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
This recall has been terminated (originally issued July 11, 2013).
- Recall Initiated
- May 24, 2013
- Posted
- July 11, 2013
- Terminated
- October 7, 2019
- Recall Number
- Z-1693-2013
- Quantity
- 725 units
- Firm Location
- Waltham, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Incorrect rubber nitrile O-rings distributed instead of the correct material EPDM. (Ethylene Propylene Dine Monomer (M-class) rubber)
Distribution
Nationwide Distribution including the states of AR, CA, FL, GA, KY, LA, MA, MD, NC, NJ, NY, PA, PR, SC, TX and VA.
Lot / Code Info
Part Number: 640919
Root Cause
Nonconforming Material/Component
Action Taken
Fresenius notified customers on May 24, 2013, by telephone and by certified mail with signature confirmation and fax-back form. Customers were instructed to examine their stock immediately to determine whether they have any of the affected parts on hand. If customers have the affected parts, they will be instructed to immediately discontinue use and place all 0-rings in a secure area for return to Fresenius Medical Care North America. Please contact your Fresenius Medical Care Technical Service Team at 1-800-227-2572, (choose option 4, then option 2) for instructions how to return the recalled product.