Date Initiated by Firm |
November 20, 2009 |
Date Posted |
August 15, 2010 |
Recall Status1 |
Terminated 3 on February 07, 2011 |
Recall Number |
Z-2226-2010 |
Recall Event ID |
54546 |
510(K)Number |
K911459
|
Product Classification |
Dialysate Concentrate For Hemodialysis (Liquid Or Powder) - Product Code KPO
|
Product |
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 |
Code Information |
Catalog Numbers G047-80101 and RTLG047-80101 |
Recalling Firm/ Manufacturer |
Fresenius Medical Care North America 920 Winter St Waltham MA 02451-1521
|
For Additional Information Contact |
800-662-1237
|
Manufacturer 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.
|
FDA Determined Cause 2 |
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 cord or plug. |
Quantity in Commerce |
957 |
Distribution |
Product distributed to 5404 customers throughout the US and the world. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = KPO and Original Applicant = FRESENIUS USA, INC.
|