Z-0801-2025Class II

Dialyzer Optiflux 160NRe

Name: Z-0801-2025 Dialyzer Optiflux 160NRe
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2024-12-05
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2024-12-05 / Open, Classified / root cause: manufacturing process

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of Dialyzer Optiflux 160NRe on 2024-12-05. FDA classified it as Class II and gives the reason as "Potential for internal blood leaks due to cracked polyurethane". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0801-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-12-05
Posted: 2025-01-03
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: Dialyzer Optiflux 160NRe
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: Potential for internal blood leaks due to cracked polyurethane
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Fresenius Medical Care notified consignees on about 12/05/2024 via URGENT MEDICAL DEVICE RECALL letter. Consignees were instructed to stock immediately for either of the affected lot numbers, immediately discontinue use of Optiflux F160NRe Dialyzer(s) with lot codes, place any of the affected units in a secure, segregated area, arrange for return of affected product and complete and return the provided Reply Form. Additionally, consignees were instructed to forward the notification to any personnel within the organization or to customers where product was further distributed.
Quantity in commerce: 5,351 cases (64,212 dialyzers)
Distribution: Nationwide Distribution.
Product codes and lots: UDI NUMBERS: 24HU06011-00840861100149-270630, 24HU06010-00840861100149-270630. Expiration date: 06/30/2027.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0801-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0801-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-15	2025-01-03

Product code KDI

K162488Class IIOptiflux dialyzerFresenius Medical Care North America / cleared 2017-04-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)