Fresenius Medical Care Renal Therapies Group, LLC recalls 2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy.

Recall date

October 5, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0829-2018

FDA classification

Class II

Brand / firm

Fresenius Medical Care Renal Therapies Group, LLC

Sold / distributed

US Nationwide Distribution

Why it was recalled

While reviewing documentation for the next software release of the 2008T, an R&D technician identified that setting the UF goal to '0' introduces a discrepancy between the UF rate displayed and the actual UF pump rate. The software anomaly is also applicable to the 2008T Machines that contained the 2.63 Bug Fix per DCAF 17-088. 2008T Upgrade kits that contained the 2.63 Bug Fix are also affected. Additionally, SW version 2.64 (in design freeze) is also impacted by this anomaly.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy.