Home › Fresenius Usa, Inc. › 2008® Series Hemodialysis Machines
2008® Series Hemodialysis Machines
Fresenius Usa, Inc. · Model 190904 · UDI-DI 00840861100965
ONW
Prescription
4
510(k) clearances
137
Adverse events (25 deaths)
4
Recalls
5
Facilities
Description
2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2013-08-29 | Fresenius Medical Care Holdings, Inc. | Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss |
| 2013-08-29 | Fresenius Medical Care Holdings, Inc. | Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss |
| 2013-08-29 | Fresenius Medical Care Holdings, Inc. | Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss |
| 2011-05-04 | Fresenius Medical Care Holdings, Inc. | Upgrade software to implement new on screen graphics and instructions, the addition of a bracket on the side of the machine to temporarily hold the bloodlines during set up in orde |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.