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1. #2008t hemodialysis machine operator's manual code#
2. #2008t hemodialysis machine operator's manual series#

Worldwide Distribution - USA (nationwide) and Internationally Mexico and Canada.ġ A record in this database is created when a firm initiates a correction or removal action. Customers with questions were instructed to call 1-80.įor questions regarding this recall call 80.ġ11,504 units US and 3,638 Canada and Mexico. 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 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. The letter identified the product, the problem, and the action to be taken by the customer.

#2008t hemodialysis machine operator's manual series#

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.Ģ008 Series Hemodialysis Machines complaints of saline bags inappropriately filling during recirculation and setupįresenius Medical issued a Product Notification letter dated November 12, 2013, to all affected customers. The Fresenius 2008K~home is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The 2008K, 2008KT are designed to provide hemodialysis treatment by controlling and monitoring both the dialysate and extracorporeal blood circuits. They can be used for patients suffering chronic or acute renal failure. The 2008K, 20081(T hemodialysis machines are designed to perform hemodialysis in hospitals and dialysis clinics. The dialysate delivery machine is used for hemodialysis in hospital, dialysis centers, and at home. Hemodialysis is indicated for patients with acute or chronic renal failure, when conservative therapy is judged to be inadequate. The 2008H Hemodialysis machine is indicated for acute and chronic dialysis therapy.

#2008t hemodialysis machine operator's manual code#

Class 2 Device Recall Fresenius 2008 Series Hemodialysis Machinesĭialyzer, high permeability with or without sealed dialysate system - Product Code KDIįresenius 2008 Series Hemodialysis Machines: