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Fresenius Medical Care Renal Therapies Group, LLC recalls Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic Hemodialysis
Recalled April 13, 2016 · FDA recall Z-1324-2016 · Fresenius Medical Care Renal Therapies Group
Hazard
Dialyzer header leak due to possible improper torque · FDA Class II
Units
1,650 units
Sold at
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.
Description
Dialyzer header leak due to possible improper torque
Product
Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic Hemodialysis
Manufacturer(s)
Fresenius Medical Care Renal Therapies Group, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →