Reported Oct 15, 2025 · Ongoing
Optiflux¿ High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E…
Fresenius Medical Care Holdings, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fresenius Medical Care Holdings, Inc. · 920 Winter St Bld 920 · Waltham, MA · 02451-1521
Is this the product you have?
- 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
- Lot codes and dates
4 of 4 products
Products covered by this recall Model / number Barcodes Product as published 0500316E840861100149OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, UDI-DI: 840861100149, All Lots manufactured after SEP/06/2023 0500318E840861100156OPTIFLUX F180NRe 12/CS 1.7SA EBEAM, UDI-DI: 840861100156, All Lots manufactured after SEP/06/2023 0500320E840861100163OPTIFLUX F200NRe 12/CS 1.9SA EBEAM, UDI-DI: 840861100163, All Lots manufactured after SEP/06/2023 0500325E840861100170OPTIFLUX F250NRe 12/CS 2.5SA EBEAM, UDI-DI: 840861100170, All Lots manufactured after SEP/06/2023 - Amount recalled
- 172,494,732 units (14,374,561 cases @ 12 units per case)
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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