REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended to temporarily relieve minor muscle ach

FDA device recall Z-1398-2023 · posted 2023-04-18 · Open, Classified

Recall details

Recalling firm

Compass Health Brands (Corporate Office)

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

Action taken

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

Root cause

Labeling design

Status

Open, Classified

Product code

IRP

Quantity affected

30 units

Distribution

Worldwide distribution - US Nationwide and the country of Canada.

Date initiated

2023-03-07

Date posted

2023-04-18

Location

Middleburg Heights, OH

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