Baxter Integrated APD Set Recalled for Potential Cassette Leaks
Baxter Healthcare is recalling L5C4531 X1 Integrated APD Sets because cassettes may leak, risking sterile fluid path contamination and peritonitis.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where injury has not yet been reported, specifically the potential for peritonitis due to contamination.
Plain-English summary
Baxter Healthcare Corporation is recalling the L5C4531 X1 Integrated APD Set with Cassette 3-Prong. The product is a sterile, nonpyrogenic fluid path sterilized by ethylene oxide. The recall involves 8,640 units from Lot Number H18D22030.
The recall is due to a potential presence of leaks from the cassettes, which may occur 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, which may predispose the patient to peritonitis.
The affected units were distributed in the United States to the following states and districts: VA, DC, CA, FL, SC, MD, DE, PA, NC, WA, GA, TX, and NV. There was no foreign distribution. Consumers and healthcare providers should stop using the affected product and contact Baxter Healthcare Corporation for further instructions.
The recalled product
- Product
- L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide.
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- Affected units
- 8,640
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number H18D22030
Distribution
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