Recall Z-0932-2015— Baxter Healthcare Corp.

Name: FDA recall Z-0932-2015
Creator: U.S. Food and Drug Administration
Published: 2014-04-24

Class II · Terminated

Class II FDA medical device recall by Baxter Healthcare Corp., initiated 2014-04-24, terminated 2017-07-21. It names one FDA 510(k) clearance: K124018. Product: Baxter Amia Automated PD systems are used in the treatment of adult renal failure patients to perform automated peritoneal dialysis.. Reason: System error 01779 is produced when the battery cannot be charged due to specific voltage differences between the battery and the charger..

Recalling firm: Baxter Healthcare Corp.
Classification: Class II
Status: Terminated
Initiated: 2014-04-24
Terminated: 2017-07-21
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K124018 — AMIA AUTOMATED PD SYSTEMDeka Research & Development Corp.·cleared 2013-06-14

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 Amia Automated PD systems are used in the treatment of adult renal failure patients to perform automated peritoneal dialysis.

Reason for recall

System error 01779 is produced when the battery cannot be charged due to specific voltage differences between the battery and the charger.

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