—#126881

Product

Revision K Actuator Test Boards sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T). Part Number: 190713 Revision K

FDA product code: KDI — Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device class: Class 2
Medical specialty: Gastroenterology, Urology
Affected lot / code info: Revision K Actuator Test Boards

Why it was recalled

2008-Series Hemodialysis Machines with Revision K Actuator Test Boards may fail to detect a disconnected Ultrafiltration (UF) Pump

Root cause (FDA determination)

Device Design

Action the firm took

Fresenius Medical issued Urgent Recall letter issued on 4/25/14 by certified mail with signature confirmation and fax-back form. Customers instructed to examine their inventory to determine whether they have any of the affected 2008T machines or if they have installed any of the affected replacement boards. If customers have the affected machines or replacement boards, they will be instructed to contact FMC-RTG Technical Service to have the Actuator Test Boards replaced. Contact the FMCNA Technical Service Team at 1-800-227-2572.

Recalling firm

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

Distribution

Distribution pattern: USA (nationwide) and the country of Canada.*

Timeline

Recall initiated: 2014-04-25
Posted by FDA: 2014-05-13
Terminated: 2021-05-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #126881. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.