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Baxter Healthcare Corporation recalls Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
Recalled April 5, 2023 · FDA recall Z-1316-2023 · Baxter Healthcare
Hazard
The electrical safety testing was not properly performed on the impacted devices and additional testing is required · FDA Class II
Units
16 units
Sold at
US distribution to AL, AR, AZ, FL, IL, ND, NY, OH, TX, WA.
Description
The electrical safety testing was not properly performed on the impacted devices and additional testing is required
Product
Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
Manufacturer(s)
Baxter Healthcare Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →