CLASS II Device recall · Reported 13 Apr 2016 · FDA Enforcement Report

Fresenius Hemoflow F3 Dialyzer recalled by Fresenius Medical Care Renal

Fresenius Medical Care Renal Therapies Group is recalling Fresenius Hemoflow F3 Dialyzer, distributed nationwide in the US. The recall was initiated on 26 Feb 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: 15KU04011 Exp. Date : 08/31/2013

Quantity recalled1,650 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1324-2016
FDA event ID: 73387
Recalling firm: Fresenius Medical Care Renal Therapies Group, Waltham, MA
Classification: Class II
Status: Terminated
Recall initiated: 26 Feb 2016
FDA classified: 5 Apr 2016
Reported: 13 Apr 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

26 Feb 2016	Recall initiated by company
5 Apr 2016	Classified by FDA	+39 days
13 Apr 2016	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Dialyzer header leak due to possible improper torque

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide Arizona California Connecticut District of Columbia Georgia Illinois Indiana Michigan Minnesota Missouri Mississippi New York Ohio Pennsylvania South Carolina South Dakota Texas Washington

Questions about this recall

Why was it recalled?

Dialyzer header leak due to possible improper torque

Which lots are affected?

Lot Number: 15KU04011 Exp. Date : 08/31/2013

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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