| Date Initiated by Firm |
September 08, 2009 |
| Date Posted |
February 16, 2010 |
| Recall Status1 |
Terminated 3 on August 21, 2012 |
| Recall Number |
Z-0608-2010 |
| Recall Event ID |
54226 |
| Product Classification |
Suntan Lamp - Product Code REG
|
| Product |
Model ST-400 Solafeet Foot portable tanners; Solafeet, Inc.
Use: feet tanner. |
| Code Information |
Any codes associated with Model ST-400. |
Recalling Firm/
Manufacturer |
Solafeet, Inc.
W University Pkwy Unit A
Sarasota FL 34243-2742
|
| For Additional Information Contact |
941-359-2608
|
Manufacturer Reason
for Recall |
Product failed to have a label that contained a recommended exposure schedule; the operator's manual provided inadequate instructions for use; and label implication may result in overexposure.
|
FDA Determined
Cause 2 |
Radiation Control for Health and Safety Act |
| Action |
Solafeet sent letters to customers informing them that the labeling and instructions included with the product were not in accordance with the FDA requirements. Attached with the letter was a replacement label and a replacement set of instructions. Customers are to attach the new label on top of the old label and use the new instructions, noting the change in exposure limits. Questions should be directed to 941-359-2608 or info@solafeet.com. |
| Quantity in Commerce |
72 units |
| Distribution |
Nationwide Distribution |
| 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.
|
