Z-1015-2015Class II

ASSY, POWER SUPPLY 130V 50HZ. This component is used with the following machines: 2008T Hemodialysis Machine...

Name: Z-1015-2015 ASSY, POWER SUPPLY 130V 50HZ. This component is used with the following machines: 2008T Hemodialysis Machine...
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2014-12-16
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2014-12-16 / Terminated

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of ASSY, POWER SUPPLY 130V 50HZ. This component is used with the following machines: 2008T Hemodialysis Machine, 2008K Hemodialysis Delivery Equipment, 2008 K2... on 2014-12-16. FDA classified it as Class II and gives the reason as "Unqualified power assemblies shipped to customers". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1015-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-16
Posted: 2015-01-27
Terminated: 2021-01-29
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: ASSY, POWER SUPPLY 130V 50HZ. This component is used with the following machines: 2008T Hemodialysis Machine, 2008K Hemodialysis Delivery Equipment, 2008 K2 Hemodialysis Delivery Equipment 2008K@home Hemodialysis Delivery System
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: Unqualified power assemblies shipped to customers.
FDA root cause: Under Investigation by firm
Action: Consignees were notified of the recall via letter sent on 12/18/2014 via certified mail. The letter informs consignees of the recall and requests that they take the following steps: Please check your stock for any 50 Hz Power Supplies (P/N 190092) with the name Electro Assemblies, LLC which is visible on the Transformer contained inside the Power Supply and discontinue use. Place the product in a secure, segregated area. Please contact your Fresenius Technical Services at 1-800-227-2572 option 4 then option 1, and reference the Field Action Number above. They will issue you a Return Good Authorization so you can return this product. that a reply form is completed and returned via fax or scanned email copy. In addition, consignees are asked to complete a reply form and return via fax/mail.
Quantity in commerce: 10
Distribution: Distributed in OK and FL.
Product codes and lots: 4P¿226813; 4P¿226815; 4P-226817; 4P-226818; 4P¿226819; 4P-226820; 4P-226821; 4P-226822

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1015-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1015-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-04	2015-01-27

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)