Recall Z-1056-2017— Baxter Healthcare Corporation

Name: FDA recall Z-1056-2017
Creator: U.S. Food and Drug Administration
Published: 2016-12-16

Class II · Terminated

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2016-12-16, terminated 2017-08-24. It names one FDA 510(k) clearance: K102936. Product: APD Set with Cassette 3-Prong Peritoneal Dialysis Set 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: Customer complaints received for the presence of leaks.

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Terminated
Initiated: 2016-12-16
Terminated: 2017-08-24
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

APD Set with Cassette 3-Prong Peritoneal Dialysis Set 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

Customer complaints received for the presence of leaks

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