CLASS II Device recall · Reported 5 Mar 2014 · FDA Enforcement Report

Optiflux F200A High Flux Dialyzers recalled by Fresenius Medical Care

Fresenius Medical Care Holdings is recalling Optiflux F200A High Flux Dialyzers, distributed nationwide in the US. The recall was initiated on 4 Feb 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: 13NU04009

Quantity recalled5,244 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-1104-2014
FDA event ID: 67313
Recalling firm: Fresenius Medical Care Holdings, Waltham, MA
Classification: Class II
Status: Terminated
Recall initiated: 4 Feb 2014
FDA classified: 26 Feb 2014
Reported: 5 Mar 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

4 Feb 2014	Recall initiated by company
26 Feb 2014	Classified by FDA	+22 days
5 Mar 2014	Published in enforcement report	+7 days

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

Reason for recall

Dialysate Port Leak During Priming of the Dialyzers

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

Optiflux F200A High Flux Dialyzers; Product Number: 0500320A. Single Use acute or chronic hemanalysis treatment.

Where it was distributed

Worldwide distribution: USA (nationwide) and the country of: Mexico.

Nationwide

Questions about this recall

Why was it recalled?

Dialysate Port Leak During Priming of the Dialyzers

Which lots are affected?

Lot Number: 13NU04009

Where was it sold?

Worldwide distribution: USA (nationwide) and the country of: Mexico.

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.

Other products in this recall event

8 other products · FDA event 67313

This product is part of a recall event; the main page for the event is Optiflux F200NR High Flux Dialyzers recalled by Fresenius Medical Care.

Reported	Class	Recall	Company	Reason	Where
5 Mar 2014	CLASS II	Optiflux F200NR High Flux Dialyzers recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Packaging Defects	Nationwide
5 Mar 2014	CLASS II	Optiflux F200NRe High Flux Dialyzers recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Packaging Defects	Nationwide
5 Mar 2014	CLASS II	Optiflux F160NRe High Flux Dialyzers recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Packaging Defects	Nationwide
5 Mar 2014	CLASS II	Optiflux B200 Flux Dialyzers recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Packaging Defects	Nationwide
5 Mar 2014	CLASS II	Optiflux F18Nre Flux Dialyzers recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Packaging Defects	Nationwide
5 Mar 2014	CLASS II	Optiflux F180NR High Flux Dialyzers recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Packaging Defects	Nationwide
5 Mar 2014	CLASS II	Optiflux F160NR High Flux Dialyzers recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Packaging Defects	Nationwide
5 Mar 2014	CLASS II	Optiflux F180NRe High Flux Dialyzers recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Packaging Defects	Nationwide

More recalls from Fresenius Medical Care Holdings

All 165

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All 13,778

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