—#97801

Product

Fresenius Optiflux F250NRe Hemodialyzer, Single Use, Catalog Number: 0500325E, Advanced Fresenius Polysulfone. Intended for use as an artificial kidney system to the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration and hemodiafiltration.

FDA product code: KDI — Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K082414
Affected lot / code info: Lot numbers: 10HU02012, Expiration Date: 06/30/2013; and 10LU02016, Expiration Date: 09/30/2013.

Why it was recalled

There is an increased risk of an internal blood leak.

Root cause (FDA determination)

Process control

Action the firm took

FMCNA notified consignees on 2/16/11 by telephone and follow-up with an Urgent FMCNA Optiflux F250NRe Recall letter via Certified Mail, return Receipt requested. The firm states in the letter that there is an increased risk of an internal blood leak affecting a small percentage of the two lots of dialyzers. They are asking customers to examine their inventory, to discontinue use, and segregate the affected product in a secure place. Customers are to contact their FMCNA Customer Service Team at 1-800-323-5188 for instructions on how to return product. Used dialyzers should not be returned. If there are any questions, Customer Service should be contacted.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution -- USA and Canada.

Timeline

Recall initiated: 2011-02-16
Posted by FDA: 2011-03-22
Terminated: 2013-02-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #97801. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.