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Terminated

Fresenius 2008T Series Hemodialysis System

FDA Recall Z-1026-2017 · Posted None

Recalling FirmFresenius Medical Care Renal Therapies Group, LLC
Recall StatusTerminated
Product CodeKDI
Date Initiated2016-12-21
Date Terminated2023-03-17
Product Quantity65361 units (US) 249 units (OUS)

Reason for Recall

When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine

Firm Action

Fresenius issued Customer Notification via Certified Mail on 12/21/2016. Users provided with problem and recommendation, when adjusting the UF Rate, UF Goal, or Tx Time, is to use the numeric data entry keys instead of the up or down arrow keys. Change the values by using data entry keys, then save by pressing CONFIRM. Fresenius will make arrangements to install software on the hemodialysis machine. Confirmation of the noticed by the consignee will be required via a Reply Form.

Root Cause

Device Design

Distribution Pattern

Nationwide Foreign: Canada, Mexico, Jamaica, Germany, Guam

Official Source

View FDA Recall →

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

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