Recall Z-0629-2014— Fresenius Medical Care Holdings, Inc.

Name: FDA recall Z-0629-2014
Creator: U.S. Food and Drug Administration
Published: 2013-11-12

Class II · Terminated

Class II FDA medical device recall by Fresenius Medical Care Holdings, Inc., initiated 2013-11-12, terminated 2019-03-26. It names 4 FDA 510(k) clearances: K070049, K093902, K994267 and 1 more. 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.. Reason: 2008 Series Hemodialysis Machines complaints of saline bags inappropriately filling during recirculation and setup.

Recalling firm: Fresenius Medical Care Holdings, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-11-12
Terminated: 2019-03-26
Firm location: Waltham, MA, United States

510(k) clearances named in this recall

4 on FDA's record

K070049 — FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTORFresenius Medical Care North America·cleared 2011-02-03
K093902 — MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 190573Fresenius Medical Care North America·cleared 2010-05-27
K994267 — FRESENIUS 2008KFresenius Medical Care·cleared 2000-03-16
K921456 — FRESENIUS 3008/FDS-08 DIALYSATE DELIVERY SYSTEMFresenius USA, Inc.·cleared 1994-04-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.