Z-0829-2018Class II

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

Name: Z-0829-2018 2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy
Creator: Fresenius Medical Care Renal Therapies Group, LLC
Published: 2017-10-05
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2017-10-05 / Terminated / root cause: software

FDA source

Fresenius Medical Care Renal Therapies Group, LLC began a recall of 2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy on 2017-10-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0829-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-05
Posted: 2018-02-20
Terminated: 2021-07-28
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: 2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy.
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software Design Change
Action: Fresenius Medical Care sent an Urgent Medical Device Correction letter dated April 24, 2017 to affected customers. the letter identified the affected product, problem and actions to be taken. For questions contact Technical Services at 1-800-227-2572.
Quantity in commerce: 15 machines
Distribution: US Nationwide Distribution
Product codes and lots: 2008T machines: 190766 2008T Hemodialysis System w/Bibag 190895 2008T GEN 2 Bibag without CDX 190766 = 00840861100910 (+Serial Number) 190895 = 00840861100927 (+Serial Number)ux=&Su

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0829-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0829-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-03-01

Product code KDI

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)