FDAClass IIApril 29, 2020

Fresenius 2008T BlueStar Hemodialysis Machine recall

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

Why was Fresenius 2008T BlueStar Hemodialysis Machine 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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All serial numbers

Product
Fresenius 2008T BlueStar Hemodialysis Machine Part Number Description: 191124 2008T HD SYS. CDX BLUEST AR; 191126 2008T HD SYS. CDX W/BIBAG BLUEST AR…
Recalling firm
Fresenius Medical Care Holdings, Inc.
Quantity
15,342
Distribution
Nationwide Foreign: Canada, Curaca, Guam
Recall date
April 29, 2020
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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