Recall of Ventlab V-Care manual resuscitators with integrated manometer due to CO2 rebreathing hazard in patient valve. Affected models include Child, Infant, Pediatric and Small Adult Resuscitators with specific reference numbers.
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
SunMed Holdings, LLC is recalling Ventlab V-Care manual resuscitators with integrated manometers because a backwards leak in the patient valve allows CO2 rebreathing. This hazard could cause serious injury during resuscitation attempts if the device is used incorrectly.
The patient valve's integrated manometer has a backwards leak that allows carbon dioxide to be rebreathed by the patient during resuscitation. This can lead to dangerous CO2 buildup in the patient's lungs, potentially causing serious injury or death if the device is used incorrectly.
Healthcare professionals and emergency responders who use Ventlab V-Care resuscitators with integrated manometers are most at risk. The recall includes multiple model types for different age groups.
Check for the following reference numbers: V-Care Child Resuscitator (VN4100MB, VN4100MCFB-3, VN4100MCP), V-Care Infant Resuscitator (VN3100OB, VN3100MB-2, etc.), V-Care Pediatric Resuscitator (VN2100MB, VN2102MB, etc.), and V-Care Small Adult Resuscitator (VN5000MB, VN5002MB, etc.). All units manufactured from September 21, 2018, to present are affected.
Identify your V-Care resuscillator model by checking the reference numbers listed in the recall notice.
If you have the affected model, stop using the device until you can contact Ventlab for a replacement or repair.
The recall includes V-Care Child, Infant, Pediatric, and Small Adult Resuscitators with specific reference numbers listed in the notice. All units manufactured from September 21, 2018, to present are affected.
Check the reference numbers on your device. Affected models include V-Care Child Resuscitator (VN4100MB, VN4100MCFB-3, VN4100MCP), V-Care Infant Resuscitator (VN3100OB, VN3100MB-2, etc.), V-Care Pediatric Resuscitator (VN2100MB, VN2102MB, etc.), and V-Care Small Adult Resuscitator (VN5000MB, VN5002MB, etc.).
If you have the affected model, stop using it immediately and contact Ventlab for a replacement or repair. The recall does not specify a deadline for action.
We’ve drafted a message you can send Ventlab to request your refund or repair — edit it as you like.
Subject: Recall Z-0367-2024 — Ventlab Ventlab Hello, I own a Ventlab that is covered by recall Z-0367-2024 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.
