Recall Z-1031-2015— Baxter Healthcare Corp.

Name: FDA recall Z-1031-2015
Creator: U.S. Food and Drug Administration
Published: 2014-10-21

Class II · Terminated

Class II FDA medical device recall by Baxter Healthcare Corp., initiated 2014-10-21, terminated 2015-09-01. It names one FDA 510(k) clearance: K102936. Product: HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. Product codes 5C8310, 5C8310R, R5C8320, and 5C4474.. Reason: The keypad buttons on HomeChoice devices may be activated without the operator pressing them..

Recalling firm: Baxter Healthcare Corp.
Classification: Class II
Status: Terminated
Initiated: 2014-10-21
Terminated: 2015-09-01
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

HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. Product codes 5C8310, 5C8310R, R5C8320, and 5C4474.

Reason for recall

The keypad buttons on HomeChoice devices may be activated without the operator pressing them.

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