Recall – Dialysis system exhibits shortened dwell times with certain settings

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

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.