Fresenius 2008 Series Hemodialysis Machines recall
Fresenius 2008 Series Hemodialysis Machines: Models: 2008H, 2008K, 2008K2, 2008k@Home, 2008T The 2008H Hemodialysis machine is indicated for acute and…
Why was Fresenius 2008 Series Hemodialysis Machines recalled?
2008 Series Hemodialysis Machines complaints of saline bags inappropriately filling during recirculation and setup
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 2008 Series Hemodialysis Machines: Models: 2008H, 2008K, 2008K2, 2008k@Home, 2008T The 2008H Hemodialysis machine is indicated for acute and…
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Quantity
- 111,504 units US and 3,638 Canada and Mexico-
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally Mexico and Canada.
- Recall date
- January 15, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)