Baxter Healthcare Corp.: Medical Device Recall in 2016 - (Recall #: Z-2609-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

1) The HomeChoice automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. 2) The HomeChoice PRO automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. The HomeChoice/HomeChoice Pro Automated Personal Cycler peritoneal dialysis system is intended for automatic control of dialysate solution exchange in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.

Product Classification:

Class II

Date Initiated: October 7, 2013

Date Posted: August 31, 2016

Recall Number: Z-2609-2016

Event ID: 66606

Reason for Recall:

In systems with version 10.4 software Initial Drain logic, the device will attempt to drain the patient to empty at the beginning of therapy (initial drain). The operator can stop, but cannot bypass, the active Initial Drain. This is to mitigate against Unintended Increased Intraperitoneal Volume (IIVP). This can cause serious problems in patients with unrelated a co-morbid condition of ascites.

Status: Terminated

Product Quantity: *** 1) Product Codes 5C4471 and 5C4471R: Approximately 48,600 units; *** 2) Product Codes 5C8310 and 5C8310R: Approxiamtely 16,990 units

Code Information:

*** 1) HomeChoice automated peritoneal dialysis system: Product Codes: 5C4471 and 5C4471R; Serial Numbers: All serial numbers; *** 2) HomeChoice Pro automated peritoneal dialysis system: Product Codes: 5C8310 and 5C8310R; Serial Numbers: All serial numbers

Distribution Pattern:

Worldwide distribution. US nationwide including Puerto Rico; Australia, Canada, New Zealand, and Japan

Voluntary or Mandated:

Voluntary: Firm initiated