FDA-Device2021-11-17Class II
Hemodialysis Delivery System, Software Version 2.x.
Baxter Healthcare Corporation
Hazard
If the operator initiates therapy with a saved prescription profile and makes a change to the prescription after a disposable filter change using the Same Patient button, the system may suggest values from the original prescription profile, rather than the current prescription.
Sold states
Distributed nationwide to AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OR, PA, SC,SD, TN, TX, UT, VA, WA, WI and internationally to Mexico, Brazil, Canada, Australia, Singapore, Hong Kong, Vietnam, Austria, Belgium, Denmark, Finland, Germany, Greece, Ireland, Israel, Italy, Luxemburg, Netherlands, Norway, Poland, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
Affected count
4248
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Hemodialysis Delivery System, Software Version 2.x.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0215-2022Don't want to check this manually?
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