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
Reported: July 17, 2013 Initiated: May 24, 2013 #Z-1693-2013
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
Reason for Recall
Incorrect rubber nitrile O-rings distributed instead of the correct material EPDM. (Ethylene Propylene Dine Monomer (M-class) rubber)
Details
- Recalling Firm
- Fresenius Medical Care Holdings, Inc.
- Units Affected
- 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.
- Location
- Waltham, MA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Fresenius Medical Care Holdings, Inc.. Units affected: 725 units.
Why was this product recalled? ▼
Incorrect rubber nitrile O-rings distributed instead of the correct material EPDM. (Ethylene Propylene Dine Monomer (M-class) rubber)
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 17, 2013. Severity: Moderate. Recall number: Z-1693-2013.
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