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Baxter Healthcare Corporation Recall: L5C4531 X1 Integrated APD Set with Cassette 3-Prong

Baxter Healthcare Corporation Recall: L5C4531 X1 Integrated APD Set with Cassette 3-Prong is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Baxter Healthcare Corporation; Product: L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene

Recalling firmBaxter Healthcare Corporation
ProductL5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide.
Reason for recallPotential 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.
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusTerminated
DistributionU.S.: VA, DC, CA, FL, SC, MD, DE, PA, NC, WA, GA, TX, NV. No foreign (OUS) distribution.
Recall initiated20181010
Recall numberZ-0030-2020
Categorydevice
StateIL
CountryUnited States

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