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Fresenius 2008 Series Hemodialysis Machines recallZ-0629-2014 · Fresenius Medical Care Holdings, Inc. · initiated Nov 12, 2013

Class II Terminated All recalls posted in January 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Fresenius Medical Care Holdings, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-0629-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Nov 12, 2013
Posted by the FDA
Jan 6, 2014
Recalling firm
Fresenius Medical Care Holdings, Inc.
Quantity
111,504 units US and 3,638 Canada and Mexico-
Product code
KDI
FDA submissions
K070049, K093902, K921456, K994267
Distribution
Worldwide Distribution - USA (nationwide) and Internationally Mexico and Canada.

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.

Code information (models, lots, serial numbers)

All serial numbers

Other devices under the same FDA submission

2 devices cleared under K070049, K093902, K921456, K994267 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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