FDAFDA · Food and drugs·Recall number Z-1811-2017
Volt Resistance Heated Slipper Gray (All sizes) Deep penetrating heat garment and wraps
Published April 19, 2017 · Recall initiated: April 15, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- 2k Innovations Inc.
- Distributor
- Nationwide Distribution
- Lot
- Item #VS-GR
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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