Recall Z-1693-2013 · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

Fresenius Medical Care Holdings, Inc.

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

Date	Jul 11, 2013 (initiated May 24, 2013)
Status	Terminated
Reason	Incorrect rubber nitrile O-rings distributed instead of the correct material EPDM. (Ethylene Propylene Dine Monomer (M-class) rubber)
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 reca
Quantity	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.
FDA record	Open on fda.gov

510(k) clearances named in this recall

K080964	FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE Fresenius Medical Care North America, Jan 14, 2009
K093902	MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 190573 Fresenius Medical Care North America, May 27, 2010
K101715	FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573 Fresenius Medical Care North America, Design Cente, Dec 21, 2010
K111639	FRESENIUS 2008T HEMODIALYSIS MACHINE Fresenius Medical Care, Oct 21, 2011
K113427	FRESENIUS 2008T HEMODIALYSIS MACHINE Fresenius Medical Care North America, Dec 21, 2011
K120505	FRESENIUS 2008T HEMODIALYSIS MACHINE Fresenius Medical Care North America, Design Cente, Mar 6, 2012