Z-2224-2010

Fresenius 2008H Dialysate Delivery Machine, Manufactured by Fresenius USA Inc., Walnut Creek, CA

Name: Z-2224-2010 Fresenius 2008H Dialysate Delivery Machine, Manufactured by Fresenius USA Inc., Walnut Creek, CA
Creator: Fresenius Medical Care North America
Published: 2009-11-20
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2009-11-20 / Terminated / root cause: design

FDA source

Fresenius Medical Care North America began a recall of Fresenius 2008H Dialysate Delivery Machine, Manufactured by Fresenius USA Inc., Walnut Creek, CA on 2009-11-20. The reason FDA records is "Power cords may fail if the prongs crack or fail at the plug, and may become a fire/burn/shock hazard or delay/interrupt therapy". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2224-2010
Status: Terminated
Initiated: 2009-11-20
Posted: 2010-08-15
Terminated: 2011-02-07
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: Fresenius 2008H Dialysate Delivery Machine, Manufactured by Fresenius USA Inc., Walnut Creek, CA
Product code: FKP System, Dialysate Delivery, Single Patient
Reason for recall: Power cords may fail if the prongs crack or fail at the plug, and may become a fire/burn/shock hazard or delay/interrupt therapy.
Root cause tag: design
FDA root cause: Component design/selection
Action: An urgent device recall notification was sent to all consignees. Customers are asked to inspect cords for defects, and are refered to preventive maintenance requirements in the manual. Customers who identify the defective cords will be instructed to discontinue use as soon as possible without jeopardizing patient care. Customers are instructed to monitor cords regularly, and pay attention to machines that are frequently plugged or unplugged. Personnel are instructed to not use the cord to unplug the device from the wall (yanking the plug from the wall) and to refrain from rolling over the cord or plug.
Quantity in commerce: 33
Distribution: Product distributed to 5404 customers throughout the US and the world.
Product codes and lots: Catalog numbers 501228, R190188 (Refurbished), R501228, RTLR501228 (Refurbished)

Product code FKP

K921456Class IIFresenius 3008/Fds-08 Dialysate Delivery SystemFresenius USA, Inc. / cleared 1994-04-20

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)