SunMed recalls Curaplex manual resuscitators with integrated manometers due to a backwards leak causing CO2 rebreathing. Affected models include Adult, Child, and Infant BVMs with specific reference numbers and production dates.
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
SunMed is recalling Curaplex manual resuscitators that have a defect in the manometer causing CO2 rebreathing. This hazard could lead to dangerous buildup of carbon dioxide during resuscitation attempts, especially in emergency medical 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 carbon dioxide buildup during resuscitation attempts, potentially leading to respiratory distress or other complications.
Healthcare professionals using Curaplex resuscitators for emergency medical care are most at risk. Patients receiving resuscitation with these devices may experience carbon dioxide buildup.
Check for the model numbers: 2442-BVMPAD, 2442-BVMPCH, 2442-BVMCIN, 2442-BVMPIN, or 2442-BVMPSA. These devices were manufactured from September 21, 2018, to present with expiration dates up to October 11, 2028.
Identify your Curaplex resuscillator model using the reference numbers listed in the recall notice.
Reach out to SunMed Holdings, LLC for further instructions on how to address the issue.
The affected models include Curaplex Adult Premium BVM (REF # 2442-BVMPAD), Child Premium BVM (REF # 2442-BVMPCH), Child Premium BVM with Infant Mask (REF # 2442-BVMCIN), Infant Premium BVM (REF # 2442-BVMPIN), and Small Adult Pediatric Premium BVM (REF # 2442-BVMPSA).
All affected devices were manufactured from September 21, 2018, to present with expiration dates up to October 11, 2028.
The recall notice does not specify a fix or remedy; affected users should contact SunMed Holdings, LLC for instructions.
We’ve drafted a message you can send SunMed to request your refund or repair — edit it as you like.
Subject: Recall Z-0368-2024 — SunMed SunMed Hello, I own a SunMed that is covered by recall Z-0368-2024 from SunMed. 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.
