Recall Z-0291-2016— Baxter Healthcare Corp.

Name: FDA recall Z-0291-2016
Creator: U.S. Food and Drug Administration
Published: 2015-06-29

Class III · Terminated

Class III FDA medical device recall by Baxter Healthcare Corp., initiated 2015-06-29, terminated 2017-01-24. It names one FDA 510(k) clearance: K102936. Product: Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.. Reason: 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..

Recalling firm: Baxter Healthcare Corp.
Classification: Class III
Status: Terminated
Initiated: 2015-06-29
Terminated: 2017-01-24
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

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

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.

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