FDA-Device2019-02-27Class II
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.
Baxter Healthcare Corporation
Hazard
Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy
Sold states
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.
Affected count
1,085 devices
Manufactured in
1 Baxter Pkwy, Deerfield, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0850-2019Don't want to check this manually?
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