Baxter Healthcare Corp.: Medical Device Recall in 2015 - (Recall #: Z-1039-2015)

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 Integrated APD Set with Cassette 3-Prong, Sterile, nonpyrogenic fluid path. Product Usage: The recall device is indicated for use in the treatment of patients with renal failure to provide PD fluid exchanges with Baxter HomeChoice PD Systems in clinical and home use settings.

Product Classification:

Class II

Date Initiated: December 8, 2014

Date Posted: February 11, 2015

Recall Number: Z-1039-2015

Event ID: 70062

Reason for Recall:

Baxter is issuing a recall for one lot of Integrated Automated Peritoneal Dialysis set with Cassette 3 prong due to complaints received for leakage.

Status: Terminated

Product Quantity: 8,640 units

Code Information:

H13L22013

Distribution Pattern:

US Nationwide Distribution in the states of FL, WI, AR, TN, TX, NC, MO, NM, NJ, CT, PA, NV, NY, CA, MI, WI, KS, and OH.

Voluntary or Mandated:

Voluntary: Firm initiated