SunMed Holdings recalls RescuMed manual resuscitators with integrated manometers due to a backwards leak causing CO2 rebreathing. Affected models include adult, infant, and pediatric resuscitators with specific serial numbers and production dates.
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
SunMed Holdings is recalling RescuMed manual resuscitators with integrated manometers because a backwards leak in the patient valve allows CO2 rebreathing. This could lead to dangerous buildup of carbon dioxide during resuscitation attempts, especially in emergency situations.
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 buildup of carbon dioxide during resuscitation attempts, potentially leading to respiratory distress or other complications.
Healthcare professionals and emergency responders who use the RescuMed resuscitators are most at risk. The recall affects specific models sold from September 2018 through present.
Check the product's serial numbers: adult resuscitators have REF #s like BVM510-F, infant models include BVMB710, and pediatric models have BVMB812. The devices were manufactured from September 21, 2018, through present and expire by October 11, 2028.
Discontinue use of the affected RescuMed manual resuscitators as they pose a risk of CO2 rebreathing.
Adult resuscitators with REF #s BVM510-F, BVMB510-10, BVMB510-F, BVMB510S-F; infant resuscitators with REF #s BVMB710, BVMB710-F; and pediatric resuscitators with REF #s BVMB812, BVMB812-F, BVMB810, BVMB810-F, BVMB810S-F.
All affected devices were manufactured from September 21, 2018, through present.
A backwards leak in the integrated manometer allows carbon dioxide rebreathing, which can cause dangerous buildup of carbon dioxide during resuscitation attempts.
We’ve drafted a message you can send SunMed Holdings to request your refund or repair — edit it as you like.
Subject: Recall Z-0364-2024 — SunMed Holdings SunMed Holdings Hello, I own a SunMed Holdings that is covered by recall Z-0364-2024 from SunMed Holdings. 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.
