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