Home / Recalls / 2k Innovations Inc. / Z-1808-2017

Z-1808-2017 Class II Terminated

Recalled by 2k Innovations Inc. — Saint Augustine, FL

Recall Details

Product Type
Devices
Report Date
April 19, 2017
Initiation Date
April 15, 2016
Termination Date
August 7, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
22,757 items in total

Product Description

Volt Resistance Frostie Heated Gloves (All sizes) Deep penetrating heat garment and wraps

Reason for Recall

During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.

Distribution Pattern

Nationwide Distribution

Code Information

Item #GL-7V-FR

Other recalls by 2k Innovations Inc.

  • Z-1805-2017 Class II — Volt Resistance Heated Therapy Foot Wrap Deep penetrating heat garment and wrap (April 15, 2016)
  • Z-1809-2017 Class II — Volt Resistance Heated Socks (All sizes) Deep penetrating heat garment and wrap (April 15, 2016)
  • Z-1806-2017 Class II — Volt Resistance Heated Therapy Knee Wrap Deep penetrating heat garment and wrap (April 15, 2016)
  • Z-1810-2017 Class II — Volt Resistance Heated Slipper Black (All sizes) Deep penetrating heat garment (April 15, 2016)
  • Z-1811-2017 Class II — Volt Resistance Heated Slipper Gray (All sizes) Deep penetrating heat garment a (April 15, 2016)
  • Z-1804-2017 Class II — Volt Resistance Heated Therapy Shoulder Wrap Deep penetrating heat garment and (April 15, 2016)
  • Z-1812-2017 Class II — Volt Resistance Heated Slipper (All sizes) Deep penetrating heat garment and w (April 15, 2016)
  • Z-1803-2017 Class II — Volt Resistance Heated Lower Back Garment Deep penetrating heat garment and wra (April 15, 2016)
  • Z-1807-2017 Class II — Volt Resistance Heated Elbow Garment Deep penetrating heat garment and wraps (April 15, 2016)
  • Z-1813-2017 Class II — Volt Resistance Unisex Rechargeable Heated Slipper (All sizes) Deep penetratin (April 15, 2016)