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Baxter Healthcare Corporation recalls AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution
Recalled February 27, 2019 · FDA recall Z-0849-2019 · Baxter Healthcare
Hazard
Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy · FDA Class II
Units
7,688 devices
Sold at
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 and Japan.
Description
Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy
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.
Manufacturer(s)
Baxter Healthcare Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →