Z-0334-06

Optiflux Series Fresenius Polysulfone F180NR dialyzer High Flux Catalog Number: 0500318N

Name: Z-0334-06 Optiflux Series Fresenius Polysulfone F180NR dialyzer High Flux Catalog Number: 0500318N
Creator: Fresenius Medical Care North America
Published: 2005-11-28
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2005-11-28 / Terminated / root cause: labeling and UDI

FDA source

Fresenius Medical Care North America began a recall of Optiflux Series Fresenius Polysulfone F180NR dialyzer High Flux Catalog Number: 0500318N on 2005-11-28. The reason FDA records is "Mislabeled: Inner product mislabeled as 180NR (Catalog Number 0500318N) instead of 160NR". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0334-06
Status: Terminated
Initiated: 2005-11-28
Posted: 2005-12-31
Terminated: 2006-08-10
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: Optiflux Series Fresenius Polysulfone F180NR dialyzer High Flux Catalog Number: 0500318N
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: Mislabeled: Inner product mislabeled as 180NR (Catalog Number 0500318N) instead of 160NR
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Fresenius Medical notified consignees by letter dated 11/28/05 sent Certified Mail on 11/29/05 requesting return of product inventory.
Distribution: Nationwide
Product codes and lots: Lot Number: 5LU319

Product code KDI

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)