Z-0920-2014Class II

Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine Part Number: 650103. The adapter is...

Name: Z-0920-2014 Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine Part Number: 650103. The adapter is...
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2013-12-17
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2013-12-17 / Terminated

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine Part Number: 650103. The adapter is a socket that accepts the 2008 machine spike to... on 2013-12-17. FDA classified it as Class II and gives the reason as "Bicarbonate Jug Adapter distributed prior to 510(k) approval". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0920-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-17
Posted: 2014-02-03
Terminated: 2021-05-18
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine Part Number: 650103. The adapter is a socket that accepts the 2008 machine spike to draw concentrate from the container.
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: Bicarbonate Jug Adapter distributed prior to 510(k) approval
FDA root cause: No Marketing Application
Action: Fresenius notified customers by telephone and Formal notification on 12/17/13 via the Urgent Bicarbonate Jug Adapter Recall letter sent certified mail with signature confirmation and fax-back form. Customers were instructed to examine their stock immediately to determine whether they have any of the affected parts on hand. If customers have the affected parts, they are instructed to discontinue use and place all Bicarbonate Jug Adapters in a secure area for return to Fresenius Medical Care Renal Therapies Group, LLC (FMC-RTG). Customers instructed to contact their Fresenius Medical Care Technical Services Team for instructions on how to return the recalled product.
Quantity in commerce: 703 units
Distribution: Nationwide Distribution.
Product codes and lots: N/A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0920-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0920-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-12	2014-02-03

Product code KDI

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)