Fresenius Medical Care Holdings, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1693-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: May 24, 2013

Date Posted: July 17, 2013

Recall Number: Z-1693-2013

Event ID: 65090

Reason for Recall:

Incorrect rubber nitrile O-rings distributed instead of the correct material EPDM. (Ethylene Propylene Dine Monomer (M-class) rubber)

Status: Terminated

Product Quantity: 725 units

Code Information:

Part Number: 640919

Distribution Pattern:

Nationwide Distribution including the states of AR, CA, FL, GA, KY, LA, MA, MD, NC, NJ, NY, PA, PR, SC, TX and VA.

Voluntary or Mandated:

Voluntary: Firm initiated