Z-1951-2010

Optiflux F180NR Dialyzers, Catalog Number: 0500318E. Manufactured by Fresenius Medical Care North America...

Name: Z-1951-2010 Optiflux F180NR Dialyzers, Catalog Number: 0500318E. Manufactured by Fresenius Medical Care North America...
Creator: Fresenius Medical Care North America
Published: 2010-05-14
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2010-05-14 / Terminated / root cause: manufacturing process

FDA source

Fresenius Medical Care North America began a recall of Optiflux F180NR Dialyzers, Catalog Number: 0500318E. Manufactured by Fresenius Medical Care North America, Ogden, UT 84404. Designed for single use acute and... on 2010-05-14. The reason FDA records is "Hemodialyzer may leak at the header/end cap". 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-1951-2010
Status: Terminated
Initiated: 2010-05-14
Posted: 2010-07-01
Terminated: 2011-09-13
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: Optiflux F180NR Dialyzers, Catalog Number: 0500318E. Manufactured by Fresenius Medical Care North America, Ogden, UT 84404. Designed for single use acute and chronic hemodialysis.
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: Hemodialyzer may leak at the header/end cap
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Fresenius Medical notified customers by telephone script beginning May 14, 2010 and follow up letter advising users to examine inventory for recalled lot, discontinue use and contact Fresenius Customer Care 1-800-325-5188 , ext. 6610 for instructions on how to return the recalled product.
Quantity in commerce: 34,152 units
Distribution: Nationwide Distribution
Product codes and lots: Lot Number: 10AU04011, Exp 01/13.

Product code KDI

K002277Class IIFresenius Optiflux 200NrFresenius Medical Care North America / cleared 2000-08-25

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)