Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported third-party connector use conditions, which may lead to water aspiration, which may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.
ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap Hybrid Tubing/Cap Set for Fujifilm Scopes, REF: 20325-203;
REF/UDI-DI/Lots: 20325-201/04065655000603/W4466253, W4466254, W4466256, W4466257, W4466258, WO471080, WO471081, WO471083, WO471084, WO473975, WO473976, WO477586, WO477587, WO477588, WO477589, WO477590; 20325-203/04065655001211/WO473986
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.