Z-0825-2012

Fresenius Optiflux F250NRe Hemodialyzer, , intended for single use in acute and chronic hemodialysis Catalog...

Name: Z-0825-2012 Fresenius Optiflux F250NRe Hemodialyzer, , intended for single use in acute and chronic hemodialysis Catalog...
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2011-12-27
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2011-12-27 / Terminated / root cause: manufacturing process

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of Fresenius Optiflux F250NRe Hemodialyzer, , intended for single use in acute and chronic hemodialysis Catalog No. 0500325E The Fresenius Optiflux F250NRe... on 2011-12-27. The reason FDA records is "Optiflux F250NRe Hemodialyzers have 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-0825-2012
Status: Terminated
Initiated: 2011-12-27
Posted: 2012-01-20
Terminated: 2013-07-08
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: Fresenius Optiflux F250NRe Hemodialyzer, , intended for single use in acute and chronic hemodialysis Catalog No. 0500325E The Fresenius Optiflux F250NRe Hemodialyzers are intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: Optiflux F250NRe Hemodialyzers have increased risk of an internal blood leak
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Fresenius Medical Care North America contacted customers by telephone on December 27, 2011, and sent a Customer Notification letter dated December 27, 2011, via certified mail return receipts and fax - back requested to all affected customers. Customers were instructed to examine your stock of dialyzers, and isolate and discontinue use of the before mentioned lots. If you have identified dialyzers from the recalled lots, please contact Customer Service for a Return Goods Authorization. We will pick up the product you currently have in stock and supply replacement product. All products for return will be picked up during your next scheduled Fresenius delivery. Promtly fill out the fax-back reply form attached to the notification. Please do not return used dialyzers. For further questions, please call 1 (800) 662-1237.
Quantity in commerce: 599,436 units
Distribution: Worldwide Distribution -- USA (nationwide) and the country of Canada.
Product codes and lots: Lot Codes: 8SU203 EXPIRATION DATE: 12/31/2011, 8SU204 EXPIRATION DATE: 12/31/2011, 8SU205 EXPIRATION DATE: 12/31/2011, 09DU02013 EXPIRATION DATE: 04/30/2012, 09DU02014 EXPIRATION DATE: 04/30/2012, 09DU02022 EXPIRATION DATE: 04/30/2012, 09NU02011 EXPIRATION DATE: 10/31/2012, 09PU02011 EXPIRATION DATE: 11/30/2012, 09SU02001 EXPIRATION DATE: 12/31/2012, 09SU02007 EXPIRATION DATE: 12/31/2012, 10AU02013 EXPIRATION DATE: 01/31/2013, 10CU02001 EXPIRATION DATE: 03/31/2013, 10EU02010 EXPIRATION DATE: 05/31/2013, 10EU02017 EXPIRATION DATE: 05/31/2013, 10HU02013 EXPIRATION DATE: 06/30/2013, 10HU02014 EXPIRATION DATE: 06/30/2013, 10LU02001 EXPIRATION DATE: 09/30/2013, 10LU02013 EXPIRATION DATE: 09/30/2013, 10LU02014 EXPIRATION DATE: 09/30/2013, 10LU02015 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)