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Early Alert: Breathing Circuit Set Issue from Hamilton Medical
The FDA is aware that Hamilton Medical has issued a letter to affected customers regarding updated use instructions for certain coaxial breathing circuit sets used with HAMILTON-C1, HAMILTON T-1, and HAMILTON-MR1. Users should review and follow the pre-operative test instructions and troubleshooting instructions prior to continued use.
Hamilton Medical has reported that certain lots of coaxial breathing circuit sets preassembled with an expiratory valve set do not perform as intended. In some cases, the expiratory valve membrane adhered to the sealing ring on the body of the expiratory valve, impairing valve opening and expiratory gas flow.
An obstruction of expiratory flow results in inadequate ventilation and impaired gas exchange. Acute respiratory compromise due to impaired exhalation may result in inadequate ventilation and oxygen desaturation (hypoxemia).
As of May 13, Hamilton Medical has reported four serious injuries and no deaths associated with this issue.
CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Hamilton Medical at complaints@hamiltonmedical.com or call 1-800-426-6331.
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