Class 2 Device Recall KT RECOVERY ICE/HEAT MASSAGE BALL

• Date Initiated by Firm: September 16, 2019
• Create Date: April 21, 2020
• Recall Status: Terminated on October 01, 2021
• Recall Number: Z-1754-2020
• Recall Event ID: 85315
• Product Classification: Pack, hot or cold, reusable - Product Code IME
• Product: KT RECOVERY+ ICE/HEAT MASSAGE BALL Rolling ball with hot and cold packs that can be interchanged depending on the therapy type desired
• Code Information: UPC Codes: 814179022226 814179022561 814179022721
• FEI Number: 3007282994
• Recalling Firm/ Manufacturer: KT Health, LLC; 584 E 1100 S Ste 4; American Fork UT 84003-3887
• For Additional Information Contact: Consumer Affairs; 801-655-0519
• Manufacturer Reason for Recall: If over-heated may leak which, if not noticed, may cause hot fluid to come in contact with the user.
• FDA Determined Cause: Unknown/Undetermined by firm
• Action: Recall notifications were sent out on 9/16/2019 by letter to distributors. Firm indicated they used first class mail, email or facsimile. The notice informs users that the Company has received reports of product failures resulting in the release of the hot liquid from the Heat Gel-Core Insert component (orange ball) after being heated in the microwave. These included five reports of skin contact resulting in temporary or medically reversible adverse health consequences (first-degree burns and possibly one second degree burn), one of which required medical treatment. There were also four reports of skin contact with hot liquid that did not result in burns, and several reports of skin contact at room temperature with no adverse consequences The firm is asking Distributors to: 1) Immediately examine your inventory (in all locations), remove from sale/distribution and quarantine product subject to recall. 2) This recall should be carried out to the retailer and consumer level, so to the extent you have further distributed this product, please identify and alert your retailers and notify them at once of this product recall. Your notification to your retailers may be enhanced by including the enclosed sub-recall letter for them. 3) Please return all quarantined/recalled product to our warehouse at the following address for a full refund: KT Health, LLC Attn: Recall Returns 584 East 1100 South, Suite #4 American Fork, UT 84003 4) The firm will cover return shipping costs. If you have other costs kindly call us at: 801- 224-2717 5) Please acknowledge receipt of this recall letter by filling out the attached Return Response form and sending it by any of the following means: a. FAX: 858-947-3832 b. EMAIL: recalls@kttape.com c. MAIL: KT Health, LLC Attn: Recall Returns 584 East 1100 South, Suite #4 American Fork, UT 84003 All returns of full products will have the hot gel core insert balls removed and sent for destruction as noted above.
• Quantity in Commerce: 94,554
• Distribution: US Nationwide distribution, no Government Consignees.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.