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Open, Classified

Dialyzer Optiflux 160NRe

FDA Recall Z-0801-2025 · Posted 2025-01-03

Recalling FirmFresenius Medical Care Holdings, Inc.
Recall StatusOpen, Classified
Product CodeKDI
Date Initiated2024-12-05
Product Quantity5,351 cases (64,212 dialyzers)

Reason for Recall

Potential for internal blood leaks due to cracked polyurethane

Firm 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.

Root Cause

Process control

Distribution Pattern

Nationwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K162488Optiflux dialyzerFresenius Medical Care North America · 2017-04-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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