Recalls / —

—#125393

Product

Optiflux F18Nre Flux Dialyzers; Product Number: 0500308E. Single Use acute or chronic hemanalysis treatment.

FDA product code

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

Device class

Class 2

Medical specialty

Gastroenterology, Urology

510(k) numbers

K043244

Affected lot / code info

Lot Number: 13PU03011

Why it was recalled

Dialysate Port Leak During Priming of the Dialyzers

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Fresenius Medical issued Notice to Clinics and Clinics with Patients Letters Dated - 1st Mailing - February 4, 2014 and Patients Letters Dated - February 5, 2014 - these letters contained the correct information.Corrected letters to Clinics and Clinics with Patients issued 2/14/14 via certified mail with return receipt and fax-back form . Users are advised the leak may be stopped by tightening the dialysate port cap more securely. Questions associated with this product notification to your Customer Service Team at 1-800-323-5188.

Recalling firm

Firm

Fresenius Medical Care Holdings, Inc.

Address

920 Winter St, Waltham, Massachusetts 02451-1521

Distribution

Distribution pattern

Worldwide distribution: USA (nationwide) and the country of: Mexico.

Timeline

Recall initiated

2014-02-04

Posted by FDA

2014-02-26

Terminated

2021-05-18

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #125393. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.