Model ST-400 Solafeet Foot portable tanners; Solafeet, Inc. Use: feet tanner.
FDA Recall Z-0608-2010 · Posted 2010-02-16
Recalling FirmSolafeet, Inc.
Recall StatusTerminated
Product CodeREG
Date Initiated2009-09-08
Date Terminated2012-08-21
Product Quantity72 units
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.
Firm 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 [email protected].
Root Cause
Radiation Control for Health and Safety Act
Distribution Pattern
Nationwide Distribution
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.