L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide. — recall Z-0030-2020
U.S. FDA — Device Enforcement · United States · 2018-10-10 · Class II
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Reported risk: Potential presence of leaks from the cassettes, which may be present due to an incomplete seal of the sheeting to the cassette. A leaking cassette could lead to contamination of the sterile fluid path with micro-organisms. This may predispose the patient to peritonitis.
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