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Recall Observatory FDA recall evidence

Device product

EVEXIA LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF(s): EVE-11/EVE-X11, Rx Only, Not Sterile

Z-2325-2021

July 09, 2021

Class II

Product summary

Firm
Ortho8, Inc.
Event
Event 88308
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-2325-2021

Official wording

Reason: EVEXIA LUXE DVT PREVENTION DEVICE is marketed without FDA clearance

Code information: All Lots

Distribution pattern: US Nationwide distribution in the states of Al, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MD, MA, MI, MO, NC, NV, NJ, NY, OK, PA, SC, TN, TX, UT, VA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    EVEXIA LUXE DVT PREVENTION DEVICE is marketed without FDA clearance