FDAFDA · Food and drugs·Recall number Z-0629-2014
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.
Published January 15, 2014 · Recall initiated: November 12, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
2008 Series Hemodialysis Machines complaints of saline bags inappropriately filling during recirculation and setup
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Distributor
- Worldwide Distribution - USA (nationwide) and Internationally Mexico and Canada.
- Lot
- All serial numbers
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.