Fresenius Medical Care Holdings, Inc. recalls Fresenius Service Replacement 0-Ring. Used in as a service part in 4 sub-assemblies manufactured and/or refurbished

Recalled July 17, 2013 · FDA recall Z-1693-2013 · Fresenius Medical Care Holdings

Hazard

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

Units

725 units

Sold at

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

Description

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

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

Manufacturer(s)

Fresenius Medical Care Holdings, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →