medical Class II Updated 2019-02-27

Baxter Healthcare Corporation recalls AMIA Automated Peritoneal Dialysis System Product Usage:

Recalled 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.


Hazard / Issue

Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Product code 5C9320. All serial numbers are affected for devices distributed from 02/11/2016 through 11/27/2018.
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →