Z-1622-2011

Fresenius Optiflux F250NRe Hemodialyzer, Single Use, Catalog Number: 0500325E, Advanced Fresenius...

Name: Z-1622-2011 Fresenius Optiflux F250NRe Hemodialyzer, Single Use, Catalog Number: 0500325E, Advanced Fresenius...
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2011-02-16
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2011-02-16 / Terminated / root cause: manufacturing process

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of Fresenius Optiflux F250NRe Hemodialyzer, Single Use, Catalog Number: 0500325E, Advanced Fresenius Polysulfone. Intended for use as an artificial kidney system... on 2011-02-16. The reason FDA records is "There is an increased risk of an internal blood leak". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1622-2011
Status: Terminated
Initiated: 2011-02-16
Posted: 2011-03-22
Terminated: 2013-02-12
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
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.
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: There is an increased risk of an internal blood leak.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 38,364 units
Distribution: Worldwide Distribution -- USA and Canada.
Product codes and lots: Lot numbers: 10HU02012, Expiration Date: 06/30/2013; and 10LU02016, Expiration Date: 09/30/2013.

Product code KDI

K082414Class IIOptiflux F250nr, Model 0500325EFresenius Medical Care North America / cleared 2008-10-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)