—#107744

Product

Fresenius Optiflux F160NRe Hemodialyzer Catalog number: 0500316E Intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.

FDA product code: KDI — Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K003498
Affected lot / code info: Lot Number 11PU01012 Exp Date: 11/2014

Why it was recalled

Risk of internal blood leaks affecting the hemodialyzers.

Root cause (FDA determination)

Process control

Action the firm took

Fresenius North America notified consignees on 3/6/12 by recall notification letter titled:Urgent FMCNA Optiflux F160NRe Hemodialyzer Recall, by certified mail with return receipt. The letter identified the affected product and described the reason for the recall. Customers were instructed to examine their stock immediately to determine whether they have any of the affected lot on hand. If customers have the affected lot, they have been instructed to immediately discontinue use and place all unused units in a secure area for return to Fresenius Medical Care North America. A Reply Response from is to be completed and returned. Customers have been instructed to contact their Fresenius Medical Care Customer Service Team for instructions on how to return the recalled product. Contact 1-800-323-5188.

Recalling firm

Firm: Fresenius Medical Care Holdings, Inc.
Address: 920 Winter St, Waltham, Massachusetts 02451-1521

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2012-03-06
Posted by FDA: 2012-03-30
Terminated: 2016-08-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #107744. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.