Recalls / —

—#211440

Product

Dialyzer Optiflux 160NRe

FDA product code

KDI — Dialyzer, High Permeability With Or Without Sealed Dialysate System

Device class

Class 2

Medical specialty

Gastroenterology, Urology

510(k) numbers

K162488

Affected lot / code info

UDI NUMBERS: 24HU06011-00840861100149-270630, 24HU06010-00840861100149-270630. Expiration date: 06/30/2027.

Why it was recalled

Potential for internal blood leaks due to cracked polyurethane

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm

Fresenius Medical Care Holdings, Inc.

Address

920 Winter St, Bld 920, Waltham, Massachusetts 02451-1521

Distribution

Distribution pattern

Nationwide Distribution.

Timeline

Recall initiated

2024-12-05

Posted by FDA

2025-01-03

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #211440. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.