Revision K Actuator Test Boards sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008

FDA device recall Z-1619-2014 · posted 2014-05-13 · Terminated

Recall details

Recalling firm

Fresenius Medical Care Holdings, Inc.

Reason for recall

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

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

KDI

Quantity affected

39 units

Distribution

USA (nationwide) and the country of Canada.*

Date initiated

2014-04-25

Date posted

2014-05-13

Date terminated

2021-05-18

Location

Waltham, MA