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Baxter Healthcare Corporation recalls L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide.
Recalled October 9, 2019 · FDA recall Z-0030-2020 · Baxter Healthcare
Hazard
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. · FDA Class II
Units
8640 eaches
Sold at
U.S.: VA, DC, CA, FL, SC, MD, DE, PA, NC, WA, GA, TX, NV. No foreign (OUS) distribution.
Description
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.
Product
L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide.
Manufacturer(s)
Baxter Healthcare Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →