Fresenius 2008 Series Hemodialysis Machines: Models: 2008H, 2008K, 2008K2, 2008k@Home, 2008T The 2008H Hemodialysis mach

FDA device recall Z-0629-2014 · posted 2014-01-06 · Terminated

Recall details

Recalling firm

Fresenius Medical Care Holdings, Inc.

Reason for recall

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

Action taken

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

Status

Terminated

Product code

KDI

Quantity affected

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

Distribution

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

Date initiated

2013-11-12

Date posted

2014-01-06

Date terminated

2019-03-26

Location

Waltham, MA

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