SunMed Holdings, LLC is recalling 11,358 Adult Manual Resuscitators because the filter was incorrectly attached to the patient port instead of the exhalation port. This manufacturing error can cause an interruption or delay in emergency resuscitation efforts. While no injuries have been reported, the resuscitators were distributed nationwide through Medline and may be found in clinical or emergency settings.
If the filter is attached to the wrong port, airflow to the patient is obstructed or delayed. This can lead to life-threatening consequences, including severe lack of oxygen (hypoxia), organ failure, and death.
Quantity affected: 11,358 units.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.