Fresenius Medical Care Holdings, Inc. recalls Fresenius 2008 Series Hemodialysis Machines: Models: 2008H, 2008K, 2008K2, 2008k@Home, 2008T The 2008H Hemodialysis

Recalled January 15, 2014 · FDA recall Z-0629-2014 · Fresenius Medical Care Holdings

Hazard

2008 Series Hemodialysis Machines complaints of saline bags inappropriately filling during recirculation and setup · FDA Class II

Units

111,504 units US and 3,638 Canada and Mexico-

Sold at

Worldwide Distribution - USA (nationwide) and Internationally Mexico and Canada.

Description

2008 Series Hemodialysis Machines complaints of saline bags inappropriately filling during recirculation and setup

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.

Manufacturer(s)

Fresenius Medical Care Holdings, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →