CLASS II Device recall · Reported 20 Nov 2013 · FDA Enforcement Report

Combiset Blood Line Hemodialysis use recalled by Fresenius Medical Care

Fresenius Medical Care Holdings is recalling Combiset Blood Line Hemodialysis use, distributed nationwide in the US. The recall was initiated on 29 Aug 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lot codes

Quantity recalled508,029 cases

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-0186-2014
FDA event ID: 65739
Recalling firm: Fresenius Medical Care Holdings, Waltham, MA
Classification: Class II
Status: Terminated
Recall initiated: 29 Aug 2013
FDA classified: 8 Nov 2013
Reported: 20 Nov 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

29 Aug 2013	Recall initiated by company
8 Nov 2013	Classified by FDA	+71 days
20 Nov 2013	Published in enforcement report	+12 days

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

Reason for recall

Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss

Product as listed by the FDA

Combiset Blood Line Hemodialysis use Catalog Number: 03-2622-3. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.

Where it was distributed

Worldwide Distribution-USA (nationwide) and the country of Canada.

Nationwide

Questions about this recall

Why was it recalled?

Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss

Which lots are affected?

All lot codes

Where was it sold?

Worldwide Distribution-USA (nationwide) and the country of Canada.

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

2 other products · FDA event 65739

This product is part of a recall event; the main page for the event is 2008K@ Home Blood lines Combiset True Flow Series recalled.

Reported	Class	Recall	Company	Reason	Where
20 Nov 2013	CLASS II	2008K@ Home Blood lines Combiset True Flow Series recalled	Fresenius Medical Care Holdings	Other	Nationwide
20 Nov 2013	CLASS II	Combiset Blood Line with BVM for Hemodialysis use recalled	Fresenius Medical Care Holdings	Other	Nationwide

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