Baxter Healthcare recalls L5C453: X1 Integrated APD Sets with 3-prong cassettes due to potential leaks causing contamination and peritonitis risk. Affected units include specific lot numbers.
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.
Baxter Healthcare is recalling certain X1 Integrated APD Sets with 3-prong cassettes because leaks could contaminate sterile fluid paths, potentially leading to peritonitis in patients. This recall affects medical devices used in hospital settings.
Leaking cassettes may allow micro-organisms to enter the sterile fluid path. This contamination could lead to peritonitis, a serious infection of the abdominal cavity, especially in patients with medical devices.
Healthcare facilities using Baxter's L5C4531 X1 Integrated APD Sets with 3-prong cassettes are most at risk. Patients receiving these devices could face peritonitis if contamination occurs.
Check for the model L5C4531 X1 Integrated APD Set with 3-prong cassettes. Affected units were sterilized by ethylene oxide and include lot number H18D22030.
Inspect the cassette for signs of leakage, which could indicate a compromised seal.
Reach out to Baxter Healthcare for specific guidance on handling the recalled product.
The recalled product is the L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path.
Check for the model L5C4531 X1 Integrated APD Set with 3-prong cassettes and lot number H18D22030.
The recall record does not specify a remedy, so contact Baxter Healthcare directly for guidance.
We’ve drafted a message you can send Baxter Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0030-2020 — Baxter Healthcare Baxter Healthcare Hello, I own a Baxter Healthcare that is covered by recall Z-0030-2020 from Baxter Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.