Z-1808-2017 Class II Terminated
FDA device recall Z-1808-2017 was initiated by 2k Innovations Inc. on April 15, 2016 and is designated Class II. Reason for recall: During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website. The recall status is terminated (terminated August 7, 2019). Affected quantity: 22,757 items in total.
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