Baxter Healthcare Corp. recalls Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated Peritoneal Dialysis (APD) therapy for p…

Recall date

June 29, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0291-2016

FDA classification

Class III

Brand / firm

Baxter Healthcare Corp.

Sold / distributed

Nationwide Distribution, District of Columbia, and Puerto Rico.

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.