FDA-Device2023-04-05Class II
Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
Baxter Healthcare Corporation
Hazard
The electrical safety testing was not properly performed on the impacted devices and additional testing is required
Sold states
US distribution to AL, AR, AZ, FL, IL, ND, NY, OH, TX, WA.
Affected count
16 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1316-2023Don't want to check this manually?
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