Z-0738-2008

Optiflux 180NR Advanced Fresenius Polysulfone, Catalog No.: 0500318E, Fresenius Medical Care North America...

Name: Z-0738-2008 Optiflux 180NR Advanced Fresenius Polysulfone, Catalog No.: 0500318E, Fresenius Medical Care North America...
Creator: Fresenius Medical Care North America
Published: 2007-12-03
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2007-12-03 / Terminated / root cause: manufacturing process

FDA source

Fresenius Medical Care North America began a recall of Optiflux 180NR Advanced Fresenius Polysulfone, Catalog No.: 0500318E, Fresenius Medical Care North America, Waltham, MA 02451. (Hemodialyzer) on 2007-12-03. The reason FDA records is "Leaking: the Dialyzer may leak at the header resulting in small amounts of blood loss". 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-0738-2008
Status: Terminated
Initiated: 2007-12-03
Posted: 2008-02-01
Terminated: 2008-02-08
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: Optiflux 180NR Advanced Fresenius Polysulfone, Catalog No.: 0500318E, Fresenius Medical Care North America, Waltham, MA 02451. (Hemodialyzer)
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: Leaking: the Dialyzer may leak at the header resulting in small amounts of blood loss.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Consignees were notified by telephone and certified letter , Urgent Device Recall, on 12/03/2007. They were told to discontinue use and to return all unused affected dialyzers to Fresenius.
Quantity in commerce: 2,791 cases (33,492 dialyzers)
Distribution: Nationwide including the states of AZ, CA, HI, IA, ID, IL, IN, KS, KY, MI, MN, MO, NE, NV, NY, OH, OR, PA, WA, and WI.
Product codes and lots: Lot # 7LU416

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