Erbe Medical, LLC is recalling 289,821 units of various ERBEFLO CleverCap and pump tubing sets used in endoscopic procedures. These devices, which provide sterile water, CO2, and air, were manufactured with a connector configuration that can lead to unintended water flow. This defect can cause patients to aspirate water during a procedure, which may lead to serious health complications like pneumonia, acute respiratory distress syndrome, or respiratory failure.
A manufacturing defect in the irrigation connector makes the system susceptible to unintended water flow when used with certain third-party connectors. If water flows unexpectedly into the patient's airway, it can cause aspiration, potentially progressing to severe lung inflammation or complete respiratory failure.
Clinical / hospital device corrective action
Hybrid CO2 Tubing/Cap Sets for various scope brands including Olympus, Pentax, Fujifilm, and Fujinon.
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.
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Sources: FDA iRES · Raw API Response
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