Z-1693-2013Class II

Fresenius Service Replacement 0-Ring. Used in as a service part in 4 sub-assemblies manufactured and/or...

Name: Z-1693-2013 Fresenius Service Replacement 0-Ring. Used in as a service part in 4 sub-assemblies manufactured and/or...
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2013-05-24
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2013-05-24 / Terminated / root cause: manufacturing process

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of Fresenius Service Replacement 0-Ring. Used in as a service part in 4 sub-assemblies manufactured and/or refurbished Fresenius hemodialysis machines, models... on 2013-05-24. FDA classified it as Class II and gives the reason as "Incorrect rubber nitrile O-rings distributed instead of the correct material EPDM. (Ethylene Propylene Dine Monomer (M-class) rubber)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1693-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-24
Posted: 2013-07-11
Terminated: 2019-10-07
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: Fresenius Service Replacement 0-Ring. Used in as a service part in 4 sub-assemblies manufactured and/or refurbished Fresenius hemodialysis machines, models 2008K, 2008K2, 2008K@Home and 2008T
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: Incorrect rubber nitrile O-rings distributed instead of the correct material EPDM. (Ethylene Propylene Dine Monomer (M-class) rubber)
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Fresenius notified customers on May 24, 2013, by telephone and by 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 will be instructed to immediately discontinue use and place all 0-rings in a secure area for return to Fresenius Medical Care North America. Please contact your Fresenius Medical Care Technical Service Team at 1-800-227-2572, (choose option 4, then option 2) for instructions how to return the recalled product.
Quantity in commerce: 725 units
Distribution: Nationwide Distribution including the states of AR, CA, FL, GA, KY, LA, MA, MD, NC, NJ, NY, PA, PR, SC, TX and VA.
Product codes and lots: Part Number: 640919

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1693-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1693-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-11

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)