—#102875

Product

Fresenius 2008K@home 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 product code: ONW — Hemodialysis System For Home Use
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K070049
Affected lot / code info: All serial numbers

Why it was recalled

Upgrade software to implement new on screen graphics and instructions, the addition of a bracket on the side of the machine to temporarily hold the bloodlines during set up in order to conform to approved 510(k)

Root cause (FDA determination)

Device Design

Action the firm took

Fresenius Medical NA issued a formal field correction notification dated May 4 ,2011, sent by certified mail with return receipt requested. The letter identified the product the problem and the action needed to be taken by the customer. The customer was notified of the retrofit that would be done to their machines. The patients' facilities were made aware of the changes that would be made to each of their patient's 2008K@home machines on May 4, 2011. On May 13, 2011, all facilities with active 2008K@home machines were sent a notification letter of the retrofit. Please return the receipt for confirmation that you have received this notice. Please call (781) 699-2053, to schedule a certified technician to conduct the machine retrofit.

Recalling firm

Firm: Fresenius Medical Care Holdings, Inc.
Address: 920 Winter St, Waltham, Massachusetts 02451-1521

Distribution

Distribution pattern: Nationwide Distribution. Canada - FMCNA is not conducting the recall to Canada, as Health Canada did not require the same modifications to the machines

Timeline

Recall initiated: 2011-05-04
Posted by FDA: 2011-08-29
Terminated: 2014-08-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #102875. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.