Recall Z-1398-2023 ยท IRP Massager, Powered Inflatable Tube
Compass Health Brands (Corporate Office)
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
| Date | Apr 18, 2023 (initiated Mar 7, 2023) |
| Status | Open, Classified |
| Reason | 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 |
| Root 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 |
| Quantity | 30 units |
| Distribution | Worldwide distribution - US Nationwide and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192358 | Pressure Therapy System PT1003 Xiamen Senyang Co., Ltd., Apr 23, 2020 |