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U.S. Department of Health and Human Services

Medical Device Recalls
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510(K) Number: K162488
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Optiflux® High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM,... 2 10/03/2025 FEI # 3001451489
Fresenius Medical Care Holdings, Inc.
Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E 2 06/30/2022 FEI # 3001451489
Fresenius Medical Care Holdings, Inc.
Dialyzer Optiflux 160NRe 2 01/03/2025 FEI # 3001451489
Fresenius Medical Care Holdings, Inc.
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