FDAClass IIIJune 12, 2019

2008T BlueStar Machine Software v.2.72-Hemodialysis recall: Software Issue

2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: The 2008T hemodialysis machine is indicated for…

Why was 2008T BlueStar Machine Software v.2.72-Hemodialysis recalled?

Power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72.

What should I do if I have this product?

Review the official FDA enforcement record for current 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?

Software v.2.72

Product
2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: The 2008T hemodialysis machine is indicated for…
Recalling firm
Fresenius Medical Care Renal Therapies Group, LLC
Quantity
257 units
Distribution
US Nationwide distribution.
Recall date
June 12, 2019
Classification
Class III
Status
Terminated
Agency
FDA (device)
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