FDA recall Z-1398-2023

Compass Health Brands (Corporate Office) · Class II · device

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

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

Distribution

Worldwide distribution - US Nationwide and the country of Canada.

Key facts

Status: Ongoing
Initiation date: 2023-03-07
Report date: 2023-04-26
Voluntary/Mandated: Voluntary: Firm initiated
Location: Middleburg Heights, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1398-2023