Fresenius 2008K, 2008K2 and 2008 K2@home Hemodialysis Machines, Manufactured by Fresenius USA Inc., Walnut Creek, CA
FDA device recall Z-2225-2010 · posted 2010-08-15 · Terminated
Recall details
- Recalling firm
- Fresenius Medical Care North America
- Reason for recall
- Power cords may fail if the prongs crack or fail at the plug, and may become a fire/burn/shock hazard or delay/interrupt therapy.
- Action taken
- An urgent device recall notification was sent to all consignees. Customers are asked to inspect cords for defects, and are refered to preventive maintenance requirements in the manual. Customers who identify the defective cords will be instructed to discontinue use as soon as possible without jeopardizing patient care. Customers are instructed to monitor cords regularly, and pay attention to machines that are frequently plugged or unplugged. Personnel are instructed to not use the cord to unplug the device from the wall (yanking the plug from the wall) and to refrain from rolling over the cord or plug.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- KDI
- Quantity affected
- 60885
- Distribution
- Product distributed to 5404 customers throughout the US and the world.
- Date initiated
- 2009-11-20
- Date posted
- 2010-08-15
- Date terminated
- 2011-02-07
- Location
- Waltham, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FRESENIUS 2008K (K994267) | Fresenius Medical Care | 2000-03-16 |