CLASS II ONGOING Device recall · Reported 29 Apr 2020 · FDA Enforcement Report

Fresenius 2008T BlueStar Hemodialysis Machine recalled

Fresenius Medical Care Holdings is recalling Fresenius 2008T BlueStar Hemodialysis Machine, distributed nationwide in the US. The recall was initiated on 12 Mar 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll serial numbers

Quantity recalled15,342

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-1749-2020
FDA event ID: 85310
Recalling firm: Fresenius Medical Care Holdings, Waltham, MA
Classification: Class II
Status: Ongoing
Recall initiated: 12 Mar 2020
FDA classified: 20 Apr 2020
Reported: 29 Apr 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

12 Mar 2020	Recall initiated by company
20 Apr 2020	Classified by FDA	+39 days
29 Apr 2020	Published in enforcement report	+9 days

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

Reason for recall

A "Remove USB Device 2" false alarm may be displayed when no USB device or a non-powered USB device is connected to the USB port on the rear of the machine

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Fresenius 2008T BlueStar Hemodialysis Machine Part Number Description: 191124 2008T HD SYS. CDX BLUEST AR; 191126 2008T HD SYS. CDX W/BIBAG BLUEST AR; 191128 2008T HD SYS. W/O CDX BLUEST AR; 191130 2008T HD SYS. W/O CDX W/BIBAG BLUEST AR

Where it was distributed

Nationwide Foreign: Canada, Curaca, Guam

Nationwide

Questions about this recall

Is Fresenius 2008T BlueStar Hemodialysis Machine recalled?

Yes. Fresenius Medical Care Holdings recalled Fresenius 2008T BlueStar Hemodialysis Machine on 12 Mar 2020. The recall is Class II and its status is Ongoing. Recall number Z-1749-2020.

Why was it recalled?

A "Remove USB Device 2" false alarm may be displayed when no USB device or a non-powered USB device is connected to the USB port on the rear of the machine

Which lots are affected?

All serial numbers

Where was it sold?

Nationwide Foreign: Canada, Curaca, Guam

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

More recalls from Fresenius Medical Care Holdings

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