Ventlab SafeSpot manual resuscitators with integrated manometer have a backwards leak causing CO2 rebreathing. Affected models include SafeSpot Infant Resuscitators and Safe Spot Bag with specific serial numbers. Recalled due to risk of rebreathing CO2 during resuscitation.
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Ventlab SafeSpot manual resuscitators with integrated manometers have a backwards leak that allows CO2 rebreathing. This could cause dangerous buildup of carbon dioxide during emergency resuscitation attempts. Affected units include specific infant resuscitators and Safe Spot Bag models with listed serial numbers.
A backwards leak in the patient valve's integrated manometer allows carbon dioxide to be rebreathed by the patient during resuscitation. This can lead to dangerous buildup of carbon dioxide in the patient's body, potentially causing respiratory distress or other complications.
Healthcare professionals using these resuscitators for emergency medical care are most at risk. The affected units were sold from September 2018 through present, with expiration dates up to October 2028.
Check for specific serial numbers listed in the recall notice: SS3200OBPC-T, SS3204MB-D12, and other model numbers starting with SS3200MB or SS3204MB. Units manufactured from September 2018 through present are affected.
Look for the specific serial numbers listed in the recall notice, such as SS3200OBPC-T or SS3204MB-D12.
Reach out to Ventlab for guidance on next steps if you have an affected unit.
Affected models include SafeSpot Infant Resuscitators with serial numbers starting with SS3200MB or SS3204MB, such as SS3200OBPC-T, SS3204MB-D12, and others listed in the recall notice.
Units were manufactured from September 2018 through present, with expiration dates up to October 2028.
The recall notice does not specify a fix or remedy; affected units should be checked and contacted with Ventlab for guidance.
We’ve drafted a message you can send Ventlab to request your refund or repair — edit it as you like.
Subject: Recall Z-0365-2024 — Ventlab Ventlab Hello, I own a Ventlab that is covered by recall Z-0365-2024 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.
