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Terminated

Volt Resistance Heated Lower Back Garment Deep penetrating heat garment and wraps

FDA Recall Z-1803-2017 · Posted None

Recalling Firm2k Innovations Inc.
Recall StatusTerminated
Product CodeIRT
Date Initiated2016-04-15
Date Terminated2019-08-07
Product Quantity22,757 items in total

Reason for Recall

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

Firm Action

2k Innovations sent e-mail communication from 04/15/2016 thru 09/09/2016 informing their consignees that the firm is no longer linking their products to any medical and therapeutic claims and that new labels and boxes will be corrected and the claims will be taken out of the website. For questions customers should call 888-518-6871, ext 700.

Root Cause

Labeling False and Misleading

Distribution Pattern

Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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