps after identifying your device model.
Affected models include adult resuscitators (BT5107F, BT5104P), child resuscitators (BT3030, BT3034, BT3025), infant resuscitators (multiple BT2000 series numbers), and pediatric resuscitators (BT4000 series numbers).
All affected units were manufactured from September 21, 2018, to present.
Check your device's reference number against the list provided in the recall notice and contact Ventlab for guidance on next steps.
We’ve drafted a message you can send Ventlab to request your refund or repair — edit it as you like.
Subject: Recall Z-0362-2024 — Ventlab Ventlab Hello, I own a Ventlab that is covered by recall Z-0362-2024 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.
