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Terminated

Fresenius 2008T Hemodialysis Machine with Revision K Actuator Test Boards and also sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T). Part Number: 190234 Revision K

FDA Recall Z-1618-2014 · Posted 2014-05-13

Recalling FirmFresenius Medical Care Holdings, Inc.
Recall StatusTerminated
Product CodeKDI
Date Initiated2014-04-25
Date Terminated2021-05-18
Product Quantity79 units

Reason for Recall

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

Firm Action

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

Distribution Pattern

USA (nationwide) and the country of Canada.*

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K121341FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEMFresenius Medical Care North America · 2012-12-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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