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REX (Recovery Exercise X-Trainer) Pressure Therapy System-… recallZ-1398-2023 · Compass Health Brands (Corporate Office) · initiated Mar 7, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Compass Health Brands (Corporate Office) or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Labeling design

What the company is doing

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 [email protected]. 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

Recall details

Recall number
Z-1398-2023
Status
Open, Classified
Initiated by the company
Mar 7, 2023
Posted by the FDA
Apr 18, 2023
Recalling firm
Compass Health Brands (Corporate Office)
Quantity
30 units
Product code
IRP
FDA submissions
K192358
Distribution
Worldwide distribution - US Nationwide and the country of Canada.

Product description

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 (models, lots, serial numbers)

UDI-DI: DVTREX-L: 00092237622933 DVTREX-U: 00092237622926 All Serial Numbers

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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