Company: Baxter Healthcare Corporation
Date of Enforcement Report: 2/27/2019
Class II:
PRODUCT
AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing Peritoneal dialysis.
Recall Number: Z-0849-2019
Kaguya Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing Peritoneal dialysis.
Recall Number: Z-0850-2019
REASON
Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Corporation on 12/11/2018. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
7,688 devices
DISTRIBUTION
US Nationwide and International