FDA-Device2019-10-09Class II
L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide.
Baxter Healthcare Corporation
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.
Sold states
U.S.: VA, DC, CA, FL, SC, MD, DE, PA, NC, WA, GA, TX, NV. No foreign (OUS) distribution.
Affected count
8640 eaches
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0030-2020Don't want to check this manually?
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