Recall Z-1039-2015— Baxter Healthcare Corp.

Name: FDA recall Z-1039-2015
Creator: U.S. Food and Drug Administration
Published: 2014-12-08

Class II · Terminated

Class II FDA medical device recall by Baxter Healthcare Corp., initiated 2014-12-08, terminated 2015-10-28. It names one FDA 510(k) clearance: K102936. Product: 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.. Reason: Baxter is issuing a recall for one lot of Integrated Automated Peritoneal Dialysis set with Cassette 3 prong due to complaints received for leakage..

Recalling firm: Baxter Healthcare Corp.
Classification: Class II
Status: Terminated
Initiated: 2014-12-08
Terminated: 2015-10-28
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K102936 — HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310RBaxter Healthcare Corp·cleared 2011-03-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.