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Hemodialysis System For Home Use

FDA product code ONW · Class 2 · Gastroenterology, Urology

5
Registered devices
137
Adverse events
4
Recalls
4
510(k) clearances

Devices with this code

2008® Series Hemodialysis Machines — Fresenius Usa, Inc.2008® Series Hemodialysis Machines — Fresenius Usa, Inc.2008® Series Hemodialysis Machines — Fresenius Usa, Inc.WetAlert™ wireless wetness detector — Fresenius Usa, Inc.CombiSet — Fresenius Medical Care Holdings, Inc.

Recent recalls

DateFirmReason
2013-08-29Fresenius 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
2013-08-29Fresenius 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
2013-08-29Fresenius 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
2011-05-04Fresenius 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 d

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.