Z-0658-2019Class II

Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E

Name: Z-0658-2019 Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E
Creator: Fresenius Medical Care Renal Therapies Group, LLC
Published: 2018-11-05
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2018-11-05 / Terminated

FDA source

Fresenius Medical Care Renal Therapies Group, LLC began a recall of Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E on 2018-11-05. FDA classified it as Class II and gives the reason as "Potential for external blood leaks from the dialyzer header". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0658-2019
Classification: Class II
Status: Terminated
Initiated: 2018-11-05
Posted: 2018-12-21
Terminated: 2023-04-17
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: Potential for external blood leaks from the dialyzer header
FDA root cause: Other
Action: On November 6, 2018, Fresenius Medical Care issued URGENT MEDICAL DEVICE RECALL notices to customers. Customers were advised to take the following actions: 1. Check your inventory for the affected lot numbers. 2. If found, discontinue use of these lots. 3. Please all affected units in a secure, segregated area. 4. Contact Stericycle at 1-888-731-7986 for instructions on how to return the recalled product or if replacement product is needed right away. (Refer to EVENT # 6273). 5. Complete and return the Reply Form. Customers with questions may contact Medical Information and Communications at 855-616-2309 or thru the website www.fresenius-medinfo.com.
Quantity in commerce: 9,097 cs x 12 units each
Distribution: US Nationwide
Product codes and lots: Lot Numbers: 18HU06016, 18HU06017, 18HU06018 and 18HU06019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0658-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0658-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-26	2018-12-20

Product code KDI

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)