Z-1303-2022Class II

Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E

Name: Z-1303-2022 Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2022-05-04
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2022-05-04 / Terminated

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E on 2022-05-04. FDA classified it as Class II and gives the reason as "Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm's standard operating procedure". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1303-2022
Classification: Class II
Status: Terminated
Initiated: 2022-05-04
Posted: 2022-06-30
Terminated: 2024-05-06
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm's standard operating procedure.
FDA root cause: Under Investigation by firm
Action: A Customer Notification was sent to the five (5) affected consignees on 05/04/2022 via USPS First Class Mail. The firm also followed up with phone calls with consignees with instructions to examine their stock to determine whether they have affected product on hand, and to remove product from their inventory.
Quantity in commerce: 19 cases
Distribution: US Nationwide distribution in the state of Pennsylvania.
Product codes and lots: UDI-DI (GTIN): (01)00840861100163 Lot 22AU04017

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1303-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1303-2022	Class II	Terminated	Voluntary: Firm initiated	2022-07-06	2022-06-30

Product code KDI

K162488Class IIOptiflux dialyzerFresenius Medical Care North America / cleared 2017-04-06

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)