Z-1103-2014Class II

Optiflux F200NR High Flux Dialyzers; Product Number: 0500320N. Single Use acute or chronic hemanalysis...

Name: Z-1103-2014 Optiflux F200NR High Flux Dialyzers; Product Number: 0500320N. Single Use acute or chronic hemanalysis...
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2014-02-04
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2014-02-04 / Terminated

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of Optiflux F200NR High Flux Dialyzers; Product Number: 0500320N. Single Use acute or chronic hemanalysis treatment on 2014-02-04. FDA classified it as Class II and gives the reason as "Dialysate Port Leak During Priming of the Dialyzers". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1103-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-04
Posted: 2014-02-26
Terminated: 2021-05-18
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: Optiflux F200NR High Flux Dialyzers; Product Number: 0500320N. Single Use acute or chronic hemanalysis treatment.
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: Dialysate Port Leak During Priming of the Dialyzers
FDA root cause: Under Investigation by firm
Action: Fresenius Medical issued Notice to Clinics and Clinics with Patients Letters Dated - 1st Mailing - February 4, 2014 and Patients Letters Dated - February 5, 2014 - these letters contained the correct information.Corrected letters to Clinics and Clinics with Patients issued 2/14/14 via certified mail with return receipt and fax-back form . Users are advised the leak may be stopped by tightening the dialysate port cap more securely. Questions associated with this product notification to your Customer Service Team at 1-800-323-5188.
Quantity in commerce: 19,596 units
Distribution: Worldwide distribution: USA (nationwide) and the country of: Mexico.
Product codes and lots: Lot Number: 13NU04008

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1103-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1098-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-26
Z-1099-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-26
Z-1100-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-26
Z-1101-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-26
Z-1102-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-26
Z-1103-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-26
Z-1104-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-26
Z-1105-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-26
Z-1106-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-26

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)