Baxter Healthcare Corp.: Medical Device Recall in 2015 - (Recall #: Z-0291-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: June 29, 2015

Date Posted: November 25, 2015

Recall Number: Z-0291-2016

Event ID: 71818

Reason for Recall:

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.

Status: Terminated

Product Quantity: 29355

Code Information:

All HomeChoice and HomeChoice PRO devices. All LOT numbers and Serial number for Product Codes 5C4471, 5C4471R, 5C8310 and 5C8310R. Dates Distributed: 1994 to present Quantity Distributed: All

Distribution Pattern:

Nationwide Distribution, District of Columbia, and Puerto Rico.

Voluntary or Mandated:

Voluntary: Firm initiated