REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended to temporarily relieve minor muscle ach
Summary
The FDA issued a Class II for REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended by Compass Health Brands (Corporate Office). 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 .
Details
Source
Device Recall
External ID
Z-1398-2023
Action Date
2023-04-26
Status
Ongoing
Category
device
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
Lot/Code Info: UDI-DI: DVTREX-L: 00092237622933 DVTREX-U: 00092237622926 All Serial Numbers
Quantity Affected: 30 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-03-07
Company
Middleburg Heights, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 134 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Compass Health Brands (Corporate Office) has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Compass Health Brands (Corporate Office)) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Compass Health Brands (Corporate Office) have FDA actions?
Compass Health Brands (Corporate Office) has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1398-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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