Class 2 Device Recall REX Ricmar

• Date Initiated by Firm: March 07, 2023
• Date Posted: April 18, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1398-2023
• Recall Event ID: 91923
• 510(K)Number: K192358
• Product Classification: Massager, powered inflatable tube - Product Code IRP
• Product: REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. Models: DVTREX-U and DVTREX -L
• Code Information: UDI-DI: DVTREX-L: 00092237622933 DVTREX-U: 00092237622926 All Serial Numbers
• FEI Number: 3012316249
• Recalling Firm/ Manufacturer: Compass Health Brands (Corporate Office); 6753 Engle Rd; Middleburg Heights OH 44130-7934
• For Additional Information Contact: Compass Health Customer Support; 800-947-1728
• Manufacturer Reason for Recall: Error in the Introduction section of the user manual that indicates the device may be used for the prevention of deep vein thrombosis (DVT). Marketed without a 510k for this indication
• FDA Determined Cause: Labeling design
• Action: Compass Health Brands issued Urgent Medical Device Recall Letter REX (Recovery Exercise Trainer) Pressure Therapy System - USER MANUAL on 3/7/23 via Email/US Mail notification to Distributors and End Users consignees and posted to the Compass Health Brands website http://www.compasshealthbrands.com. Letter states reason for recall, health risk and action to take: Immediately replace the current user manual included with the device with the attached, corrected version, and dispose of the current manual. Compass Health Brands will additionally mail you a replacement user Consumer Notification manual in booklet format (which is the same format as the current user manual), if you prefer to use that as a replacement, instead. REQUIRED ACTION: 1. The USER MANUAL for the REX (Recovery Exercise Trainer) Pressure Therapy System requires replacement. Visit https://compasshealthbrands.com/product-recall to obtain a replacement user manual, or Contact Compass Health Brands at (800) 947-1728 to order a replacement user manual in booklet format, or Indicate on your Reply Form (attached) that you would like a replacement user manual. 2. Complete and return the attached Consumer Field Correction Response Form to Compass Health Brands within fifteen (15) calendar days of receipt of this field correction notification confirming your acknowledgement. Send completed form to Compass Health Brands via email at regulatory@compasshealthbrands.com. Complete and return this form even if you do not have affected product on hand. If you have transferred possession of this product to another individual/department/location, please notify them of this recall communication. This voluntary Field Correction notification is being conducted with the knowledge of the United States Food and Drug Administration (FDA) in accordance with U.S. regulations. Any complaints and/or adverse events experienced with the use of this product must be reported promptly to Compass Health Brands Customer Suppor
• Quantity in Commerce: 30 units
• Distribution: Worldwide distribution - US Nationwide and the country of Canada.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = IRP