Optiflux recallZ-0801-2025 · Fresenius Medical Care Holdings, Inc. · initiated Dec 5, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Fresenius Medical Care Holdings, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for internal blood leaks due to cracked polyurethane
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-0801-2025
- Status
- Open, Classified
- Initiated by the company
- Dec 5, 2024
- Posted by the FDA
- Jan 3, 2025
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Quantity
- 5,351 cases (64,212 dialyzers)
- Product code
- KDI
- FDA submissions
- K162488
- Distribution
- Nationwide Distribution.
Product description
Dialyzer Optiflux 160NRe
Code information (models, lots, serial numbers)
UDI NUMBERS: 24HU06011-00840861100149-270630, 24HU06010-00840861100149-270630. Expiration date: 06/30/2027.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Optiflux® 0500316EFresenius Medical Care Holdings, Inc. · DIALYZER, CAPILLARY, HOLLOW FIBER2 recalls7 deaths2,282 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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