SunMed Holdings recalls Ventlab STAT-Check manual resuscitators with integrated manometers that can cause CO2 rebreathing due to a backwards leak in the patient valve. Affected models include Adult, 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 is recalling Ventlab STAT-Check manual resuscitators with integrated manometers because a backwards leak in the patient valve allows CO2 rebreathing. This hazard could lead to dangerous buildup of carbon dioxide in the patient's body during resuscitation attempts.
The integrated manometer in the patient valve has a backwards leak that allows carbon dioxide to be rebreathed by the patient during resuscitation. This can cause dangerous buildup of carbon dioxide in the patient's body, potentially leading to respiratory distress or other complications.
Healthcare professionals using Ventlab STAT-Check resuscitators with the specific model numbers and production dates listed in the recall notice are most at risk. Patients receiving resuscitation with these devices could be affected if the leak causes CO2 rebreathing.
Check for the model numbers SC9101B, SC7101B, or SC8121B on the device. These resuscitators were manufactured from September 21, 2018, through present and have an expiration date up to October 11, 2028.
Look for the model numbers SC9101B (Adult), SC7101B or SC7101B-M0 (Infant), or SC8121B (Pediatric) on the device.
Reach out to SunMed Holdings for further guidance on the recall and potential remedies.
The affected models include Ventlab STAT-Check Adult Resuscitator (SC9101B), Infant Resuscitators (SC7101B and SC7101B-M0), and Pediatric Resuscitator (SC8121B).
These devices were manufactured from September 21, 2018, through present with an expiration date up to October 11, 2028.
Check the model number on your device and contact SunMed Holdings for further guidance on the recall and potential remedies.
We’ve drafted a message you can send Ventlab to request your refund or repair — edit it as you like.
Subject: Recall Z-0366-2024 — Ventlab Ventlab Hello, I own a Ventlab that is covered by recall Z-0366-2024 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.
