Z-1339-2012

Fresenius Optiflux F160NRe Hemodialyzer Catalog number: 0500316E Intended for patients with acute or chronic...

Name: Z-1339-2012 Fresenius Optiflux F160NRe Hemodialyzer Catalog number: 0500316E Intended for patients with acute or chronic...
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2012-03-06
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2012-03-06 / Terminated / root cause: manufacturing process

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of Fresenius Optiflux F160NRe Hemodialyzer Catalog number: 0500316E Intended for patients with acute or chronic renal failure when conservative therapy is judged... on 2012-03-06. The reason FDA records is "Risk of internal blood leaks affecting the hemodialyzers". 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-1339-2012
Status: Terminated
Initiated: 2012-03-06
Posted: 2012-03-30
Terminated: 2016-08-08
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
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.
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: Risk of internal blood leaks affecting the hemodialyzers.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 30,576 units
Distribution: Nationwide Distribution
Product codes and lots: Lot Number 11PU01012 Exp Date: 11/2014

Product code KDI

K003498Class IIFresenius Optiflux 200AFresenius Medical Care North America / cleared 2001-01-04

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)