Recall Z-2226-2010 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Fresenius Medical Care North America
Fresenius Granuflo 1 Mixer Dissolution Unit - Tested, and Granuflo Dissolution Tank, Model Numbers G047-80101 and RTLG047-80101, Manufactured by Fresenius USA Inc., Walnut Creek, CA
| Date | Aug 15, 2010 (initiated Nov 20, 2009) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Component design/selection |
| Action | 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 c |
| Quantity | 957 |
| Distribution | Product distributed to 5404 customers throughout the US and the world. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K911459 | GRANULYTE POWDER DIALYSATE CONCENTRATE AND MIXING Fresenius USA, Inc., Jul 17, 1991 |