device recall
saveFresenius Medical Care Holdings, Inc. device recall (Cls II)
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Optiflux¿ High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFLUX F180NRe 12/CS 1.7SA EBEAM, (3) 0500320E OPTIFLUX F200NRe 12/CS 1.9SA EBEAM, (4) 0500325E OPTIFLUX F250NRe 12/CS 2.5SA EBEAM — Reason: To provide further information to the user to ensure proper use of the medical device. the caps had been changed from a threaded version to a press-on version whereby the user must press the caps firmly onto the dialyzer to securely affix the cap. — Status: Ongoing
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same company · ±60 days · 5
- device 510kFresenius Medical Care North America — AquaA (510k cleared)Sep 9, 2025
- device 510kFresenius Medical Care Renal Therapies Group, LLC — Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W) (510k cleared)Sep 9, 2025
- device 510kFresenius Medical Care Renal Therapies Group, LLC — DIASAFEplusUS (F00013010) (510k cleared)Oct 9, 2025
- device recallFresenius Medical Care Holdings, Inc. device recall (Cls II)Oct 25, 2025
- recallFresenius Medical Care Holdings, Inc. recall (Cls II)Jul 2, 2025
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