Medline manual resuscitators with integrated manometers have a backwards leak causing CO2 rebreathing. Affected models include adult, infant, and pediatric resuscitators with specific serial numbers. Stop using immediately to prevent potential health risks.
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Medline recalls manual resuscitators with integrated manometers that can cause CO2 rebreathing due to a backwards leak. This hazard could lead to dangerous carbon dioxide buildup 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 carbon dioxide buildup in the lungs, potentially leading to respiratory distress or other serious health issues during emergency resuscitation.
Healthcare providers using Medline resuscitators with the listed model numbers and serial codes are affected. Patients receiving care with these devices are at risk of carbon dioxide buildup during emergency resuscitation.
Check the product's serial numbers (REF #s) listed in the recall notice. Affected models include adult, infant, and pediatric resuscitators with specific serial numbers starting with CPRM1116, CPRM3312, or CPRM2216. All units manufactured from September 21, 2018, to present are affected.
Discontinue use of the affected resuscitators as they pose a risk of carbon dioxide rebreathing.
Adult, infant, and pediatric resuscitators with specific serial numbers starting with CPRM1116, CPRM3312, or CPRM2216. All units manufactured from September 21, 2018, to present are affected.
The recall notice does not mention a fix or replacement. Affected units must be stopped from use immediately.
Check the serial numbers (REF #s) on your device. Affected models include adult, infant, and pediatric resuscitators with specific serial numbers listed in the recall notice.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-0369-2024 — Medline Medline Hello, I own a Medline that is covered by recall Z-0369-2024 from Medline. 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.
