Baxter Healthcare Corporation recalls AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exc…

Recall date

December 11, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0849-2019

FDA classification

Class II

Brand / firm

Baxter Healthcare Corporation

Sold / distributed

Worldwide Distribution - US Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Distributed internationally to Canada an…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.