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Recall Observatory FDA recall evidence

Device 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

Z-1693-2013

May 24, 2013

Class II

Product summary

Firm
Fresenius Medical Care Holdings, Inc.
Event
Event 65090
Status
Terminated
Classification
Class II
Quantity
725 units
Official record key
device-enforcement:Z-1693-2013

Official wording

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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