Optiflux¿ High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFL
Summary
The FDA issued a Class II for Optiflux¿ High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NR by Fresenius Medical Care Holdings, Inc.. 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.
Details
Source
Device Recall
External ID
Z-0041-2026
Action Date
2025-10-15
Status
Ongoing
Category
device
Product Description
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/Code Info: 1. Model: 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, UDI-DI: 840861100149, All Lots manufactured after SEP/06/2023, 2. Model: 0500318E OPTIFLUX F180NRe 12/CS 1.7SA EBEAM, UDI-DI: 840861100156, All Lots manufactured after SEP/06/2023, 3. Model: 0500320E OPTIFLUX F200NRe 12/CS 1.9SA EBEAM, UDI-DI: 840861100163, All Lots manufactured after SEP/06/2023, 4. Model: 0500325E OPTIFLUX F250NRe 12/CS 2.5SA EBEAM, UDI-DI: 840861100170, All Lots manufactured after SEP/06/2023;
Quantity Affected: 172,494,732 units (14,374,561 cases @ 12 units per case)
Reason for Recall
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.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-08-29
Company
Waltham, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 161 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Fresenius Medical Care Holdings, Inc. has 69 FDA actions in our database, including 69 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Fresenius Medical Care Holdings, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Fresenius Medical Care Holdings, Inc. have FDA actions?
Fresenius Medical Care Holdings, Inc. has 69 FDA actions in our database, including 69 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0041-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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