Z-1324-2016Class II

Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic Hemodialysis

Name: Z-1324-2016 Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic Hemodialysis
Creator: Fresenius Medical Care Renal Therapies Group, LLC
Published: 2016-02-26
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2016-02-26 / Terminated / root cause: manufacturing process

FDA source

Fresenius Medical Care Renal Therapies Group, LLC began a recall of Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic Hemodialysis on 2016-02-26. FDA classified it as Class II and gives the reason as "Dialyzer header leak due to possible improper torque". 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-1324-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-26
Posted: 2016-04-05
Terminated: 2017-06-26
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic Hemodialysis
Product code: FJI Dialyzer, Capillary, Hollow Fiber
Reason for recall: Dialyzer header leak due to possible improper torque
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm, Fresenius Medical Care Renal Therapies Group, LLC issued an "URGENT MEDICAL DEVICE RECALL" letter dated 2/24/16 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use of your Hemoflow F3 Dialyzer; place all affected units in a secure, segregated area; contact your FMCRTG, LLC Customer Service Team at 1-800-323-5188 for instructions on how to return the recalled product, and fill out and return the attached Reply Form via fax to: 781-699-9796 ATTN: Quality Department or scan and email to: [email protected] at your earliest convenience. If you have any additional medical concerns or questions, please contact Medical Information and Communication at 855-616-2309 or Website: www.fresenius-medinfo.com.
Quantity in commerce: 1,650 units
Distribution: US Nationwide Distribution including states of: AZ, CA, CT, DC, GA, IL, IN, MI, MN, MO, MS, NY, OH, PA, SC, SD, TX, and WA.
Product codes and lots: Lot Number: 15KU04011 Exp. Date : 08/31/2013

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1324-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1324-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-13	2016-04-05

Product code FJI

K874872Class IIFresenius Hemoflow F3, F4, F5, F7Seratronics, Inc. / cleared 1988-02-19

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)