Hamilton Medical breathing circuit sets recalled for expiratory valve membrane adhesion risk
What this means
Certain coaxial breathing circuit sets used with Hamilton Medical ventilators (models C1, T1, and MR1) may have expiratory valve membranes that stick to the valve body. This defect is not always detectable before use and can trigger an "exhalation obstructed" alarm during ventilation, potentially leading to inadequate ventilation and oxygen desaturation in patients.
- Perform a lung action test on the breathing circuit prior to each use
- If an "exhalation obstructed" alarm occurs during use, remove and inspect the expiratory valve set or replace it immediately
- Contact Hamilton Medical if you have questions about affected lot numbers (200379–205050)
The agency's original wording
Ventilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to valve body, not detectable during pre-operative test, which will result in "exhalation obstructed " alarm, which may result in inadequate ventilation, oxygen desaturation. Advising: Prior to use, test lung action. If alarm occurs, expiratory valve set removal to overcome membrane adhesion or replacement
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2463-2026More Hamilton Medical AG recalls
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