FDA-Device2015-11-25Class III
Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.
Baxter Healthcare Corp.
Hazard
Loud operating sounds, which was unacceptable to the end users when the device was powered on. The HomeChoice devices continue to perform as intended, as the issue is only associated with the noise coming from the device and not the function of it. May delay treatment if changing to a different system.
Sold states
Nationwide Distribution, District of Columbia, and Puerto Rico.
Affected count
29355
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0291-2016Don't want to check this manually?
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