Z-1550-2015Class II

2008 Series Hemodialysis Machines: 2008T with the following product code and description: 190395 2008K at...

Name: Z-1550-2015 2008 Series Hemodialysis Machines: 2008T with the following product code and description: 190395 2008K at...
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2015-02-20
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2015-02-20 / Terminated / root cause: software

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of 2008 Series Hemodialysis Machines: 2008T with the following product code and description: 190395 2008K at Home System - 1st Gen. - Canada; 190828 2008K at Home... on 2015-02-20. FDA classified it as Class II and gives the reason as "The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l. The correct value is shown on the dialysate screen". 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-1550-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-20
Posted: 2015-04-29
Terminated: 2021-05-18
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: 2008 Series Hemodialysis Machines: 2008T with the following product code and description: 190395 2008K at Home System - 1st Gen. - Canada; 190828 2008K at Home System - 2nd Gen - U.S.; 190904 2008K at Home System w/ Bibag; 190828 2008KatHOME HEMODIALYSIS SYSTEM; 190395 2008KatHOME MACHINE, SHORT CAB, OLC/DP, HP The Fresenius 2008K is indicated for acute and chronic dialysis therapy.
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l. The correct value is shown on the dialysate screen.
Root cause tag: software
FDA root cause: Software design
Action: The firm, Fresenius Medical Care, sent an "URGENT - MEDICAL DEVICE CORRECTION" letter dated February 19, 2015 to its Consignees via certified mail on February 26, 2015. The letter describes the product, problem and actions to be taken. The consignees were instructed to sign and return the attached "Reply Form" via fax to: 781-699-9769 Attn: Quality Department or Scan and E-mail to: [email protected] to confirm that they received and understand the customer notification. The firm will be providing a software update and stated that in the near future, your local clinic will be contacting you about installing the software update. If you have any questions pertaining to this Customer Notification, please contact your local clinic, 800-227-2572 or the Corrections and Removals Manager at 800-662-1237.
Quantity in commerce: 133,751 in total (US: 130,337 and OUS: Canada 1,201 and Mexico 2,213)
Distribution: Worldwide Distribution: US (Nationwide) and countries of: Canada and Mexico.
Product codes and lots: Serial Numbers: 0T0S100031- 101358, 1T0S101359- 127938, 2T0S109489- 118130, 3T0S118131- 126163, 4T0S126164- 135408, 9T0S100002, 9T0S100004, 9T0S100007- 100010, 9T0S100012, 9T0S100014- 100016

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1550-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1549-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-06	2015-04-29
Z-1550-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-06	2015-04-29
Z-1551-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-06	2015-04-29
Z-1552-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-06	2015-04-29

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)