FDA-Device2016-04-13Class II
Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic Hemodialysis
Fresenius Medical Care Renal Therapies Group, LLC
Hazard
Dialyzer header leak due to possible improper torque
Sold states
US Nationwide Distribution including states of: AZ, CA, CT, DC, GA, IL, IN, MI, MN, MO, MS, NY, OH, PA, SC, SD, TX, and WA.
Affected count
1,650 units
Manufactured in
920 Winter St, N/A, Waltham, MA, United States
Products
Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic Hemodialysis
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1324-2016Don't want to check this manually?
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