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Is the Ventlab, LLC V-Care manual resuscitators with… safe?

SunMed Holdings, LLC · Recalled Oct 11, 2023
No — the Ventlab, LLC V-Care manual resuscitators with… was recalled on Oct 11, 2023 due to a safety issue. A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. If you have this product: Stop using this product and follow the manufacturer's recall instructions for a refund or replacement. Contact your pediatrician if your baby was exposed and shows any symptoms.
Why it was recalled
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
What to do
Stop using this product and follow the manufacturer's recall instructions for a refund or replacement. Contact your pediatrician if your baby was exposed and shows any symptoms.
View the official FDA recall →
This is an official recall published by FDA. Recall details are current as of 2026-06-25; verify the latest status at the source.

Ventlab, LLC V-Care manual resuscitators with…: common questions

Is the Ventlab, LLC V-Care manual resuscitators with… safe?
No. The Ventlab, LLC V-Care manual resuscitators with… was recalled on Oct 11, 2023 due to a safety issue. A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Has the Ventlab, LLC V-Care manual resuscitators with… been recalled?
Yes. The Ventlab, LLC V-Care manual resuscitators with… was recalled on Oct 11, 2023. The recall was issued by FDA (recall ID Z-0367-2024).
Why was the Ventlab, LLC V-Care manual resuscitators with… recalled?
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
What should I do if I have the Ventlab, LLC V-Care manual resuscitators with…?
Stop using this product and follow the manufacturer's recall instructions for a refund or replacement. Contact your pediatrician if your baby was exposed and shows any symptoms.
Where can I find the official recall notice for the Ventlab, LLC V-Care manual resuscitators with…?
The official FDA recall record is available here. Always verify recall details with the official source.

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