Fresenius Medical Care Holdings, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0629-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: November 12, 2013

Date Posted: January 15, 2014

Recall Number: Z-0629-2014

Event ID: 66622

Reason for Recall:

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

Status: Terminated

Product Quantity: 111,504 units US and 3,638 Canada and Mexico-

Code Information:

All serial numbers

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated