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