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Terminated

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.

FDA Recall Z-0629-2014 · Posted 2014-01-06

Recalling FirmFresenius Medical Care Holdings, Inc.
Recall StatusTerminated
Product CodeKDI
Date Initiated2013-11-12
Date Terminated2019-03-26
Product Quantity111,504 units US and 3,638 Canada and Mexico-

Reason for Recall

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

Firm Action

Fresenius Medical issued a Product Notification letter dated November 12, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers who encounter a saline bag that is inappropriately filling, should discontinue the setup and remove the machine from service until the drain line and drain-associated hydraulic components can be checed by a qualified service technician. Customers were also instructed to ensure that the hemodialysis machine is installed and operated in compliance with the Machine Specification section of their operator's manual, including the specification located in the Water/Drain Section. Customers with questions were instructed to call 1-800-227-2572. For questions regarding this recall call 800-662-1237.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K070049FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTORFresenius Medical Care North America · 2011-02-03K093902MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 190573Fresenius Medical Care North America · 2010-05-27K994267FRESENIUS 2008KFresenius Medical Care · 2000-03-16K921456FRESENIUS 3008/FDS-08 DIALYSATE DELIVERY SYSTEMFresenius USA, Inc. · 1994-04-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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