FDA Device recall Z-0629-2014
Fresenius 2008 Series Hemodialysis Machines: Models: 2008H, 2008K, 2008K2, 2008k@Home, 2008T The 2008H Hemodialysis machine is indicated fo…
- FDA Device
- Class II
- terminated
- Published 2014-01-15
On 2014-01-15 the FDA classified a Class II recall of Fresenius 2008 Series Hemodialysis Machines: Models: 2008H, 2008K, 2008K2, 2008k@Home, 2008T The 2008H Hemodialysis machine is indicated fo… by Fresenius Medical Care Holdings, citing 2008 Series Hemodialysis Machines complaints of saline bags inappropriately filling during recirculation and setup.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0629-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-11-12 |
| Published | 2014-01-15 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Fresenius Medical Care Holdings |
| Distribution | US |
Product
Fresenius 2008 Series Hemodialysis Machines: Models: 2008H, 2008K, 2008K2, 2008k@Home, 2008T The 2008H Hemodialysis machine is indicated for acute and chronic dialysis therapy. Hemodialysis is indicated for patients with acute or chronic renal failure, when conservative therapy is judged to be inadequate. The dialysate delivery machine is used for hemodialysis in hospital, dialysis centers, and at home. The 2008K, 20081(2 and 2008T hemodialysis machines are designed to perform hemodialysis in hospitals and dialysis clinics. They can be used for patients suffering chronic or acute renal failure. The 2008K, 2008K2 and 2008T are designed to provide hemodialysis treatment by controlling and monitoring both the dialysate and extracorporeal blood circuits. The Fresenius 2008K~home is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The 2008K~home is also indicated for hemodialysis in the home and must be observed by a trained and qualified person as prescribed by their physician.
Reason
2008 Series Hemodialysis Machines complaints of saline bags inappropriately filling during recirculation and setup
Identifiers
| code_info | All serial numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0629-2014%22
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