FDA-Device2015-02-04Class II
HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. Product codes 5C8310, 5C8310R, R5C8320, and 5C4474.
Baxter Healthcare Corp.
Hazard
The keypad buttons on HomeChoice devices may be activated without the operator pressing them.
Sold states
AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MO, NC, NE, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, VT, WA, WI and District of Columbia
Affected count
200
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. Product codes 5C8310, 5C8310R, R5C8320, and 5C4474.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1031-2015Don't want to check this manually?
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