SunMed Holdings recalls Horizon manual resuscitators with integrated manometers due to a backwards leak causing CO2 rebreathing. Affected models include adult, infant, and pediatric versions 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 Horizon manual resuscitators with integrated manometers because a backwards leak in the patient valve can cause CO2 rebreathing. This hazard may lead to dangerous buildup of carbon dioxide 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 buildup of carbon dioxide in the lungs during resuscitation attempts, potentially leading to respiratory distress or other complications.
Healthcare professionals using the Horizon resuscitators for emergency medical care are most at risk. The recall includes adult, infant, and pediatric models with specific serial numbers and production dates from September 2018 onward.
Check the product's serial number (REF #) on the device. Affected models include adult, infant, and pediatric Horizon resuscitators with specific serial numbers listed in the recall notice. The devices were manufactured from September 21, 2018, to present.
Look for the product's serial number (REF #) on the device to determine if it is affected. Affected models include adult, infant, and pediatric Horizon resuscitators with specific serial numbers listed in the recall notice.
Reach out to SunMed Holdings for further assistance or to confirm if your device is affected. They provide details on the specific models and serial numbers that are recalled.
The recall includes Horizon Adult Resuscitators with REF #s: 9122HZ, HZI9000, HZI9108, 9106HZ, 9110HZ, 9120HZ, 9111HZ, 9100HZ, 9105HZ, 9108HZ, 9006HZ, 9002HZ; Horizon Infant Resuscitators with REF #s: 6112HZ, 6123HZ, 6125HZ, 6200HZ, 6106HZ, 6118HZ, 6107HZ, 6013HZ, 6117HZ, 6116HZ, 6019HZ, HZI6000, 6009HZ; and Horizon Pediatric Resuscitators with REF #s: 8106HZ, 8119HZ, 8115HZ, 8107HZ, 8010HZ, 8004HZ, 8105HZ, 8113HZ, 8109HZ, 8116HZ, 8003HZ, HZI8100.
The affected devices were manufactured from September 21, 2018, to present.
Check your device's serial number to see if it is affected. If it is, contact SunMed Holdings for further assistance or to confirm if your device is part of the recall.
We’ve drafted a message you can send SunMed Holdings to request your refund or repair — edit it as you like.
Subject: Recall Z-0363-2024 — SunMed Holdings SunMed Holdings Hello, I own a SunMed Holdings that is covered by recall Z-0363-2024 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.
