Fresenius 2008T Series Hemodialysis System recall
Fresenius 2008T Series Hemodialysis System
Why was Fresenius 2008T Series Hemodialysis System recalled?
When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine
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?
All serial numbers
- Product
- Fresenius 2008T Series Hemodialysis System
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Quantity
- 65361 units (US) 249 units (OUS)
- Distribution
- Nationwide Foreign: Canada, Mexico, Jamaica, Germany, Guam
- Recall date
- January 25, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)