Reported Apr 26, 2023 · Ongoing
REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended to temporarily relieve minor muscle…
Compass Health Brands (Corporate Office)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Compass Health Brands (Corporate Office) · 6753 Engle Rd · Middleburg Heights, OH · 44130-7934
Is this the product you have?
- 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
- ModelsDVTREX-U and DVTREX -L
- Lot codes and dates
- UDI-DIDVTREX-L: 00092237622933
- DVTREX-U00092237622926 All Serial Numbers
- Amount recalled
- 30 units
Where it was sold
- Nationwide
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
This product could cause temporary or reversible health problems — stop using it.
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