Home / Recalls / Medical Devices
Fresenius Medical Care Renal Therapies Group, LLC recalls Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E
Recalled December 26, 2018 · FDA recall Z-0658-2019 · Fresenius Medical Care Renal Therapies Group
Hazard
Potential for external blood leaks from the dialyzer header · FDA Class II
Units
9,097 cs x 12 units each
Sold at
US Nationwide
Description
Potential for external blood leaks from the dialyzer header
Product
Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E
Manufacturer(s)
Fresenius Medical Care Renal Therapies Group, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →